Drug and Medical Device Recalls Archive

Iodine-containing Contrast Agents for Medical Imaging: Drug Safety Communication - Rare Cases of Underactive Thyroid in Infants
11/17/2015 Medical Recall

Labels of all iodinated contrast media (ICM) products will include information about these cases. No changes to current prescribing, administration, or monitoring practices are recommended.

  • Company:
    ICM
G5 Ventilator by Hamilton: Class I Recall - Ventilation and Alarm Failure
11/14/2015 Medical Recall

If failure occurs, and the operator does not intervene, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death.

  • Category
    Adverse Event
Endoscope Washer/Disinfectors by Custom Ultrasonics: Safety Communication - FDA Recommends Health Care Facilities Transition to Alternate Reprocessing Methods
11/13/2015 Medical Recall

Identified facility violations could result in an increased risk of infection transmission.

  • Company:
    Custom Ultrasonics
Plavix (clopidogrel): Drug Safety Communication - Long-term Treatment Does Not Change Risk of Death
11/06/2015 Medical Recall

FDA review determines that long-term use of clopidogrel does not increase/decrease overall risk of death in patients with, or at risk for, heart disease, and does not suggest that clopidogrel increases risk of cancer/death from cancer.

  • Category
    Health Care
Auvi-Q (epinephrine injection, USP): Recall - Potential Inaccurate Dosage Delivery
10/29/2015 Medical Recall

If a patient experiencing a serious allergic reaction (i.e., anaphylaxis) does not receive the intended dose, there could be significant health consequences, including death.

Entacapone: Drug Safety Communication - FDA Review Found No Increased Cardiovascular Risks
10/26/2015 Medical Recall

Drug labels for Comtan and Stalevo will remain unchanged.

  • Company:
    Stalevo
Hepatitis C Treatments Viekira Pak and Technivie: Drug Safety Communication - Risk of Serious Liver Injury
10/22/2015 Medical Recall

Cases of hepatic decompensation and liver failure in patients with underlying liver cirrhosis who were taking these medicines.

Kayexalate (sodium polystyrene sulfonate): Drug Safety Communication - FDA Requires Drug Interaction Studies
10/22/2015 Medical Recall

Prescribers and patients should consider separating Kayexalate dosing from other medications taken by mouth by at least 6 hours.

  • Category
    Pharmacology
Downing Labs, LLC Sterile Compounded Products: Recall - Lack of Sterility Assurance
10/21/2015 Medical Recall

If there is a contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.

  • Category
    Health Care Provider
Heater-Cooler Devices: FDA Safety Communication - Use of Devices Associated With Nontuberculous Mycobacteria Infections
10/15/2015 Medical Recall

Potential for contaminated water to transmit bacteria through the air (aerosolize) through the device’s exhaust vent into the environment and to the patient.

  • Company:
    Safety Communication
Acetaminophen Tablets by Medline Industries: Recall - Mislabeling with Incorrect Strength
10/15/2015 Medical Recall

If the product is taken at the maximum labeled dose, or with other medications containing acetaminophen, it may lead to liver toxicity or liver failure.

  • Company:
    Medline Industries, Inc.
Bioprosthetic Aortic Valves: FDA Notification - Reduced Leaflet Motion
10/05/2015 Medical Recall

FDA is working to design clinical studies to fully evaluate reduced valve leaflet motion. At this time, FDA believes that bioprosthetic aortic valves remain reasonably safe and effective when used according to their approved indications.

  • Category
    Warfarin
Drug Products Intended to be Sterile by Chen Shwezin Inc., dba Park Compounding Pharmacy: FDA Statement - Lack of Sterility Assurance
10/03/2015 Medical Recall

Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.

  • Company:
    Chen Shwezin Inc.
PROFEMUR Neck Varus/Valgus CoCr 8 Degree, Part number PHAC 1254 by MicroPort Orthopedics: Class I Recall - Unexpected Rate of Fractures After Surgery
10/02/2015 Medical Recall

Acute fracture and emergency revision surgery is a serious adverse health consequence and could lead to neurovascular damage, hematoma, hemorrhage, or death.

  • Company:
    MicroPort Orthopedics Inc.
Cranial Perforators With an Automatic Clutch Mechanism: Safety Communication - Failure to Disengage
09/28/2015 Medical Recall

Clutch mechanism may fail to disengage if proper use, patient considerations, and device selection are not followed in accordance with the manufacturer’s instructions for use.

  • Category
    Brain
Sterile Compounded Products by US Compounding, Inc: Recall - Lack of Sterility Assurance
09/24/2015 Medical Recall

If the sterility of a compounded preparation intended to be sterile is compromised, patients may be at risk.

  • Company:
    US Compounding, Inc.
Avycaz (ceftazidime and avibactam): Drug Safety Communication - Dose Confusion and Medication Errors
09/22/2015 Medical Recall

FDA revised the labels to indicate that each vial contains Avycaz 2.5 gram, equivalent to ceftazidime 2 gram and avibactam 0.5 gram.

  • Company:
    Avycaz
Tramadol: Drug Safety Communication - FDA Evaluating Risks of Using in Children Aged 17 and Younger
09/21/2015 Medical Recall

Ultra-rapid metabolizers are more likely to have higher-than-normal amounts of the active form of the opioid in their blood after taking tramadol, which can result in breathing difficulty that may lead to death.

  • Category
    Health Care
Freedom Driver System by SynCardia: Class I Recall - Part May Fail Causing Device to Stop Working
09/18/2015 Medical Recall

If the device stops pumping, the patient will lose consciousness almost immediately, which can lead to serious injury or death.

  • Company:
    Freedom Driver Systems
Ayurvedic Dietary Supplements by Shree Baidyanath: Consumer Advice Notice - Products Contain High Levels of Lead and/or Mercury
09/17/2015 Medical Recall

Testing has found that these products contain high levels of lead and/or mercury, which can cause serious health problems.

  • Category
    Health Care
Reprocessed Flexible Bronchoscopes: FDA Safety Communication - Risk of Infection
09/17/2015 Medical Recall

If scope reprocessing procedure is not followed meticulously, the flexible bronchoscope can remain contaminated, potentially resulting in infection transmission from one patient to the next.

  • Category
    Adverse Event
HeartMate II Left Ventricular Assist System (LVAS) by Thoratec Corporation: Urgent Medical Device Correction - Monitor the Backup Battery Expiration Date
09/16/2015 Medical Recall

Certain preventable advisory alarms may result in patients deciding to attempt a System Controller exchange.

  • Company:
    Thoratec Corporation
Clozapine: Drug Safety Communication - FDA Modifies Monitoring for Neutropenia; Approves New Shared REMS Program
09/15/2015 Medical Recall

Enhanced labeling explaining how to monitor patients for neutropenia/manage clozapine treatment. Approval of new, shared REMS.

  • Category
    Schizophrenia
Miracle Diet 30 and Miracle Rock 48 Capsules by The One Minute Miracle Inc.: Recall - Due to Presence of Undeclared Drug Products
09/12/2015 Medical Recall

FDA analysis revealing that these dietary supplements contain undeclared drug products making them unapproved drugs.

  • Category
    Food And Drug Administration
Invokana and Invokamet (canagliflozin): Drug Safety Communication - New Information on Bone Fracture Risk and Decreased Bone Mineral Density
09/10/2015 Medical Recall

FDA added a new Warning and Precaution and revised the Adverse Reactions section of the Invokana and Invokamet drug labels.

  • Company:
    Canagliflozin
Medistat RX Sterile Drug Products: Recall - Possible Contamination
09/10/2015 Medical Recall

Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.

  • Company:
    Medistat RX
Compounded or Repackaged Drugs Stored in Becton-Dickinson Syringes: FDA Expands Warning
09/08/2015 Medical Recall

An interaction with the rubber stopper in certain lots of these syringes can cause some drugs stored in these syringes to lose potency if filled and not used immediately.

  • Category
    Morphine
Puritan Bennett 980 Ventilators by Covidien: Class I Recall - Amount of Air Delivered May Be Lower Than Programmed
09/02/2015 Medical Recall

A patient not receiving enough oxygen can result in possible injury or death.

  • Company:
    Ventilator System
Evita V500 and Babylog VN500 Ventilators by Dräger Medical: Class I Recall - Faulty Batteries
09/02/2015 Medical Recall

If the ventilator shuts down, a patient may not receive necessary oxygen. This could cause patient injury or death.

  • Category
    Adverse Event
DPP-4 Inhibitors for Type 2 Diabetes: Drug Safety Communication - May Cause Severe Joint Pain
08/28/2015 Medical Recall

New information added to the WARNINGS AND PRECAUTIONS section of the drug labeling.

  • Category
    Health Care
OmniPod (Pod) Insulin Management System by Insulet Corporation: Recall - Possibility of a Higher Rate of Failure
08/28/2015 Medical Recall

Use may result in interruption of insulin delivery that can cause hyperglycemia, which, if left untreated, can result in diabetic ketoacidosis.

  • Company:
    Insulet Corporation
Alaris Medley Large Volume Pump (LVP) Frame Membrane by Elite Biomedical Solutions: Class I Recall - Frame Membrane May Allow Over or Under Delivery of Fluid by an Infusion Pump
08/27/2015 Medical Recall

Over or under infusion of fluids to the patient has the potential to cause patient injury or death.

Alaris Syringe Pump by CareFusion: Class I Recall - Alarm Error May Cause Interruption of Therapy
08/27/2015 Medical Recall

Failure of syringe module may result in a delay or interruption of therapy and can lead to serious patient injury or death.

  • Category
    Patient
Hudson RCI Sheridan Sher-I-Bronch Endobroncial Tube by Teleflex Medical: Class I Recall - Connector May Crack or Separate
08/26/2015 Medical Recall

The connector may break or separate on the tube. If this happens, the device may leak, causing the patient to not receive enough oxygen (hypoxia) or experience respiratory distress.

  • Company:
    Teleflex Medical
Refresh Lacri-Lube, Refresh P.M., FML 0.1 Percent and Blephamide 10 Percent/0.2 Percent by Allergan: Recall - Particulate Matter
08/25/2015 Medical Recall

Potential adverse events may include eye pain, eye sewelling, ocular discomfort or eye irritation.

  • Company:
    Allergan
Picato (ingenol mebutate) Gel: Drug Safety Communication - FDA Warns of Severe Adverse Events, Requires Label Changes
08/21/2015 Medical Recall

Severe allergic reactions, skin rashes, & cases of shingles (herpes zoster reactivation) reported. Severe eye injuries and skin reactions have occurred when Picato gel is not applied according to recommendations in the label.

  • Company:
    Picato
OxyTOTE Portable Oxygen Unit by Western/Scott Fetzer Company: Class I Recall - May Ignite and Burst
08/18/2015 Medical Recall

Reports of internal flash fire when the OxyTOTE is mishandled or dropped.

  • Category
    Health Care
Prolotherapy with Phenol by Hartley Medical: Recall - Non-sterility Concerns
08/18/2015 Medical Recall

Parenteral administration of non-sterile injection products may result in a site-specific or systemic infection, which in turn may cause hospitalization, significant morbidity, or a fatal outcome.

  • Company:
    Hartley Medical
Compounded Drugs Stored in Becton-Dickinson (BD) 3 ml and 5 ml Syringes: FDA Warning - Do Not Use
08/18/2015 Medical Recall

Preliminary information indicates that drugs stored in these syringes may lose potency over a period of time due to a possible interaction with the rubber stopper in the syringe.

  • Category
    Pharmacology
Mammograms at Boston Diagnostic Imaging in Orlanda, Florida: FDA Safety Communication - Quality Problems
08/17/2015 Medical Recall

Patients should consider having their mammograms re-evaluated at a certified facility.

  • Company:
    Safety Communication
Beacon Tip Angiographic Catheters by Cook Medical: Class 1 Recall - Catheter Tip May Slip or Separate
08/07/2015 Medical Recall

If this occurs, the tip could enter the patient’s bloodstream. This could cause serious injury to the patient and require additional medical intervention to retrieve the tip, or cause death.

  • Company:
    Cook Medical
Implantable Left Ventricular Assist Devices (LVADs): FDA Safety Communication - Serious Adverse Events
08/05/2015 Medical Recall

Increased rate of pump thrombosis, high rate of stroke, bleeding complications.

Gilenya (fingolimod): Drug Safety Communication - FDA Warns About Cases of Rare Brain Infection
08/04/2015 Medical Recall

Cases of PML in two patients with no prior exposure to immunosuppressant drugs.

  • Company:
    MS
Duodenoscope Reprocessing: FDA Safety Communication - Supplemental Measures to Enhance Reprocessing
08/04/2015 Medical Recall

Hospitals and health care facilities can, in addition to meticulously following manufacturer reprocessing instructions, take additional steps to further reduce the risk of infection.

  • Category
    Endoscopic Retrograde Cholangiopancreatography
Hydrochlorothiazide Tablets by Unichem Pharmaceuticals (USA), Inc: Recall - Potential Presence of Foreign Tablets Contamination
08/01/2015 Medical Recall

Missing a dose of Hydrochlorothiazide could result in uncontrolled blood pressure or swelling caused by excess fluid (edema).

  • Company:
    Unichem
Symbiq Infusion System by Hospira: FDA Safety Communication - Cybersecurity Vulnerabilities
07/31/2015 Medical Recall

The device could be accessed remotely through a hospital’s network. This could allow an unauthorized user to control the device and change the dosage the pump delivers, which could lead to over- or under-infusion of critical patient therapies.

  • Company:
    Symbiq Infusion System
0.9 Percent Sodium Chloride Injection, USP (AUTO-C) by Baxter International: Recall - Potential For Leaking Containers, Particulate Matter and Missing Port
07/31/2015 Medical Recall

Leaking containers, particulate matter and missing port protectors could result in contamination of the solution. If not detected, this could lead to a bloodstream infection or other serious adverse health consequences.

  • Company:
    Baxter International Inc.
Brintellix (vortioxetine) and Brilinta (ticagrelor): Drug Safety Communication - Name Confusion
07/30/2015 Medical Recall

FDA warns about prescribing and dispensing errors resulting from brand name confusion with antidepressant Brintellix (vortioxetine) and antiplatelet Brilinta (ticagrelor).

  • Category
    Selective Serotonin Reuptake Inhibitor
Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) by Teva Parenteral Medicines: Recall - Particulate Matter
07/27/2015 Medical Recall

Administration of an intravenous product with particulate matter has the potential to result in inflammation, allergic reactions, or blockage of blood vessels, leading to tissue death, which may be life-threatening if vital organs are affected.

  • Company:
    Teva Parenteral Medicines
Gadolinium-based Contrast Agents for Magnetic Resonance Imaging (MRI): Drug Safety Communication - FDA Evaluating the Risk of Brain Deposits With Repeated Use
07/27/2015 Medical Recall

Health care professionals should consider limiting GBCA use to clinical circumstances in which the additional information provided by the contrast is necessary.

  • Company:
    GBCA
Sterile Human and Veterinary Compounded Drugs by Moses Lake Professional Pharmacy: Recall - Lack of Sterility Assurance
07/25/2015 Medical Recall

If there is contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.

  • Category
    Health Care Provider
0.9 Percent Sodium Chloride Injection, USP, 50mL and 100mL by Baxter: Recall - Particulate Matter
07/20/2015 Medical Recall

Injecting a product containing particulate matter, in the absence of in-line filtration, may result in blockage of blood vessels, which can result in stroke, heart attack or damage to other organs.

  • Company:
    Baxter International Inc.
Proglycem (diazoxide): Drug Safety Communication - Reports of Pulmonary Hypertension in Infants and Newborns
07/16/2015 Medical Recall

Monitor patients, especially those with risk factors for pulmonary hypertension, for signs of respiratory distress, including tachypnea, flaring nostrils, grunting, and chest wall retractions.

  • Company:
    Proglycem
Calcium Chloride Intravenous Infusion 10% w/v 10mL Prefilled Syringe by Mylan: Market Withdrawal - Difficulties in Administration
07/14/2015 Medical Recall

Calcium Chloride Intravenous Infusion 10% w/v 10mL Prefilled Syringe by Mylan: Market Withdrawal - Difficulties in Administration

  • Company:
    Mylan Institutional
Lariat Suture Delivery Device for Left Atrial Appendage (LAA) Closure by SentreHEART: FDA Safety Communication - Reports of Patient Deaths and Other Serious Adverse Events
07/13/2015 Medical Recall

Safety and effectiveness of the Lariat Suture Delivery Device to close the LAA and prevent stroke in patients with atrial fibrillation has not been established.

  • Category
    Heart
Non-aspirin Nonsteroidal Anti-inflammatory Drugs (NSAIDs): Drug Safety Communication - FDA Strengthens Warning of Increased Chance of Heart Attack or Stroke
07/09/2015 Medical Recall

Patients and health care professionals should remain alert for heart-related side effects the entire time that NSAIDs are being taken.

  • Category
    Non Steroidal Anti Inflammatory Drug
Lifesaver Single Patient Use Manual Resuscitator by Teleflex Hudson RCI: Class I Recall - Intake Port Blockage
07/02/2015 Medical Recall

Recalled device may not deliver breathing support to the patient. A delay in treatment may potentially lead to patient injury or death.

  • Company:
    Teleflex
Unapproved Prescription Ear Drop (Otic) Products: Not FDA Evaluated for Safety, Effectiveness and Quality
07/01/2015 Medical Recall

Unapproved products may be contaminated or manufactured incorrectly, which could result in patients receiving the wrong dose, even when administered according to the labeled directions for use.

  • Category
    Health Care Provider
Codeine Cough-and-Cold Medicines in Children: Drug Safety Communication - FDA Evaluating Potential Risk of Serious Side Effects
07/01/2015 Medical Recall

FDA investigating the safety of codeine-containing medicines to treat coughs and colds in children under 18 years because of the potential for slowed or difficult breathing.

  • Category
    Health Care
FLOW-i Anesthesia Systems by Maquet: Class 1 Recall - Dislodged Patient Cassette May
07/01/2015 Medical Recall

May cause anesthesia gas to leak and could prevent the ventilator from providing breathing support if not corrected immediately.

  • Company:
    Maquet Service
Daytrana Patch (methylphenidate transdermal system): Drug Safety Communication - Permanent Skin Color Changes
06/24/2015 Medical Recall

New warning added to drug label to describe risk of chemical leukoderma. chemical leukoderma, have been associated with the use of the Daytrana patch.

  • Category
    Attention Deficit Hyperactivity Disorder
Covidien Shiley Neonatal and Pediatric Tracheostomy Tubes by Medtronic: Recall - Tubes Formed With Wider-angle Bend Than Standard Models
06/24/2015 Medical Recall

Reports of 12 serious patient injuries, including breathing difficulties that impacted oxygen levels in patients.

  • Company:
    Medtronic
HeartWare Ventricular Assist System: Class I Recall – Updated with Multiple Reasons for Recall
06/22/2015 Medical Recall

FDA will update recall with new information as it becomes available.

  • Company:
    HVAD
M/L Taper with Kinectiv Technology Prosthesis by Zimmer: Class I Recall - Higher than Expected Levels of Manufacturing Residues
06/20/2015 Medical Recall

Can cause serious adverse health issues including allergic reactions, pain, infections, or death.

  • Company:
    Zimmer
HeartWare Ventricular Assist System: Class I Recall - Damaged Alignment Guides or Connection Pins May Cause Pump to Stop
06/16/2015 Medical Recall

An interruption in electrical connection would cause the pump to stop, which could cause serious patient injury or death.

  • Company:
    HeartWare
Potiga (ezogabine): Drug Safety Communication - FDA Determines 2013 Labeling Adequate to Manage Risks of Retinal Abnormalities, Potential Vision Loss, and Skin Discoloration
06/16/2015 Medical Recall

Health care professionals should continue to follow the recommendations provided in the BOXED WARNING, FDA’s most serious type of warning, and the WARNINGS AND PRECAUTIONS and INDICATIONS AND USAGE sections of the labeling.

  • Company:
    Potiga
Vascu-Guard Peripheral Vascular Patch by Baxter: Recall - Difficulty Distinguishing the Smooth from Rough Surface
06/03/2015 Medical Recall

Incorrect orientation of the patch with the rough side toward the bloodstream may increase the risk of vessel thrombosis and/or embolism. Posted 06/03/2015

  • Company:
    Baxter International Inc.
Unintentional Injection of Soft Tissue Filler into Blood Vessels in the Face: FDA Safety Communication - Risk of Serious Patient Injury
05/28/2015 Medical Recall

Risk of embolization, which can cause vision impairment, blindness, stroke and damage and/or death of the skin and underlying facial structures.

  • Category
    Health Care Provider
Avea Ventilator by CareFusion: Recall - Potential Malfunction of Pressure Transducer
05/27/2015 Medical Recall

Ventilator may activate false Extended High Ppeak or Circuit Occlusion audio and visual alarms, open the safety valve and stop ventilating.

  • Company:
    CareFusion
Zerbaxa (ceftolozane and tazobactam): Drug Safety Communication - FDA Cautions about Dose Confusion and Medication Errors
05/20/2015 Medical Recall

Can lead to to administration of more drug than was prescribed.

  • Company:
    Zerbaxa
SGLT2 inhibitors: Drug Safety Communication - FDA Warns Medicines May Result in a Serious Condition of Too Much Acid in the Blood
05/15/2015 Medical Recall

High levels of blood acids called ketones may require hospitalization. Posted 05/15/2015

  • Category
    Medical Prescription
LifeCare PCA3 and PCA5 Infusion Pump Systems by Hospira: FDA Safety Communication - Security Vulnerabilities
05/13/2015 Medical Recall

An unauthorized user with malicious intent could access the pump remotely and modify the dosage it delivers, which could lead to over- or under-infusion of critical therapies.

  • Company:
    Infusion Pump Systems
Tiger Paw System II by Maquet Medical Systems: Class I Recall - May Cause Tears and Bleeding in Heart Tissue
05/07/2015 Medical Recall

Possibility of a tear on the left atrial wall during use of the device.

  • Company:
    Maquet Medical Systems
Adrucil (fluorouracil Injection, USP) 5 g/100 mL (50 mg/mL): Recall - Particulate Matter
05/05/2015 Medical Recall

Administration of product with particulate matter has potential to result in inflammation, allergic reactions, or blockage of blood vessels, which may be life-threatening if vital organs are affected.

  • Company:
    Teva Parenteral Medicines
Mammograms at Coastal Diagnostic Center in Pismo Beach, California: FDA Safety Communication - Quality Problems
04/30/2015 Medical Recall

Patients may need a repeat mammogram or additional medical follow-up.

  • Company:
    Safety Communication
Injectable Products by Mylan: Recall - Presence of Particulate Matter
04/24/2015 Medical Recall

Administration of a sterile injectable that has foreign particulates has the potential of severe health consequences.

  • Company:
    Agila Onco Therapies Limited
Bupivacaine HCl Injection by Hospira: Recall - Iron Oxide Particulate In Glass Vials
04/24/2015 Medical Recall

Injected particulate may result in local inflammation, low-level allergic or immune responses, granuloma formation or mechanical irritation of tissue.

  • Company:
    Hospira
Ebola Virus One-Step Test Kits by LuSys Laboratories: Class I Recall - Not Cleared for Marketing
04/23/2015 Medical Recall

The results obtained from these test kits have not been demonstrated to be accurate and should not be used as diagnostic tests for Ebola infection. Posted 04/23/2015

  • Company:
    LuSys Laboratories
Mucinex Fast-MAX Products: Recall - Incorrect Labeling
04/22/2015 Medical Recall

Consumers could take a product with undeclared levels of acetaminophen, dextromethorphan, guaifenesin, phenylephrine and/or diphenhydramine.

  • Company:
    Reckitt Benckiser
Flurbiprofen-Containing Topical Pain Medications: FDA Alert - Illnesses and Deaths in Pets Exposed to Prescription Topical Pain Medication
04/17/2015 Medical Recall

Evidence of NSAID toxicity in the pets exposed to flurbiprofen and died.

  • Category
    Non Steroidal Anti Inflammatory Drug
VV13F Reinforced Dual Lumen ECMO Catheters by OriGen Biomedical: Recall - Potential for Separation of Tube from Hub
04/16/2015 Medical Recall

Separation could result in required intervention to prevent permanent impairment or damage.

  • Company:
    OriGen Biomedical
Intravenous (IV) Solutions (Select Lots) by Baxter: Recall - Potential Presence of Particulate Matter
04/10/2015 Medical Recall

Particles in IV solutions may cause: local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, and systemic embolization.

  • Company:
    Baxter International Inc.
Products from Prescription Center Pharmacy in Fayetteville, N.C.: Recall - Lack of Sterility Assurance
04/02/2015 Medical Recall

Human and veterinary drug products made by the Prescription Center have been distributed nationwide and to Canada.

  • Company:
    Prescription Center
Feraheme (ferumoxytol): Drug Safety Communication – Warnings Strengthened and Prescribing Instructions Changed
03/31/2015 Medical Recall

Risk of potentially life-threatening allergic reactions.

  • Company:
    Feraheme
Duodenoscope Model TJF-Q180V by Olympus: FDA Safety Communication - New Reprocessing Instructions Validated
03/26/2015 Medical Recall

If not properly reprocessed patients may be exposed to serious infections.

  • Company:
    Olympus
Mammograms at Richard D. Adelman M.D. in Raleigh, North Carolina: FDA Safety Communication - Quality Problems
03/24/2015 Medical Recall

The facility may not perform mammography due to the revocation of its accreditation.

  • Category
    Mammography Quality Standards Act
Hepatitis C Treatments Containing Sofosbuvir in Combination With Another Direct Acting Antiviral Drug: Drug Safety Communication - Serious Slowing of Heart Rate When Used With Antiarrhythmic Drug Amiodarone
03/24/2015 Medical Recall

Postmarketing cases of serious and life-threatening symptomatic bradycardia, as well as one fatal cardiac arrest and cases requiring pacemaker insertion, have been reported.

  • Category
    Amiodarone
Zyprexa Relprevv (olanzapine pamoate): Drug Safety Communication - FDA Review of Study Sheds Light on Two Deaths Associated with the Injectable Schizophrenia Drug
03/23/2015 Medical Recall

FDA is unable to exclude the possibility that the deaths were caused by rapid, but delayed, entry of the drug into the bloodstream following intramuscular injection.

  • Company:
    Zyprexa Relprevv
Over-the-Counter Asthma Products Labeled as Homeopathic: FDA Statement - Consumer Warning About Potential Health Risks
03/19/2015 Medical Recall

If asthma is not appropriately treated and managed, patients may be at risk for life-threatening asthma attacks.

  • Category
    Asthma
Lactated Ringer's Irrigation, 3000mL by Hospira: Recall - Mold Contamination
03/12/2015 Medical Recall

Contaminated solution used on a patient may result in bacteremia, sepsis, septic shock and endocarditis, and death may result.

  • Company:
    Hospira
Treanda (bendamustine hydrochloride) Solution by Teva: FDA Statement - Not Compatible with Closed System Transfer Devices, Adapters, and Syringes Containing Polycarbonate or Acrylonitrile-Butadiene-Styrene
03/11/2015 Medical Recall

Can lead to device failure, possible product contamination, and potential serious adverse health consequences.

  • Company:
    Treanda Injection
Chantix (varenicline): Drug Safety Communication - FDA Updates Label to Include Potential Alcohol Interaction
03/09/2015 Medical Recall

Rare risk of seizures, and studies of side effects on mood, behavior, or thinking. Posted 03/09/2015

  • Category
    Smoking Cessation
Magnesium Sulfate in 5 Percent Dextrose Injection by Hospira: Recall - Incorrect Barcode Labeling
03/06/2015 Medical Recall

Potential for delay in treatment of magnesium sulfate in 5% dextrose, that can result in life-threatening seizures, stroke, cerebral hemorrhage and maternal death, and attendant risks to the fetus, including fetal demise.

  • Company:
    USP
Plum A+ and Plum A+3 Infusion Systems by Hospira: Class I Recall - Alarm Volume Failure
03/06/2015 Medical Recall

Risk of injury or death resulting from prolonged interruption in therapy.

  • Company:
    Stericycle, Inc.
0.9 Percent Sodium Chloride Injection, USP, 250 mL VisIV Container by Hospira: Recall - Particulate Matter
03/06/2015 Medical Recall

Injected particulate material may result in localized inflammation, phlebitis, allergic reaction, granuloma formation or microembolic effects, and/or low-level allergic response.

  • Company:
    Hospira
Testosterone Products: Drug Safety Communication - FDA Cautions About Using Testosterone Products for Low Testosterone Due to Aging; Requires Labeling Change to Inform of Possible Increased Risk of Heart Attack And Stroke
03/03/2015 Medical Recall

FDA requiring manufacturers to change labeling to clarify the approved uses of these medications, and to add information about a possible increased risk of heart attacks and strokes in patients taking testosterone.

  • Company:
    Testosterone Products
HeartWare Ventricular Assist System Controllers by HeartWare International: Recall - Clinical Trial Controllers Susceptible to Electrostatic Discharge
02/27/2015 Medical Recall

Electrostatic discharge event could result in a pump stop, which could cause serious injury or death.

Colistimethate for Injection USP, 150 mg and Rifampin for Injection USP, 600 mg/vial by Heritage Pharmaceuticals: Recall - Lack of Sterility Assurance
02/25/2015 Medical Recall

Administration of non-sterile injection products may result in a site-specific or systemic infection, with the potential to cause hospitalization, permanent organ damage, or death.

  • Company:
    Heritage Pharmaceuticals Inc.
Magnetic Resonance Imaging (MRI) Systems with Magnet Rundown Unit by GE Healthcare: Class I Recall - Potential Disabling of the Magnet Rundown Unit
02/25/2015 Medical Recall

Risk of life-threatening injuries or death if a metal object is brought into the magnetic field.

  • Company:
    GE Healthcare
MAQUET Servo Humidifier 163 by Teleflex Medical: Class I Recall - Cracks in Connector Tubes May Lead to Leak Failures
02/25/2015 Medical Recall

Cracks may prevent device from delivering sufficient support to the patient. This may potentially cause serious injury or death.

  • Company:
    INMED
Atracurium Besylate Injection by Sagent Pharmaceuticals: Recall - Potential Impact on Product Sterility
02/24/2015 Medical Recall

Has the potential to result in infections, which could be fatal, especially in patients who are immunocompromised.

  • Company:
    Atracurium Besylate Injection
Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes: FDA Safety Communication - Design May Impede Effective Cleaning
02/19/2015 Medical Recall

Patients may be exposed to serious infections.

  • Category
    Health Care
Ketorolac Tromethamine Injection by Hospira: Recall - Particulate in Glass Vials
02/11/2015 Medical Recall

Administration of particulates has the potential for localized inflammation, allergic reaction, granuloma formation, microembolic effects, or delay of therapy.

  • Company:
    Hospira
Trellis 6 and Trellis 8 Peripheral Infusion Systems by Covidien: Class I Recall - Balloon Inflation Ports Mislabeled
02/11/2015 Medical Recall

The physician using the device may deflate the balloons in the incorrect order. If this happens, there is a potential for blood clots to dislodge and move into the lungs.

  • Company:
    Covidien
0.9 Percent Sodium Chloride Injection, USP, 250 mL by Hospira : Recall - Particulate Matter
01/23/2015 Medical Recall

Injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response.

  • Company:
    Hospira
Bone Graft Substitutes Containing Recombinant Proteins or Synthetic Peptides in Patients Under Age 18: FDA Safety Communication - Reports of Serious Injuries
01/21/2015 Medical Recall

Risk of excess bone growth, fluid accumulation, inhibited bone healing, and swelling.

  • Category
    Health Care Provider
Simulated IV Solutions from Wallcur: CDER Statement- FDA's Investigation into Patients being Injected
01/14/2015 Medical Recall

Adverse events include fever, chills, tremors and headache,and there is one death associated with the use of these products.

  • Company:
    Wallcur
Prescription and Over-the-Counter (OTC) Pain Medicines: Drug Safety Communication - FDA Review of Possible Risks of Pain Medicine Use During Pregnancy
01/09/2015 Medical Recall

Pregnant women urged to discuss all medicines with their health care professionals before using them.

  • Category
    Non Steroidal Anti Inflammatory Drug
Virazole (Ribavirin Powder For Solution) by Valeant Pharmaceutical North America, LLC: Recall- Due to Microbial Contamination
01/02/2015 Medical Recall

Inhalation of a non-sterile product with microbial contamination into the airways could increase the risk of respiratory infection.

  • Company:
    Valeant Pharmaceutical North America
KimVent Microcuff Subglottic Suctioning Endotracheal Tubes by Halyard Health: Class I Recall - Component May Detach During Use
12/31/2014 Medical Recall

An air leak between cuff and tracheal wall may reduce the amount of air that reaches the lungs. Use of this recalled product could cause serious health risks, including delayed patient treatment, breathing difficulties, and death.

  • Company:
    Halyard Health
Nellcor Puritan Bennett 980 Ventilator System by Covidien: Class I Recall - Component Failure May Cause Burning Odor
12/31/2014 Medical Recall

Problems in the manufacturing process may lead to unexpected need to stop the ventilator and transfer the patient to another ventilator.

  • Company:
    Covidien
IV Solutions from Wallcur of San Diego: CDER Statement - FDA Warns Health Care Professionals Not to Inject Patients
12/31/2014 Medical Recall

There have been reports of serious adverse events associated with the use of certain of these products.

  • Company:
    Wallcur
Caramel Apples: Warning - Illnesses, Including Deaths, Linked to Listeria Monocytogenes Contamination
12/26/2014 Medical Recall

Listeriosis can be fatal, especially in certain high-risk groups, including the elderly, and people with weakened immune systems and certain chronic medical conditions (such as cancer).

  • Company:
    Apple
Mitoxantrone by Hospira: Recall - Confirmed Subpotency and Out-Of-Specification
12/24/2014 Medical Recall

Potential for decreased potency which can lead to decreased effectiveness, additional dosing, and the potential for cumulative impurity toxicity requiring medical intervention.

  • Company:
    Hospira
B-Lipo Capsules by Bethel Nutritional Consulting, Inc.: Recall - Undeclared Drug Ingredient
12/22/2014 Medical Recall

Serious adverse events, which may be life-threatening, include damage to the heart valve, or serotonin syndrome particularly if taken with other medications that work similarly.

  • Company:
    Bethel Nutritional Consulting, Inc.
SLIM-K Capsules by Bethel Nutritional Consulting, Inc.: Recall - Undeclared Drug Ingredients
12/22/2014 Medical Recall

Can increase blood pressure and/or pulse rate, interact in life threatening ways with other medications, casue serious GI disturbances, irregular heartbeat, and cancer with long-term use.

  • Company:
    Bethel Nutritional Consulting, Inc.
0.9 Percent Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container by Baxter: Recall - Particulate Matter
12/16/2014 Medical Recall

Intravenous administration of a solution containing particulate matter may lead to local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, and systemic embolization.

  • Company:
    Baxter International Inc.
Ziprasidone (Marketed as Geodon and Generics): Drug Safety Communication - Rare But Potentially Fatal Skin Reactions
12/11/2014 Medical Recall

Symptoms may include a rash that can spread to all parts of the body, fever, swollen lymph nodes, and inflammation of organs such as the liver, kidney, lungs, heart, or pancreas.

  • Category
    Atypical Antipsychotic
Dietary Supplements Containing Live Bacteria or Yeast in Immunocompromised Persons: Warning - Risk of Invasive Fungal Disease
12/09/2014 Medical Recall

FDA advises practitioners to approach the application of these interventions with caution.

  • Company:
    ABC Dophilus Powder
Siemens Healthcare Diagnostics, Rapid Gram Negative Combo Panels: Class I Recall - May Produce Incorrect Results
12/02/2014 Medical Recall

Using these recalled devices may cause ineffective patient treatment.

  • Category
    Pseudomonas Aeruginosa
Slim-Vie: Public Notification - Undeclared Drug Ingredient
11/26/2014 Medical Recall

Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.

  • Category
    Medicine
Tecfidera (dimethyl fumarate) by Biogen Idec: Drug Safety Communication - Case of Rare Brain Infection PML Reported
11/25/2014 Medical Recall

Symptoms of PML may include: progressive weakness on one side of the body or clumsiness of limbs; disturbance of vision; and changes in thinking, memory and orientation. The progression of deficits can lead to severe disability or death.

  • Company:
    Tecfidera
Bee Thin: Public Notification - Undeclared Drug Ingredient
11/24/2014 Medical Recall

Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.

  • Category
    Medicine
Black Storm: Public Notification - Undeclared Drug Ingredient
11/24/2014 Medical Recall

Sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.

  • Category
    Erectile Dysfunction
Super Extreme Accelerator: Public Notification - Undeclared Drug Ingredient
11/24/2014 Medical Recall

Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.

  • Category
    Medicine
Bee Slim: Public Notification - Undeclared Drug Ingredient
11/24/2014 Medical Recall

Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.

  • Category
    Medicine
Gabapentin Capsules, USP 300 mg, by Aurobindo Pharma USA: Recall - Complaints of Empty Capsules
11/24/2014 Medical Recall

Risk of missed dose(s) resulting in no effect, short term reduction in efficacy, short term withdrawal effect, or status epilepticus (long period seizures) that could be life-threatening.

  • Company:
    Aurobindo Pharma USA
Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL by Baxter: Recall - Mislabeled Overpouch
11/21/2014 Medical Recall

Administration of a dose lower than intended, especially in patients prone to severe electrolyte imbalance, may lead to serious, life-threatening adverse health consequences.

  • Company:
    Baxter International Inc.
Forever Beautiful Bee Pollen by REFA Enterprises: Recall - Undeclared Drug Ingredients
11/20/2014 Medical Recall

Risk for those with a history of coronary artery disease, congestive heart failure, arrhymias or stroke

  • Company:
    REFA Enterprises
Respironics California, Esprit V1000 and V200 Ventilators: Class I Recall - Power Failure May Occur
11/19/2014 Medical Recall

Failure of power supply may cause ventilator to shut off, resulting in too much carbon dioxide or not enough oxygen in patient’s blood, or death.

  • Company:
    Generation Power Supplies
ABC Dophilus Powder by Solgar, Inc: Recall - Risk of Infection
11/17/2014 Medical Recall

The product was found to contain Rhizopus oryzae, which may cause health problems to consumers, particularly premature infants/infants, children, and those with weakened immune systems.

  • Company:
    Solgar ABC Dophilus Powder
Long-term Antiplatelet Therapy: Safety Announcement - Preliminary Trial Data Shows Benefits But a Higher Risk of Non-Cardiovascular Death
11/16/2014 Medical Recall

FDA believes the benefits of clopidogrel (Plavix) and prasugrel (Effient) therapy continue to outweigh their potential risks when used for approved uses.

  • Category
    Myocardial Infarction
Gel-E Donut and Squishon 2 Products by Children’s Medical Ventures: Recall - Potential Mold Contamination
11/15/2014 Medical Recall

There is the possibility of fungal infection should patients come in contact with the mold.

  • Company:
    Philips Healthcare
Mayhem: Public Notification - Undeclared Drug Ingredients
11/14/2014 Medical Recall

Risk of impaired ability to fight infections, high blood sugar levels, muscle injuries, and psychiatric problems.

  • Category
    Health Care
Nellcor Puritan Bennett, 980 Ventilator System: Class I Recall - Software Issue May Stop Ventilator
11/07/2014 Medical Recall

Ventilator may stop working after the air and oxygen gas supply lines are disconnected and then reconnected. This can lead to serious health problems or death.

  • Company:
    Covidien
GemStar Power Supply, 3VDC for GemStar Infusion Pumps by Hospira: Class I Recall - Power Supply May Not Deliver Enough Electricity
11/05/2014 Medical Recall

Use of recalled devices may cause serious health risks, including delay in therapy, delivery of too much fluid, too high or too low blood pressure, slow or fast heart rhythm/beat, shock, trauma, 1st or 2nd degree burns, smoke inhalation, problems breathing, stroke, and death.

  • Company:
    GemStar Infusion Pump
V26 Slimming Coffee: Public Notification - Undeclared Drug Ingredient
11/05/2014 Medical Recall

Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.

  • Category
    Medicine
10 Percent Neutral Buffered Formalin by Richard-Allan Scientific: Class I Recall - May Contain Incorrect Concentration of Formalin
10/31/2014 Medical Recall

Use of this defective Formalin may prevent or delay diagnoses and treatment decisions.

  • Company:
    Emergency Medicine
Ginseng Kianpi Pil: Public Notification - Undeclared Drug Ingredients
10/31/2014 Medical Recall

Risk of impaired ability to fight infections, high blood sugar levels, muscle injuries and psychiatric problems. Undeclared drug ingredients may also cause serious side effects when combined with other medications.

  • Company:
    Kweilin Drug Manufactory
Baby Wipes by Nutek Disposables, Inc.: Recall - May Contain Bacteria
10/27/2014 Medical Recall

Those with weakened immune system or chronic lung disease may be more susceptible to infections with B. cepacia.

  • Company:
    Nutek
Intravia Containers by Baxter: Recall - Particulate Matter
10/25/2014 Medical Recall

Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. Posted 10/25/2014

  • Company:
    INTRAVIA Container
Assured Brand Naproxen Sodium Tablets by Contract Packaging Resources, Inc.: Recall - Packaging Mix-Up
10/22/2014 Medical Recall

Risk of allergic reactions, from mild irritation or hives to serious reactions such as anaphylaxis that may be life-threatening.

  • Company:
    Dollar Tree
Saba Shark Cartilage Complex, 60 Capsule Bottles: Recall - Possible Salmonella Contamination
10/20/2014 Medical Recall

Salmonella can cause serious and sometimes fatal infections in young children frail or elderly people, and others with weakened immune systems. Posted 10/20/2014

  • Company:
    AMS Health Sciences
Lidocaine HCI Injection, USP 10 MG Per ML, 30 ML Single-Dose, Preservative-Free, by Hospira: Recall - Particulate Matter
10/17/2014 Medical Recall

Injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response to the particulate or microembolic effects.

  • Company:
    Hospira
September 2014
10/16/2014 Medical Recall

September 2014 Drug Safety Labeling Changes includes 55 products with revisions to Prescribing Information.

  • Category
    5 Ht3 Antagonist
LifeCare Flexible Intravenous Solutions by Hospira, Inc.: Recall - Potential for Leakage
10/15/2014 Medical Recall

A puncture in the primary container may be difficult to detect and lead to contamination, compromised sterility, and other adverse events.

  • Company:
    Stericycle
Medi-Trace Cadence and Kendall Multi-function Defibrillation Electrodes by Covidien: Field Safety Alert - Electrodes Will Not Connect with Philips FR3 or FRx AED units
10/13/2014 Medical Recall

The mismatch of these devices could contribute to a delay in resuscitation and may contribute to subsequent death.

  • Company:
    Philips
Sit and Slim II: Public Notification - Hidden Drug Ingredients
10/10/2014 Medical Recall

FDA analysis found these products to contain undeclared Sibutramine, which may increase blood pressure and/or pulse rate, and may also interact in life-threatening ways with other medications.

  • Category
    Hypertension
CareFusion EnVe and ReVel Ventilators: Class 1 Recall - Power Connection Failure
10/10/2014 Medical Recall

Ventilator shut-off from power failures may lead to serious patient injury or death.

  • Company:
    CareFusion
ICU Medical ConMed Stat2 Flow Controller: Class 1 Recall - Delivers Higher Flow Rate than Intended
10/10/2014 Medical Recall

Use of the affected product may cause serious adverse health consequences, including death.

  • Company:
    ICU Medical, Inc
Oregon Compounding Centers, Inc. Unexpired Sterile Products: Recall - Lack of Sterility Assurance
10/10/2014 Medical Recall

Patients in Oregon and Washington may be at risk of serious infections which may be life threatening.

  • Company:
    Oregon Compounding Centers
Vancomycin Hydrochloride for Injection USP, Equivalent to 1 Gram Vancomycin (Sterile Powder) by Hospira, Inc.: Recall - Uncontrolled Storage During Transit
10/08/2014 Medical Recall

One lot may have experienced temperature excursions during shipment.

  • Company:
    Stericycle
SAM Junctional Tourniquet Accessory (Axilla) Strap - SAM Medical Products: Recall - Potential Clip Failure
10/08/2014 Medical Recall

Product failure could cause a potential delay in controlling axilla hemorrhage.

  • Company:
    SAM Medical Products
Hudson RCI Pediatric Anesthesia Breathing Circuits by Teleflex Medical: Class I Recall - Circuit Ends May Crack or Break
10/07/2014 Medical Recall

Defect could cause serious health risks, including delayed patient treatment, breathing difficulties, or death if not replaced immediately.

  • Company:
    Teleflex Medical
Ketorolac Tromethamine Injection, USP, 30mg/ml by Sagent Pharmaceuticals: Recall - Incorrect Labeling
10/06/2014 Medical Recall

The labeled expiration date is longer than the known stability of the product.

  • Company:
    Ketorolac Tromethamine Injection
Bo Ying Compound by Eu Yan Sang (Hong Kong) Ltd: FDA/CDER Statement - Risk of Lead Poisoning
09/27/2014 Medical Recall

Exposure to lead can cause serious damage to the central nervous system, the kidneys, and the immune system.

  • Company:
    Hong Kong) Ltd.
Xolair (omalizumab): Drug Safety Communication - Slightly Elevated Risk of Cardiovascular and Cerebrovascular Serious Adverse Events
09/26/2014 Medical Recall

FDA approves label changes after review of a five year safety study.

  • Category
    Asthma
Potassium Chloride Injection (Baxter): Recall - Shipping Carton Mislabeling
09/17/2014 Medical Recall

Potential risk of medication error or delay in therapy for patients that require high concentration potassium chloride.

  • Company:
    Baxter International Inc.
Heparin Sodium, 1,000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), In 0.9 percent Sodium Chloride Injection, 500 mL by Hospira: Recall - Particulate Matter
09/12/2014 Medical Recall

Risk of injected particulate material which may result in local inflammation, phlebitis, and/or low-level allergic response.

  • Company:
    Hospira
Pharmacy Creations Certain Products: Recall – Potential Non-Sterility
09/06/2014 Medical Recall

Compromised sterility of a product may lead to risk for infection

  • Company:
    Pharmacy Creations
Martin Avenue Pharmacy, Inc. Compounded Sterile Preparations: Recall - Lack of Assurance of Sterility
09/02/2014 Medical Recall

Compromised sterility of a compounded preparation may lead to risk for infection.

  • Category
    Health Care
Dermatend Original and Dermatend Ultra: Recall - Safety Concerns
09/02/2014 Medical Recall

Using these Dermatend products instead of seeking medical attention could result in delayed diagnosis of conditions such as cancer.

  • Company:
    Dermatend Original
DePuy Synthes Craniomaxillofacial Distraction System: Class I Recall - May Reverse Directions After Surgery
08/28/2014 Medical Recall

Infants at highest risk for injury. Sudden obstruction of trachea could lead to respiratory arrest/death. In all patient populations, failure may result in need for surgical intervention to replace failed device.

  • Company:
    DePuy Synthes
Sterile Convenience Surgical Packs by Customed, Inc.: Recall - Potential Loss of Sterility
08/26/2014 Medical Recall

Potential adhesion defect which may lead to infection.

  • Company:
    Customed, Inc.
Children’s Medical Ventures Gel-E Donut and Squishon 2: Class 1 Recall - Possibility of Mold
08/22/2014 Medical Recall

Cladosporium and Penicillium Fungi which may cause difficulty in breathing, allergic reactions and serious health consequences, including death.

  • Company:
    s Medical Ventures
CloverSnare 4-Loop Vascular Retrieval Snare by Cook Medical: Recall - Risk of Loop to Separate From Shaft
08/20/2014 Medical Recall

Use of affected product may result in loss of device function, potential for embolization of snare fragments, and the potential need for intervention to retrieve the separated snare.

  • Company:
    Cook Medical
Diamondback 360 Peripheral Orbital Atherectomy System by Cardiovascular Systems: Class I Recall - Sheath May Fracture During Use
08/19/2014 Medical Recall

Fragments of the sheath could possibly block blood vessels.

  • Company:
    Orbital Atherectomy Systems
Dianeal Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5 Percent Dextrose 5000mL (Ambu-Flex II): Recall - Presence of Particulate Matter
08/15/2014 Medical Recall

Particulate matter could potentially serve as a focal point for infection should any pre-existing peritonitis exist, and may lead to a fatal outcome.

  • Company:
    Baxter International Inc.
IPM Wound Gel by Edwards Pharmaceuticals: Class I Recall - Microbial Contamination
08/12/2014 Medical Recall

Use of the affected product may cause serious adverse health consequences, including sepsis, limb loss, and death.

  • Company:
    Edwards Pharmaceuticals Inc.
Arize: Public Notification - Undeclared Drug Ingredient
08/11/2014 Medical Recall

Undeclared sulfoaildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.

  • Company:
    Arize
Herbal Vigor Quick Fix: Public Notification - Undeclared Drug Ingredient
08/11/2014 Medical Recall

Undeclared tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.

  • Category
    Pharmacology
CUBICIN (daptomycin for injection) 500 mg in 10 mL Single Use Vials: Recall - Foreign Particulate Matter
08/09/2014 Medical Recall

Administration of particulate matter poses a potential safety risk to patients such as a thromboembolism or a life-threatening pulmonary embolism.

  • Company:
    Cubist Pharmaceuticals
White and Blue Lion Tattoo Kits: Recall - Bacterial Contamination of Needles and Ink Bottles
08/08/2014 Medical Recall

Use of these products may cause bacterial infection and can lead to sepsis, a potentially life-threatening complication of an infection.

  • Company:
    Primary Care Provider
RegenESlim Appetite Control Capsules: Recall - Presence Of DMAA
08/08/2014 Medical Recall

DMAA can narrow blood vessels and arteries, which can cause a rise in blood pressure or other cardiovascular problems such as shortness of breath, arrhythmias, tightening in the chest, and heart attack.

  • Company:
    DMAA
Cubicin (daptomycin for injection) 500 mg in 10 mL Single Use Vials: Recall - Presence Of Particulate Matter
08/08/2014 Medical Recall

The administration of a glass particulate poses a potential safety risk to patients such as a thromboembolism or a life-threatening pulmonary emboli.

  • Company:
    Cubicin
Expression Injectable by Enhancement Medical: FDA Safety Communication - Adverse Events Associated with Unapproved Use As a Dermal Filler
08/05/2014 Medical Recall

Events have included swelling, tenderness, firmness, lumps, bumps, bruising, pain, redness, discoloration, itching, and the development of hard nodules.

  • Company:
    Enhancement Medical LLC
Lidocaine HCI Injection, USP, 2 percent, by Hospira: Recall - Visible Particulates
07/30/2014 Medical Recall

Injected particulate could result in delay in therapy, local inflammation, mechanical disruption of tissue or immune response to the particulate.

  • Company:
    Hospira
GE Healthcare, LLC, Single-Width Airway Modules (E-MiniC) and Accessories and Extension Modules (N-FC, N-FCREC): Class I Recall - CO2 Detector May Fail Leading to Injury
07/25/2014 Medical Recall

Physicians may make decisions based on incorrect values which could lead to permanent, irreversible impairment or life-threatening changes in patients.

  • Category
    Health Care
Ibuprofen and Oxcarbazepine Tablets by American Health Packaging: Recall - Mislabeled Packaging
07/21/2014 Medical Recall

Failure to receive the proper dose of oxcarbazepine could increase the chances of patients having a seizure and inadvertent consumption of ibuprofen may cause adverse reactions.

  • Company:
    Oxcarbazepine Tablets
Sterile Drug Products by Downing Labs (aka NuVision Pharmacy): Drug Alert - Lack of Sterility Assurance
07/19/2014 Medical Recall

Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death

  • Company:
    NuVision Pharmacy
Baxter IV Sodium Chloride and Potassium Chloride Solutions: Recall - Particulate Matter
07/18/2014 Medical Recall

If infused, the presence of particulate foreign matter may elicit inflammatory and allergic responses, both chronic and acute, and may be life threatening.

  • Company:
    Potassium Chloride Solutions
Sterile Drug Products by Unique Pharmaceuticals Ltd.: Alerting Health Care Professionals - Lack of Sterility Assurance
07/12/2014 Medical Recall

Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.

  • Company:
    Unique Pharmaceuticals
Hospira Lactated Ringer's And 5% Dextrose Injection, 1000 ML, Flexible Containers: Recall (One Lot) - Mold Contamination
07/11/2014 Medical Recall

Voluntary Nationwide Recall Of One Lot. Intravenous administration of a non-sterile product can result in infections that may be life-threatening, and may result in prolonged hospitalization or organ failure.

  • Company:
    Hospira Lactated Ringer
Weight Loss Products: Public Notification - Undeclared Drug Ingredients
07/09/2014 Medical Recall

May present significant risk for patients with history of CAD, CHF, arrhythmias, or stroke. May interact, in life-threatening ways, with other medications.

  • Category
    Hypertension
Langston V2 Dual Lumen Catheters (Models 5540 and 5550) by Vascular Solutions: Class I Recall - Inner Catheter May Separate During Use and Cause Injury
07/07/2014 Medical Recall

The use of affected product may cause serious adverse health consequences, including death.

  • Company:
    Vascular Solutions
Medtronic Duet External Drainage and Monitoring System, Medtronic Neurosurgery: Class 1 Recall - Tubing May Disconnect and Lead to Injury
07/02/2014 Medical Recall

Device failure may result in air within skull, infection, and over/under drainage of CSF that may contribute to serious adverse health consequences, including death.

  • Category
    Intracranial Pressure
Coumadin (warfarin sodium) for Injection by Bristol-Myers Squibb: Recall - Particulate Matter
07/01/2014 Medical Recall

Injected particulate metallic and non-metallic cellulose material can cause serious and potentially fatal adverse reactions such as embolization.

  • Company:
    Bristol-Myers Squibb Company
Medical Supply Liquidators Injectable Vitamin Products With a "Sunshine Labs" Label: Warning - Products Not FDA Approved
06/30/2014 Medical Recall

All lots of non-expired products being recalled.

  • Company:
    Medical Supply Liquidators
Lidocaine Viscous: Drug Safety Communication - Boxed Warning Required - Should Not Be Used to Treat Teething Pain
06/26/2014 Medical Recall

Too much viscous lidocaine given to infants and young children can result in seizures, severe brain injury, and problems with the heart.

  • Category
    Lidocaine
Over-The-Counter Topical Acne Products: Drug Safety Communication - Rare But Serious Hypersensitivity Reactions
06/25/2014 Medical Recall

Reactions may include throat tightness; difficulty breathing; feeling faint; or swelling of the eyes, face, lips, or tongue.

  • Company:
    Neutrogena
Olmesartan: Drug Safety Communication - FDA Review Finds Cardiovascular Risks for Diabetics Not Conclusive
06/24/2014 Medical Recall

Recommendations for use remain the same; label updates required.

  • Category
    Hypertension
Red Yeast Rice by Doctor’s Best: Recall - Undeclared Lovastatin
06/24/2014 Medical Recall

Use could result in serious muscle injury, particularly if taking with prescription “statins”; patients with pre-existing liver disease may be at an increased risk for liver injury.

  • Category
    Statin
Big Sky Diagnostic Imaging, LLC in Butte, Montana: FDA Safety Communication - Mammography Problems
06/23/2014 Medical Recall

Patients who had a mammogram performed at Big Sky Diagnostic Imaging should speak to their health care providers about whether their mammograms need to be repeated.

  • Category
    Health Care
Testosterone Products: FDA/CDER Statement - Risk of Venous Blood Clots
06/20/2014 Medical Recall

Warning about venous thromboembolism, including deep vein thrombosis and pulmonary embolism.

  • Category
    Vein
ConvaTec, Inc., Flexi-Seal CONTROL Fecal Management System Kit: Class I Recall - Not Cleared for Marketing
06/20/2014 Medical Recall

Reports of 12 serious injuries and one death.

  • Company:
    ConvaTec, Inc.
Docetaxel: Drug Safety Communication - May Cause Symptoms of Alcohol Intoxication
06/20/2014 Medical Recall

Docetaxel contains alcohol, which affects the central nervous system.

  • Category
    Chemotherapy
HydroFinity Hydrophilic Guidewires by NDC/Covidien: Recall - Outer Jacket Damage
06/20/2014 Medical Recall

Damage to the jacket can result in embolization of polymer, potentially leading to vessel occlusion or damage.

  • Company:
    Covidien
Weight Loss Products: Immediate Public Notification: Undeclared Drug Ingredients
06/19/2014 Medical Recall

Products may substantially increase blood pressure and/or pulse rate in some patients.

  • Category
    Selective Serotonin Reuptake Inhibitor
Marcaine (Bupivacaine HCI Injection, USP), 0.5 percent, 30 ML, Single-Dose, Preservative-Free Vial: Recall - Visible Particulates
06/18/2014 Medical Recall

Injected particulate could result in blocked administration of the drug to the patient, causing a delay in therapy.

  • Company:
    Hospira
May 2014
06/13/2014 Medical Recall

Safety Labeling Changes includes 37 products with revisions to Prescribing Information. Posted 06/13/2014.

  • Category
    File Format
Captomer and Captomer-250 by Thorne Research: FDA Warning - Potential Health Risks
06/13/2014 Medical Recall

FDA advises consumers to avoid all products offered over-the-counter (OTC) for chelation or detoxification.

  • Company:
    Thorne Research
Smiths Medical Portex Low Dead Space Connector with Sideport, 3.5mm: Class I Recall- One Lot Mislabeled
06/13/2014 Medical Recall

One lot of 3.0mm sized connectors were placed in packages labeled as 3.5mm.

  • Company:
    Smiths Medical
Advocate Redi-Code+ Blood Glucose Test Strips by Diabetic Supply of Suncoast: Recall- Labeling Error
06/11/2014 Medical Recall

Delayed or inappropriate treatment of hyperglycemic or hypoglycemic states due to missed/delayed detection could lead to serious health consequences, including death.

  • Company:
    Diabetic Supply
La Jiao Shou Shen: Public Notification - Undeclared Drug Ingredient
06/11/2014 Medical Recall

Cancer-causing risk in addition to increased blood pressure and/or pulse rate.

  • Category
    Medicine
Male Sexual Enhancement Products: Immediate Public Notification: Undeclared Drug Ingredients
06/03/2014 Medical Recall

Risk of interaction with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels.

  • Company:
    Eyeful
Soliris (eculizumab) Concentrated Solution for IV Infusion by Alexion: Recall - Visible Particulates
06/02/2014 Medical Recall

Particulates could cause blockage of blood flow, which could be life-threatening.

  • Company:
    Alexion
Advanced Sterilization Products Sterrad Cyclesure 24 Biological Indicator: FDA Safety Communication - Product Shortage
05/23/2014 Medical Recall

Hospitals should prioritize use of existing supplies based on patients with the most critical need until supplies are able to meet demand.

  • Company:
    Advanced Sterilization Products
Fisher and Paykel Healthcare, Ltd., Infant Nasal CPAP Prongs: Class I Recall - Prongs May Detach from Nasal Tubing and Interrupt Therapy
05/23/2014 Medical Recall

Device malfunction may lead to low blood oxygen (hypoxemia), and a risk of choking and airway obstruction.

  • Company:
    Fisher & Paykel Healthcare
NaturaLyte Liquid Bicarbonate Concentrate: Recall - Potential Health Risk
05/22/2014 Medical Recall

Bacterial contamination of the dialysate may lead to bacteremia or systemic infection.

  • Company:
    Fresenius Medical Care North America
Baxter ABACUS TPN Calculation Software: Class I Recall - Software Errors May Cause Toxic/Overdose Symptoms
05/22/2014 Medical Recall

A fatal outcome is possible, especially with the high risk population.

  • Company:
    Baxter Support Services
Alaris Pump Module (Model 8100), Version 9.1.18 Software by CareFusion 303, Inc: Class I Recall - May Not Properly Delay an Infusion
05/21/2014 Medical Recall

"Delay Until" Option or "Multidose" feature software failure may result in unintented infusion start time.

  • Company:
    Alaris Pump
Ventlab Resuscitator Bags: Recall - Possible Health Risk
05/16/2014 Medical Recall

May result in delay of treatment, life threatening health consequences that include hypoxia and hypoventilation.

  • Company:
    Ventlab Resuscitator Bags
MV5 Days: Public Notification - Undeclared Drug Ingredient
05/16/2014 Medical Recall

May interact with nitrates found in some prescription drugs, and may lower blood pressure to dangerous levels.

  • Category
    Erectile Dysfunction
Asset Bold: Public Notification - Undeclared Drug Ingredient
05/16/2014 Medical Recall

Risk of increased blood pressure and/or pulse rate.

  • Category
    Heart
April 2014
05/16/2014 Medical Recall

Drug Safety Labeling Changes, April 2014

  • Category
    The Legend Of Zelda: A Link To The Past
Labetalol Hydrochloride Injection 100 MG/20 ML (5MG/ML), 20 ML, Multidose Vial by Hospira: Recall - Visible Particulates
05/16/2014 Medical Recall

Risk of injection site reactions and local irritation in the blood vessels, tissues and organs or delay in therapy.

  • Company:
    Hospira, Inc.
Eszopiclone Containing Sleep Aids: Drug Safety Communication - Can Cause Next-Day Impairment
05/15/2014 Medical Recall

FDA recommends a decreased starting dose for both women and men.

  • Category
    Food And Drug Administration
Dobutamine Injection (250mg/20mL)/Hospira: Recall - Visible Particulates
05/15/2014 Medical Recall

Injected particulate matter may result in local inflammation, phlebitis, and/or low level allergic response.

  • Company:
    Hospira, Inc.
Pradaxa (dabigatran): Drug Safety Communication - Lower Risk for Stroke and Death, but Higher Risk for GI Bleeding Compared to Warfarin
05/13/2014 Medical Recall

Study finds lower risk of clot-related strokes, bleeding in brain, and death for Pradaxia versus warfarin, but increased risk of major GI bleeding.

  • Company:
    Pradaxa
Datascope Corp/MAQUET, Certain Intra-Aortic Balloon Pumps: Recall - Potential Mechanical Failure of Power Supply Fan Assembly
05/12/2014 Medical Recall

Failure could result in the balloon pump shutting down without warning, which could result in worsened heart failure, decreased blood flow to the heart, and/or decreased blood flow to the body and brain.

  • Company:
    Balloon Pumps
Asset Bee Pollen: Public Notification - Undeclared Drug Ingredient
05/12/2014 Medical Recall

Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients.

  • Category
    Heart
Alere INRatio2 PT/INR Professional Test Strips: Recall - Higher INR when Performed by Central Laboratory
05/07/2014 Medical Recall

Therapeutic or near therapeutic INR with the test strips but a significantly higher INR when performed by a central laboratory.

  • Company:
    Alere
African Black Ant, Black Ant, and Mojo Risen by Eugene Oregon, Inc: Recall - Undeclared Drug Ingredient
05/07/2014 Medical Recall

may contain undeclared amounts of sildenafil and tadalafil.

  • Company:
    Eugene Oregon, Inc.
Slim Trim U: Public Notification - Undeclared Drug Ingredient
05/06/2014 Medical Recall

Risk of increased blood pressure and/or pulse rate.

  • Category
    Heart
Natural Body Solution: Public Notification - Undeclared Drug Ingredient
05/06/2014 Medical Recall

Risk of increased blood pressure and/or pulse rate.

  • Category
    Heart
Abbott Acclaim and Hospira Acclaim Encore Infusion Pumps by Hospira, Inc: Class I Recall - Broken Door Assemblies
05/02/2014 Medical Recall

May Result in Over-Infusion or Delay of Therapy.

  • Company:
    Abbott Acclaim Infusion Pumps
Gemstar Docking Station by Hospira, Inc: Class I Recall - Potential for Error or Failure to Power Up
05/02/2014 Medical Recall

A delay or interruption in therapy has a worst case potential to result in significant injury or death.

  • Company:
    GemStar
Sigma Spectrum Infusion Pumps with Master Drug Library by Baxter Healthcare: Class I Recall - System Error May Interrupt or Delay Therapy
05/02/2014 Medical Recall

Pump may stop the infusion, requiring a clinician to reset the alarm, reprogram the pump, and confirm the infusion is running properly.

  • Company:
    Baxter Healthcare
Flawless Beauty and Skin Products: Recall - Unapproved Drugs
04/30/2014 Medical Recall

Risks include unknown quality, safety, and efficacy.

  • Category
    Liver Biopsy
GenStrip Blood Glucose Test Strips by Shasta Technologies: FDA Safety Communication - May Report False Results
04/29/2014 Medical Recall

Recent FDA inspection of manufacturer found extensive violations of federal regulations intended to assure the quality of product.

  • Company:
    Shasta Technologies LLC
HeartWare, Inc., Heartware Ventricular Assist System: Class I Recall - Locking Mechanism of Pump Driveline Connector May Fail to Engage
04/29/2014 Medical Recall

Failure could result in the pump stopping and lead to serious adverse health consequences, including death.

  • Company:
    HeartWare, Inc.
Super Arthgold by Nano Well-being Health: Recall - Undeclared Drug Ingredients
04/24/2014 Medical Recall

Risk of myocardial infarction, stroke, congestive heart failure, renal toxicity, and bleeding, ulceration, or perforation of the stomach or intestines.

  • Company:
    Nano Well-being Health Inc.
Epidural Corticosteroid Injection: Drug Safety Communication - Risk of Rare But Serious Neurologic Problems
04/23/2014 Medical Recall

Injection of corticosteroids into the epidural space of the spine may result in loss of vision, stroke, paralysis, and death.

  • Category
    Health Care
Marcaine (Bupivacaine HCI Injection, USP) 0.25 percent, 10 ml, Single-Dose, Preservative-Free Vial: Recall - Visible Particulates
04/22/2014 Medical Recall

Injected particulate could result in local inflammation, mechanical disruption of tissue or immune response to the particulate.

  • Company:
    Hospira
Thinogenics Products by Nature’s Universe: Recall - Undeclared Drug Ingredient
04/18/2014 Medical Recall

Use of undeclared sibutramine can lead to increased risk of seizures, heart attacks, arrhythmia and stroke.

  • Company:
    Thinogenics
Propofol Injectable Emulsion, USP by Hospira: Recall - Visible Particulates
04/18/2014 Medical Recall

Injected particulate matter may result in local inflammation, phlebitis, and/or low level allergic response through mechanical disruption of tissue or immune response to the particulate.

  • Company:
    Hospira
S.W.A.G: Public Notification - Undeclared Drug Ingredient
04/18/2014 Medical Recall

Contains undeclared Sildenafil, which may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.

  • Category
    Erectile Dysfunction
CUBICIN (daptomycin for injection) by Cubist Pharmaceuticals: Recall - Presence of Particulate Matter
04/18/2014 Medical Recall

Potential risk of thromboembolism, pulmonary emboli, phlebitis, mechanical block of the capillaries or arterioles, activation of platelets, subsequent generation of microthrombi, and emboli.

  • Company:
    Cubicin
Lidocaine HCI Injection, USP, by Hospira: Recall - Visible Particulates
04/18/2014 Medical Recall

Risk of local inflammation, and/or mechanical disruption of tissue or immune response to the particulate, and/or a delay in therapy.

  • Company:
    Stericycle
Laparoscopic Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication - Use Discouraged Due to Increased Risk in Women With Uterine Fibroids
04/17/2014 Medical Recall

If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis.

  • Category
    Uterine Fibroids
ARKON Anesthesia Delivery System with Version 2.0 Software by Spacelabs Healthcare: Class I Recall - Software Defect May Cause System to Stop Working
04/16/2014 Medical Recall

Defect may cause serious adverse health consequences, including hypoxemia and death.

  • Company:
    Spacelabs Healthcare
Infinity: Public Notification - Undeclared Drug Ingredient
04/11/2014 Medical Recall

Use may increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.

  • Company:
    Infinity
Lite Fit USA: Public Notification - Undeclared Drug Ingredient
04/11/2014 Medical Recall

Use may increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.

  • Company:
    Lite Fit USA
March 2014
04/11/2014 Medical Recall

Safety Labeling Changes includes 30 products with revisions to Prescribing Information. Posted 04/11/2014.

  • Category
    File Format
Covidien Pipeline Embolization Device and Alligator Retrieval Device: Recall - Coating on Delivery Wire Could Delaminate
04/11/2014 Medical Recall

Use of affected products could potentially lead to embolic occlusion in the cerebral vasculature, with the risk of stroke and/or death.

  • Company:
    Alligator Retrieval Devices
Zi Xiu Tang Bee Pollen Capsules by Guangzhou Zi Xiu Tang Biotechnology Co., Ltd: Warning - Undeclared Drug Ingredients
04/08/2014 Medical Recall

Risk of increased blood pressure and/or pulse rate.

  • Company:
    Zi Xiu Tang Bee Pollen
PS500 Power Supply Unit by Dräger: Recall - Early Depletion of Battery Charge
04/02/2014 Medical Recall

Battery depletion will require manual ventilation until the device is connected to main power.

  • Company:
    Dräger
Revatio (sildenafil): Drug Safety Communication - FDA clarifies Warning About Pediatric Use for Pulmonary Arterial Hypertension
03/31/2014 Medical Recall

Health care professionals must consider whether the benefits of treatment with the drug are likely to outweigh its potential risks for each patient.

  • Company:
    FDAs
Nova Products, Inc. Dietary Supplements: Recall - Undeclared Drug Ingredients
03/31/2014 Medical Recall

Sildenafil and tadalafil can interact with nitrates found in some prescription drugs (such as nitroglycerin), resulting in decreased blood pressure.

  • Company:
    Nova Products, Inc.
Alli (60 mg orlistat capsules) by GlaxoSmithKline: Recall - Product Tampering
03/28/2014 Medical Recall

Some packages of the product were tampered with and may contain product that is not authentic.

  • Company:
    Alli
Bella Vi Brand Products by Pure Edge Nutrition: Recall - Undeclared Drug Ingredients
03/26/2014 Medical Recall

Sibutramine can increase blood pressure and/or pulse rate in some patients and may present a risk for those with a history of coronary artery disease, congestive heart failure, arrhymias or stroke.

  • Company:
    Pure Edge Nutrition
New Life Nutritional Center Dietary Supplements: Recall - Undeclared Drug Ingredients
03/26/2014 Medical Recall

Undeclared sibutramine and phenolphthalein make these products unapproved new drugs for which safety and efficacy have not been established.

  • Company:
    New Life Nutritional Center
Pleo Homeopathic Drug Products by Terra-Medica: Recall - Potential for Undeclared Penicillin
03/21/2014 Medical Recall

Exposure to penicillin can result in a range of allergic reactions from mild rashes to severe and life-threatening anaphylactic reactions.

  • Company:
    Terra-Medica
February 2014
03/19/2014 Medical Recall

Drug Safety Labeling Changes, February 2014

  • Category
    File Format
Vitaccino Coffee: Public Notification - Undeclared Drug Ingredient
03/19/2014 Medical Recall

Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients, and may also present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.

  • Company:
    Vitaccino Coffee
Playtex Nurser Deluxe Double Electric Breast Pump: Recall - Potential for Electric Shock
03/19/2014 Medical Recall

The casing on some AC/DC power adapters may become loose and separate, resulting in a potential for electric shock.

  • Company:
    Playtex Nurser
Hospira Hemostat Dual Channel Plum Set: Recall-Risk of over-delivery of blood products
03/18/2014 Medical Recall

Over-delivery of blood products in the populations at greatest risk may result in injuries that require medical intervention.

  • Company:
    Stericycle
FreeStyle and FreeStyle Flash Blood Glucose Meter by Abbott: Recall - May Produce Mistakenly Low Blood Glucose Results
03/17/2014 Medical Recall

Symptoms of high blood sugar include excessive thirst, excessive urination, blurred vision, weakness, nausea, vomiting and abdominal pain.

  • Category
    Glucose Meter
McKesson Technologies Anesthesia Care: Recall – Patient Case Data May Not Match Patient Data
03/15/2014 Medical Recall

Class 1 recall of computer-based system.

  • Company:
    McKesson Technologies Anesthesia Care
VPRIV (velaglucerase alfa for injection): Recall - Visible Particulate Matter
03/14/2014 Medical Recall

Risk of rare but serious adverse events associated with infusion containing particulates.

  • Company:
    Shire Pharmaceuticals
Reumofan Plus: Recall - Undeclared Drug Ingredient
03/14/2014 Medical Recall

UPDATED 03/14/2014. Pain Free by Nature is voluntarily recalling all lots of Reumofan Plus Tablets. Originally posted 06/01/2012.

  • Company:
    Reumofan Plus
Merit Medical Systems, Custom Procedural Trays/Kits Containing 1 percent Lidocaine HCl Injection, USP, 10mg/mL: Recall - Particulates Found in Hospira supplied Lidocaine
03/14/2014 Medical Recall

Presence of oxidized stainless steel particulate may put a patient at risk from strong magnetic field exposure such as MRI, and other adverse events resulting in serious life-threatening complications.

  • Company:
    Merit Medical
Greatbatch, Inc. Standard Offset Cup Impactors: Recall - Sterilization Recommendation in Instructions Do Not Meet Sterility Assurance Requirements
03/12/2014 Medical Recall

Lack of sterility assurance has the potential to result in surgical infection.

  • Company:
    Greatbatch Inc.
Effexor XR 150 Mg Extended-Release Capsules (Pfizer) and Venlafaxine HCl 150 Mg Extended-Release Capsules (Greenstone): Recall - Possible Presence of Tikosyn Capsules
03/07/2014 Medical Recall

The use of Tikosyn by an Effexor XR/Venlafaxine HCl patient could cause serious adverse health consequences that could be fatal.

  • Company:
    Pfizer Inc.
DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5 Percent Dextrose 6000mL: Recall - Contamination With Mold
03/07/2014 Medical Recall

Administration of a product contaminated with mold could result in life-threatening fungal peritoneal infection or sepsis.

  • Company:
    Baxter International
Doribax (doripenem): Drug Safety Communication - Risk When Used to Treat Pneumonia on Ventilated Patients
03/07/2014 Medical Recall

Increased risk of death and lower clinical cure rates compared to use of imipenem and cilastatin.

  • Category
    Health Care
HeartMate II LVAS Pocket System Controller by Thoratec Corporation: Medical Device Correction - Updated Labeling and Training Materials
03/05/2014 Medical Recall

Reports of four deaths and five incidents of loss of consciousness or other symptoms of hypoperfusion, occurring in patients who were converted to the Pocket Controller after being originally trained on an older model.

  • Company:
    Thoratec Corporation
GE Healthcare Resuscitation Systems: Class I Recall - Oxygen and Air Inlet Fittings Reversed During Assembly
02/28/2014 Medical Recall

Recalled products may interfere with oxygen delivery, resulting in inaccurate oxygen regulation in neonates. This may cause death in neonates, particularly those who are critically ill.

  • Company:
    GE Healthcare
ACME Monaco Guidewire .035x150 3MMJ TCFC, Item 88241 by Medline Industries: Class I Recall - Potential for Coating to Flake Off
02/25/2014 Medical Recall

Use of this recalled product may result in serious adverse health consequences.

  • Company:
    ACME Monaco Guidewire
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port (with and without Preloaded Stylet) by Teleflex Medical – Class I Recall: Potential Kinking During Patient Use
02/24/2014 Medical Recall

If a tracheal tube kinks, it can deprive the patient of adequate ventilation causing serious patient injury including hypoxic injury and/or anoxia, and death.

  • Category
    Patient
Etomidate Injection/Pfizer-Mylan: Recall - Presence of Particulate Matter and/or Illegible and Missing Lot Number and/or Expiry Date
02/20/2014 Medical Recall

Intravenous administration of particles may lead to impairment of microcirculation, phlebitis, infection, embolism and subsequent infarction.

  • Company:
    Agila Specialties
Trilogy Ventilator Models 100, 200 and 202 by Philips Respironics: Recall - Failure to Deliver Mechanical Breaths
02/20/2014 Medical Recall

Potential ventilator failure and reduced alarm functionality may result in serious adverse health consequences or death.

  • Company:
    Philips
Acetylcysteine Solution 10 Percent: Recall - Glass Particles in Product
02/15/2014 Medical Recall

Use of an inhaled product with glass particles has potential to cause choking which could be life-threatening. Aerosolization of small glass particles in airways could result in recurrent infections.

  • Company:
    Ben Venue Laboratories
Reduce Weight Fruta Planta: Recall - Undeclared Drug Ingredient
02/14/2014 Medical Recall

Consumption of this product could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use.

  • Category
    File Format
L-citrulline by Medisca: Alert - Potentially Subpotent Product
02/14/2014 Medical Recall

Subpotent L-citrulline in patients with certain urea cycle defects can lead to high ammonia levels, which is serious and potentially life-threatening.

  • Company:
    Medisca Inc
Saxagliptin (marketed as Onglyza and Kombiglyze XR): Drug Safety Communication - FDA to Review Heart Failure Risk
02/11/2014 Medical Recall

FDA has requested clinical trial data from the manufacturer of saxagliptin to investigate a possible association between use of the type 2 diabetes drug and heart failure.

  • Company:
    Onglyza
Calcium gluconate 10 percent Injections by Rx Formulations: Recall - Microbial Contamination
02/07/2014 Medical Recall

FDA testing confirmed the presence of gram-positive rod bacteria in the product, which can cause infection in patients.

  • Company:
    Rx Formulations
Testosterone Products: Drug Safety Communication - FDA Investigating Risk of Cardiovascular Events
01/31/2014 Medical Recall

FDA assessing safety issues based on two separate studies that suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy.

  • Category
    Health Care
Mega Slim Herbal Appetite Management Pills by YoungYou International: Recall - Presence of DMAA
01/31/2014 Medical Recall

DMAA may cause a rise in blood pressure or other cardiovascular problems such as shortness of breath, tightening in the chest or heart attack.

  • Company:
    DMAA
Trufill n-BCA Liquid Embolic System by Codman Neuro: Recall - Incorrect Instructions For Use
01/22/2014 Medical Recall

Incorrectly mixed product can result in the liquid mixture solidifying too slowly and could result in significant impact to the patient, including neurological deficits, pulmonary emboli and possibly death.

  • Company:
    Codman Neuro
Dream Body Slimming Capsule: Public Notification - Undeclared Drug Ingredient
01/22/2014 Medical Recall

Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.

  • Category
    Myocardial Infarction
Magic Slim: Public Notification - Undeclared Drug Ingredient
01/22/2014 Medical Recall

Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.

  • Category
    Hypertension
StemAlive 90 Capsules: Recall - Contains Undeclared Milk
01/20/2014 Medical Recall

Risk of serious or life-threatening allergic reaction.

  • Company:
    StemAlive
Rohto Eye Drops - Mentholatum: Recall - Sterility Control Review
01/17/2014 Medical Recall

Production facility in Vietnam reviewing manufacturing sterility controls.

  • Company:
    The Mentholatum Company
Acetaminophen Prescription Combination Drug Products with more than 325 mg: FDA Statement - Recommendation to Discontinue Prescribing and Dispensing
01/15/2014 Medical Recall

Inadvertent overdose from prescription combination drugs containing acetaminophen accounts for nearly half of all cases of acetaminophen-related liver failure in the United States, some of which result in liver transplant or death.

  • Category
    Health Care
t:slim Insulin Cartridges by Tandem Diabetes Care: Recall - Potential for Cartridge Leak
01/14/2014 Medical Recall

Cartridge leak could potentially result in the device delivering too much or too little insulin.

  • Company:
    Tandem Diabetes Care
Pro ArthMax by Human Science Foundation: Recall - Undeclared Drug Ingredients
01/14/2014 Medical Recall

Undeclared Chlorzoxazone, Nefopam, Diclofenac, Ibuprofen, Naproxen, and Indomethacin. Pro ArthMax has a reasonable probability of resulting in fatal adverse events.

  • Company:
    Nefopam
Boost Ultra, XZone Gold, Sexy Monkey, Triple MiracleZen Platinum, Magic for Men,"New" Extenze, and New XZen Platinum Marketed as Dietary Supplements: Recall - Undeclared Drug Ingredients
01/10/2014 Medical Recall

Analysis found these products to contain undeclared Sildenafil and/or Tadalafil, may interact with nitrates found in some prescription drugs, and may lower blood pressure to dangerous levels.

  • Company:
    Midwest Wholesale
Puritan Bennett 840 Series Ventilator by Covidien - Class I Recall - Software Problem
01/10/2014 Medical Recall

Ventilator may stop functioning, triggering the safety alarm and causing the patient to suddenly be required to breathe on his or her own.

  • Company:
    Covidien
December 2013
01/10/2014 Medical Recall

Safety Labeling Changes includes 39 products with revisions to Prescribing Information.

  • Category
    The Legend Of Zelda: A Link To The Past
Sodium Phosphate Over-the-Counter Products: Drug Safety Communication - Possible Harm From Exceeding Recommended Dose
01/08/2014 Medical Recall

Reports of severe dehydration and changes in the levels of serum electrolytes from taking more than the recommended dose, resulting in serious adverse effects, in some cases resulting in death.

  • Category
    Health Care
Truebalance and Truetrack Blood Glucose Meters by Nipro Diagnostics: Recall - Incorrect Factory-set Measure
01/08/2014 Medical Recall

If a consumer were not to notice the incorrect unit of measure, it is possible that the meter result could be read as a lower than expected blood glucose result.

  • Company:
    Nipro Diagnostics
SafeSpout and SafeShower Filtration Products by Nephros: Class I Recall - Exposure to Bacteria or Virus
01/07/2014 Medical Recall

The fiber filter or the sealing compound, holding the fiber in place, could break apart, exposing patients to bacteria or viruses, which could result in infection or death.

  • Company:
    Nephros Filtration Products
Nephros Filtration Products: Class I Recall - Labeling Promoting Medical Claims
01/07/2014 Medical Recall

Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.

  • Company:
    DSU
CLINIMIX and CLINIMIX E Injection/Baxter: Recall - Particulate Matter in Products
01/06/2014 Medical Recall

If infused, particulate matter may result in blockages of blood vessels, which can result in stroke, heart attack, or damage to other organs such as the kidney or liver.

  • Category
    Protein
CO2 Multi Absorber by Vital Signs Devices: Field Corrective Action - Loss of Anesthetic Gases, Ventilation and Oxygenation
01/01/2014 Medical Recall

A potential safety issue due to air leakage associated with the CO2 Multi Absorber.

  • Company:
    GE Healthcare Company
Baxter 5 Percent Dextrose Injection, USP And 0.9 Percent Sodium Chloride Injection, USP Intravenous (IV) Solutions: Recall - Particulate Matter In Solution
12/27/2013 Medical Recall

Injecting a product containing particulate matter may result in blockages of blood vessels, which can result in stroke, heart attack or damage to other organs such as the kidney or liver.

  • Company:
    USP
Burn 7 Capsules by Deseo Rebajar: Recall - Undeclared Drug Ingredient
12/24/2013 Medical Recall

Undeclared Sibutramine, known to substantially increase blood pressure and/or pulse rate in some patients.

  • Company:
    Deseo Rebajar Inc.
Lidocaine HCl Injection 2%, 5 ml Vial by Hospira: Recall - Presence of Particulate Matter
12/24/2013 Medical Recall

If infused, particulate matter could lead to local inflammation, tissue trauma, mechanical disruption of tissue, and/or local granuloma formulation.

  • Company:
    Stericycle
Muscle Growth Product Called Mass Destruction: FDA Health Risk Warning - Undeclared Ingredients
12/23/2013 Medical Recall

The product is labeled to contain at least one synthetic anabolic steroid and has been linked to at least one reported serious illness.

  • Company:
    Blunt Force Nutrition
Abrams Royal Pharmacy Sterile Products - Recall - Lack of Sterility Assurance
12/19/2013 Medical Recall

Use of Microbial contamination in products intended to be sterile can put patients at risk for serious, potentially life-threatening infections.

  • Category
    Health Care Provider
Methylphenidate ADHD Medications: Drug Safety Communication - Risk of Long-lasting Erections
12/17/2013 Medical Recall

Prolonged erections (priapism) can lead to permanent damage to the penis.

  • Category
    Attention Deficit Hyperactivity Disorder
Soliris (Eculizumab) Concentrated Solution for Intravenous Infusion by Alexion: Recall - Visible Particles
12/16/2013 Medical Recall

Two lots were found to contain visible particles. Particulates could cause blockage of flow of blood in vessels, which could be life-threatening.

  • Company:
    Alexion Pharmaceuticals, Inc.
Nipple Aspirate Test: Safety Communication - Breast Cancer Screening Test Is Not An Alternative To Mammography
12/12/2013 Medical Recall

Misleading claims about a nipple aspirate test may lead patients to not get mammograms and/or other needed breast imaging tests or biopsies. This may lead to serious adverse health consequences.

  • Category
    Cancer
Onfi (clobazam): Drug Safety Communication - Risk of Serious Skin Reactions
12/03/2013 Medical Recall

Cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) Reported.

  • Category
    Medicine
HeartStart Automated External Defibrillators (AED) From Philips Healthcare: Safety Communication - Failure Of An Electrical Component That Could Cause AEDs To Fail To Deliver Appropriate Shock
12/03/2013 Medical Recall

When normal heart rhythms are not restored quickly, sudden cardiac arrest can cause death.

  • Company:
    Philips Medical Systems
Hydravax Dietary Supplement by IQ Formulations: Recall - Possible Undeclared Drug Ingredient
12/01/2013 Medical Recall

Sample from one lot of Hydravax revealed the presence of a diuretic. Possible effects of using a diuretic include an electrolyte imbalance due to water loss.

  • Company:
    Hydravax
FreeStyle and FreeStyle Lite Blood Glucose Test Strips by Abbott: Recall - Erroneously Low Blood Glucose Results
11/28/2013 Medical Recall

Falsely low blood glucose results can lead patients to try to raise their blood glucose when it is unnecessary, or to fail to treat elevated blood glucose due to a falsely low reading.

  • Category
    Customer Service
Nitroglycerin in 5% Dextrose Injection by Baxter: Recall - Particulate Matter
11/27/2013 Medical Recall

Voluntary recall of one lot due to particulate matter found in one vial. If infused, particulate matter could lead to potential venous and/or arterial thromboembolism.

  • Company:
    Baxter International Inc
Spacelabs Healthcare, Inc., Spacelabs Anesthesia Workstations and Service Kits: Class I Recall - Bag-to-Vent Switch in CAS I/II Absorbers May Fail
11/26/2013 Medical Recall

Potential for a large leak from the absorber circuit while operating in bag mode and could impede the ability to provide ventilation in bag mode.

  • Company:
    Spacelabs Healthcare
CLR Medicals International Inc. Viscoelastic Products: Recall - Quality System Deficiencies And Lack Of Premarket Approval (PMR)
11/26/2013 Medical Recall

Clinical consequences associated with use of the contaminated and/or adulterated products may include intraocular infection, inflammation and elevated intraocular pressure.

  • Company:
    CLR Medicals International Inc.
Rosiglitazone-containing Diabetes Medicines: Drug Safety Communication - Removal of Some Prescribing and Dispensing Restrictions
11/25/2013 Medical Recall

Health care professionals, pharmacies, and patients will no longer be required to enroll in the rosiglitazone REMS program to be able to prescribe, dispense, or receive rosiglitazone medicines.

  • Company:
    Dear Healthcare Provider
Hospira GemStar Infusion System: Class I Recall - Pressure Sensor Calibration Drift
11/25/2013 Medical Recall

May result in a delay, interruption or over-infusion in therapy, which have a worst case potential to result in significant injury or death depending on the drug and the dosage administered.

  • Company:
    Hospira
Meridian Medical Technologies Auto-Injectors: Extension of Expiration Dates
11/22/2013 Medical Recall

FDA is currently reviewing data for the potential use of these auto-injectors beyond their labeled expiration dates, in order to mitigate any potential shortages.

  • Company:
    Meridian
Adipotrim XT by Deseo Rebajar: Recall - Undeclared Drug Ingredient
11/21/2013 Medical Recall

Undeclared Fluoxetine, a selective serotonin reuptake inhibitor (SSRI). Use of SSRIs have been associated with serious side effects including suicidal thinking, abnormal bleeding, and seizures.

  • Company:
    Adipotrim XT
Lexiscan (regadenoson) and Adenoscan (adenosine): Drug Safety Communication - Rare but Serious Risk of Heart Attack and Death
11/20/2013 Medical Recall

Cases of myocardial infarction and death have occurred following the administration of Lexiscan (regadenoson) injection or Adenoscan (adenosine) infusion.

  • Company:
    Lexiscan
P-Boost, NatuRECT by Tendex: Recall - Undeclared Drug Ingredient
11/20/2013 Medical Recall

Undeclared tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to unsafe levels.

  • Company:
    NatuRECT
RezzRX: Recall - Undeclared Drug Ingredients
11/19/2013 Medical Recall

Undeclared hydroxylthiohomosildenafil and aminotadalafil (PDE-5) inhibitors may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to unsafe levels.

  • Company:
    Fossil Fuel Products
Rhino 5 Plus, Maxtremezen and Extenzone: Recall - Undeclared Drug Ingredients
11/19/2013 Medical Recall

Undeclared Desmethylcarbondenafil, a posphodiesterase (PDE-5) inhibitor, and dapoxetine, an ingredient not approved by the FDA, may present a health risk which could be life threatening.

  • Company:
    Jobbers Wholesale
Nature's Pharmacy and Compounding Center Sterile Compounded Products: Recall - Lack of Sterility Assurance
11/16/2013 Medical Recall

In the event a sterile product is compromised, patients are at risk for very serious infections.

  • Category
    Health Care Provider
New Reliance Traders, Inc. Special Eyeliner: Recall - Elevated Lead Levels
11/16/2013 Medical Recall

Recent analysis of the product found that the products contained lead levels high as 167387 parts per million (ppm)

  • Company:
    New Reliance Traders
Medtronic Guidewires: Recall - Potential For Coating On Surface To Delaminate And Detach
11/16/2013 Medical Recall

Some Medtronic models of its guidewires from recent lots have the potential for the coating on their surface to delaminate and detach.

  • Company:
    Medtronic
VitaliKOR Fast Acting: Recall - Undeclared Drug Ingredients
11/15/2013 Medical Recall

Undeclared Vardenafil and Tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to unsafe levels.

  • Company:
    Vitality Research Labs
Over-the-Counter Topical Antiseptic Products: Drug Safety Communication - FDA Requests Label Changes and Single-Use Packaging to Decrease Risk of Infection
11/13/2013 Medical Recall

Clinical infections have also been reported to FDA, leading to some product recalls. The reported outcomes ranged from localized infections at injection sites to systemic infections that resulted in death.

  • Category
    Antiseptic
Vega One Nutritional Shakes and Vega Sport Performance Protein: Recall - Traces of Antibiotic
11/12/2013 Medical Recall

Risk of aplastic anemia and allergic reactions.

  • Company:
    Sequel Naturals Inc.
OxyElite Pro Dietary Supplements by USP Labs: Recall - Products Linked to Liver Illnesses
11/10/2013 Medical Recall

The products contained aegeline, a new dietary ingredient that lacks a history of use or other evidence of safety.

  • Company:
    OxyElite Pro
Baylis Medical TorFlex Transseptal Guiding Sheath Kit: Class I Recall - Sheath Could Remove Particulate
11/06/2013 Medical Recall

Particulate could potentially migrate into a patient’s bloodstream.

  • Company:
    Baylis Medical Company
Low Molecular Weight Heparins: Drug Safety Communication - Recommendations to Decrease Risk of Spinal Column Bleeding and Paralysis
11/06/2013 Medical Recall

All anticoagulants carry the risk of causing epidural or spinal hematomas when used in conjunction with epidural/spinal anesthesia or spinal puncture.

  • Company:
    Lovenox
Edwards Lifesciences LLC, EMBOL-X Glide Protection System: Class I Recall - Deformed Cannula Tip
11/04/2013 Medical Recall

Use of defective product may lead to tip separation and embolization.

  • Company:
    Edwards Lifesciences LLC
Perrigo Acetaminophen Infant Suspension Liquid: Recall - Potential Defect with Co-packaged Oral Syringe
11/02/2013 Medical Recall

Using an oral syringe without dose markings can result in inaccurate dosing, especially in infants who could mistakenly get too high a dose. Posted 11/02/2013

  • Company:
    The Perrigo Company
September 2013
11/01/2013 Medical Recall

September 2013 drug safety labeling changes

  • Category
    The Legend Of Zelda: A Link To The Past
Potiga (Ezogabine): Drug Safety Communication - Linked To Retinal Abnormalities And Blue Skin Discoloration
11/01/2013 Medical Recall

UPDATE: Boxed Warning and other labeling changes approved.

  • Company:
    Potiga
PENTAX Medical Gas/Water Valves, Model OF-B194: Recall - Manufacturing Defect
11/01/2013 Medical Recall

May prevent users from turning off CO2 gas flow during an endoscopic procedure, leading to risk of peritonitis, perforations, sepsis, death, and bowel perforations requiring surgical repair.

  • Company:
    PENTAX Medical Company
MedStream Programmable Infusion Pump and Refill Kits by Codman and Shurtleff: Class 1 Recall - Drug Over Infusion
10/23/2013 Medical Recall

Air in the pump reservoir may release a higher dosage of drug than expected, leading to drug overdose.

  • Company:
    Codman & Shurtleff, Inc.
Specialty Medicine Compounding Pharmacy Certain Unexpired Compounded Sterile Products: Recall - Particulate Matter Found in Vials
10/21/2013 Medical Recall

If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections. Posted 10/21/2013

  • Category
    Health Care Provider
Bard LifeStent Solo Vascular Stent: Class 1 Recall - Failure to Deploy
10/18/2013 Medical Recall

Serious adverse health consequences, including complications of bleeding, loss of limb, heart attack, or stroke.

  • Category
    Myocardial Infarction
Albuterol Sulfate Inhalation Solution, 0.083 percent (Nephron Pharmaceuticals): Recall - Aseptic Processing Simulation Results
10/17/2013 Medical Recall

Finding of bacterial growth.

  • Company:
    Nephron Pharmaceuticals
St. Jude Amplatzer Atrial Septal Occluder (ASO): Safety Communication - Reports of Tissue Erosion
10/17/2013 Medical Recall

Tissue surrounding the Amplatzer ASO can break down (erode) and result in life-threatening emergencies that require immediate surgery.

  • Company:
    Amplatzer ASO
Engström Ventilator, Aespire View, Aisys, And Avance Anesthesia Machines: Voluntary Field Corrective Action - Potential Safety Issue
10/16/2013 Medical Recall

May result in the inability to access certain menu functions which could possibly lead to delay in treatment.

  • Company:
    GE Healthcare
Avance, Aisys And Avance CS2 Anesthesia Delivery Systems: Voluntary Field Corrective Action - Potential Safety Issue
10/15/2013 Medical Recall

A unique sequence of inputs and a collapsed bellow could result in delivery of higher-than-expected tidal volume.

  • Company:
    GE Healthcare
Inclusig (Ponatinib): Drug Safety Communication - Increased Reports Of Serious Blood Clots In Arteries And Veins
10/11/2013 Medical Recall

Health care professionals should consider for each patient, whether the benefits of Iclusig treatment are likely to exceed the risks of treatment.

  • Company:
    Iclusig
Perfect Body Solutions and Burn 7: Public Notification - Undeclared Ingredients
10/10/2013 Medical Recall

May increase blood pressure and/or pulse rate and can present a significant risk for patients with a history certain cardiovascular conditions or stroke.

  • Company:
    Perfect Body Solutions
Dr. Mao Slimming Capsules: Public Notification - Undeclared Ingredients
10/10/2013 Medical Recall

May increase blood pressure and/or pulse rate and can present a significant risk for patients with a history certain cardiovascular conditions or stroke.

  • Category
    Blood Pressure
Bella Vi Insane Amp’d And Bella Vi Amp’d Up: Public Notification - Undeclared Ingredients
10/10/2013 Medical Recall

May increase blood pressure and/or pulse rate and can present a significant risk for patients with a history certain cardiovascular conditions or stroke.

  • Company:
    Bella Vi Amp
Be Inspired: Public Notification - Undeclared Ingredients
10/10/2013 Medical Recall

May increase blood pressure and/or pulse rate and can present a significant risk for patients with a history certain cardiovascular conditions or stroke.

  • Category
    Health Care
Slim Fortune, Lidiy And Slim Expert Dietary Supplement: Recall - Undeclared Ingredients
10/09/2013 Medical Recall

May substantially increase blood pressure and/or pulse rate or present a significant risk for patients with a history of certain cardiovascular conditions or stroke.

  • Company:
    Slim Fortune
Cefepime For Injection, USP And Dextrose Injection, USP By B. Braun Medical Inc.: Recall - Visible Particulate Matter
10/08/2013 Medical Recall

May illicit inflammatory responses, both chronic and acute, and may be life threatening.

  • Company:
    Braun Medical Inc.
OxyElite Pro: Health Advisory - Acute Hepatitis Illness Cases Linked To Product Use
10/08/2013 Medical Recall

FDA advises consumers to stop using products labeled OxyElite Pro while the investigation continues.

  • Company:
    OxyElite Pro
Fabius Anesthesia Machines: Recall - Did Not Pass High Voltage Test Portion Of Final Production Test
10/08/2013 Medical Recall

In extreme cases, may cause a failure of the automatic ventilation function of the device.

  • Company:
    Fabius GS Premium
Breast Health Test and Mammary Aspiration Specimen Cytology Test: Recall - Instructions For Use, Promotional Claims and FDA Clearance Concerns
10/05/2013 Medical Recall

Atossa will remove existing product from the market until concerns are addressed.

  • Company:
    Atossa
1% Lidocaine HCL Injection By Hospira: Recall - Presence Of Dark Particulate
10/05/2013 Medical Recall

May result in local inflammation, phlebitis, and/or low-level allergic response, and could block administration of the drug to the patient, causing a delay in therapy.

  • Company:
    Hospira
Emergency Cricothyrotomy Kit By H&H Medical Corporation: Recall - Defective Cuff Balloon On Endotracheal Airway
10/04/2013 Medical Recall

Defect due to a reduction in package density, a higher than average dose of gamma sterilization, and the occasional slippage of a protective silicon sleeve during shipping.

  • Company:
    H&H Medical Corporation
Metoclopramide Injection And Ondansetron Injection by Hospira: Recall - Glass Strand Particulates Caused By Glass Supplier
10/02/2013 Medical Recall

Administration of an injectable with the presence of foreign particulates may result in local inflammation, thrombophlebitis, and/or low-level allergic response.

  • Company:
    Hospira
Virilis Pro, PHUK and Prolifta Capsules : Recall - Undeclared Ingredients
10/01/2013 Medical Recall

Potential to interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to unsafe levels.

  • Company:
    Virilis Pro
Carefusion Avea Ventilator: Recall - Underreporting Of Tidal Volume If Used In Conjunction With Neonatal Hotwire Flow Sensor
10/01/2013 Medical Recall

Patients may receive a higher than expected tidal

  • Company:
    CareFusion
Afikim Electric Vehicles Issues Nationwide Recall Of Breeze C Scooter: Recall - Potential For Malfunction
10/01/2013 Medical Recall

May become unresponsive during operation, resulting in the driver not being able to stop the scooter during operation.

  • Company:
    Afikim Electric Vehicles
Tygacil (tigecycline): Drug Safety Communication - Increased Risk of Death
09/27/2013 Medical Recall

BOXED WARNING describes risk for FDA-approved and non-approved uses.

  • Company:
    Tygacil
The Compounding Shop: FDA News Release - Lack of Sterility Assurance of Drug Products
09/27/2013 Medical Recall

UPDATED 09/27/2013. Budesonide solution, used for nasal irrigation, from The Compounding Shop may be contaminated and should not be used or administered to patients. Originally posted 05/08/2013

  • Company:
    The Compounding Shop
W.S. Badger Company Daily SPF 30 Kids & Baby Sunscreen Lotion: Recall - Microbial Contamination
09/25/2013 Medical Recall

Lab testing found certain product lots were contaminated with Pseudomonas aeruginosa, Candida parapsilosis and Acremonium fungi.

  • Company:
    W.S. Badger Co. Inc.
Arzerra (ofatumumab) and Rituxan (rituximab): Drug Safety Communication - New Boxed Warning, Recommendations to Decrease Risk of Hepatitis B Reactivation
09/25/2013 Medical Recall

Hepatitis B reactivation occurred in patients with prior HBV exposure and later treated with Arzerra & Rituxan. Cases of fulminant hepatitis, hepatic failure, and death reported.

  • Category
    Hepatitis B
Xzen 1200, Xzen Gold and Xzen XPress: Public Notification - Undeclared Ingredients
09/24/2013 Medical Recall

May interact with nitrates found in some prescription drugs lower blood pressure to dangerous levels.

  • Company:
    Xzen XPress
XZone Premium: Public Notification - Undeclared Drug Ingredient
09/24/2013 Medical Recall

Contains contains sildenafil and tadalafil, which may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.

  • Category
    Erectile Dysfunction
Wood-E: Public Notification - Undeclared Drug Ingredient
09/24/2013 Medical Recall

Contains sildenafil, which may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.

  • Category
    Erectile Dysfunction
Duragesic (fentanyl) Patches: Drug Safety Communication - Packaging Changes to Minimize Risk of Accidental Exposure
09/23/2013 Medical Recall

Accidental exposure to fentanyl can cause serious harm and death in children, pets, and others.

  • Category
    Fentanyl
Baxter Dual Luer Lock Caps: Class I Recall - Presence of Loose Particulate Matter Found In Packaging
09/20/2013 Medical Recall

May result in thrombotic and embolic events, including: pulmonary embolism, myocardial infarction and stroke.

  • Company:
    Baxter International Inc.
Shou Fu Ti Tun Guo Xiang Xing Jian Fei Jiao Nang: Public Notification - Undeclared Drug Ingredient
09/17/2013 Medical Recall

May substantially increase blood pressure and/or pulse rate in some patients and presents a risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.

  • Category
    Hypertension
HeartSine Technologies Samaritan 300/300P PAD Public Access Defibrillators: Recall - Power, Battery Issues
09/17/2013 Medical Recall

Two separate issues may affect the ability to deliver therapy to a patient in a sudden cardiac arrest event.

  • Company:
    HeartSine Technologies
Bupivacaine HCL Injection 0.25% (2.5 MG/ML) and Bupivacaine HCL 0.75% (7.5 MG/ML), 30 ML Single-Dose Vials by Hospira, Inc.: Recall- Presence of Particulate Matter
09/14/2013 Medical Recall

One lot of each strength recalled, administration of an injectable with the presence of foreign particulates may potentially cause thrombophlebitis, bacteremia, sepsis, and/or endocarditis and death may result.

  • Company:
    Bupivacaine HCl
Creafuse Powder Grape and Creafuse Powder Fruit Punch: Recall - Contains DMAA
09/13/2013 Medical Recall

Ingestion of DMAA can elevate blood pressure and lead to cardiovascular problems.

  • Company:
    Ge Pharma
Leiter's Compounding Pharmacy: Recall - Concerns of Sterility Assurance
09/12/2013 Medical Recall

Use of a non-sterile injectable product exposes patients to the risk of contracting serious life-threatening infections.

  • Company:
    Compounding Pharmacy
Park Compounding Sterile Medication: Recall – Concerns of Sterility Assurance
09/10/2013 Medical Recall

If there is microbial contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.

  • Company:
    Front Range Laboratories
Avella Specialty Pharmacy Sterile Medications: Recall - Concerns Of Sterility Assurance At Testing Vendor
09/09/2013 Medical Recall

If microbial contamination occurs in medications intended to be sterile, patients are at risk of serious infections that may be life threatening.

  • Company:
    Avella Specialty Pharmacy
MOTRIN Infants Drops Original Berry Flavor 1/2 fl oz: Recall - Particles Identified
09/08/2013 Medical Recall

May contain tiny plastic particles.

  • Company:
    McNeil Consumer Healthcare
University Compounding Pharmacy Injection Products: Recall - Lack of Sterility Assurance
09/08/2013 Medical Recall

If there is microbial contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.

  • Company:
    Sesame Oil
Medaus Pharmacy Sterile Compounded Products - Recall: Inability to Confirm Sterility
09/05/2013 Medical Recall

Questions Surrounding an Independent Third Party's Sterility Testing

  • Company:
    Medaus Pharmacy
Siemens MicroScan Synergies Plus And MicroScan RapID/S Plus Negative Panels: Class I Recall - False Susceptible And False Intermediate Results
09/04/2013 Medical Recall

Defect may lead to treatment with an inappropriate antibiotic or a delay in initiating appropriate therapy.

  • Company:
    Siemens
Aminosyn II 10 percent, Sulfite-Free (Hospira): Recall - Particulate Matter Noted in One Lot
09/03/2013 Medical Recall

Particle confirmed by Hospira as human hair.

  • Company:
    Hospira
Cubicin (daptomycin for injection): Recall - Glass Particulate Matter Present in Four Lots
08/29/2013 Medical Recall

Risk of thromboembolism and pulmonary emboli, some life-threatening.

  • Category
    File Format
Gilenya (fingolimod) - Drug Safety Communication: Investigating Rare Brain Infection
08/29/2013 Medical Recall

Patient has developed a rare and serious brain infection after taking the drug.

  • Company:
    Novartis
Stryker Spine: Class 1 Recall - OASYS Midline Occiput Plate
08/29/2013 Medical Recall

Post-operative fracture of the pin that connects the head to the plate body.

  • Company:
    OASYS
Pro Power Max, Evil Root and 72HP By Hardmenstore.com: Recall - Undeclared Ingredient
08/28/2013 Medical Recall

May interact with nitrates found in some prescription drugs,lower blood pressure to dangerous levels or cause side effects, such as headaches and flushing.

  • Category
    Hypertension
Wellness Pharmacy, Inc. Products: Recall - Laboratory Results Indicating Microbial Contamination
08/27/2013 Medical Recall

If there is microbial contamination in medications intended to be sterile, patients are at risk of serious infections which may be life threatening.

  • Company:
    Wellness Pharmacy
JCB Laboratories Products: Recall - Sterility Assurance at Testing Vendor
08/27/2013 Medical Recall

If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections.

  • Company:
    JCB Laboratories
Compounded Sterile Preparations By Park Pharmacy & Compounding Center: Recall - Lack of Sterility Assurance
08/27/2013 Medical Recall

Methods used by the laboratory to assess sterility may have resulted in pharmacies receiving inaccurate laboratory test results.

  • Category
    Pharmacy
Ortiga Contains Hidden Drug Ingredient
08/22/2013 Medical Recall

FDA laboratory analysis confirmed that Ortiga contains the prescription drug ingredient, diclofenac.

  • Company:
    Ortiga
Jack Rabbit Dietary Supplement: Recall - Undeclared Drug Ingredients
08/21/2013 Medical Recall

Undeclared Sildenafil and Tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin, and may lower blood pressure to dangerous levels.

  • Company:
    Jack Rabbit Inc.
Covidien Monoject Prefill Flush Syringes: Recall - Not Subjected To AutoClave Sterilization Process Or Mismatched Syringe Tip Cap, Syringe Label, Filled Volume And Wrapper
08/20/2013 Medical Recall

Health risk of life-threatening infection to the blood stream or patency of device may not be maintained and clotting may occur.

  • Company:
    Covidien
Esbelder Man Capsules, Esbelder Fem Capsules, And Esbelder Siloutte Capsules Vitamin Supplements By Herbal Give Care LLC: Recall - Undeclared Ingredients
08/20/2013 Medical Recall

May substantially increase blood pressure and/or pulse rate as well as present significant other health risks for patients.

  • Company:
    Herbal Give Care LLC
Aidapak Services LLC, Select Repackaged Pharmaceuticals: Recall - Potential Incorrect Labeling
08/17/2013 Medical Recall

Aidapak Services LLC, Specific Unit Dose Repackaged Products: Recall - Potential Incorrect Labeling

  • Company:
    Aidapak Services LLC
Fluoroquinolone Antibacterial Drugs: Drug Safety Communication- Risk for possibly permanent nerve damage
08/15/2013 Medical Recall

The risk of peripheral neuropathy occurs only with fluoroquinolones that are taken by mouth or by injection.

  • Company:
    Medication Guides
Hospira Blood Sets: Recall - Instances Of Outer Wall Of Blood Bags Punctured With Piercing Pin
08/14/2013 Medical Recall

Spillage of the blood and blood products stored in the bag may result in delay/interruption in therapy or exposure to the healthcare professional.

  • Company:
    Hospira
Iradimed Corporation, MRidium 3860+ Infusion Systems equipped with MRidium 1145 Dose Error Reduction System (DERS) Drug Library Kit: Class I Recall - Potential for Incorrect Recommended Infusion Rate
08/12/2013 Medical Recall

Increased risk of over-infusion or under-infusion if the infusion is started with the incorrect rate. This can cause serious adverse health consequences, including death.

  • Company:
    Infusion Pumps
Specialty Compounding Sterile Products: FDA Alert - Bacterial Infections
08/09/2013 Medical Recall

Bacterial infections have been potentially associated with contaminated calcium gluconate infusions.

  • Company:
    Specialty Compounding, LLC
Cordis Optease Retrievable Inferior Vena Cava (IVC) Filter: Recall - Labeling Correction
08/08/2013 Medical Recall

The company is making corrections and improvements to the device labeling to minimize likelihood of implanting the filter backwards.

  • Company:
    Cordis
CareFusion Alaris PC unit (model 8015) with version 9.12 Keyboard Processor: Class I Recall - Potential Loss of Communication Between Main Processor and Keyboard
08/07/2013 Medical Recall

Device malfunction can result in the sudden unintended discontinuation of medications. This can lead to cause serious adverse health consequences, including death.

  • Company:
    CareFusion
Tranquility by Health and Beyond, LLC: Recall - Undeclared Drug Ingredient
08/07/2013 Medical Recall

Consuming this product potentially could result in dizziness and cause public health risk.

  • Company:
    Beyond LLC
BEST SLIM 40 Pills By CTV Best Group: Recall - Undeclared Ingredients
08/06/2013 Medical Recall

Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk.

  • Company:
    CTV
Bethel Advance And Quick Thin Products By Bethel Nutritional Consulting, Inc.: Recall - Undeclared Ingredients
08/06/2013 Medical Recall

Sibutramine and Phenolphthalein may pose health threats or interact in life-threatening ways with other medications a consumer may be taking.

  • Company:
    Bethel Nutritional Consulting, Inc.
Benztropine Mesylate Injection (Nexus Pharmaceuticals): Recall - Visible Particulate Matter
08/02/2013 Medical Recall

Risk of thromboembolism, some life-threatening (such as pulmonary emboli), as well as other serious adverse events.

  • Company:
    Nexus Pharmaceuticals Inc.
Acetaminophen: Drug Safety Communication - Association with Risk of Serious Skin Reactions
08/01/2013 Medical Recall

Events are rare but can be fatal.

  • Category
    Non Steroidal Anti Inflammatory Drug
DePuy Orthopaedics-LPS Lower Extremity Dovetail Intercalary Component: Class 1 Recall - Potential for Fracture of Device
08/01/2013 Medical Recall

Patients weighing more than 200 pounds and/or those with high levels of activity are at higher risk.

  • Company:
    DePuy Orthopaedics
Beacon Hill Medical Pharmacy/Rxtra Solutions: Recall - Lack of Sterility Assurance
08/01/2013 Medical Recall

Sterile compounded products distributed nationwide

  • Company:
    Beacon Hill/Rxtra Solutions
Nova Max Glucose Test Strips: Recall - May Report False, Abnormally High Blood Glucose Result
07/29/2013 Medical Recall

A false test result may lead to an insulin dosing error that could lead to a serious health risk requiring immediate medical attention.

  • Company:
    Nova Diabetes Care
Mefloquine Hydrochloride: Drug Safety Communication - Label Changes Due To Risk of Serious Psychiatric and Nerve Side Effects
07/29/2013 Medical Recall

Effects from use may include dizziness, loss of balance, ringing in the ears, feeling anxious, mistrustful, or depressed, or having hallucinations.

  • Company:
    Lariam
GE Healthcare Nuclear Medicine Systems: Class I Recall - Serious Injuries or Deaths Could Occur
07/29/2013 Medical Recall

Facilities are instructed to cease use of their Nuclear Medicine system until a GE Engineer is able to do a complete inspection of the system

  • Company:
    GE Healthcare
Nizoral (ketoconazole): Drug Safety Communication - Potentially Fatal Liver Injury, Risk of Drug Interactions and Adrenal Gland Problems
07/26/2013 Medical Recall

Nizoral tablets should be used only for the treatment of certain life-threatening mycoses when the potential benefits outweigh the risks, and alternative therapeutic options are not available or tolerated.

  • Category
    Pharmacology
Healthy Life Chemistry By Purity First B-50: FDA Health Risk Warning - Undeclared Ingredients
07/26/2013 Medical Recall

Using anabolic steroid-containing products may cause acute liver injury and some of the cases reported have resulted in hospitalization.

  • Category
    Nutrition
LeMaitre Vascular, Inc., Albograft Vascular Graft: Class I Recall - Blood Leak
07/24/2013 Medical Recall

Use of this product may cause serious adverse health consequences, including death.

  • Category
    Adverse Event
Diabetes Treatments: FDA Alerts of Illegal Sales - Undeclared Ingredients
07/23/2013 Medical Recall

Some products may cause harm because they contain undeclared active drug ingredients or may not have been manufactured and handled according to FDA quality standards.

MedStream Programmable Infusion Pump: Class 1 Recall - Malfunction In The Fill Level Sensor
07/23/2013 Medical Recall

The recommended pump refill date, computed by the Control Unit, may be incorrect.

  • Company:
    Codman
Esbelin Silouttte Te and Esbelin Siloutte Vitamin Supplement: Recall - Undeclared Drug Ingredients
07/23/2013 Medical Recall

These products pose a health threat to Consumers because Sibutramine is known to increase blood pressure and/or pulse rate and other related health risks.

  • Company:
    Herbal Give Care LLC
Bryan Medical Tracoe Mini 3.0mm Tracheostomy Tube: Class 1 Recall - Mislabeled Packaging
07/22/2013 Medical Recall

Using an oversized tracheostomy tube may cause permanent injury to the trachea.

  • Category
    Vertebrate Trachea
Volcano Male Enhancement Liquid and Volcano Male Enhancement Capsules: Recall - Undeclared Drug Ingredients
07/22/2013 Medical Recall

Lab tests revealed products contain PDE 5 inhibitors and other drug ingredients that can be life threatening.

  • Company:
    Volcano Company
Silver Sword and Clalis by hardmenstore.com: Recall - Undeclared Drug Ingredient
07/15/2013 Medical Recall

Use of these products, which contain Sildenafil, can result in decreased blood pressure, light-headedness, and dizziness.

  • Company:
    Clalis
Medtronic MiniMed Paradigm Insulin Infusion Sets: Class 1 Recall - Potential for Over or Under Delivery of Insulin
07/12/2013 Medical Recall

May result in hypoglycemia or hyperglycemia, which can be severe and lead to serious illness.

  • Company:
    Medtronic
Verathon, Inc., GlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2, 3, 4 and 5 Reusable Blades: Class I Recall - Risk of Blade Tip Breakage and Premature Failure
07/10/2013 Medical Recall

Blade may break off in patients’ mouth, where it may be swallowed or block the airway. This can lead to serious adverse health consequences, including hypoxemia (low blood oxygen), severe cuts to the airway leading to a significant loss of blood, and/or death.

  • Category
    Health Care
Olmesartan Medoxomil: Drug Safety Communication - Label Changes To Include Intestinal Problems (Sprue-Like Enteropathy)
07/03/2013 Medical Recall

Enteropathy may develop months to years after starting olmesartan, and sometimes requires hospitalization.

  • Company:
    ARB
RECOMBIVAX HB (Hepatitis B Vaccine (Recombinant)) Adult Formulation by Merck Sharp and Dohme Corp.: Recall - Potential For Cracked Vials
07/03/2013 Medical Recall

If vial is cracked, integrity of the vial and sterility of any product remaining could not be assured.

  • Company:
    Merck & Co.
Benztropine Mesylate Injection by Fresenius Kabi USA: Recall - Potential Presence Of Glass Particles
07/02/2013 Medical Recall

If present, the administration of glass particulate poses a potential safety risk to patients.

  • Company:
    Fresenius Kabi USA
Medtronic SynchroMed Implantable Infusion System Devices: Class 1 Recalls - Feed Through Failure, Failure of Priming Bolus, and Catheter Occlusion
06/28/2013 Medical Recall

Medtronic SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps and Sutureless Connector Intrathecal Catheter Products Recalled.

  • Company:
    Medtronic
JaDera and Xiyouji Qingzhi Dietary Supplements by Dolphin Intertrade Corp.: Recall - Undeclared Drug Ingredient
06/28/2013 Medical Recall

Products have been found to contain undeclared Sibutramine, known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

  • Company:
    Dolphin Intertrade Corp.
Hydroxyethyl Starch Solutions: FDA Safety Communication - Boxed Warning on Increased Mortality and Severe Renal Injury and Risk of Bleeding
06/24/2013 Medical Recall

FDA has analyzed recent data indicating increased mortality and renal injury in critically ill adult patients who are treated with HES solutions. Posted 06/24/2013

  • Category
    Blood
Oxyphen, Phentalene, Phen FX, and Red Vipers by Beta Labs, LTD: Recall - Contains DMAA
06/24/2013 Medical Recall

Ingestion of DMAA can elevate blood pressure and lead to cardiovascular problems.

  • Company:
    DMAA
Medtronic Xomed NIM Trivantage EMG Endotracheal Tube: Class I Recall - Cuff Leak or Cuff Deflation When Inflation Valve Cap Inappropriately Removed
06/21/2013 Medical Recall

Physician may need to re-inflate or replace deflated tube to ensure the continued breathing support of the patient.

  • Company:
    Medtronic
Respironics California, Inc. - Class 1 Recall: V60 Ventilators - Issue with software
06/20/2013 Medical Recall

Ventilator support may be lost with potentially no audible alarm from the ventilator.

  • Company:
    Philips Healthcare
Enteric Coated Aspirin 81 mg Tablets by Advance Pharmaceutical Inc.: Recall of One Lot - May Contain Acetaminophen 500 mg Tablets
06/19/2013 Medical Recall

Consumers may inadvertently take Acetaminophen 500 mg instead of Enteric Coated Aspirin 81 mg which may cause severe liver damage.

  • Company:
    Advance Pharmaceutical Inc.
Zyprexa Relprevv (Olanzapine Pamoate): Drug Safety Communication - FDA Investigating Two Deaths Following Injection
06/18/2013 Medical Recall

Two patients died 3-4 days after receiving an appropriate dose of the drug. Posted 06/18/2013

Endologix, Inc. AFX Introducer System: Class 1 Recall - Reports Of Dilator Breaking During Procedures
06/18/2013 Medical Recall

Use of this recalled product may cause serious adverse health consequences, including death. Posted 06/18/2013

  • Company:
    AFX
Cybersecurity for Medical Devices and Hospital Networks: FDA Safety Communication
06/17/2013 Medical Recall

Many medical devices contain configurable embedded computer systems that can be vulnerable to cybersecurity breaches.

  • Category
    Health Care
May 2013
06/13/2013 Medical Recall

MedWatch May 2013 drug safety labeling changes

  • Category
    Methylphenidate
Main Street Family Pharmacy in Tennessee: FDA Alerts Health Care Providers of Adverse Reactions Associated with Steroid Injections
06/13/2013 Medical Recall

UPDATED 06/13/2013. FDA identified the specific bacterial and fungal growth in two MPA lots. Originally posted 05/24/2013.

  • Category
    Bacteria
Warfarin 2 mg Tablets by Zydus Pharmaceuticals USA Inc.: Recall - Due to Oversized Tablets
06/12/2013 Medical Recall

Ingestion of a greater than intended dose of Warfarin, could lead to an increased pharmacological effect of warfarin. As a result, patients would be more likely to develop bleeding and in some patients that bleeding into a critical organ could be fatal.

  • Company:
    Zydus Pharmaceuticals USA Inc.