Recalls for Custom Ultrasonics

FDA Orders Recall under Consent Decree for all Custom Ultrasonics Automated Endoscope Reprocessors
11/16/2015 Food Recall

The U.S. Food and Drug Administration today ordered Custom Ultrasonics to recall all of its automated endoscope reprocessors (AERs) from health care facilities due to the firm's continued violations of federal law and a consent decree entered with the company in 2007. The identified violations could result in an increased risk of infection transmission.

  • Company:
    Custom Ultrasonics
  • Problem
    Injury And Impact Hazards (Recall Alert)
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