Recalls, Market Withdrawals, & Safety Alerts > FDA Orders Recall under Consent Decree for all Custom Ultrasonics Automated Endoscope Reprocessors

Recalls, Market Withdrawals, & Safety Alerts > FDA Orders Recall under Consent Decree for all Custom Ultrasonics Automated Endoscope Reprocessors

FDA Orders Recall under Consent Decree for all Custom Ultrasonics Automated Endoscope Reprocessors

11/16/2015 04:57 PM EST

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.