FDA orders recall under consent decree for all Custom Ultrasonics automated endoscope reprocessors
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. FDA ordered this recall under the terms of the Consent Decree. The agency also issued a safety communication today recommending that health care facilities currently using Custom Ultrasonics AERs transition away from their use to alternative methods to reprocess flexible endoscopes as soon as possible.
