FDA orders recall of Custom Ultrasonics endoscope cleaners

Patient Safety Monitor Insider

November 18, 2015

The FDA ordered a recall of all Custom Ultrasonic brand automated endoscope reprocessors (AER) such as the System 83 Plus, System 83 Plus 2, and System 83 Plus 9. The recall urges healthcare facilities to find alternative methods of cleaning endoscopes such as manual high-level disinfection, liquid chemical sterilization, using alternative AERs or other sterilization methods that comply with instructions from the endoscope manufacturer.

Exactly 10 days before the FDA recall, an ECRI Institute report put infections from dirty endoscopes at the top of its list of 2016 health tech hazards. An FDA inspection of Custom Ultrasonics’ facilities in April found the company could not properly verify if its products were actually able to disinfect endoscopes correctly. There are 2,800 Custom Ultrasonics brand AERs being used nationwide and the FDA has given the company seven days to come up with a written recall proposal.

"We are taking action because Custom Ultrasonics failed to meet its legal and regulatory obligations," said William Maisel, MD, MPH, deputy director for science and chief scientist in the FDA's Center for Devices and Radiological Health, in an FDA release. "The FDA's recall order stemmed from the company's continued violations of federal law and the consent decree and is necessary to protect the public health."

This is not the first time the Custom Ultrasonics has come under fire from the FDA. In 2012, The FDA ordered Custom Ultrasonics to stop making AERs because the company failed to get clearance for a major AER software update. Although the company has not been authorized to manufacture or distribute new AERs during this time, it is allowed to service older models still on the market.