FDA Recalls Custom Ultrasonics Automated Endoscope Reprocessors, Citing 'Continued Violations' At Facility

WASHINGTON, D.C. — As part of its ongoing investigation into infections associated with automated endoscope reprocessors (AERs), the FDA has ordered Custom Ultrasonics to recall all of its AERs due to continued violations at its facility and advised healthcare facilities to use alternative methods for washing flexible endoscopes.

In the Nov. 13 Safety Communication, the agency explained that its April 2015 inspection of Custom Ultrasonics’ facility revealed continued violations, which “include the inability to validate that its AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection.”

The FDA says the identified violations “could result …