FDA Orders Custom Ultrasonics to Recall Automated Endoscope Reprocessors

The U.S. Food and Drug Administration ordered Custom Ultrasonics to recall all of its automated endoscope reprocessors (AERs) from health care facilities.  An April 2015 inspection of Custom Ultrasonics' facility revealed continued violations of federal law, including an inability to validate that the AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection.  AERs are used to wash and disinfect endoscopes, which have been blamed for spreading deadly bacteria in hospitals. [11/17/16]

Search