February 25, 2016

FDA: Facilities should transition from Custom Ultrasonics endoscope reprocessors

By: Judy Mathias

Editor’s Note

The Food and Drug Administration (FDA) on February 23 updated its Safety Communication on the November 2015 recall of Custom Ultrasonics automated endoscope reprocessors. The update recommends that healthcare facilities transition to alternative methods to reprocess flexible endoscopes as soon as possible.

In November, the FDA cited violations with the reprocessors that could result in an increased infection risk. Custom Ultrasonics (Ivyland, Pennsylvania) submitted a recall strategy the FDA found inadequate. The company has to date made no additional proposals to the FDA to recall its reprocessors. 


The FDA is revising its November 2015 Safety Communication to provide updated information about its communications with Custom Ultrasonics regarding its November 2015 Recall Order . On November 12, 2015, in accordance with a Consent Decree entered in January 2007 with Custom Ultrasonics (Consent Decree), FDA ordered Custom Ultrasonics to recall, at its expense, all of its Automated Endoscope Reprocessors (AERs).

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