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FDA Orders Custom Ultrasonics To Recall All Endoscope Reprocessors

The rare recall order comes as a result of a consent-decree violation by the company, which supplies endoscope reprocessors to almost 3,000 hospitals nationwide. FDA says Custom Ultrasonics has failed to validate its device designs, among other concerns.

FDA has ordered Custom Ultrasonics Inc. to recall of its Automated Endoscope Reprocessors (AERs) from health care facilities because the company is in violation of a 2007 consent decree, the agency announced Nov. 13.

FDA estimates 2,800 AERs manufactured by Custom Ultrasonics are now being used in hospitals and outpatient clinics throughout the United States. The recall order applies to all Custom Ultrasonics AERs,...

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