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Medical Devices / Postmarket Safety

FDA Lifts Custom Ultrasonics’ AER Recall

May 18, 2016

The FDA has lifted a recall affecting Custom Ultrasonics’ automated endoscope reprocessors while the company carries out corrective actions, the company announced Monday. 

The FDA ordered Custom Ultrasonics to recall its AERs last November, following a slew of infection outbreaks related to duodenoscopes, according to a company statement.

Moving forward, the company is working with the agency to correct its procedures and protocols.  The lift does not apply to duodenoscopes. — Anisa Jibrell


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