FDA Lifts Recall On Custom Ultrasonics' Endoscope Reprocessors

Custom Ultrasonics said today that the FDA lifted the recall on its endoscope reprocessors while the company looks to correct the violations that prompted the recall.

Ivyland, Pa.-based Custom Ultrasonics said the action allows its devices to remain in the field to clean and sterilize endoscopes, excluding a type called duodenoscopes that caused a string of deadly “superbug” infections.

In November 2015 the FDA ordered Custom Ultrasonics to recall all 2,800 of its automated endoscope reprocessors over “continued violations of federal law and a consent decree entered with the company in 2007.”

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