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FDAAugust 16, 2021device

BF-Q180-AC EVIS EXERA II Bronchovideoscope, Model No. BF-Q180-AC

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."

What to do

FDA enforcement status: Terminated

Brands named

olympus

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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