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FDAAugust 17, 2021device

EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160

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

The hazard

A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a potential for the insertion tube to develop a leak, which poses an infection control risk.

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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