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FDANovember 6, 2023device

Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal...

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

The hazard

Reports of a pink or green coloration of the image. If the issue is encountered during a procedure, device exchange could potentially result in prolonged surgery; potential visual impacts mucosal injury or bleeding may occur.

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

0404276107496404042761074971

Recall history

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

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