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FDAOctober 16, 2023device

PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE

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

The hazard

Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.

What to do

FDA enforcement status: Ongoing

Brands named

aizu olympusaizu

UPCs

04953170305191

Recall history

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

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