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FDASeptember 25, 2023device

Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.

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

The hazard

Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

What to do

FDA enforcement status: Ongoing

Brands named

aizu olympusaizu

UPCs

04953170340178

Recall history

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

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Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP. — Recall Details · AllClear