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FDASeptember 25, 2023device

Ultrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs Model Number: TGF-UC180J.

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

04953170328480

Recall history

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

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