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FDASeptember 25, 2023device

Ureteralscope- for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and hepatic duct). Model Numbers: URF-P6, URF-P6R.

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

0495317034080204953170340833

Recall history

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

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