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FDASeptember 13, 2024device

Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product Description: Outer sheaths can be combined with rigid Telescopes. Component: N/A

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

The hazard

Olympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from the Instruction for Use (IFU) due to the potential for a damaged tip during use of a laser probe.

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

04042761051729

Recall history

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

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