FDA-Device2026-03-04Class II
Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
Olympus Corporation of the Americas
Hazard
Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the device.
Sold states
Distribution US nationwide.
Affected count
633 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1437-2026Original summary
Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A; Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the device. Model: WA2280A; UDI: 04042761051729; Lot#: All lots; Distribution: Distribution US nationwide. Affected quantity: 633 units
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