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Olympus Corporation of the Americas: Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;

Medical DevicesSource: FDA (device) · Date: 2026-03-04

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Olympus Corporation of the Americas
Product
Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
Distribution US nationwide.
Recall initiated
2024-09-13
Code info
Model: WA2280A; UDI: 04042761051729; Lot#: All lots;
Product quantity
633 units
Voluntary mandated
Voluntary: Firm initiated
City
Center Valley
State
PA
Country
United States
Event id
98300
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