BEUDAMED
    FDA Enforcement Class II Ongoing

    Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;

    Recall: Z-1437-2026 · Reported March 4, 2026

    Enforcement

    Recall Number
    Z-1437-2026
    Event ID
    98300
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 4, 2026
    Initiation Date
    September 13, 2024
    Classification Date
    February 20, 2026
    Address
    3500 Corporate Pkwy, N/A, Center Valley, PA, 18034-8229, United States

    Description

    Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;

    Reason

    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.

    Code Info

    Model: WA2280A; UDI: 04042761051729; Lot#: All lots;

    Distribution

    Distribution US nationwide.

    Quantity

    633 units