BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1437-2026 · Initiated September 13, 2024

    Recall

    Recall Number
    Z-1437-2026
    Event Number
    98300
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    GCP
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    September 13, 2024
    Posted
    February 20, 2026
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229

    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.

    Action

    On January 15, 2026 URGENT: MEDICAL DEVICE REMOVAL letters were sent to customers. Actions to be taken: 1. Examine your inventory and quarantine any identified devices immediately. 2. Immediately cease usage of any affected products in your inventory. 3. Olympus requests that you acknowledge receipt of this letter through the recall web portal provided. 4. Please contact Customer Service at 1-800-848-9024, option 2, to obtain a Return Material Authorization. Olympus will arrange for the return of your device to Olympus. Olympus will issue a credit to your facility upon receipt of your WA22810A outer sheath. 5. If you have further distributed this product, please forward this notification to other users.

    Distribution

    Distribution US nationwide.

    Quantity

    633 units