BEUDAMED
    FDA Enforcement Class II Ongoing

    Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applications.

    Recall: Z-1438-2026 · Reported March 4, 2026

    Enforcement

    Recall Number
    Z-1438-2026
    Event ID
    98288
    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
    November 11, 2025
    Classification Date
    February 20, 2026
    Address
    3500 Corporate Pkwy, N/A, Center Valley, PA, 18034-8229, United States

    Description

    Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applications.

    Reason

    Complaints of the ceramic tip of the resection sheath breaking have been received.

    Code Info

    Model: A22014A (UDI: 04042761020893) and A22014T (UDI: 04042761020909). All lots.

    Distribution

    US Nationwide Distribution.

    Quantity

    29 units