BEUDAMED
    FDA Enforcement Class I Ongoing

    Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.

    Recall: Z-1353-2026 · Reported February 25, 2026

    Enforcement

    Recall Number
    Z-1353-2026
    Event ID
    98243
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 25, 2026
    Initiation Date
    January 16, 2026
    Classification Date
    February 18, 2026
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229, United States

    Description

    Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.

    Reason

    Issue with software algorithm which may lead to overpressure events.

    Code Info

    Model Number: UHI-2; UDI-DI: N/A; All Serial Numbers

    Distribution

    Nationwide distribution

    Quantity

    744 units