BEUDAMED
    FDA Recall Open, Classified

    Olympus High Flow Insufflation Unit. Model Number: UHI-3. 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-1354-2026 · Initiated January 16, 2026

    Recall

    Recall Number
    Z-1354-2026
    Event Number
    98243
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    HIF
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    January 16, 2026
    Posted
    February 18, 2026
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229

    Description

    Olympus High Flow Insufflation Unit. Model Number: UHI-3. 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.

    Action

    Olympus notified consignees on about 01/16/2026 via "URGENT: MEDICAL DEVICE REMOVAL" letter. Consignees were instructed to cease usage of the affected product immediately. They are advised to use available alternatives including an existing UHI-4 if available or switching to an insufflation device from another manufacturer. If no alternative is available on site, contact Olympus to arrange a loaner or purchase a replacement. Additionally, consignees were instructed to examine inventory and quarantine any identified devices, immediately cease usage of any UHI, UHI-2, and/or UHI-3 in inventory, call Olympus Customer Service at 1-800-848-9024, option 2 to obtain a Return Material Authorization to return your device. Consignees were also requested to acknowledge receipt of this letter through their recall web portal as follows: a. Go to https://olympusamerica.com/recall, b. Enter the recall number "0489 and c. Complete the form as instructed. Please indicate in your response if you no longer have the device(s). If any consignees have further distributed this UHI product, they were instructed to identify affected customers and forward this notice to them immediately. If you require additional information, please do not hesitate to contact me by phone at (647) 999-3203 or by email at [email protected].

    Distribution

    Nationwide distribution

    Quantity

    485 units