BEUDAMED
    FDA Recall Open, Classified

    Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.

    Recall: Z-1612-2026 · Initiated February 12, 2026

    Recall

    Recall Number
    Z-1612-2026
    Event Number
    98371
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    FEB
    Status
    Open, Classified
    Root Cause
    Reprocessing Controls
    Initiated
    February 12, 2026
    Posted
    March 20, 2026
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229

    Description

    Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.

    Reason

    The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

    Action

    Olympus notified consignees on about 02/12/2026 via URGENT: MEDICAL DEVICE CORRECTION letter. Consignees were instructed to immediately cease reprocessing the MAJ-1443 and MAJ-1444 valves in an OER-Pro or OER-Elite and ensure all personnel are completely knowledgeable and thoroughly trained on the content of this notification and the full extent of the MAJ-1443 and MAJ-1444 reprocessing steps as detailed in the provided Instructions for Use (IFU). The updated IFU can also be accessed electronically through OlympusConnect.com. Additionally, consignees were instructed to replace any existing copies of the MAJ-1443/MAJ-1444 IFU with the updated IFU provided in this letter, identify and notify all customers if affected units were further distributed and complete and confirm receipt of the notification via the Olympus web portal.

    Distribution

    US Nationwide distribution.

    Quantity

    2,929 units