BEUDAMED
    FDA Recall Open, Classified

    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.

    Recall: Z-1904-2026 · Initiated March 25, 2026

    Recall

    Recall Number
    Z-1904-2026
    Event Number
    98544
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    FEB
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    March 25, 2026
    Posted
    April 22, 2026
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229

    Description

    OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.

    Reason

    Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

    Action

    Olympus notified consignees on about 03/25/2026 via letter titled "URGENT: MEDICAL DEVICE REMOVAL." Consignees were notified of the issue and hazard involved and were instructed to examine inventory and OER-ELITE devices for the affected product. The current version has black lock levers. The previous versions have gray lock levers or integrated lock levers, which are the same color as the rest of the connector. Consignees were instructed that if they have sufficient quantities of the current version (black) to support reprocessing needs, stop using the previous version and set aside for return. They may proceed with using the current version, only. If they have insufficient quantities of the current version (black) available, and do not have another method of endoscope reprocessing readily available, they may continue using the previous version(s) consistent with the Instructions for Use, which require users to inspect the connecting tube prior to use. Transition to the current version as soon as possible by placing an order through Customer Service at 1-800-848-9024, option 2. When sufficient quantities of the current version (black) are obtained to support reprocessing needs, stop using the previous version and only use the current version going forward. Then arrange for return the previous version of the connector. Consignees were also requested to confirm receipt of the letter through the Olympus web portal and forward the notification to other users who may have the affected products if product were further distributed.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.

    Quantity

    373 units