BEUDAMED
    FDA Recall Open, Classified

    ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80

    Recall: Z-0147-2026 · Initiated September 11, 2025

    Recall

    Recall Number
    Z-0147-2026
    Event Number
    97654
    Firm
    Ethicon Endo-Surgery Inc
    FEI Number
    1527736
    Product Code
    GDW
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    September 11, 2025
    Posted
    October 14, 2025
    Address
    4545 Creek Rd, Blue Ash, OH, 45242-2803

    Description

    ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80

    Reason

    The devices were shipped unsterilized.

    Action

    An IMPORTANT CUSTOMER NOTIFICATION was sent to customers beginning 9/11/25. Actions Required Complete the Business Reply Form (BRF) (Attachment 1) confirming receipt and your understanding of this notification.

    Distribution

    International distribution to the countries of United Arab Emirates.

    Quantity

    3 units