BEUDAMED
    FDA Recall Open, Classified

    Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;

    Recall: Z-2281-2026 · Initiated April 15, 2026

    Recall

    Recall Number
    Z-2281-2026
    Event Number
    98871
    FEI Number
    1219930
    Product Code
    OCW
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    April 15, 2026
    Posted
    June 1, 2026
    Address
    LP 60 Middletown Ave, Covidien, North Haven, CT, 06473-3908

    Description

    Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;

    Reason

    The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and protect the product from environmental exposure.

    Action

    On April 23, 2026 URGENT: VOLUNTARY MEDICAL DEVICE RECALL letters were sent to customers. Customer actions: - Immediately identify and quarantine all unused impacted product listed above. - See Appendix A for guidance on identifying affected lots. - This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Return all unused impacted product listed above to Medtronic. Medtronic Actions: - Medtronic representatives will assist customers with the return of affected product, upon request. - Medtronic representatives will work with customers to ensure replacement products are available to avoid interruptions in patient care.

    Distribution

    Domestic: Nationwide distribution; International: Austria, Canada, Denmark, France, Italy;

    Quantity

    2448 units