BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-2281-2026 · Reported June 10, 2026

    Enforcement

    Recall Number
    Z-2281-2026
    Event ID
    98871
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Covidien, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 10, 2026
    Initiation Date
    April 15, 2026
    Classification Date
    June 1, 2026
    Address
    60 Middletown Ave, North Haven, CT, 06473-3908, United States

    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.

    Code Info

    1. Product Number: 170053; UDI-DI: 10884521126732; UPN: 20884521126739; Lot number: J5L2332Y; 2. Product Number: 170071; UDI-DI: 10884521126787; UPN: 20884521126784; Lot number: J5H2924Y;

    Distribution

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

    Quantity

    2448 units