BEUDAMED
    FDA Enforcement Class II Ongoing

    Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITL

    Recall: Z-1469-2025 · Reported April 9, 2025

    Enforcement

    Recall Number
    Z-1469-2025
    Event ID
    96393
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 9, 2025
    Initiation Date
    February 25, 2025
    Classification Date
    March 28, 2025
    Address
    1941 Stryker Way, Portage, MI, 49002-9711, United States

    Description

    Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITL

    Reason

    There is a potential for blister seals on the product to present a bubble on the seal area of the packaging. This seal acts as a sterile barrier and, in this event, indicates that the sterility seal has been breached.

    Code Info

    5400-010-000 UDI-DI: 07613327301663, Lot Numbers:2023011112, 2023020334, 2023072413, 2024032615; 5400-010-000ITL UDI-DI: 07613327359510, Lot Numbers: 2023022132 2023112213 2024020515 2024032013

    Distribution

    US Nationwide distribution.

    Quantity

    182,344 total units