BEUDAMED
    FDA Enforcement Class II Ongoing

    Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITL

    Recall: Z-1475-2025 · Reported April 9, 2025

    Enforcement

    Recall Number
    Z-1475-2025
    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 Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITL

    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

    5400-020-100 UDI-DI: 07613327301656, Lot Numbers: 2022101016 2023021716 2023062115 2023082113 2024022114; 5400-020-100ITL UDI-DI: 07613327359497, Lot Numbers: 2023021715 2023100214 2023102315 2024012414 2024022615 2024041015 2024052114 2024082713 2023072513 2023100515 2023102615 2024012914 2024030515 2024041714 2024052415 2023082114 2023101015 2023111515 2024020117 2024030815 2024042214 2024060412 2023082915 2023101312 2024010813 2024021315 2024031314 2024050713 2024072912 2023092532 2023101815 2024011115 2024021615 2024040515 2024051414 2024081415

    Distribution

    US Nationwide distribution.

    Quantity

    182,344 total units