BEUDAMED
    FDA Enforcement Class II Ongoing

    Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034

    Recall: Z-2620-2025 · Reported October 1, 2025

    Enforcement

    Recall Number
    Z-2620-2025
    Event ID
    97285
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Stryker Communications
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 1, 2025
    Initiation Date
    July 15, 2025
    Classification Date
    September 24, 2025
    Address
    571 Silveron Blvd, N/A, Flower Mound, TX, 75028, United States

    Description

    Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034

    Reason

    Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur.

    Code Info

    UDI-DI: 07613327296167 and 07613327651317 REF/Serial Numbers: CH00000001/7000010116, 7000010117, 7000010118, 7000010119, 7000010120, 7000010121, 7000010122, 7000010123, 7000010124, 7000010125, 7000010141, 7000010142, 7000010177, 7000010178, 7000010148, 7000010149, 7000010157, 7000010137, 7000010175, 7000010176, 7000010145, 7000010146, 7000010147, 7000010309, 7000010305, 7000010307, 7000010296, 7000010143, 7000010150, 7000010151, 7000010155. P60034/1000022, 1000023, 1000024, 1000016, 1000017, 1000018, 1000019, 1000020, 1000021

    Distribution

    US Nationwide distribution in the states of TX, IL, NY, UT, OR, AZ, VT, NY, IL, MN.

    Quantity

    40