BEUDAMED
    FDA Enforcement Class II Ongoing

    HarmonyAIR A-Series Surgical Lighting System

    Recall: Z-2449-2026 · Reported June 24, 2026

    Enforcement

    Recall Number
    Z-2449-2026
    Event ID
    98768
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Steris Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 24, 2026
    Initiation Date
    May 15, 2026
    Classification Date
    June 15, 2026
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834, United States

    Description

    HarmonyAIR A-Series Surgical Lighting System

    Reason

    The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.

    Code Info

    UDIs: 00724995185947, 00724995186418, 00724995187156, 00724995188009, 00724995188498, 00724995189198, 00724995185954, 00724995186425, 00724995187170, 00724995188016 00724995188504, 00724995189211, 00724995185961, 00724995186432, 00724995187187 00724995188047, 00724995188535, 00724995189228, 00724995185978, 00724995186548 00724995187217, 00724995188054, 00724995188542, 00724995189280,00724995185985, 00724995186555, 00724995187248, 00724995188078, 00724995188580, 00724995189372, 00724995186067, 00724995186562, 00724995187262, 00724995188122, 00724995188597, 00724995189419, 00724995186074, 00724995186579, 00724995187279, 00724995188221, 00724995188603, 00724995189990, 00724995186081, 00724995186593, 00724995187286, 00724995188238, 00724995188610, 00724995190002, 00724995186098, 00724995186616, 00724995187347, 00724995188245, 00724995188627, 00724995190033, 00724995186111, 00724995186623, 00724995187378, 00724995188252, 00724995188634, 00724995190040, 00724995186128, 00724995186661, 00724995187385, 00724995188269, 00724995188641, 00724995190354, 00724995186135, 00724995186678, 00724995187415, 00724995188276, 00724995188658, 00724995190361, 00724995186203, 00724995186685, 00724995187453, 00724995188283, 00724995188665, 00724995199364, 00724995186302, 00724995186692, 00724995187484, 00724995188290, 00724995188672, 00724995199913, 00724995186319, 00724995186722, 00724995187538, 00724995188306, 00724995188689, 00724995199944, 00724995186326, 00724995186739, 00724995187569, 00724995188313, 00724995188702, 00724995200480, 00724995186333, 00724995186746, 00724995187576, 00724995188320, 00724995188726, 00724995200886, 00724995186340, 00724995186753, 00724995187583, 00724995188337, 00724995188849, 00724995200909,00724995186357, 00724995186760, 00724995187606, 00724995188344, 00724995188948, 00724995200930, 00724995186364, 00724995186784, 00724995187620, 00724995188375, 00724995189068, 00724995200947, 00724995186371, 00724995186807, 00724995187712, 00724995188412, 00724995189075, 00724995200961, 00724995186388, 00724995186906, 00724995187729, 00724995188467, 00724995189105, 00724995201074, 00724995186395, 00724995187125, 00724995187989, 00724995188474, 00724995189136, 00724995217372, 00724995186401, 00724995187149, 00724995187996, 00724995188481, 00724995189181, 00724995222970

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    2101 units