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HarmonyAIR A-Series Surgical Lighting System

Class II
Recalling firm
Steris Corporation
Reason for recall
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
Affected products (lot / model / serial)
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
Units affected
2101 units
Distribution pattern
Worldwide - US Nationwide distribution.
Firm location
Mentor, OH, United States
Recall type
Voluntary: Firm initiated
How the firm notified customers
Letter
Product type
Devices
Status
Ongoing
Recall number
Z-2449-2026
Recall initiated
May 15, 2026
FDA classification date
June 15, 2026
FDA report date
June 24, 2026
FDA event ID
98768
Last updated on HTM Vibe
July 23, 2026
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