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HarmonyAIR A-Series Surgical Lighting System

Class II
Recalling firm
Steris Corporation
Reason for recall
There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.
Affected products (lot / model / serial)
UDIs: 00724995186388, 00724995186401, 00724995188320, 00724995188481, 00724995188467, 00724995188498, 00724995189433, 00724995186562, 00724995188696, 00724995188627, 00724995188610, 00724995186074, 00724995186081, 00724995186302, 00724995186319, 00724995188269, 00724995186371, 00724995188634, 00724995186326, 00724995186067, 00724995186548, 00724995186579, 00724995188580, 00724995187149, 00724995187170, 00724995187989, 00724995187644, 00724995188337, 00724995189297, 00724995188313, 00724995186128, 00724995188689, 00724995188252, 00724995188474, 00724995188597, 00724995188221, 00724995189174, 00724995188276, 00724995186180, 00724995189143 00724995186111, 00724995186340, 00724995187224, 00724995189075, 00724995188306 00724995188603, 00724995189051, 00724995200954, 00724995200022, 00724995199906 00724995190033, 00724995186678, 00724995188351, 00724995188665, 00724995187996 00724995189068, 00724995189099, 00724995189150, 00724995199869, 00724995187385 00724995187347, 00724995200886, 00724995190361, 00724995200893, 00724995200916 00724995186333, 00724995187026, 00724995187262, 00724995186715, 00724995186746 00724995188283, 00724995187279, 00724995186135, 00724995188511, 00724995188009, 00724995188245, 00724995189310, 00724995186555, 00724995188504, 00724995187033 00724995190354, 00724995188238, 00724995186739, 00724995188290, 00724995199890, 00724995187156, 00724995187187, 00724995187521, 00724995187552, 00724995186142, 00724995186647, 00724995185985, 00724995186104, 00724995187781, 00724995189334 00724995185954, 00724995186418, 00724995187217, 00724995189181, 00724995187415 00724995188030, 00724995189372, 00724995201128, 00724995189990, 00724995189235 00724995189204, 00724995200251, 00724995201135, 00724995200367, 00724995200343 00724995200114, 00724995200909, 00724995186357, 00724995188542, 00724995186173 00724995186661, 00724995200732, 00724995186807, 00724995200701, 00724995187569, 00724995186364, 00724995199401, 00724995186203, 00724995189198, 00724995190040 00724995186098, 00724995189136, 00724995189105, 00724995200329, 00724995188412, 00724995185978, 00724995186784, 00724995187712, 00724995188047, 00724995187088 00724995186685, 00724995186692, 00724995188641, 00724995186920, 00724995188658 00724995199388, 00724995200138, 00724995186500, 00724995199876, 00724995199364 00724995188672, 00724995188535, 00724995188122, 00724995186425, 00724995186616 00724995188375, 00724995187798, 00724995185947, 00724995186487, 00724995188016 00724995186753, 00724995188726, 00724995186166, 00724995199371, 00724995186906, 00724995188399, 00724995186449, 00724995189167, 00724995187231, 00724995187200 00724995187460, 00724995200770, 00724995200084, 00724995187576, 00724995187606 00724995200466, 00724995188108, 00724995186395, 00724995188054, 00724995189211 00724995200480, 00724995200947, 00724995189228, 00724995187620, 00724995189419 00724995201074, 00724995187125, 00724995188344, 00724995186623, 00724995188849 00724995200930, 00724995188078, 00724995188948, 00724995187286, 00724995187453 00724995199944, 00724995199913, 00724995186432, 00724995187484, 00724995187538 00724995190002, 00724995187248, 00724995188702, 00724995187378, 00724995185961 00724995186593, 00724995200961, 00724995189280, 00724995186722, 00724995186760 00724995187729, and 00724995187583; Serial Numbers: 0400224025 0402925005 0405124082 0407625017 0410525114 0413525005 0416725078 0419625227 0421623131 0423023296 0424625031 0426724199 0428824307 0431124255 0433724085 0400324053 0402925009 0405124092 0407625022 0410525120 0413525006 0416725082 0419625232 0421623135 0423023301 0424625032 0426824004 0428824308 0431225037 0433724089 0400324060 0402925023 0405124097 0407625025 0410525124 0413525008 0416725086 0419625237 0421623139 0423023332 0424625033 0426824008 0428923045 0431225041 0433724093 0400324064 0402925028 0405124102 0407625028 0410525128 0413525009 0416725091 0419625260 0421623143 0423023336 0424625034 0426825108 0428924044 0431225045 0433724097 0400324068 0402925033 0405124
Units affected
4138 units
Distribution pattern
Worldwide distribution - US Nationwide and the countries of Australia, Canada, India, New Zealand, Panama.
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-2448-2026
Recall initiated
May 15, 2026
FDA classification date
June 15, 2026
FDA report date
June 24, 2026
FDA event ID
98767
Last updated on HTM Vibe
July 23, 2026
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