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Home › FDA recalls › HarmonyAIR A-Series Surgical Lighting System
CLASS II · ModerateFDA

Steris Corporation recalls HarmonyAIR A-Series Surgical Lighting System

📅 May 15, 2026 · 📍 Nationwide
Recalling company
Steris Corporation
Product
HarmonyAIR A-Series Surgical Lighting System
Reason
There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
May 15, 2026
Reported
Jun 24, 2026
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Canada, India, New Zealand, Panama.
Status
Ongoing
Quantity
4138 units
Lot / codes
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
Company location
Mentor, OH
Recall type
Voluntary: Firm initiated
Recall number
Z-2448-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2448-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.