HarmonyAIR A-Series Surgical Lighting System recall (Steris Corporation)
Medical deviceClass IIOngoing
Summary: Steris Corporation is recalling HarmonyAIR A-Series Surgical Lighting System. Reason: The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
What is being recalled
HarmonyAIR A-Series Surgical Lighting System
Why
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide - US Nationwide distribution.
How to tell if yours is affected
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
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2449-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | May 15, 2026 |
| Reported | June 24, 2026 |
| Company | Steris Corporation |
| Company location | Mentor, OH, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 2101 units |
More recalls from Steris Corporation · all medical device recalls · recalls from May 2026