FDA DevicesClass II
HarmonyAIR A-Series Surgical Lighting System
Published: June 24, 2026Recall ID: Z-2449-2026Category: devicesCountry: US
Reason for Recall / Hazard
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
Product Description & Identification
HarmonyAIR A-Series Surgical Lighting System
Additional Source Details
| Field | Value |
|---|---|
| City | Mentor |
| State | OH |
| Event id | 98768 |
| Address 1 | 5960 Heisley Rd |
| 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, 007249... [TRUNCATED] |
| Postal code | 44060-1834 |
| Report date | 20260624 |
| Product type | Devices |
| Product quantity | 2101 units |
| Reason for recall | The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260515 |
| Initial firm notification | Letter |
| Center classification date | 20260615 |
Overview
- Recalling FirmSteris Corporation
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - US Nationwide distribution.