FDA DevicesClass II
HarmonyAIR A-Series Surgical Lighting System
Published: June 24, 2026Recall ID: Z-2448-2026Category: devicesCountry: US
Reason for Recall / Hazard
There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.
Product Description & Identification
HarmonyAIR A-Series Surgical Lighting System
Additional Source Details
| Field | Value |
|---|---|
| City | Mentor |
| State | OH |
| Event id | 98767 |
| Address 1 | 5960 Heisley Rd |
| Code info | 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, 0072499... [TRUNCATED] |
| Postal code | 44060-1834 |
| Report date | 20260624 |
| Product type | Devices |
| Product quantity | 4138 units |
| Reason for recall | There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads. |
| 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 distribution - US Nationwide and the countries of Australia, Canada, India, New Zealand, Panama.