FDA Device recall Z-2448-2026
HarmonyAIR A-Series Surgical Lighting System
- FDA Device
- Class II
- ongoing
- Published 2026-06-24
On 2026-06-24 the FDA classified a Class II recall of HarmonyAIR A-Series Surgical Lighting System by Steris, citing there is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2448-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-05-15 |
| Published | 2026-06-24 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Steris |
| Distribution | US |
Product
HarmonyAIR A-Series Surgical Lighting System
Reason
There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.
Identifiers
| code_info | UDIs: 00724995186388, 00724995186401, 00724995188320, 00724995188481, 00724995188467, 00724995188498, 00724995189433, 0…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2448-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.