HarmonyAIR A-Series Surgical Lighting System — Class II medical device recall Z-2449-2026
Ongoing recall by Steris Corporation, reported 2026-06-24, distributed nationwide. The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
| Recall number | Z-2449-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Steris Corporation, Mentor, OH, United States |
| Recall initiated | 2026-05-15 |
| Classified | 2026-06-15 |
| Reported by FDA | 2026-06-24 |
| Distributed | Nationwide (US) |
| Quantity | 2,101 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00724995185947, 00724995185954, 00724995185961, 00724995185978, 00724995185985, 00724995186067, 00724995186074, 00724995186081, 00724995186098, 00724995186111, 00724995186128, 00724995186135, 00724995186203, 00724995186302, 00724995186319, 00724995186326, 00724995186333, 00724995186340, 00724995186357, 00724995186364, 00724995186371, 00724995186388, 00724995186395, 00724995186401, 00724995186418 and 119 more |
Product
HarmonyAIR A-Series Surgical Lighting System
Reason for recall
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2449-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.