HarmonyAIR A-Series Surgical Lighting System — Class II medical device recall Z-2448-2026
Ongoing recall by Steris Corporation, reported 2026-06-24, distributed nationwide. There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.
| Recall number | Z-2448-2026 |
|---|---|
| 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) |
| Countries outside the US | AU, CA, IN, NZ, PA |
| Quantity | 4,138 units |
| UPC / GTIN / UDI-DI | 00724995185947, 00724995185954, 00724995185961, 00724995185978, 00724995185985, 00724995186067, 00724995186074, 00724995186081, 00724995186098, 00724995186104, 00724995186111, 00724995186128, 00724995186135, 00724995186142, 00724995186166, 00724995186173, 00724995186180, 00724995186203, 00724995186302, 00724995186319, 00724995186326, 00724995186333, 00724995186340, 00724995186357, 00724995186364 and 182 more |
| Serial numbers | 0400224025, 0400324053, 0400324060, 0400324064, 0400324068, 0400324072, 0400324076, 0400324080, 0400424007, 0400424011, 0400424015, 0400424019, 0400424023, 0400424027, 0400424031, 0400424035, 0400424048, 0400424053, 0400424058, 0400424063, 0400424068, 0400424073, 0400424078, 0400424083, 0400625020 and 475 more |
Product
HarmonyAIR A-Series Surgical Lighting System
Reason for recall
There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.
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-2448-2026. 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.