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MEDICAL DEVICE RECALLMODERATE
HarmonyAIR A-Series Surgical Lighting System
HarmonyAIR A-Series surgical lights recalled: intensity buttons may detach.
What to do
Stop using the affected surgical lighting system and contact Steris Corporation for instructions on repair or replacement.
Why it was recalled
Steris Corporation is recalling the HarmonyAIR A-Series Surgical Lighting System because the plus and minus buttons (+/-) used to control light intensity on the light heads may detach, posing a risk of malfunction during surgical procedures.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | Recall # | UDI-DI |
|---|---|---|
| HarmonyAIR A-Series Surgical Lighting System | Z-2449-2026 | 00724995185947, 00724995186418, 00724995187156, 00724995188009, 00724995188498, 00724995189198, 00724995185954, 00724995186425, 00724995187170, 00724995188016, 00724995188504, 00724995189211, 00724995185961, 00724995186432, 00724995187187, 00724995188047, 00724995188535, 00724995189228, 00724995185978, 00724995186548 |
| ALYON Surgical Lighting System | Z-2450-2026 | 00724995223182, 00724995223137, 00724995223151, 00724995223175, 00724995222895, 00724995222994, 00724995223014, 00724995223021, 00724995223083, 00724995223106, 00724995222758, 00724995223120, 00724995223113, 00724995222840, 00724995223038, 00724995223076, 00724995222987, 00724995223007, 00724995222703, 00724995222727 |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Device Defect recalls
Other recent recalls from Steris Corporation
Editorial summary by Recall Canary · summary updated 2026-09-08 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification