[pending] HarmonyAIR A-Series Surgical Lighting System
Pending LLM rewrite. Source: FDA_DEVICE Z-2448-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.
The recalled product
- Product
- HarmonyAIR A-Series Surgical Lighting System
- Manufacturer
- Steris Corporation
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDIs: 00724995186388
- 00724995186401
- 00724995188320
- 00724995188481
- 00724995188467
- 00724995188498
- 00724995189433
- 00724995186562
- 00724995188696
- 00724995188627
- 00724995188610
- 00724995186074
- 00724995186081
- 00724995186302
- 00724995186319
- 00724995188269
- 00724995186371
- 00724995188634
- 00724995186326
- 00724995186067
Distribution
Distributed nationwide across the United States.
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