HarmonyAIR A-Series surgical light heads may show paint delamination
HarmonyAIR A-Series Surgical Lighting Systems are being recalled because of the potential for paint delamination, meaning chipping or peeling, on the light heads. 4,138 units affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall for surface paint chipping or peeling with no clinical consequence described in the source, which fits the Moderate band.
Plain-English summary
The HarmonyAIR A-Series Surgical Lighting System from Steris Corporation is being recalled. The action covers 4,138 units, identified by the UDIs listed in the recall notice.
The stated reason is that there is a potential for paint delamination, meaning chipping or peeling, on the lighting system's light heads. The FDA classified the action as Class II. The source does not describe a resulting clinical consequence.
Distribution was worldwide, including nationwide in the United States and to Australia, Canada and other markets. The lighting systems are installed in healthcare facilities rather than sold to consumers.
Facilities should identify affected systems using the UDIs in the recall notice and follow the instructions issued by Steris.
The recalled product
- Product
- HarmonyAIR A-Series Surgical Lighting System
- Manufacturer
- Steris Corporation
- Affected units
- 4,138
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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