Official recall notice
FDA DeviceClass IINotable
FDA Recall: HarmonyAIR A-Series Surgical Lighting System
- Recall date
- 2026-06-24
- Brand
- Steris Corporation
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.
Recommended action
What to do
4138 units
Product description
There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.