Steris Corporation: Light, Surgical, Ceiling Mounted
- Recalling firm
- Steris Corporation
- Product
- HarmonyAIR A-Series Surgical Lighting System
- Reason
- There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-15
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Canada, India, New Zealand, Panama.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/0cfb06bf-336e-42c8-9770-4b015bc192f0