FDA-Device2026-06-24Class IIPROCESSING DEFECT
Steris HarmonyAIR A-Series Surgical Lighting System recalled for paint delamination
What this means
Paint on the light heads of Steris HarmonyAIR A-Series Surgical Lighting Systems may chip or peel. This could potentially affect the lighting system's performance or introduce debris into the surgical field. The FDA has classified this as a Class II recall.
- Check if your surgical lighting system matches one of the affected UDI or serial numbers listed in the FDA notice
- Contact Steris Corporation for instructions on inspection, repair, or replacement
- Do not use the system if paint delamination is visible until a remedy is provided
The agency's original wording
Hazard
There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the countries of Australia, Canada, India, New Zealand, Panama.
Affected count
4138 units
Manufactured in
5960 Heisley Rd, Mentor, OH, United States
Products
HarmonyAIR A-Series Surgical Lighting System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2448-2026Want us to check the next one for you?
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