FDA recall, , Moderate risk
HarmonyAIR A-Series Surgical Lighting System
The HarmonyAIR A-Series Surgical Lighting System has paint that may chip or peel on its light heads.
Summary by Recall Canary from the FDA notice
What happened
Steris Corporation, of Mentor, Ohio, recalled its HarmonyAIR A-Series Surgical Lighting System because there is a potential for paint delamination (chipping/peeling) on the lighting system's light heads. The recall began May 15, 2026, and was added to the FDA's Enforcement Report on June 15, 2026.
The system was distributed worldwide, including US Nationwide and the countries of Australia, Canada, India, New Zealand, and Panama.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
Incomplete list: 1,000 of 4,344 UDI-DIs shown.
A UDI-DI is the device identifier printed with the barcode on the device label.
HarmonyAIR A-Series Surgical Lighting System
- UDI-DI
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- 0429223083
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of Australia, Canada, India, New Zealand, Panama.
- Company
- Steris CorporationMentor, Ohio
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98767
- Recall number
- Z-2448-2026
- Quantity recalled
- 4138 units
All recalls from Steris Corporation
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
