Class II — Steris Corporation
| Recalling firm | STERIS Corporation |
|---|---|
| Registered facility | Key Surgical, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads. |
| Product | HarmonyAIR A-Series Surgical Lighting System |
| Quantity | 4138 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Canada, India, New Zealand, Panama. |
| Initiated | 2026-05-15 |
| Classified | 2026-06-15 |
| Recall number | Z-2448-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Steris Corporation (Z-2448-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98767/
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