Recall Z-2448-2026 ยท FSY Light, Surgical, Ceiling Mounted
Steris Corporation
HarmonyAIR A-Series Surgical Lighting System
| Date | Jun 15, 2026 (initiated May 15, 2026) |
| Status | Open, Classified |
| Reason | There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads. |
| Root cause | Process change control |
| Action | An URGENT MEDICAL DEVICE RECALL notification letter dated 5/1/26 was sent to customers. STERIS Action All affected Customers will be contacted by a STERIS Service Technician to arrange an onsite inspection of their lighting system(s) to perform the correction as soon as possible. For the paint issue, each affected lighting system will undergo a full visual inspection for any signs of paint delamination; as needed a service kit will be installed to prevent paint chipping from occurring or if deemed necessary replaced. For the button issue, each affected lighting system will undergo inspectio |
| Quantity | 4138 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Canada, India, New Zealand, Panama. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.