Recall Z-2448-2026
- Recall number
- Z-2448-2026
- Event number
- 98767
- Firm
- Steris Corporation
- Firm FEI
- 1527821
- Product code
- FSY
- Status
- Open, Classified
- Initiated
- 2026-05-15
- Posted
- 2026-06-15
- Root cause
- Process change control
- 510(k) numbers
- K102758, K132551, K000639, K900211, K011693, K024132, K891756, K974084, K040735, K063333, K072072, K040015, K031068, K873786, K122875, K131893, K892808, K093010, K071698, K820681, K854922, K943288, K030906, K083323, K042382, K090378, K896674, K132747, K982063, K061317
Product#
HarmonyAIR A-Series Surgical Lighting System
Reason for Recall#
There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.