Steris Corporation recalls ALYON Surgical Lighting System
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
- Ceiling Mounted Surgical Light
- Material/Component Contamination
The FDA has posted 8 enforcement recalls from Steris Corporation since 2025, none of them Class I (most serious). Most recent report: Jun 24, 2026.
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.
This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing process for a limited batch of MNA-6x0 (adapter) components the incorrect configuration file was used.
Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).
Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).
The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be expected to fully detach but rather hang from the wiring within…
The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from the spring arm, the yoke assembly would not be expected to fully detach but rather hang from the wiring within…
Firm name as filed with the FDA: “Steris Corporation”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.