FDA recall Z-2449-2026
Steris Corporation · Class II · device
Product
HarmonyAIR A-Series Surgical Lighting System
Reason for recall
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
Distribution
Worldwide - US Nationwide distribution.
Key facts
- Status
- Ongoing
- Initiation date
- 2026-05-15
- Report date
- 2026-06-24
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Mentor, OH, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2449-2026