Steris Corporation: Device Recall
Recall #Z-2178-2025 · 06/23/2025
Class II: Risk
Recall Details
- Recall Number
- Z-2178-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Steris Corporation
- Status
- Ongoing
- Date Initiated
- 06/23/2025
- Location
- Mentor, OH, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 59 units
Reason for Recall
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 yoke assembly.
Product Description
Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems
Distribution Pattern
Worldwide - US Nationwide and Puerto Rico and the country of Canada.
Other Recalls by Steris Corporation
- Class II: Risk 11/19/2025
- Class II: Risk 11/19/2025
- Class II: Risk 06/23/2025
- Class II: Risk 06/13/2024
- Class II: Risk 06/13/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.