Recall Z-2178-2025— Steris Corporation
Class II · Ongoing
Class II FDA medical device recall by Steris Corporation, initiated 2025-06-23. FDA's recall record names no specific 510(k) clearance for this event. Product: Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems. Reason: 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..
- Recalling firm
- Steris Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-06-23
- Firm location
- Mentor, OH, United States
Product description
Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.