Steris Corporation recalls Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Sy…

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.

Steris issued an URGENT MEDICAL DEVICE RECALL NOTICE dated 06/17/2025 to its consignees on 06/23/2025 disseminated via FedEx. The notice explained the issue, potential risk, and requested the following: User Action: Please ensure the following steps are completed: 1. Review the revised Preventive Maintenance Manual and Interval Based Check List language depending on which HarmonyAIR Surgical Lighting System model(s) are in use at your facility (A-Series and/or E-Series) (please reference Attachments B-E of the letter for maintenance instructions). 2. Immediately complete the maintenance activities as instructed, and then again annually going forward. 3. Complete the Medical Device Recall Response Form included with this letter. 4. Return the completed Response Form via email to: Regulatory_Compliance@STERIS.com, or via fax to 440-392-8963. 5. Distributors: If you have further distributed this product, please identify your Customer(s), and notify them of this recall.

• FDA enforcement recordOfficial FDA database entry for Z-2178-2025
• FDA device classification · FSYOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.4580The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Steris CorporationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.