Steris recalls specific Dual Flat Panel Monitor accessories for HarmonyAIR A-Series surgical lighting systems due to risk of yoke assembly detaching from spring arm, potentially causing injury during surgery.
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 is recalling certain Dual Flat Panel Monitor accessories for HarmonyAIR A-Series surgical lighting systems. The yoke assembly may detach from the spring arm, which could hang within the wiring and pose a risk during surgery.
The yoke assembly might detach from the spring arm but won't fully separate. Instead, it could hang within the wiring, potentially interfering with surgical procedures or causing injury if it moves unexpectedly during use.
Surgical teams using the recalled HarmonyAIR A-Series lighting systems with specific Dual Flat Panel Monitor accessories. The risk is highest for medical professionals during procedures where the accessory is in use.
Check for the specific serial numbers listed in the recall notice: 0400224028, 0401625167, and other numbers provided in the UDI (00724995203245). These accessories are part of HarmonyAIR A-Series surgical lighting systems.
Compare your accessory's serial number to the list of affected numbers provided in the recall notice.
The yoke assembly may detach from the spring arm but won't fully separate, hanging within the wiring and potentially interfering with surgical procedures.
Check if your accessory has a serial number listed in the recall notice: 0400224028, 0401625167, or other numbers provided in the UDI (00724995203245).
The recall notice does not specify a remedy, so contact Steris directly for guidance on next steps.
We’ve drafted a message you can send Steris to request your refund or repair — edit it as you like.
Subject: Recall Z-2177-2025 — Steris Steris Hello, I own a Steris that is covered by recall Z-2177-2025 from Steris. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
