FDAFDA · Food and drugs·Recall number Z-2178-2025
Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems
Published August 6, 2025 · Recall initiated: June 23, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Steris Corporation
- Distributor
- Worldwide - US Nationwide and Puerto Rico and the country of Canada.
- Lot
- UDI: 00724995171155: Serial numbers: 0416920048, 0417820084, 0417820088, 0417820096, 0417820110, 0417820092, 0417820100, 0418420047, 0419620004, 0419520013, 0428620109, 0428620112, 0430020191, 0431720044, 0435120043, 0435120047, 0435120051, 0401321042, 0413221047, 0413221199, 0413721008, 0413721012, 0417221023, 0417221027, 0417221031, 0420021018, 0420021022, 0420021026, 0420721021, 0429720003, 0420921073, 0426321186, 0426321190, 0427121121, 0427121125, 0427321012, 0427321002, 0427321005, 0413921017, 0434121095, 0434121098, 0434121101, 0434121104, 0434121107, 0434121110, 0434121113, 0400722081, 0406022021, 0406022025, 0406022034, 0406022038, 0406022017, 0406022014, 0406022011, 0417122078, 0417122081, 0417122084, 0417122087, 0417122090.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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