The FDA announced on June 23, 2025, that Steris Corporation is recalling Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems because the yoke assembly may detach from the spring arm. The agency recalled 59 units distributed worldwide, including in the U.S., Puerto Rico, and Canada.
How to tell if you have it
- Brand: Steris
- Product: Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems
- 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
- Quantity: 59 units
The hazard
According to the FDA, the DFPM yoke assembly may detach from the spring arm. The agency stated that should the yoke assembly detach, it would not be expected to fully detach but rather hang from the wiring within the yoke assembly.
Context
GovInfoNow's records show Steris Corporation has 29 other recalls on record since June 15, 2017. Other recent recalls of similar products include Steris HarmonyAIR A-Series Surgical Lights (May 15, 2026), Steris - Steris Corporation (May 15, 2026), and Steris AMSCO 7053HP Washer/Disinfector Recall (Nov. 19, 2025). Other recent recalls of similar products include Olympus HX-400U-30 Ligating Device Recall (Oct. 30, 2025) and Philips Azurion System Recall (March 31, 2026).