Data Foundry

Medical device recalls 2025

Dual Flat Panel Monitor — Class II medical device recall Z-2178-2025

Ongoing recall by Steris Corporation, reported 2025-08-06, distributed nationwide. The DFPM yoke assembly ("yoke assembly") may detach from the spring arm. Should the yoke assembly detach from

Recall numberZ-2178-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmSteris Corporation, Mentor, OH, United States
Recall initiated2025-06-23
Classified2025-07-25
Reported by FDA2025-08-06
DistributedNationwide (US)
Countries outside the USCA
Quantity59 units
Reason classesdevice malfunction
UPC / GTIN / UDI-DI00724995171155
Serial numbers0400722081, 0401321042, 0406022011, 0406022014, 0406022017, 0406022021, 0406022025, 0406022034, 0406022038, 0413221047, 0413221199, 0413721008, 0413721012, 0413921017, 0416920048, 0417122078, 0417122081, 0417122084, 0417122087, 0417122090, 0417221023, 0417221027, 0417221031, 0417820084, 0417820088 and 34 more

Product

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2178-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.