Product Wiki · Recalls · U.S. FDA — Device Enforcement

Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems — recall Z-2178-2025

U.S. FDA — Device Enforcement · United States · 2025-06-23 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2178-2025
Date of alert
2025-06-23
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Steris Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00724995171155
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.