Medical device recalls Moderate risk

Steris Corporation recalls Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems

Recall date
June 23, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2178-2025
FDA classification
Class II
Brand / firm
Steris Corporation
Sold / distributed
Worldwide - US Nationwide and Puerto Rico and the country of Canada.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems

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