Class II

Medical Device Recall: Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems

Steris Corporation · June 23, 2025

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.

Distribution

Worldwide - US Nationwide and Puerto Rico and the country of Canada.

States Affected

NATIONWIDE

Quantity Affected

167 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2177-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Steris Corporation Medical Device Recall: Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems | SafeCheck