FDA DeviceClass IINotable

FDA Recall: HarmonyAIR A-Series Surgical Lighting System

Date: 2026-06-24
Brand: Steris Corporation
Category: Medical Device
FDA Class: Class II

Description

There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.

Hazard

There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.

Remedy

4138 units

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