Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2449-2026·Announced 2026-06-24

HarmonyAIR A-Series surgical light intensity control buttons may detach

HarmonyAIR A-Series Surgical Lighting Systems are being recalled because the plus and minus buttons used to control light intensity on the light heads may detach. 2,101 units affected.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall for a detaching control button with no clinical consequence described in the source, which fits the Moderate band.

Plain-English summary

The HarmonyAIR A-Series Surgical Lighting System from Steris Corporation is being recalled. The action covers 2,101 units, identified by the UDIs listed in the recall notice.

The stated reason is that the plus and minus buttons used to control light intensity on the light heads may detach. The FDA classified the action as Class II. The source does not describe a resulting clinical consequence.

Distribution was worldwide, including nationwide in the United States. The lighting systems are installed in healthcare facilities rather than sold to consumers.

Facilities should identify affected systems using the UDIs in the recall notice and follow the instructions issued by Steris.

The recalled product

Product: HarmonyAIR A-Series Surgical Lighting System
Manufacturer: Steris Corporation
Category: Medical Device — Surgical lighting system
Hazard: component-detachment
control-button
class-ii
Affected units: 2,101

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

UDIs: 00724995185947
00724995186418
00724995187156
00724995188009
00724995188498
00724995189198
00724995185954
00724995186425
00724995187170
00724995188016 00724995188504
00724995189211
00724995185961
00724995186432
00724995187187 00724995188047
00724995188535
00724995189228
00724995185978
00724995186548 00724995187217
00724995188054
00724995188542

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Steris Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Steris Corporation

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Same hazard · component detachment