ALYON surgical light head intensity control buttons may detach
ALYON Surgical Lighting Systems are being recalled because the plus and minus buttons used to control light intensity on the light heads may detach. 549 units are 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 ALYON Surgical Lighting System from Steris Corporation is being recalled. The action covers 549 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
- ALYON Surgical Lighting System
- Manufacturer
- Steris Corporation
- Affected units
- 549
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: 00724995223182 00724995223137
- 00724995223151
- 00724995223175
- 00724995222895
- 00724995222994 00724995223014
- 00724995223021
- 00724995223083
- 00724995223106
- 00724995222758 00724995223120
- 00724995223113
- 00724995222840
- 00724995223038
- 00724995223076 00724995222987
- 00724995223007
- 00724995222703
- 00724995222727
- 00724995223090 00724995225711
- 00724995225681
- 00724995225698
- 00724995225728
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 →Related recalls
Same manufacturer · Steris Corporation
See all →- SevereSteris Recalls VERIFY Biological Steam Test Packs Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological/Integrator Challenge Pack Recall for Sterilization Monitoring Failure
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological Steam Test Pack Recalled for Spore Population Defect
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological/Integrator Challenge Pack Recall for Spore Population Defect
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological Indicator Recall Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
Same hazard · component detachment
See all →- HighOlympus BiCOAG Hemostasis Probe Recalled for Ceramic Tip Detachment Risk
FDA (Devices) · 2026-09-30
- SevereOlympus BiCOAG Hemostasis Probe Recall Due to Ceramic Tip Detachment Risk
FDA (Devices) · 2026-09-30
- HighOlympus BiCOAG Hemostasis Probe Recalled for Ceramic Tip Detachment Risk
FDA (Devices) · 2026-09-30
- HighOlympus BiCOAG Hemostasis Probe Recalled for Potential Ceramic Tip Detachment
FDA (Devices) · 2026-09-30
- ModerateGalt Medical Recalls Boston Scientific Transcarotid Access Kits
FDA (Devices) · 2026-08-19
Similar recalls
- ModerateHarmonyAIR A-Series surgical light heads may show paint delamination
FDA (Devices) · 2026-06-24
- ModerateSteris Recalls Harmony vLED Surgical Lighting Systems Due to Inconsistent Illumination
FDA (Devices) · 2015-01-14
- HighHarmonyAIR dual flat panel monitor yokes may detach from spring arm
FDA (Devices) · 2025-08-06
- HighSteris surgical light handle covers may detach during procedures
FDA (Devices) · 2023-05-10
- HighMaquet PowerLED 700 Surgical Light Recall Due to Detaching Module
FDA (Devices) · 2014-06-18
- HighHarmonyAIR E-Series monitor yokes may detach from the spring arm
FDA (Devices) · 2025-08-06