ALYON ALYON Surgical Lighting System (REF LYH12)Recalls & reported problems
Steris Corporation · ALYON High Definition Dual Light, Accessory is used with the ALYON Lighting System · Class 2
All models of ALYON (26)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00724995222857), received between Jan 30, 2026 and Jul 30, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- May 15, 2026Class IIOpen, Classified
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
Z-2450-2026 · Root cause: Material/Component Contamination · Recall details · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 30, 2026Insufficient Device Problem Information
The user facility reported a "residue" on their endoscopes from S40 Sterilant following sterilization. Report of procedure cancellations.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50084193 ↗MalfunctionJan 30, 2026Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT THE KEYPAD YOKE CONTROL BUTTON COVER FELL FROM THE HANDLE OF THEIR ALYON SURGICAL LIGHTING SYSTEM INTO THE STERILE FIELD. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24220892 ↗
Other Light, surgical, ceiling mounted devices
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- HarmonyAIR A-Series Lighting SystemSteris Corporation · Light, surgical, ceiling mounted2 recalls2 reports
- HarmonyAIR A-Series Lighting SystemSteris Corporation · Light, surgical, ceiling mounted2 recalls2 reports
- HarmonyAIR A-Series Lighting SystemSteris Corporation · Light, surgical, ceiling mounted2 recalls1 report
- HarmonyAIR A-Series Lighting SystemSteris Corporation · Light, surgical, ceiling mounted2 recalls1 report
- HarmonyAIR A-Series Lighting SystemSteris Corporation · Light, surgical, ceiling mounted2 recalls1 report
- HarmonyAIR A-Series Lighting SystemSteris Corporation · Light, surgical, ceiling mounted2 recalls1 report
- HarmonyAIR A-Series Lighting SystemSteris Corporation · Light, surgical, ceiling mounted2 recalls1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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