ALYONRecalls & reported problems across all models
Steris Corporation · 26 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one ALYON model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 2
We found 26 models of ALYON by Steris Corporation in the FDA's device registry (GUDID). Together they are named in 5 adverse event reports in the FDA's MAUDE database, received between Nov 21, 2025 and Aug 5, 2026 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
ALYON recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 15, 2026Open, 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 · names 25 of these models · Recall details · FDA record ↗
- May 15, 2026Open, Classified
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
Z-2449-2026 · Root cause: Material/Component Contamination · Recall details · FDA record ↗
Most reported ALYON problems
Device problems
- Detachment of Device or Device Component3
- Insufficient Device Problem Information1
- Power Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
ALYON models
26 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ALYON ALYON Surgical Lighting SystemLight, surgical, ceiling mounted1 recall3 reports
- ALYON ALYON Surgical Lighting SystemLight, surgical, ceiling mounted1 recall2 reports
- ALYON ALYON Surgical Lighting SystemLight, surgical, ceiling mounted1 recall0 reports
- ALYON ALYON Surgical Lighting SystemLight, surgical, ceiling mounted1 recall0 reports
- ALYON ALYON Surgical Lighting SystemLight, surgical, ceiling mounted1 recall0 reports
- ALYON ALYON Surgical Lighting SystemLight, surgical, ceiling mounted1 recall0 reports
- ALYON ALYON Surgical Lighting SystemLight, surgical, ceiling mounted1 recall0 reports
- ALYON ALYON Surgical Lighting SystemLight, surgical, ceiling mounted1 recall0 reports
- ALYON ALYON Surgical Lighting SystemLight, surgical, ceiling mounted1 recall0 reports
- ALYON ALYON Surgical Lighting SystemLight, surgical, ceiling mounted1 recall0 reports
- ALYON ALYON Light Mobile StandLight, surgical, ceiling mounted1 recall0 reports
- ALYON ALYON Surgical Lighting SystemLight, surgical, ceiling mounted1 recall0 reports
- ALYON ALYON Surgical Lighting SystemLight, surgical, ceiling mounted1 recall0 reports
- ALYON ALYON Surgical Lighting SystemLight, surgical, ceiling mounted1 recall0 reports
- ALYON ALYON Surgical Lighting SystemLight, surgical, ceiling mounted1 recall0 reports
- ALYON ALYON Surgical Lighting SystemLight, surgical, ceiling mounted1 recall0 reports
- ALYON ALYON Surgical Lighting SystemLight, surgical, ceiling mounted1 recall0 reports
- ALYON ALYON Surgical Lighting SystemLight, surgical, ceiling mounted1 recall0 reports
- ALYON ALYON Surgical Lighting SystemLight, surgical, ceiling mounted1 recall0 reports
- ALYON ALYON Surgical Lighting SystemLight, surgical, ceiling mounted1 recall0 reports
- ALYON ALYON Surgical Lighting SystemLight, surgical, ceiling mounted1 recall0 reports
- ALYON ALYON Surgical Lighting SystemLight, surgical, ceiling mounted1 recall0 reports
- ALYON ALYON Surgical Lighting SystemLight, surgical, ceiling mounted1 recall0 reports
- ALYON ALYON Surgical Lighting SystemLight, surgical, ceiling mounted1 recall0 reports
- ALYON ALYON Surgical Lighting SystemLight, surgical, ceiling mounted1 recall0 reports
- ALYON ALYON Surgical Lighting SystemLight, surgical, ceiling mounted1 recall0 reports
Recent ALYON adverse event reports
The 5 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 5, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50144102 ↗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 ↗MalfunctionJan 16, 2026Power Problem
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR ALYON DUAL LIGHT BEGAN "FLICKERING." THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24095235 ↗MalfunctionNov 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE PLASTIC CAP TO THEIR ALYON DUAL LIGHT DETACHED AND FELL OFF. THE STERILE FIELD WAS RE-ESTABLISHED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23621386 ↗
Other Steris Corporation products
All Steris Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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