Class II U.S. Food and Drug Administration

Steris Corporation ALYON Surgical Lighting System recall: The the plus and minus buttons (+/-) used to control light intensity

Recall published 4 months ago

The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2450-2026
Published
June 24, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Steris Corporation
Product type
Medical devices
Units affected
549 units
Distribution
Nationwide
Made in
United States
Lot / code info
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, 00724995222826 00724995222802, 00724995222857, 00724995222697, 00724995222956, and 00724995223229
UPC codes
00724995223182, 00724995223137, 00724995223151, 00724995223175, 00724995222895, 00724995222994, 00724995223014, 00724995223021, 00724995223083, 00724995223106, 00724995222758, 00724995223120, 00724995223113, 00724995222840, 00724995223038, 00724995223076, 00724995222987, 00724995223007, 00724995222703, 00724995222727

Products covered by this recall

ALYON Surgical Lighting System

Check your product

The notice names 20 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00724995223182
  • 00724995223137
  • 00724995223151
  • 00724995223175
  • 00724995222895
  • 00724995222994
  • 00724995223014
  • 00724995223021
  • 00724995223083
  • 00724995223106
  • 00724995222758
  • 00724995223120
  • 00724995223113
  • 00724995222840
  • 00724995223038
  • 00724995223076
  • 00724995222987
  • 00724995223007
  • 00724995222703
  • 00724995222727

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Steris Corporation — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Steris Corporation — 5960 Heisley Rd, Mentor, OH, 44060-1834

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Steris Corporation medical devices recalled?

The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach. The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00724995223182, 00724995223137, 00724995223151. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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