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ALYON recallZ-2450-2026 · Steris Corporation · initiated May 15, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Steris Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Material/Component Contamination

What the company is doing

An URGENT MEDICAL DEVICE RECALL notification letter dated 5/1/26 was sent to customers. STERIS Action All affected Customers will be contacted by a STERIS Service Technician to arrange an onsite inspection of their lighting system(s) to perform the correction as soon as possible. For the paint issue, each affected lighting system will undergo a full visual inspection for any signs of paint delamination; as needed a service kit will be installed to prevent paint chipping from occurring or if deemed necessary replaced. For the button issue, each affected lighting system will undergo inspection for any signs of potential separation from the light head and handle. Buttons failing this inspection will be replaced. User Action Users can continue to use their lighting system(s) prior to completion of the correction. Users are reminded to ensure no excess fluids remain on light head during or after cleaning, per the Operator Manuals. Should any issues be observed prior to the correction being completed, users should submit a complaint by contacting STERIS Customer Service at 1-800-548-4873. Users are also reminded to report any adverse events via FDA s MedWatch Database should an event occur. We apologize for any inconvenience this matter may cause, and as always, STERIS is dedicated to supporting our products and valued Customers. If you have questions regarding this matter, please contact your local Account Manager.

Recall details

Recall number
Z-2450-2026
Status
Open, Classified
Initiated by the company
May 15, 2026
Posted by the FDA
Jun 15, 2026
Recalling firm
Steris Corporation
Quantity
549 units
Product code
FSY
Distribution
Worldwide - US Nationwide distribution.

Product description

ALYON Surgical Lighting System

Code information (models, lots, serial numbers)

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

Devices named in this recall

25 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 98768).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page