CLASS II ONGOING Device recall · Reported 24 Jun 2026 · FDA Enforcement Report

Alyon Surgical Lighting System recalled by Steris

Steris is recalling Alyon Surgical Lighting System, distributed nationwide in the US. The recall was initiated on 15 May 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDIs: 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

Quantity recalled549 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2450-2026
FDA event ID: 98768
Recalling firm: Steris, Mentor, OH
Classification: Class II
Status: Ongoing
Recall initiated: 15 May 2026
FDA classified: 15 Jun 2026
Reported: 24 Jun 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

15 May 2026	Recall initiated by company
15 Jun 2026	Classified by FDA	+31 days
24 Jun 2026	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

ALYON Surgical Lighting System

Where it was distributed

Worldwide - US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

Worldwide - US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 98768

This product is part of a recall event; the main page for the event is HarmonyAIR A-Series Surgical Lighting System recalled by Steris.

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026	CLASS II	HarmonyAIR A-Series Surgical Lighting System recalled by Steris	Steris	Other	Nationwide

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