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Steris Corporation: ALYON Surgical Lighting System

Medical DevicesSource: FDA (device) · Date: 2026-06-24

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Steris Corporation
Product
ALYON Surgical Lighting System
Reason / hazard
The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide - US Nationwide distribution.
Recall initiated
2026-05-15
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
Product quantity
549 units
Voluntary mandated
Voluntary: Firm initiated
City
Mentor
State
OH
Country
United States
Event id
98768
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