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Recall Observatory FDA recall evidence

Device product

ALYON Surgical Lighting System

Z-2450-2026

May 15, 2026

Class II

Product summary

Firm
Steris Corporation
Event
Event 98768
Status
Ongoing
Classification
Class II
Quantity
549 units
Official record key
device-enforcement:Z-2450-2026

Official wording

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

Code information: 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

Distribution pattern: Worldwide - US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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