RegWardenFDA facility compliance records
Recall

Class II — Steris Corporation

Recalling firmSTERIS Corporation
Registered facilityKey Surgical, LLC (the firm's only registered facility)
ClassificationClass II
StatusOngoing
ReasonThe the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.
ProductALYON Surgical Lighting System
Quantity549 units
DistributionWorldwide - US Nationwide distribution.
Initiated2026-05-15
Classified2026-06-15
Recall numberZ-2450-2026
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Steris Corporation (Z-2450-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98768/

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