RegWardenFDA facility compliance records
Recall

Class II — Steris Corporation

Recalling firmSTERIS Corporation
Registered facilityKey Surgical, LLC (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonThe locking pin of the front wheel asse mbly of the Evolution Transfer Carriages may not remain full y engaged with the transfer carriage and result in the transfer carriage and loading car unexpectedly falling forward
ProductEvolution Loading Car and Transfer Carriage- Accessory to the Sterilizer, Steam
Quantity237 units
DistributionNationwide Foreign: Canada, Peru, Mexico, Brazil, Saudi Arabia, Columbia
Initiated2019-10-22
Classified2019-11-29
Terminated2020-06-09
Recall numberZ-0586-2020
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-0586-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84229/

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