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 ATLAS loading car may not remain fully engaged with the latch on the transfer carriage when the loading car is empty, potentially resulting in the loading car unexpectedly sliding forward or falling to one side.
ProductATLAS Loading Car
Quantity129
DistributionNationwide domestic distribution. Foreign distribution to Canada, Costa Rica, Indonesia, South Korea, and Taiwan.
Initiated2018-12-26
Classified2019-02-13
Terminated2020-06-16
Recall numberZ-0824-2019
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-0824-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82023/

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