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
ReasonSTERIS has identified that the pivot pin assembly located on the table top may become loose preventing the table from articulating properly.
ProductOT1000 Series Orthopedic Surgical Tables
Quantity148
DistributionAL;AK, AZ; AR; CA; CO; CT; DC; FL; GA; IL; IN; IA; NY; NJ; NC; OH; OK; OR; PA; PR; SC; TX; UT and VA. Foreign accounts: Canada; France; Korea; Panama; Qatar and Thailand.
Initiated2016-05-23
Classified2016-07-20
Terminated2016-08-22
Recall numberZ-2248-2016
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-2248-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74264/

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