Class II — Steris Corporation
| Recalling firm | STERIS Corporation |
|---|---|
| Registered facility | Key Surgical, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | STERIS has identified that the pivot pin assembly located on the table top may become loose preventing the table from articulating properly. |
| Product | OT1000 Series Orthopedic Surgical Tables |
| Quantity | 148 |
| Distribution | AL;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. |
| Initiated | 2016-05-23 |
| Classified | 2016-07-20 |
| Terminated | 2016-08-22 |
| Recall number | Z-2248-2016 |
| Initiation | Voluntary: 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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