Class III — Steris Corporation
| Recalling firm | STERIS Corporation |
|---|---|
| Registered facility | Key Surgical, LLC (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | In AMSCO Small Steam Sterilizers equipped with the CS-iQ feature, the sterilizer software inadvertently prevents the capability to operate the foot pedal, which allows the Operator to open and close the sterilizer door. |
| Product | AMSCO 400 and AMSCO C Small Steam Sterilizers |
| Quantity | 32 units |
| Distribution | US nationwide distribution. |
| Initiated | 2015-09-03 |
| Classified | 2015-11-04 |
| Terminated | 2016-01-22 |
| Recall number | Z-0210-2016 |
| 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 III recall — Steris Corporation (Z-0210-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72217/
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