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 | Potential for cleaning solution intrusion into endoscope |
| Product | Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning Part number: 0600818OKN |
| Quantity | 293 units:248 units (USA); 45 units OUS |
| Distribution | Nationwide Foreign: Canada, Italy, Kuwait, United Kingdom, United Arab Emirates |
| Initiated | 2020-10-07 |
| Classified | 2020-11-16 |
| Terminated | 2021-07-14 |
| Recall number | Z-0458-2021 |
| 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-0458-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86596/
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