Class II — Steris Corporation
| Recalling firm | STERIS Corporation |
|---|---|
| Registered facility | Key Surgical, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing process for a limited batch of MNA-6x0 (adapter) components the incorrect configuration file was used. |
| Product | Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H |
| Quantity | 10 units |
| Distribution | US Nationwide distribution in the states of FL, NC, NY, OH, TN, TX, and VA. |
| Initiated | 2025-05-23 |
| Classified | 2026-02-12 |
| Recall number | Z-1361-2026 |
| 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-1361-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98266/
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