Class II — On-X Life Technologies, Inc.
| Recalling firm | On-X Life Technologies, Inc |
|---|---|
| Registered facility | On-X Life Technologies Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications. |
| Product | On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33 |
| Quantity | 10 |
| Distribution | International distribution to the country of South Korea. |
| Initiated | 2026-02-01 |
| Classified | 2026-05-08 |
| Recall number | Z-2133-2026 |
| 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 — On-X Life Technologies, Inc. (Z-2133-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98548/
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