On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | February 01, 2026 |
| Reported | May 20, 2026 |
| Recalling firm | On-X Life Technologies, Inc. |
| Country / region | United States TX |
Hazard
Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
Affected products
- On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
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