Recall Z-2133-2026 ยท LWQ Heart-Valve, Mechanical
On-X Life Technologies, Inc.
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
| Date | May 8, 2026 (initiated Feb 1, 2026) |
| Status | Open, Classified |
| Reason | Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications. |
| Root cause | Under Investigation by firm |
| Action | On 2/1/2026, the firm contacted their customer to quarantine affected devices. |
| Quantity | 10 |
| Distribution | International distribution to the country of South Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.