fda_recall · device_recall · high
On-X Life Technologies, Inc. — Class II recall: On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
- Event date
- 2026-05-20 00:00:00Z
- Observed
- 2026-07-09 22:52:29Z
- Source ID
- Z-2133-2026
- Payload hash
- e92684c97c7d5af3756f6bc8…
Summary
Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications. Status: Ongoing.
Entities
Informational only. Not legal, financial, or medical advice.