On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
FDA device recall Z-2133-2026 · posted 2026-05-08 · Open, Classified
Recall details
- Recalling firm
- On-X Life Technologies, Inc.
- Reason for recall
- Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
- Action taken
- On 2/1/2026, the firm contacted their customer to quarantine affected devices.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- LWQ
- Quantity affected
- 10
- Distribution
- International distribution to the country of South Korea.
- Date initiated
- 2026-02-01
- Date posted
- 2026-05-08
- Location
- Austin, TX
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