On-x Life Technologies, Inc.: Heart-valve, Mechanical
- Recalling firm
- On-X Life Technologies, Inc.
- Product
- On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
- Reason
- Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
- Classification
- Class III
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-02-01
- Status
- Open, Classified
- Distribution
- International distribution to the country of South Korea.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/171ba9cd-92b5-4d1b-ae49-b17d850cb718