On-X Life Technologies, Inc. recalls On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
- Recall date
- February 1, 2026
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2133-2026
- FDA classification
- Class II
- Brand / firm
- On-X Life Technologies, Inc.
- Sold / distributed
- International distribution to the country of South Korea.
Why it was recalled
Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
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