Reported May 20, 2026 · Ongoing
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
On-X Life Technologies, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: On-X Life Technologies, Inc. · 1300 E Anderson Ln Ste B · Austin, TX · 78752-1739
Is this the product you have?
- On-X Mitral Heart Valve with Conform-X Sewing Ring
- ModelONXMC-25/33
- Lot codes and dates
- UDI-DI00851788001303
- Serial Numbers
A2013401A2013402A2013403A2013404A2013405A2013407A2013408A2013409A2013410A2013411
- Expiration2031Dec17
- Amount recalled
- 10
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.
This product could cause temporary or reversible health problems — stop using it.
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