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Limited official informationFDA Medical Device Enforcement ReportsRecall date: May 20, 2026

On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33

Verification delayed

The last verified facts remain visible. Last successful verification: Aug 4, 2026, 1:43 PM UTC. A temporary source failure does not mean the recall changed.

Official information is incomplete

Missing: action, consumer scope. The page is public for lookup but excluded from search indexing and advertising.

1Is my item affected?

Compare the complete identifiers. Name similarity alone is not a confirmed match.

On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33

Identifiers to compare

  • UDI 00851788001303
  • Model ONXMC-25/33
  • Serial Numbers
Affected variants from the official event record
Product or modelCodes and lotsQuantityRecall number
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33UDI-DI: 00851788001303. Serial Numbers: A2013401, A2013402, A2013403, A2013404, A2013405, A2013407, A2013408, A2013409, A2013410, A2013411. Expiration: 2031Dec1710Z-2133-2026

2What is the risk?

The agency's statement is shown without a site-authored severity score.

Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.

Agency classification: Class II

3What should I do?

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

Verify on the official source

The linked agency record controls if any information differs.

Official evidence

Official scope

Distribution reported by the agency

International distribution to the country of South Korea.

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

Material change history

No material affected-item, risk, action, or status change has been recorded since this page entered the tracker.