[Recalled] On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33 — Heart valves were released and distributed before all required testing was comp… | FDA 2026-02-01
A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.
Recall details
| Product | On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33 |
|---|---|
| Brand / manufacturer | On-X Life Technologies, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2133-2026 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 01 February 2026 |
| EAN / barcode | 00851788001303 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.