Drug recall
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
FDA recall event 98548 · Class II · On-X Life Technologies, Inc.
Key facts
| Event ID | 98548 |
|---|---|
| Recall numbers | Z-2133-2026 |
| Recalling firm | On-X Life Technologies, Inc. |
| Product type | Devices |
| Products | On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications. |
| Initiation date | Feb 1, 2026 |
| Report date | May 20, 2026 |
| City | Austin |
| State | TX |
| Country | United States |
| FEI number | 3001584317 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: