FDAClass II · Medical device · Recall Z-2133-2026 · Recalled May 20, 2026
On-X Mitral Heart Valve with Conform-X Sewing Ring recall — On-X Life Technologies, Inc.
Agency report date: May 20, 2026.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Agency product description and boundaries
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
2. Agency hazard and consumer action
FDA reports: Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.
Class II: may cause temporary or medically reversible health consequences.
Affected product: On-X Mitral Heart Valve with Conform-X Sewing Ring recall status
3. Open the official notice or contact
View the official FDA enforcement record (openFDA) ↗
Affected products
Companies & origin
Identifying details (verbatim from the notice)
Related recalls
Other medical device recalls from around the same time
- Automated Impella Controller (AIC) recall — Abiomed, Inc.FDA · June 3, 2026
- RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers recall — Bolton Medical Inc.FDA · June 3, 2026
- NextStep Antegrade Chronic Hemodialysis Catheter recall — ARROW INTERNATIONAL, LLCFDA · May 20, 2026
- Cannon II Plus Hemodialysis Catheter recall — ARROW INTERNATIONAL, LLCFDA · May 20, 2026
- Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter recall — ARROW INTERNATIONAL, LLCFDA · May 20, 2026
- CPSC — consumer products ↗ (aggregated here)
- NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
- FDA — food, drugs, medical devices ↗ (aggregated here)
- USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
- Recalls.gov — the U.S. government’s all-agency portal ↗
Found something wrong or missing? Report a data error.
Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved August 18, 2026 at 6:00 PM UTC.