Class II U.S. Food and Drug Administration

On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33 recall: Heart valves were released and distributed before all required testing

Recall published 5 months ago

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

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

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

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2133-2026
Published
May 20, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
On-X Life Technologies, Inc.
Product type
Medical devices
Units affected
10
Made in
United States
Lot / code info
UDI-DI: 00851788001303. Serial Numbers: A2013401, A2013402, A2013403, A2013404, A2013405, A2013407, A2013408, A2013409, A2013410, A2013411. Expiration: 2031Dec17

Products covered by this recall

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

Check your product

The notice names 7 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 2031Dec17 — 10

Model or item number

On the rating label, the box or the instruction sheet.

  • ONXMC-25
  • 33 — UDI-DI

Serial number

On the rating plate, often next to the date of manufacture.

  • A2013401
  • A2013402
  • A2013403
  • A2013404

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

On-X Life Technologies, Inc. — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: On-X Life Technologies, Inc. — 1300 E Anderson Ln Ste B, Austin, TX, 78752-1739

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was On-X Life Technologies, Inc. medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: best-by date 2031Dec17 — 10; model number ONXMC-25, 33 — UDI-DI. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

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