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On-X Mitral Heart Valve with Conform-X Sewing Ring, Model:… recallZ-2133-2026 · On-X Life Technologies, Inc. · initiated Feb 1, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from On-X Life Technologies, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

On 2/1/2026, the firm contacted their customer to quarantine affected devices.

Recall details

Recall number
Z-2133-2026
Status
Open, Classified
Initiated by the company
Feb 1, 2026
Posted by the FDA
May 8, 2026
Recalling firm
On-X Life Technologies, Inc.
Quantity
10
Product code
LWQ
FDA submissions
P000037
Distribution
International distribution to the country of South Korea.

Product description

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

Code information (models, lots, serial numbers)

UDI-DI: 00851788001303. Serial Numbers: A2013401, A2013402, A2013403, A2013404, A2013405, A2013407, A2013408, A2013409, A2013410, A2013411. Expiration: 2031Dec17

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

23 devices cleared under P000037 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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