Recall Atlas
Drugs & medicalClass II

On-X Life Technologies, Inc. recalls 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 complete, so it cannot be confirmed that they meet all release specifications.

Read the official notice →
Date
2026-05-20
Country
United States
Brand
On-X Life Technologies, Inc.
Product
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
Classification
Class II
Units
International distribution to the country of South Korea.
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

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