On-X recalls specific mitral heart valve models due to incomplete testing before release. Affected units may not meet all safety specifications.
Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
On-X is recalling certain mitral heart valve models because they were released before all required testing was complete. This means the valves might not meet all safety standards, which could pose risks during medical use.
The heart valves were distributed before completing all necessary testing, so it cannot be confirmed they meet all required safety specifications. This could lead to potential issues during medical procedures if the valves do not perform as expected.
Patients who received the specific model of mitral heart valve (ONXMC-25/33) with serial numbers listed above are affected. Medical professionals using these valves for procedures are also at risk.
Check for the model number ONXMC-25/33 and serial numbers A2013401 through A2013411. The expiration date is December 17, 2031.
Verify the model number and serial numbers listed in the recall notice to confirm if your device is affected.
The valves were released before all required testing was complete, so it cannot be confirmed they meet all safety specifications.
The recall notice does not specify a remedy, so check the product details to see if your device is affected.
The recall states the valves may not meet all safety specifications due to incomplete testing, but specific risks are not detailed.
We’ve drafted a message you can send On-X to request your refund or repair — edit it as you like.
Subject: Recall Z-2133-2026 — On-X On-X Hello, I own a On-X that is covered by recall Z-2133-2026 from On-X. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
