On-X Mitral Heart Valve with Conform-X Sewing Ring recall
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
Why was On-X Mitral Heart Valve with Conform-X Sewing Ring recalled?
Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00851788001303. Serial Numbers: A2013401, A2013402, A2013403, A2013404, A2013405, A2013407, A2013408, A2013409, A2013410, A2013411. Expiration: 2031Dec17
- Product
- On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
- Recalling firm
- On-X Life Technologies, Inc.
- Quantity
- 10
- Distribution
- International distribution to the country of South Korea.
- Recall date
- May 20, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)