FDA Medical Device Recalls (openFDA)
On-X Life Technologies, Inc.: On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
- Recall number
- Z-2133-2026
- Recalling firm
- On-X Life Technologies, Inc.
- Product
- On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
- Status
- Open, Classified
- Initiated
- 2026-02-01
- Posted
- 2026-05-08
- Terminated
- not on file
- Reason
- Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
- Root cause
- Under Investigation by firm
- Action
- On 2/1/2026, the firm contacted their customer to quarantine affected devices.
- Quantity
- 10
- Distribution
- International distribution to the country of South Korea.
- Lot, serial or model codes
- UDI-DI: 00851788001303. Serial Numbers: A2013401, A2013402, A2013403, A2013404, A2013405, A2013407, A2013408, A2013409, A2013410, A2013411. Expiration: 2031Dec17
- 510(k) numbers
- not on file
- PMA numbers
- ["P000037"]
- Product code
- LWQ
- Firm FEI
- 3001584317
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28