On-X Life Technologies, Inc. recalls On-X Mitral Heart Valve with Conform-X Sewing Ring
Reason for recall
Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- On-X Mitral Heart Valve with Conform-X Sewing Ring, Model:ONXMC-25/33UDI-DI 00851788001303.11 affected lotsA2013401A2013402A2013403A2013404A2013405A2013407A2013408A2013409
+3 more
A2013410A20134112031Dec17
What the firm is doing
On 2/1/2026, the firm contacted their customer to quarantine affected devices.
DistributionShow detailsHide
International distribution to the country of South Korea.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2133-2026
- FDA device classification · LWQOfficial FDA classification for this device type
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find On-X Life Technologies, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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