Recalling firm
On-X Life Technologies, Inc.
Product type
Device
Status
Ongoing
Report date
2026-05-20
Distribution
International distribution to the country of South Korea.
Firm state
TX
Product quantity
10
Initiated by
Voluntary: Firm initiated
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.
Product description
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
Code / lot info
UDI-DI: 00851788001303. Serial Numbers: A2013401, A2013402, A2013403, A2013404, A2013405, A2013407, A2013408, A2013409, A2013410, A2013411. Expiration: 2031Dec17
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.