On-X Mitral Heart Valve Recall Issued
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
On-X Life Technologies, Inc. is recalling 10 On-X Mitral Heart Valves distributed to South Korea because they were released before all required testing was completed.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on June 2, 2026 and geographically references South Korea. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
On-X Life Technologies, Inc. initiated a voluntary recall of certain heart valves after determining they were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
Which Products Are Affected
The recall involves the On-X Mitral Heart Valve with Conform-X Sewing Ring, Model ONXMC-25/33. A total of 10 units are affected with the following serial numbers: A2013401, A2013402, A2013403, A2013404, A2013405, A2013407, A2013408, A2013409, A2013410, A2013411. UDI-DI is 00851788001303 and expiration date is 2031Dec17. Distribution was limited to South Korea.
What You Should Do
Consumers and healthcare providers should contact the recalling firm for return or further instructions regarding the affected devices.
Why This Matters
The recall affects a small number of implantable heart valves whose compliance with release specifications cannot be confirmed.
Source
FDA Recall Z-2133-2026 - On-X Life Technologies, Inc., Austin, TX
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,065 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to June 2, 2026.
Frequently Asked Questions
Common questions about this FDA recall.