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On-X Life Technologies, Inc. recalls On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
Recalled May 20, 2026 · FDA recall Z-2133-2026 · On-X Life Technologies
Hazard
Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications. · FDA Class II
Units
10
Sold at
International distribution to the country of South Korea.
Description
Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
Product
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
Manufacturer(s)
On-X Life Technologies, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →