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Medical Device

On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33

Recall date: 2026-05-20 · Source: FDA_DEVICE
Brand / Firm
On-X Life Technologies, Inc.
Product
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
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.
Units affected
10
Description
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
View official recall notice →