AllClear
PricingSign in
FDAFebruary 1, 2026device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.

What to do

FDA enforcement status: Ongoing

Brands named

on x life technologies

UPCs

00851788001303

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

Own something like this?

AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.

Start free — 200 items, no card →