FDA recall Z-2133-2026

On-X Life Technologies, Inc. · Class II · device

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.

Distribution

International distribution to the country of South Korea.

Key facts

Status: Ongoing
Initiation date: 2026-02-01
Report date: 2026-05-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: Austin, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2133-2026