Austin, TX, United States
On-X Life Technologies, Inc. recalls
1 recall recorded since 2018, most recently on 1 February 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 1 February 2026
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2133-2026
- On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.