FDA Recall
Open, Classified
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
Recall: Z-2133-2026
·
Initiated February 1, 2026
Recall
- Recall Number
- Z-2133-2026
- Event Number
- 98548
- Firm
- On-X Life Technologies, Inc.
- FEI Number
- 3001584317
- Product Code
- LWQ
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- February 1, 2026
- Posted
- May 8, 2026
- Address
- 1300 E Anderson Ln, Ste B, Austin, TX, 78752-1739
Description
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
Reason
Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
Action
On 2/1/2026, the firm contacted their customer to quarantine affected devices.
Distribution
International distribution to the country of South Korea.
Quantity
10