Class 2 Device Recall OnX Mitral Heart Valve with ConformX Sewing Ring

• Date Initiated by Firm: February 01, 2026
• Date Posted: May 08, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2133-2026
• Recall Event ID: 98548
• PMA Number: P000037
• Product Classification: Heart-valve, mechanical - Product Code LWQ
• Product: On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
• Code Information: UDI-DI: 00851788001303. Serial Numbers: A2013401, A2013402, A2013403, A2013404, A2013405, A2013407, A2013408, A2013409, A2013410, A2013411. Expiration: 2031Dec17
• FEI Number: 3001584317
• Recalling Firm/ Manufacturer: On-X Life Technologies, Inc.; 1300 E Anderson Ln Ste B; Austin TX 78752-1739
• For Additional Information Contact: 512-339-8000
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: On 2/1/2026, the firm contacted their customer to quarantine affected devices.
• Quantity in Commerce: 10
• Distribution: International distribution to the country of South Korea.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = LWQ