Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2133-2026 — On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33

U.S. FDA — Device Enforcement · United States · 2026-02-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2133-2026
Date of alert
2026-02-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
On-X Life Technologies, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00851788001303
Reported risk: Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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