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Open, Classified

On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33

FDA Recall Z-2133-2026 · Posted 2026-05-08

Recalling FirmOn-X Life Technologies, Inc.
Recall StatusOpen, Classified
Product CodeLWQ
Date Initiated2026-02-01
Product Quantity10

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.

Firm Action

On 2/1/2026, the firm contacted their customer to quarantine affected devices.

Root Cause

Under Investigation by firm

Distribution Pattern

International distribution to the country of South Korea.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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