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RecallWatchMedical Device Safety
Class IIOngoingZ-2133-2026

On-X Life Technologies, Inc. recalls On-X Mitral Heart Valve with Conform-X Sewing Ring

On-X Life Technologies, Inc.Austin, TX, United StatesReported May 20, 2026 · 3 months ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • On-X Mitral Heart Valve with Conform-X Sewing Ring, Model:ONXMC-25/33
    UDI-DI 00851788001303.
    11 affected lots
    A2013401A2013402A2013403A2013404A2013405A2013407A2013408A2013409
    +3 moreA2013410A20134112031Dec17

What the firm is doing

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

DistributionShow details

International distribution to the country of South Korea.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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