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Recall Observatory FDA recall evidence

Device product

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

Z-2133-2026

February 01, 2026

Class II

Product summary

Firm
On-X Life Technologies, Inc.
Event
Event 98548
Status
Ongoing
Classification
Class II
Quantity
10
Official record key
device-enforcement:Z-2133-2026

Official wording

Reason: Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.

Code information: UDI-DI: 00851788001303. Serial Numbers: A2013401, A2013402, A2013403, A2013404, A2013405, A2013407, A2013408, A2013409, A2013410, A2013411. Expiration: 2031Dec17

Distribution pattern: International distribution to the country of South Korea.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.