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Recall Observatory FDA recall evidence

Device product

Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139038-01 139039-01 139040-01 139041-01 139043-01 139044-01 139045-01 139046-01 139049-01 139051-01 139052-01 139053-01 139054-01 139055-01 139056-01 139058-01 139059-01 139060-01 139061-01 139064-01 139065-01 139066-01 139067-01 139068-01 139069-01 139070-01 139071-01 139072-01 139164-01 139165-01 300

Z-0368-2026

September 30, 2025

Class II

Product summary

Firm
CareFusion 303, Inc.
Event
Event 97566
Status
Ongoing
Classification
Class II
Quantity
2,755 units
Official record key
device-enforcement:Z-0368-2026

Official wording

Reason: Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

Code information: All Serial Numbers/Ref #/UDI: 1119-00 10885403512704, 1139-00 10885403512704, 139038-01 N/A, 139039-01 N/A, 139040-01 N/A, 139041-01 N/A, 139043-01 N/A, 139044-01 N/A, 139045-01 N/A, 139046-01 N/A, 139049-01 N/A, 139051-01 N/A, 139052-01 N/A, 139053-01 N/A, 139054-01 N/A, 139055-01 N/A, 139056-01 N/A, 139058-01 N/A, 139059-01 N/A, 139060-01 N/A, 139061-01 N/A, 139064-01 N/A, 139065-01 N/A, 139066-01 N/A, 139067-01 N/A, 139068-01 N/A, 139069-01 N/A, 139070-01 N/A, 139071-01 N/A, 139072-01 N/A, 139164-01 N/A, 139165-01 N/A, 300 N/A

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, United Arab Emirates, Australia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.