CareFusion 303, Inc. recalls Various models of BD Pyxis MedFlex

Recalling company

CareFusion 303, Inc.

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

Reason

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

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Sep 30, 2025

Reported

Nov 5, 2025

Distribution

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

Status

Ongoing

Quantity

2,755 units

Lot / codes

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

Company location

San Diego, CA

Recall type

Voluntary: Firm initiated

Recall number

Z-0368-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0368-2026 in the FDA Enforcement Report. Also see FDA recall press releases.