CareFusion 303 product recalled over fire hazard

Recall date

September 30, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

CareFusion 303, Inc. recalls Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139038-01 139039-01 139040-01 139041-01 139043-0…

Recall number

Z-0368-2026

FDA classification

Class II

Brand / firm

CareFusion 303, Inc.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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