Recall Z-0368-2026— CareFusion 303, Inc.
Class II · Ongoing
Class II FDA medical device recall by CareFusion 303, Inc., initiated 2025-09-30. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- CareFusion 303, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-09-30
- Firm location
- San Diego, CA, United States
Product description
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 for recall
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Data sourced from openFDA. This site is unofficial and independent of the FDA.