CareFusion 303, Inc.: Device Recall

Recall Details

Recall Number

Z-0368-2026

Classification

Class II

Product Type

Device

Recalling Firm

CareFusion 303, Inc.

Status

Ongoing

Date Initiated

09/30/2025

Location

San Diego, CA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

2,755 units

Reason for Recall

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

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

Distribution Pattern

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

Other Recalls by CareFusion 303, Inc.

• Class II: Risk 12/03/2025
  Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.
• Class II: Risk 11/20/2025
  Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which caused a Cubie Insert event which prompts software to generate a duplicate address, which causes an error and the drawer to fail, which may lead to inability or delay in accessing stored items, delay in the replenishment of ADCs or patient specific medications stored outside of ADCs.
• Class II: Risk 11/06/2025
  Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue with hospital networks. This issue only affects the Interoperability workflow for devices with a DST invalid timestamp, impacting connectivity of the PCU to the hospital network
• Class I: Dangerous 10/17/2025
  If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so dropped/jarred pumps should be removed from use, tested, and inspected by qualified service personnel prior to reuse; tip sheet, cleaning and disinfecting procedure and reference guide updated.
• Class II: Risk 09/30/2025
  Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

View all recalls by CareFusion 303, Inc. →