HIGH

CareFusion 303 Recalls Automated Dispensing Cabinets Over Software Issues

CareFusion 303 recalled 2,079 BD Pyxis ES Enterprise Servers on December 3, 2025 due to a software issue affecting timely updates. The recall impacts devices sold worldwide, including the U.S. and Canada. Patients and healthcare providers must stop using the devices immediately.

Quick Facts at a Glance

Recall Date
December 3, 2025
Hazard Level
HIGH
Brand
CareFusion 303
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact CareFusion 303, Inc. or your healthcare provider for instructions. Notification method: Letter

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About This Product

The BD Pyxis ES Enterprise Server is a web application designed for configuring and managing automated dispensing cabinets in healthcare settings. Healthcare providers use it to ensure timely access to patient and medication information.

Why This Is Dangerous

The software malfunction prevents timely updates of critical patient and medication information, which can lead to dangerous medication errors and jeopardize patient safety.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall affects healthcare facilities' ability to manage medication dispensing safely, creating a pressing need for immediate action to prevent potential medication errors.

Practical Guidance

How to identify if yours is affected

  1. Check the catalog number on your BD Pyxis ES Enterprise Server.
  2. Verify against the recall list provided by CareFusion.
  3. Ensure your server runs software versions 1.6.1 to 1.11.0 or server application versions ES 5.4X to 5.8.X.

Where to find product info

Catalog numbers can typically be found on the device label or in the product manual.

What timeline to expect

Expect a timeline of approximately 4-6 weeks for refund processing or replacement after contacting the manufacturer.

If the manufacturer is unresponsive

  • Document your communications with CareFusion.
  • Follow up via phone if you do not receive a timely response.
  • Consider filing a complaint with the appropriate regulatory body if necessary.

How to prevent similar issues

  • Always verify the latest product recalls before purchasing medical devices.
  • Check for safety certifications and compliance with regulatory standards.
  • Stay informed of software updates and recalls from manufacturers.

Documentation advice

Keep copies of all receipts, correspondence, and notes related to your device and the recall for your records.

Product Details

The recall involves BD Pyxis ES Enterprise Servers with catalog numbers including 1115-00, 137670-02, and 139675-01. These servers operate software versions 1.6.1 to 1.11.0 and server application versions ES 5.4X to 5.8.X. They were distributed worldwide, with specific distribution in all U.S. states.

Key Facts

  • Recall date: December 3, 2025
  • Distribution: Worldwide
  • Class II recall
  • Approximate quantity: 2,079 systems
View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeAutomated Dispensing Cabinet
Sold At
Multiple Retailers

Product Details

Model Numbers
Catalog Number: 1115-00
Catalog Number: 137670-02
Catalog Number: 139675-01
Affected States
ALL
Report Date
January 14, 2026
Recall Status
ACTIVE

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