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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- CareFusion 303
- Product type
- Automated Dispensing Cabinet
- Model numbers
- Catalog Number: 1115-00, Catalog Number: 137670-02, Catalog Number: 139675-01
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 3, 2025
Reported by FDA DEVICE
January 14, 2026
RecallRadar source check
January 21, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Check the catalog number on your BD Pyxis ES Enterprise Server.
- Verify against the recall list provided by CareFusion.
- 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.
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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
- Class II recall
- Approximate quantity: 2,079 systems
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Safety Guide
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