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Medium RiskFDA Device
Medical Devices/Monitoring Devices

CareFusion 303, Inc.: BD Pyxis Dispensing Cabinets Recalled for Software-Induced Medication Delays

Agency Publication Date: July 17, 2024
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Summary

CareFusion 303, Inc. is recalling 326 BD Pyxis automated medication dispensing cabinets, including MedStation ES, Anesthesia Station ES, and CII Safe ES models. A specific software configuration conflict involving a Microsoft software patch (KB 5033688) causes an error that prevents hospital staff from accessing the dispensing application. This defect can lead to critical delays in patients receiving their prescribed medications. Consumers should contact their healthcare provider or the manufacturer regarding the affected devices.

Risk

The software error blocks users from the medication dispensing interface, which may delay the administration of time-sensitive medications to patients. While no specific injuries were reported in the data, such delays in a clinical environment can lead to serious health consequences or therapeutic failure.

What You Should Do

  1. Identify if your facility uses BD Pyxis MedStation ES, Anesthesia Station ES, or CII Safe ES cabinets running software version ES 1.7.x.
  2. Check the serial number on the device or in your system records to see if it matches any of the hundreds of affected units, which include serials such as 13534745, 16220738, 16446299, 16446303, and 15136670.
  3. Verify if software patch KB 5033688 has been installed in your production environment and if the Component Manager is set to 'installed mode'.
  4. If the cabinet software is inaccessible due to this error, use your facility’s established emergency manual override procedures to access critical medications.
  5. Contact BD/CareFusion 303, Inc. at their San Diego headquarters or through your local service representative to receive the necessary software configuration fix.
  6. Healthcare professionals or facility administrators with further questions should contact the FDA at 1-888-463-6332.

Your Remedy Options

📋Other Action

Manufacturer correction/software configuration

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: BD Pyxis: MedStation ES (Main)
Model / REF:
REF: 323
Lot Numbers:
UDI-DI: 10885403512667
Software Version: ES 1.7.x
Product: BD Pyxis: MedStation ES Tower
Model / REF:
REF: 352
Lot Numbers:
UDI-DI: 10885403512674
Software Version: ES 1.7.x
Product: BD Pyxis: Anesthesia Station ES
Model / REF:
REF: 327
Lot Numbers:
UDI-DI: 10885403477836
Software Version: ES 1.7.x
Product: BD Pyxis: CII Safe ES
Model / REF:
REF: 1116-00
Lot Numbers:
UDI-DI: 10885403512605
Software Version: ES 1.7.x
Product: BD Pyxis: CII Safe ES, Desktop PC, Wired Scanner
Model / REF:
REF: 107-254-01
Lot Numbers:
Software Version: ES 1.7.x
Product: BD Pyxis: CII Safe ES, Desktop PC, Wireless Scanner
Model / REF:
REF: 107-255-01
Lot Numbers:
Software Version: ES 1.7.x
Product: BD Pyxis: CII Safe ES, Desktop PC, Wired Scanner 1.7.3
Model / REF:
REF: 107-256-01
Lot Numbers:
Software Version: ES 1.7.x
Product: BD Pyxis: CII Safe ES, Desktop PC, Wireless Scanner 1.7.3
Model / REF:
REF: 107-257-01
Lot Numbers:
Software Version: ES 1.7.x

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94699
Status: Active
Manufacturer: CareFusion 303, Inc.
Sold By: Direct sales to hospitals and healthcare facilities
Manufactured In: United States
Units Affected: 326
Distributed To: Oregon, Kansas, Nebraska, Louisiana, North Dakota, Oklahoma, Alabama, Alaska, Wisconsin, West Virginia, Washington, Nevada, Puerto Rico, Texas, Colorado, Ohio, California, Missouri, Iowa, Arizona, Indiana, Arkansas, Illinois, Minnesota, Hawaii, New Mexico, Florida, South Dakota, Utah, New York, Virginia, Georgia, Massachusetts, North Carolina

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.