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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices

CareFusion 303, Inc.: BD Pyxis Automated Dispensing Systems Recalled for Missing Antivirus Software

Agency Publication Date: August 28, 2025
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Summary

CareFusion 303, Inc. is recalling 8,353 units of various BD Pyxis automated medication dispensing cabinets and servers, including the MedStation, Anesthesia Station, and CII Safe models. This recall was initiated because antivirus software was not consistently installed on these devices during the implementation process. The missing software could leave these critical medical systems vulnerable to cyber threats or malware, potentially affecting medication security. Healthcare facilities should contact their provider or the manufacturer to ensure their devices are properly updated.

Risk

The lack of antivirus software on these networked medical devices creates a cybersecurity vulnerability. If exploited, malware or unauthorized access could interfere with the secure storage and dispensing of medications, though no incidents or injuries have been reported to date.

What You Should Do

  1. Check your healthcare facility's equipment to identify any BD Pyxis devices, including MedStation 4000, MedStation ES, Anesthesia Station ES, CII Safe ES, or Enterprise Servers.
  2. Identify if your specific units are affected by matching the 'Atlas Key' or 'Computer Name' (such as DF36449C-9896-4A27-BC18-481981535F84 or similar unique identifiers) against the list provided in the manufacturer's notification letter.
  3. Verify affected catalog numbers, which include 303, 352, 327, 323, 1116-00, 1115-00, 111-221, 169-29, 806, and 317, among others listed in the recall documentation.
  4. Contact BD (CareFusion 303, Inc.) or your local service representative immediately to schedule the installation of the missing antivirus software.
  5. Follow any specific security protocols or workarounds provided in the firm's initial notification letter until the software has been verified and installed.
  6. Contact your healthcare provider or the manufacturer if you have questions regarding device functionality or security concerns.
  7. For additional questions, contact the FDA hotline at 1-888-463-6332 or visit the FDA website at www.fda.gov/medical-devices.

Your Remedy Options

📋Other Action

Manufacturer implementation of missing antivirus software

How to: Contact your healthcare provider or the manufacturer for further instructions on scheduling the required software installation.

Affected Products

Product: BD Pyxis MedStation 4000 Main
Model / REF:
UDI-DI 10885403512629
Catalog 303
Lot Numbers:
STDSNPYX
Product: BD Pyxis MedStation ES Tower
Model / REF:
UDI-DI 10885403512674
Catalog 352
Lot Numbers:
STDSNPYX
Product: BD Pyxis Anesthesia Station ES
Model / REF:
UDI-DI 10885403477836
Catalog 327
Lot Numbers:
STDSNPYX
Product: BD Pyxis MedStation ES (Main)
Model / REF:
UDI-DI 10885403512667
Catalog 323
Lot Numbers:
STDSNPYX
Product: BD Pyxis CII Safe ES
Model / REF:
UDI-DI 10885403512605
Catalog 1116-00
Lot Numbers:
STDSNPYX
Product: BD Pyxis Enterprise Server
Model / REF:
UDI-DI 10885403518348
UDI-DI 10885403520341
Catalog 1115-00
Lot Numbers:
STDSNPYX
Product: BD Pyxis CIISafe, V9.X, SGL IM, BIO
Model / REF:
UDI-DI 10885403512520
Catalog 111-221
Lot Numbers:
STDSNPYX
Product: BD Pyxis CIISafe, V7.X, DBL INTG MAIN
Model / REF:
Catalog 111-194
Lot Numbers:
STDSNPYX
Product: BD Pyxis MedBank Tower
Model / REF:
UDI-DI 10885403512568
Catalog 169-29
Lot Numbers:
STDSNPYX
Product: BD Pyxis Logistics
Model / REF:
Catalog 806
Lot Numbers:
STDSNPYX
Product: BD Pyxis SupplyStation V9
Model / REF:
Catalog 317
Lot Numbers:
STDSNPYX
Product: BD Care Coordination Engine (CCE)
Model / REF:
Catalog 134056-01
Lot Numbers:
STDSNPYX

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96477
Status: Active
Manufacturer: CareFusion 303, Inc.
Sold By: Hospital supply networks; Healthcare facilities
Manufactured In: United States
Units Affected: 8353 devices (6738 U.S. and 1615 O.U.S.)
Distributed To: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Northern Mariana Islands, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming

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.