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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

BD Pyxis Automated Dispensing Cabinets Recalled for Firmware Drawer Failure

Agency Publication Date: December 19, 2025
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Summary

CareFusion 303, Inc. is recalling 53,669 BD Pyxis Automated Dispensing Cabinets because a firmware update for Half Height CUBIE drawers can cause the software to generate duplicate addresses. This addressing error causes the drawer to fail, which prevents or delays healthcare staff from accessing medications or replenishing supplies. Affected models include several versions of the BD Pyxis MedStation ES, Pyxis Pro, and Pyxis CII Safe ES using firmware version 1.48.

Risk

A drawer failure can lead to significant delays in patients receiving their specific medications or critical supplies, which may adversely impact patient care and safety in clinical settings.

What You Should Do

  1. This recall affects BD Pyxis Automated Dispensing Cabinets equipped with Half Height CUBIE drawers running firmware version 1.48, including MedStation ES (REF 323, 324, 352), Pyxis Pro (REF 1149-00, 1152-00, 1155-00), and Pyxis CII Safe ES (REF 1116-00).
  2. Identify if your unit is affected by checking the firmware version (1.48) and the Reference (REF) or UDI-DI numbers located on the device label.
  3. Stop using the recalled device. Contact the manufacturer (CareFusion 303, Inc.) or your distributor to arrange return, replacement, or correction.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information.

Your Remedy Options

๐Ÿ“‹Other Action

Firmware-induced drawer failure remediation.

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: BD Pyxis MedStation ES
Model / REF:
323
UDI:
10885403512667

Firmware Version: 1.48

Product: BD Pyxis MedStation ES 7 Drawer Auxiliary
Model / REF:
324
UDI:
10885403512681

Firmware Version: 1.48

Product: BD Pyxis MedStation ES Tower
Model / REF:
352
UDI:
10885403512674

Firmware Version: 1.48

Product: BD Pyxis Pro 7-Drawer Auxiliary
Model / REF:
1149-00
UDI:
10885403517822

Firmware Version: 1.48

Product: BD Pyxis Pro 7- Drawer Auxiliary with Secure Tower
Model / REF:
1152-00
UDI:
10885403517839

Firmware Version: 1.48

Product: BD Pyxis Pro MedStation Main
Model / REF:
1155-00
UDI:
10885403521300

Firmware Version: 1.48

Product: BD Pyxis CII Safe ES
Model / REF:
1116-00
UDI:
10885403512605

Firmware Version: 1.48

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97712
Status: Active
Manufacturer: CareFusion 303, Inc.
Sold By: Authorized Medical Device Distributors; Direct Hospital Sales
Manufactured In: United States
Units Affected: 53669
Distributed To: Alaska, Alabama, Arkansas, American Samoa, 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, 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 ยท 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.