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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 Medication Stations Recalled for Potential Access Delays

Agency Publication Date: February 7, 2025
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Summary

CareFusion 303, Inc. (BD) has recalled 193,067 units of various BD Pyxis medication and anesthesia stations because the instructions for use do not provide enough information regarding potential delays in accessing medications. The affected models include the MedStation ES, MedStation 4000, and Anesthesia System 4000, which are commonly used in hospitals and clinical settings. The manufacturer is strengthening the labeling to ensure healthcare providers are aware of the risks and how to mitigate them.

Risk

Insufficient labeling regarding potential delays in medication access could lead to critical delays in patient treatment during time-sensitive medical emergencies. While no injuries or incidents have been reported, a delay in access to life-saving medication poses a serious health risk.

What You Should Do

  1. This recall affects BD Pyxis MedStation ES, MedStation ES Tower, Anesthesia Station (PAS), MedStation 4000, MedStation 4000 Console, and Anesthesia System 4000 models.
  2. Identify if your device is affected by checking for Catalog Numbers 303, 309, 323, 327, 338, or 352. For MedStation ES and PAS models, the recall only applies to units running software versions v1.10 or earlier. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action
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
Variants: Software versions v1.10 and prior
Model / REF:
323
Serial Numbers:
ALL serial numbers
UDI:
10885403512667

Affected only if running software versions v1.10 and prior.

Product: BD Pyxis Anesthesia Station (PAS)
Variants: Software versions v1.10 and prior
Model / REF:
327
Serial Numbers:
ALL serial numbers
UDI:
10885403477836

Affected only if running software versions v1.10 and prior.

Product: BD Pyxis MedStation ES Tower
Variants: Software versions v1.10 and prior
Model / REF:
352
Serial Numbers:
ALL serial numbers
UDI:
10885403512674

Affected only if running software versions v1.10 and prior.

Product: BD Pyxis MedStation 4000 Console
Variants: All serial numbers and all software versions
Model / REF:
309
Serial Numbers:
ALL serial numbers
UDI:
10885403512636
Product: BD Pyxis MedStation 4000
Variants: All serial numbers and all software versions
Model / REF:
303
Serial Numbers:
ALL serial numbers
UDI:
10885403512629
10885403513787
Product: BD Pyxis Anesthesia System 4000
Variants: All serial numbers and all software versions
Model / REF:
338
Serial Numbers:
ALL serial numbers
UDI:
10885403477829
10885403513787

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96056
Status: Active
Manufacturer: CareFusion 303, Inc.
Sold By: Direct distribution to hospitals; Medical device distributors
Manufactured In: United States
Units Affected: 193067
Distributed To: Nationwide
Agency Last Updated: November 19, 2025

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.