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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

Pyxis MedStation and Anesthesia Software Recalled for Critical Delivery Issues

Agency Publication Date: February 7, 2025
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Summary

CareFusion 303, Inc. has recalled 137,741 total units of its Pyxis MedStation ES, Anesthesia Station, MedStation ES Tower, and BD Pyxis CII Safe ES systems. These healthcare dispensing systems, running software versions v1.10 and prior, contain defects that may lead to medication delivery delays, incorrect dosing or therapy, and unauthorized access. While no injuries have been reported, these issues could result in critical patient care errors or regulatory compliance failures. Healthcare facilities should stop using the affected systems and coordinate with the manufacturer for a software correction or device replacement.

Risk

The software issues can result in clinicians administering the wrong dose, item, or therapy to a patient, or cause significant delays in accessing necessary medications. These defects also pose a risk of unauthorized access to controlled substances, potentially compromising both patient safety and institutional security.

What You Should Do

  1. This recall affects Pyxis MedStation ES (Catalog 323), Pyxis Anesthesia Station (Catalog 327), Pyxis MedStation ES Tower (Catalog 352), and BD Pyxis CII Safe ES (Catalog 1116-00) running software versions v1.10 and prior.
  2. Identify if your system is affected by checking the catalog number and software version on the device label or within the system software menu. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled software and devices immediately to avoid potential medication errors.
  4. Contact CareFusion 303, Inc. or your distributor directly to arrange for a software update, device replacement, or corrective action.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for additional questions regarding this medical device recall.

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: Pyxis MedStation ES
Variants: Software Versions v1.10 and prior
Model / REF:
323
Serial Numbers:
All Serial Numbers
UDI:
10885403512667

Software versions v1.10 and prior are affected.

Product: Pyxis Anesthesia Station (PAS)
Variants: Software Versions v1.10 and prior
Model / REF:
327
Serial Numbers:
All Serial Numbers
UDI:
10885403477836

Software versions v1.10 and prior are affected.

Product: Pyxis MedStation ES Tower
Variants: Software Versions v1.10 and prior
Model / REF:
352
Serial Numbers:
All Serial Numbers
UDI:
10885403512674

Software versions v1.10 and prior are affected.

Product: BD Pyxis CII Safe ES
Variants: Software Versions v1.10 and prior
Model / REF:
1116-00
Serial Numbers:
All Serial Numbers
UDI:
10885403512605

Software versions v1.10 and prior are affected.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96055
Status: Active
Manufacturer: CareFusion 303, Inc.
Sold By: Direct distribution to hospitals and healthcare facilities
Manufactured In: United States
Units Affected: 137,741 total
Distributed To: Nationwide

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.