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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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Low RiskFDA Device
Medical Devices

CareFusion 303, Inc.: Reports of delayed access to medication in automated dispensing cabinets because of the override/Add Item workflow.

Agency Publication Date: August 13, 2025
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Summary

CareFusion 303, Inc. has recalled 6,076 units of various BD Pyxis MedBank Mini automated dispensing cabinets due to a software workflow issue. The recall affects several models, including the 1FH-1FM, 4HM, 4HH, 3HH-1HM, 3HH-1FG, 2HM-1FM, 2HH-2HM, 2HH-1FM, 2HH-1FH, 2FM, 2FH, and 1HH-3HM configurations manufactured in the United States. The cabinets are experiencing reports of delayed access to critical medications when using the 'override' or 'Add Item' workflows, which can impact urgent patient care.

Risk

A technical error in the cabinet's medication override and item-adding process causes delays in dispensing drugs. These delays in accessing prescribed treatments or emergency medications could lead to serious medical complications or a decline in patient health during time-sensitive clinical situations.

What You Should Do

  1. Identify if your facility uses a BD Pyxis MedBank Mini cabinet by checking the REF/Model numbers on the device, specifically models 169-137, 169-113, 169-112, 169-111, 169-110, 169-109, 169-108, 169-107, 169-106, 169-105, 169-104, or 169-103.
  2. Verify your device serial number against the extensive list of over 500 affected serial numbers provided in the recall notice to confirm if your specific unit is impacted.
  3. Immediately contact your healthcare provider, facility administrator, or CareFusion 303, Inc. (BD) to discuss the risks of delayed medication access and to receive specific technical instructions or software updates.
  4. Ensure clinical staff are aware of the potential for dispensing delays when using the 'override' or 'Add Item' functions and have secondary protocols in place for accessing urgent medications.
  5. Contact the manufacturer, CareFusion 303, Inc., for further instructions regarding a potential fix or software patch for these dispensing cabinets.
  6. For additional questions or to report further issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer Notification and Guidance

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

Affected Products

Product: BD PYXIS MEDBANK MINI 1FH-1FM
Model / REF:
169-137
Product: BD PYXIS MEDBANK MINI 4HM
Model / REF:
169-113
Product: BD PYXIS MEDBANK MINI 4HH
Model / REF:
169-112
Product: BD PYXIS MEDBANK MINI 3HH-1HM
Model / REF:
169-111
Product: BD PYXIS MEDBANK MINI 3HH-1FG
Model / REF:
169-110
Product: BD PYXIS MEDBANK MINI 2HM-1FM
Model / REF:
169-109
Product: BD PYXIS MEDBANK MINI 2HH-2HM
Model / REF:
169-108
Product: BD PYXIS MEDBANK MINI 2HH-1FM
Model / REF:
169-107
Product: BD PYXIS MEDBANK MINI 2HH-1FH
Model / REF:
169-106
Product: BD PYXIS MEDBANK MINI 2FM
Model / REF:
169-105
Product: BD PYXIS MEDBANK MINI 2FH
Model / REF:
169-104
Product: BD PYXIS MEDBANK MINI 1HH-3HM
Model / REF:
169-103

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97245
Status: Active
Manufacturer: CareFusion 303, Inc.
Manufactured In: United States
Units Affected: 6076

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.