HIGHFDA DEVICE

CareFusion 303 Recalls Automated Dispensing Cabinets Due to Error Risk

CareFusion 303 recalled 53,669 units of Automated Dispensing Cabinets on November 20, 2025. A firmware update caused drawer failures, leading to potential delays in accessing medications. This recall affects devices distributed worldwide, including all U.S. states and several countries.

Official notice
CareFusion 303Health & Personal CareMedical DevicesFirmware Version: 1.48. REF/UDI-DI: 323/10885403512667324/10885403512681352/10885403512674

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
November 20, 2025
Status
ACTIVE
Severity
8/10

Quick Facts at a Glance

Recall Date
November 20, 2025
Hazard Level
HIGH
Brand
CareFusion 303
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
CareFusion 303
Product type
Automated Dispensing Cabinets (ADC)
Model numbers
Firmware Version: 1.48. REF/UDI-DI: 323/10885403512667, 324/10885403512681, 352/10885403512674, 1149-00/10885403517822, 1152-00/10885403517839, 1155-00/10885403521300, 1116-00/10885403512605
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    November 20, 2025

  2. Reported by FDA DEVICE

    December 31, 2025

  3. RecallRadar source check

    January 7, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which caused a Cubie Insert event which prompts software to generate a duplicate address, which causes an error and the drawer to fail, which may lead to inability or delay in accessing stored items, delay in the replenishment of ADCs or patient specific medications stored outside of ADCs.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact CareFusion 303, Inc. or your healthcare provider for instructions. Notification method: Letter

About This Product

Automated Dispensing Cabinets (ADC) are used in healthcare settings to store and dispense medications securely. They help streamline medication management and ensure that healthcare providers have quick access to medications.

Why This Is Dangerous

The firmware update caused a malfunction that may lead to drawer failures, preventing timely access to medications stored in the cabinets. This can cause significant delays in patient care.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall may cause inconvenience and delays in medication access, which could affect patient treatment and care.

Practical Guidance

How to identify if yours is affected

  1. Locate the model number on the device.
  2. Compare the model number with the recalled list.
  3. Check the firmware version if applicable.

Where to find product info

Model numbers and firmware versions are usually found on the back or bottom of the device.

What timeline to expect

Expect a refund or replacement processing time of approximately 4-6 weeks.

If the manufacturer is unresponsive

  • Follow up with CareFusion 303 via phone or email.
  • Document any correspondence attempts.

How to prevent similar issues

  • Research products for firmware stability before purchase.
  • Look for safety certifications on medical devices.
  • Choose devices with reliable customer support.

Documentation advice

Keep a record of your purchase, any communication regarding the recall, and any photos of the device.

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Product Details

The recall includes BD Pyxis MedStation models REF: 323, 324, 352, and BD Pyxis Pro models REF: 1149-00, 1152-00, 1155-00, and 1116-00. The units were sold worldwide, including all U.S. states, and the price is not specified.

Key Facts

  • Recall date: November 20, 2025
  • Class II recall due to high hazard

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeAutomated Dispensing Cabinets (ADC)
Sold At
Multiple Retailers

Product Details

Model Numbers
Firmware Version: 1.48. REF/UDI-DI: 323/10885403512667
324/10885403512681
352/10885403512674
1149-00/10885403517822
1152-00/10885403517839
+2 more
Affected States
ALL
Report Date
December 31, 2025
Recall Status
ACTIVE

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