HIGH

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.

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

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

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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.

The Hazard

The firmware update resulted in a Cubie Insert event that generated a duplicate address. This error can cause drawer failures, delaying access to stored medications and replenishment.

Reported Incidents

No specific incidents or injuries have been reported, but the potential for delays in medication access is significant.

What to Do

Stop using the devices immediately and follow recall instructions from the manufacturer. Contact CareFusion 303, Inc. for further guidance.

Contact Information

For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0962-2026.

Key Facts

  • Recall date: November 20, 2025
  • Class II recall due to high hazard
  • 53,669 units affected
  • Firmware version: 1.48
  • Worldwide distribution

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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
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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