The Recall Desk
HighFDA (Devices)·Z-1545-2025·Announced 2025-04-16

BD Pyxis automated dispensing cabinets recalled for software dosing bug

CareFusion 303 is recalling BD Pyxis MedBank and MedFlex automated dispensing cabinets due to a software bug that prevents accurate tracking of medication quantities, potentially causing patients to receive more than the intended dose.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall involving a software defect that creates risk of incorrect medication dosing—a serious patient safety hazard. Although no reported illnesses or injuries are stated in the source, the potential for patient harm (receiving more than intended dose) and the FDA's Class II classification support a High severity rating under the rubric's criterion for "risk-of-harm products where injury has not yet been reported."

Plain-English summary

CareFusion 303, Inc. is recalling BD Pyxis MedBank Mini, BD Pyxis MedBank Tower, BD Pyxis MedFlex, and BD Pyxis MedBank MedPass automated dispensing cabinets distributed nationwide. These devices are used in clinical settings to securely store and dispense medications.

The recall is due to a software bug that prevents the cabinet from accurately calculating countback discrepancies during the issue process. This causes incorrect transaction quantities to be recorded in the system. The bug can also cause the CUBIE (medication drawer) to open more times than necessary to complete a transaction, which may result in a patient receiving more than the intended dose of medication.

Approximately 7,357 affected units have been distributed nationwide across all U.S. states and Washington, D.C. Healthcare facilities that use these devices should contact CareFusion 303 for instructions on remediation or further guidance regarding this software issue.

The recalled product

Product
BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass are automated dispensing cabinets (ADC) intended to securely store and dispense medications to a qualified and authorized user in a clinical settings.
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Automated Dispensing Cabinet
Hazard
  • medication-dosing-error
  • software-bug

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • REF/UDI-DI(GTIN)/Software Version: 169-143/10885403512568/2.4
  • 169-145/10885403512568/2.4
  • 169-144/10885403512568/2.4
  • 169-142/10885403512568/2.4
  • 139088-01/1.2.3.23
  • 155288-01/10885403508721/2.4
  • 169-137/10885403512544/2.4
  • 155311-01/10885403510847/2.4
  • 169-151/10885403512544/1.2.3.23
  • 138921-01/2.4
  • 155159-01/10885403504655/2.4
  • 169-101/10885403512544/2.4
  • 139122-01/2.4
  • 155160-01/10885403504662/2.4
  • 169-102/10885403512544/2.4
  • 138912-01/2.4
  • 155161-01/10885403504679/2.4
  • 169-103/10885403512544/2.4
  • 138902-01/2.4
  • 169-104/10885403512544/2.4

Distribution

Distributed nationwide across the United States.

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