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

Automated Dispensing Cabinets Software Bug Risk of Medication Overdose

CareFusion's BD Pyxis automated medication dispensing cabinets contain a software bug that prevents proper tracking of medication quantities, potentially causing patients to receive more medication than prescribed.

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 risk-of-harm product where the potential for medication overdose exists due to incorrect dispensing. However, the source does not report any actual illnesses or injuries, making the hazard theoretical rather than confirmed.

Plain-English summary

CareFusion 303, Inc. is recalling BD Pyxis MedBank Mini, MedBank Tower, MedFlex, and MedBank MedPass automated dispensing cabinets due to a software bug that impacts medication tracking and dispensing.

The bug prevents the system from correctly calculating countback discrepancies during the medication dispensing process, resulting in incorrect transaction quantities being recorded. Additionally, the cabinet may open more times than necessary to complete a transaction, which may cause patients to receive more than the intended dose of medication.

Approximately 7,357 units have been distributed nationwide to healthcare facilities. These devices are used in clinical settings to securely store and dispense medications to authorized users.

Healthcare facilities using these cabinets should contact CareFusion 303, Inc. for information about a software update and should verify medication inventory accuracy in affected units.

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 — Medication Dispensing Cabinet
Hazard
  • medication-overdose
  • dosing-error
  • software-malfunction
  • incorrect-dispensing

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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