The Recall Desk
HighFDA (Devices)·Z-2017-2025·Announced 2025-07-02

Software error in BD Pyxis cabinets can delay medication dispensing

BD Pyxis medication dispensing cabinets may experience a software error during installation that prevents user access to the medication application, potentially delaying access to patient medications and supplies.

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 Class II medical device recall involves a risk-of-harm product (medication dispensing system) where access delays could impact patient care. However, no illnesses, injuries, or deaths have been reported, and the source explicitly states the issue 'may lead to delay' rather than confirmed harm. Per the severity rubric, recalls involving risk-of-harm products without reported injuries score at 3 (High).

Plain-English summary

This recall affects multiple BD Pyxis automated medication dispensing cabinet models and associated software/server components manufactured by CareFusion 303, Inc. Approximately 6,332 units have been distributed worldwide, including throughout the United States and internationally.

During cabinet installation, upgrade, or reimaging procedures, the component manager may be left in an installed mode. If a Microsoft operating system patch is subsequently installed while the component manager remains in this state, a software error may occur that prevents users from accessing the dispensing software application.

Healthcare facilities using these dispensing cabinets are affected, particularly during installation, upgrade, or reimaging activities. The software error could delay access to medications and supplies, potentially impacting patient care.

The recalled product

Product
Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation 4000 Main 10885403512629 [303], BD Pyxis MedStation ES Tower 10885403512674 [352], BD Pyxis Anesthesia Station ES 10885403477836 [327], BD Pyxis MedStation ES (M
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Automated Dispensing Cabinet
Hazard
  • software-error
  • medication-access-delay

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)

  • 2014 - March 21
  • 2025 REF or Name [UDI-DI]: Supply Server [N/A]
  • CCE Enterprise SW Site License (2-5) [N/A]
  • 806 [N/A]
  • 303 [10885403512629]
  • 352 [10885403512674]
  • 327 [10885403477836]
  • 323 [10885403512667]
  • 317 [N/A]
  • 139698-01 [N/A]
  • 136607-01 [N/A]
  • 132-53-02 [N/A]
  • 132-53-01 [N/A]
  • 132-52-02 [N/A]
  • 132-52-01[N/A]
  • 1156-00 [N/A]
  • 1132-00 [N/A]
  • 1127-0 [N/A]
  • 1128-00 [N/A]
  • 1123-00 [N/A]

Distribution

Distributed nationwide across the United States.

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