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

BD Pyxis Dispensing Cabinet Software Configuration Error Medical Device Recall

CareFusion is recalling BD Pyxis automated dispensing cabinets and related devices due to a software configuration issue that can prevent user access to the medication dispensing application. This may delay patient care when Microsoft patches are installed during system upgrades.

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 an FDA Class II recall involving a medical device with potential for patient harm through delayed access to medications and supplies. The source explicitly states no illnesses or injuries have been reported, and the hazard is conditional on specific circumstances (upgrade process followed by Microsoft patch installation), placing this at score 3 per the rubric for high-risk products where injury has not yet been reported.

Plain-English summary

CareFusion 303, Inc. is recalling multiple BD Pyxis automated dispensing cabinet models and related software components distributed worldwide. The recalled devices include BD Pyxis MedStation, CII Safe, SupplyStation, SupplyRoller, and associated server systems, along with related software licenses and security modules.

During automated dispensing cabinet upgrade, installation, or reimaging, the component manager may be left in an installed mode. If a Microsoft patch is subsequently installed, this configuration can trigger an error that prevents user access to the dispensing software application.

This access delay may prevent timely delivery and replenishment of patient-specific medication and supply orders, which may result in a delay in patient care.

Affected healthcare facilities should contact CareFusion for instructions on correcting the component manager configuration to prevent this error when Microsoft patches are installed.

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 System
Hazard
  • software-error
  • access-failure
  • care-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.

Related recalls

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