The Recall Desk
HighFDA (Devices)·Z-1375-2025·Announced 2025-03-26

BD Pyxis Medication Dispensing Systems Software Sync Error Recall

BD Pyxis medication dispensing systems may disconnect from their server due to a software error, preventing them from receiving medication updates. This could lead to incorrect medication administration or delayed access to medications.

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: FDA Class II device recall for a medication dispensing system where a software error could lead to incorrect therapy or delayed medication access. No illnesses or injuries have been reported; the hazard is potential rather than realized, meeting the criterion for risk-of-harm products without reported injury.

Plain-English summary

CareFusion 303, Inc. is recalling BD Pyxis automated medication dispensing systems, including Anesthesia Station ES, MedStation ES, MedStation ES Tower, and CII Safe ES models available in standard and Desktop PC configurations. Approximately 727 units were distributed worldwide.

A software error in the Enterprise Server may cause synchronization timeouts when transferring large amounts of data. When this occurs, dispensing devices can disconnect from the server and fail to receive updated medication information. This disconnection could result in incorrect medication administration or delayed patient access to medications.

Affected systems use Enterprise Server software versions 1.7.1 through 1.7.4, including specific versions 1.7.4.128, 1.7.4.134, 1.7.4.136, and 1.7.4.137. The devices were distributed in the United States, Puerto Rico, and internationally.

The recalled product

Product
BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF: 1116-00, CII Safe ES Desktop PC, REF: 1156-00, CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01, CII Safe ES Desktop PC, W-less SCNR, REF: 107-255-01,
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Automated Dispensing System
Hazard
  • sync-timeout
  • medication-error
  • delayed-access

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 (10)

  • BD Pyxis Enterprise Server software versions: 1.7.4.128
  • 1.7.4.134
  • 1.7.4.136
  • 1.7.4.137
  • All 1.7.1
  • All 1.7.2
  • All 1.7.3. REF/UDI-DI: 327/10885403477836
  • 323/10885403512667
  • 352/10885403512674
  • 1116-00/10885403512605

Distribution

Distributed nationwide across the United States.

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