The Recall Desk
HighFDA (Devices)·Z-1119-2025·Announced 2025-02-19

Pyxis Medication and Anesthesia Dispensing Systems Recalled for Software Vulnerabilities

CareFusion recalls Pyxis medication dispensing systems due to software issues that could delay access to medications, result in incorrect doses, or allow unauthorized access.

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 risk-of-harm product (medication dispensing system) where no injuries have been reported, placing it at Score 3 (High) per the severity rubric. The FDA Class II classification and potential for serious medication errors (wrong dose, item, or timing) justify the High rating despite lack of confirmed harm.

Plain-English summary

CareFusion 303, Inc. is recalling four models of Pyxis medication and anesthesia dispensing systems. The affected devices are Pyxis MedStation ES (Catalog No. 323), Pyxis Anesthesia Station (Catalog No. 327), Pyxis MedStation ES Tower (Catalog No. 352), and BD Pyxis CII Safe ES (Catalog No. 1116-00). All serial numbers of these models with software version v1.10 and prior are affected. A total of 137,741 units have been distributed.

The recall is due to software issues that could potentially result in delays in accessing the dispensing software application, wrong therapy administration (including incorrect dose, medication item, or timing), or unauthorized access and compliance-related issues. These risks could compromise patient safety and medication management protocols.

The affected devices have been distributed domestically nationwide and internationally to North America, Latin America, EMEA, and Greater Asia. Healthcare facilities currently using these Pyxis systems should contact CareFusion 303, Inc. for information about remediation or replacement options.

The recalled product

Product
(1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis CII Safe ES, Catalog No. 1116-00
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Medication Dispensing System
Hazard
  • medication-error
  • software-vulnerability
  • unauthorized-access
  • 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 (14)

  • (1) Pyxis MedStation ES
  • Catalog No. 323
  • UDI-DI 10885403512667
  • (2) Pyxis Anesthesia Station (PAS)
  • Catalog No. 327
  • UDI-DI 10885403477836
  • (3) Pyxis MedStation ES Tower
  • Catalog No. 352
  • UDI-DI 10885403512674
  • (4) BD Pyxis CII Safe ES
  • Catalog No. 1116-00
  • UDI-DI 10885403512605
  • All Serial Numbers
  • Software Versions v1.10 and prior Affected

Distribution

Distributed nationwide across the United States.

Related recalls

Same category