The Recall Desk
HighFDA (Devices)·Z-1927-2024·Announced 2024-06-05

BD Pyxis MedStation ES Medication Cabinet Fluid Ingress Fire Hazard

BD Pyxis MedStation ES medication cabinets may experience fluid ingress, potentially causing smoke, fire, or system downtime. CareFusion is recalling 212,367 units globally.

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 with a significant hazard potential (fire and smoke) but no reported incidents. The recall qualifies as a risk-of-harm product where injury has not yet been reported, per the FDA severity rubric criteria for Score 3.

Plain-English summary

CareFusion 303, Inc. is recalling the BD Pyxis MedStation ES medication cabinet (REF: 323). Approximately 212,367 units were distributed worldwide, including throughout all U.S. states and to numerous countries globally.

The medication cabinet may experience fluid ingress, which could result in smoke generation, system downtime, or fire.

Healthcare facilities and organizations using the affected medication cabinets are included in this recall.

For information regarding the recalled units, healthcare facility administrators and users should contact CareFusion 303, Inc. for further instruction. The recall is assigned FDA number Z-1927-2024.

The recalled product

Product
BD Pyxis MedStation ES, REF: 323, Medication Cabinet
Manufacturer
CareFusion 303, Inc.
Hazard
  • fluid-ingress
  • fire
  • smoke
  • system-downtime

Distribution

Distributed nationwide across the United States.