The Recall Desk
HighFDA (Devices)·Z-0976-2025·Announced 2025-01-29

BD Pyxis Med 4000 Auxiliary Drawer and Door Failures Delay Medication Access

CareFusion 303, Inc. is recalling 5 units of the BD Pyxis Med 4000 Auxiliary medication dispensing system due to drawer and door failures that may delay access to medications. Three failure modes identified: door latch failure, cable ribbon damage, and magnet falling out.

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 FDA Class II recall involves a medication dispensing system with potential mechanical failures (door latch, cable damage, or fallen magnet) that could delay access to medications. No hospitalizations or injuries have been reported. Per the rubric, risk-of-harm products without reported injuries score at most High (3).

Plain-English summary

CareFusion 303, Inc. is recalling 5 units of the BD Pyxis Med 4000 Auxiliary (AUX), REF 314, a medication dispensing system. The units may experience drawer and/or door failures that could delay healthcare staff access to medications.

Three failure modes have been identified: door latch failure, cable ribbon damage, and magnet falling out. The affected units have the following serial numbers: 16140589, 16194078, 16194079, 16194081, and 16079165.

Healthcare facilities that may have received these specific units should verify the serial numbers against their inventory and contact CareFusion 303, Inc. for guidance on inspection and replacement. The units were distributed worldwide.

The recalled product

Product
BD Pyxis Med 4000 Auxiliary (AUX), REF 314
Manufacturer
CareFusion 303, Inc.
Hazard
  • drawer-door-failure
  • 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 (6)

  • UDI/DI 10885403512650
  • Serial Numbers: 16140589
  • 16194078
  • 16194079
  • 16194081
  • 16079165.

Distribution

Distribution scope not specified by the agency.