The Recall Desk
HighFDA (Devices)·Z-1050-2025·Announced 2025-02-05

BD Pyxis MedStation Door Latch Assembly Failures in Automated Dispensing Cabinets

The FDA is recalling approximately 33,589 BD Pyxis MedStation automated dispensing cabinets due to door latch assembly failures that may leave doors open, potentially delaying medication access and enabling medication diversion.

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 automated dispensing cabinets with door latch failures, creating a risk-of-harm situation in healthcare settings. Potential medication access delays and diversion could impact patient care and medication security, though no illnesses or injuries have been reported.

Plain-English summary

BD Pyxis MedStation ES AUX Tower (REF 343) and BD Pyxis MedStation 4000 AUX Tower (REF 314) are automated dispensing cabinets used in healthcare facilities to store and dispense medications. CareFusion 303, Inc. is recalling approximately 33,589 units due to an increase in complaints of door latch assembly failures that may cause the doors to be left in an open state.

When doors remain open, inventory discrepancies may occur, access to medications may be delayed, and medications could be diverted. The recalled systems have been distributed to healthcare facilities across the United States, its territories, Germany, and Japan.

Healthcare facilities with affected systems should immediately contact CareFusion 303, Inc. for instructions on remediation. Facilities should verify that cabinet doors are functioning properly and securing their medication inventory until the issue is addressed.

The recalled product

Product
BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES and Pyxis" MedStation 4000 are automated dispensing cabinets (ADC) that are intended to securely store and dispense medications to a qualified and authorized he
Manufacturer
CareFusion 303, Inc.
Hazard
  • door-latch-failure
  • medication-diversion
  • access-delay

Distribution

Distributed in 54 states:

  • AK
  • AL
  • AR
  • AZ
  • CA
  • CO
  • CT
  • DC
  • DE
  • FL
  • GA
  • GU
  • HI
  • IA
  • ID
  • IL
  • IN
  • KS
  • KY
  • LA
  • MA
  • MD
  • ME
  • MI
  • MN
  • MO
  • MP
  • MS
  • MT
  • NC
  • ND
  • NE
  • NH
  • NJ
  • NM
  • NV
  • NY
  • OH
  • OK
  • OR
  • PA
  • PR
  • RI
  • SC
  • SD
  • TN
  • TX
  • UT
  • VA
  • VT
  • WA
  • WI
  • WV
  • WY