Home / Recalls / CareFusion 303, Inc. / Z-1028-2026

Z-1028-2026 Class II Ongoing

Recalled by CareFusion 303, Inc. — San Diego, CA

FDA device recall Z-1028-2026 was initiated by CareFusion 303, Inc. on December 3, 2025 and is designated Class II. Reason for recall: Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems. The recall status is ongoing. Affected quantity: 2,079 systems.

Recall Details

Product Type
Devices
Report Date
January 14, 2026
Initiation Date
December 3, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,079 systems

Product Description

BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 139676-01, 139421-01, 139420-01, 139419-01, 139419-02, 139673-01, 137081-01, 136451-01, 136451-02, 136450-01, 136450-02, 136449-01, 136449-02, 134148-01, 133760-01, 134149-01, 137669-02, 137669-03, 139675-01, 139672-01 139418-01, 139418-02, 136448-01, 136448-02, 137673-02, 137673-03 139422-01, 133744-01, 136452-01, 136452-02, 138551-01, 134157-01 Software Versions: System Versions 1.6.1 - 1.11.0 Server Application Versions ES 5.4X - 5.8.X The BD Pyxis Enterprise Server is a web application intended to configure and manage BD Pyxis ES automated dispensing cabinets (ADC) and associated BD PyxisTM ES products.

Reason for Recall

Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.

Distribution Pattern

Worldwide - U.S. Nationwide distribution including in the states of 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, 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, and WY. The countries of Bermuda, and Canada.

Code Information

Catalog Number: 1115-00 Software Versions: UDI-DI code for Hardware: 10885403518348 UDI-DI code for Software: 10885403520341 System Versions 1.6.1 - 1.11.0 Server Application Versions ES 4.13 - 5.8.X

Other recalls by CareFusion 303, Inc.

  • Z-2304-2026 Class II — BD Pyxis MedBank Mini REF: 1147-00 Medication cabinet (April 30, 2026)
  • Z-2302-2026 Class II — BD Pyxis MedStation ES Tower REF: 352 Medication cabinet (April 30, 2026)
  • Z-2297-2026 Class II — BD Pyxis MedStation 4000 REF: 303 Medication cabinet (April 30, 2026)
  • Z-2300-2026 Class II — BD Pyxis Anesthesia Station 4000 REF: 338 Medication cabinet (April 30, 2026)
  • Z-2301-2026 Class II — BD Pyxis Mini Main REF: 349 Medication cabinet (April 30, 2026)
  • Z-2298-2026 Class II — BD Pyxis MedStation ES REF: 323 Medication cabinet (April 30, 2026)
  • Z-2299-2026 Class II — BD Pyxis Anesthesia Station ES REF: 327 Medication cabinet (April 30, 2026)
  • Z-2303-2026 Class II — BD Pyxis MedBank Tower REF: 1145-00 Medication cabinet (April 30, 2026)
  • Z-1645-2026 Class II — BD Alaris" System with Guardrails" Suite MX with Point of Care Unit (February 11, 2026)
  • Z-0962-2026 Class II — BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, (November 20, 2025)

FDA data resources