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FDA-Device2026-01-14Class IIPROCESSING DEFECT

BD Pyxis ES Enterprise Server recalled for software update delays

CareFusion
OTHERNationwide distribution

Check your BD Pyxis ES Enterprise Server

A software issue in certain BD Pyxis ES Enterprise Server systems may prevent timely updates of patient, medication, and related information from reaching the dispensing cabinets. This could delay access to critical data in healthcare settings. BD and the FDA are working to address the problem.

  • If your facility uses a BD Pyxis ES Enterprise Server, contact BD or your IT administrator to check if your system is affected
  • Verify your system's catalog number and software version against the recall notice
  • Follow any updates or patches provided by BD to resolve the software issue
Hazard

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

Sold states
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.
Affected count
2,079 systems
Manufactured in
10020 Pacific Mesa Blvd, San Diego, CA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1028-2026

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