Class 2 Device Recall BD Pyxis ES Server

• Date Initiated by Firm: December 03, 2025
• Date Posted: January 08, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1028-2026
• Recall Event ID: 97546
• Product Classification: Cabinet, table and tray, anesthesia - Product Code BRY
• Product: 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.
• 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
• FEI Number: 2016493
• Recalling Firm/ Manufacturer: CareFusion 303, Inc.; 10020 Pacific Mesa Blvd; San Diego CA 92121-4386
• For Additional Information Contact: Stephanie Chavez; 858-336-8754
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: On 12/03/2025, the firm sent U.S. Postal and email an "URGENT: MEDICAL DEVICE CORRECTION" Letter to customers informing them that BD received customer complaints of BD Pyxis" equipment not receiving timely updates of patient, medication, or related information from enterprise systems. This resulted in new patient and/or order information to be delayed from displaying on connected Pyxis equipment, and a delay in any changes to current patient orders being applied to the patient profile within Pyxis. Customers are instructed to: 1.Refer to the BD Pyxis" ES User Guides warning: Instruct end users to utilize the BD Pyxis" ES System patient/order information in conjunction with the medical record when making clinical decisions. Making clinical decisions solely from BD Pyxis" ES System information may result in errors in care resulting in serious injury or death. 2.BD Pyxis" MedStation" devices can be utilized in both profile mode (specific medications orders are associated with specific patients) and non-profiled mode. 3.Facilities should establish comprehensive policies and procedures for situations when an automated dispensing system is not receiving updated information and medications may not be loaded in device inventory. 4.Device keys can be used to manually access unavailable drawers. Keys must be readily available and retrievable to constitute risk mitigation. 5.Devices can also be placed into critical override mode, where all contents of the device will be available to users. (For additional detailed instruction - refer to Urgent Medical Device Correction letter. BD recommends that customers who are preparing to implement or upgrade to ES 1.11 continue as planned in order to receive the bug fixes it contains and prepare to receive the ES 1.11.1 patch when it is available. For Questions: BD Remediation Support: Email: US-Pyxis-Field-Action-Remediation@bd.com BD Technical Support: Website: bd.com/self-service, Phone: 1-800-727-6102, Hours: 24 hours, 7 days a week
• Quantity in Commerce: 2,079 systems
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.