Z-1028-2026Class II

BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02...

Name: Z-1028-2026 BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02...
Creator: CareFusion 303, Inc.
Published: 2025-12-03
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2025-12-03 / Open, Classified / root cause: software

FDA source

CareFusion 303, Inc. began a recall of 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... on 2025-12-03. FDA classified it as Class II and gives the reason as "Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1028-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-03
Posted: 2026-01-08
Recalling firm: CareFusion 303, Inc
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.
Product code: BRY Cabinet, Table And Tray, Anesthesia
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.
Root cause tag: software
FDA root 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: [email protected] 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1028-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1028-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-14	2026-01-08

Product code BRY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)