BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 1

FDA device recall Z-1028-2026 · posted 2026-01-08 · Open, Classified

Recall details

Recalling firm

CareFusion 303, Inc.

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.

Action taken

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

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

BRY

Quantity affected

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

Date initiated

2025-12-03

Date posted

2026-01-08

Location

San Diego, CA