CareFusion 303, Inc. recalls BD Pyxis ES Enterprise Server Catalog Numbers 1115-00

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

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

• FDA enforcement recordOfficial FDA database entry for Z-1028-2026
• FDA device classification · BRYOfficial FDA classification for this device type
• CFR regulation · 21 CFR 868.6100The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find CareFusion 303, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.