BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 13... (CareFusion 303, Inc.) – due a software issue that may result ... (2025)
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
CareFusion 303, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
CareFusion 303, Inc. is recalling BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 13 due to Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
This page aggregates publicly available data. Always confirm recall details directly with the U.S. Food and Drug Administration (FDA) before taking action.
View official FDA recall noticePage updated: Jan 10, 2026
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