CareFusion 303, Inc. recalls BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 1…

Antivirus software was not consistently installed on impacted devices during the implementation process.

On 05/08/2025, the firm sent via mail and email an "URGENT MEDICAL DEVICE PRODUCT CORRECTION" Letter informing customers of two issues. For this recall the issue pertains to technicians failing to install (ESET) antivirus software on affected devices. This can potentially result in a malicious actor that could exploit a cybersecurity weakness on a device that is configured without antivirus protection within a hospital network. Customer are instructed and/or informed: For Clinical Users: -to utilize user facility policies and procedures for cybersecurity issues or disaster recovery. -to remove devices from network and continue to use operational devices in critical override per the BD Pyxis" MedStation" ES user guide DME 10000430667, version 00 (pages 74-75). For IT, Safety and Security: -Firewall Protection - The hospital firewall can block vulnerable ports. -Limit physical access to only authorized personnel. -Tightly control management of system passwords provided to authorized users. -Monitor and log network traffic attempting to reach the affected products for suspicious activity. -Isolate affected products in a secure VLAN or behind firewalls with restricted access that only permits communication with trusted hosts in other networks when needed. -Physical security - Manage who can access network or server rooms to reduce cyberattack or data breach risks. -Secure user access implement secure user passwords and/or biometric logins at the application level. -Regular database backups (ES devices only). -Additional Security layers - There are other layers of security still in place to mitigate potential malicious activity on ES devices such as secure Operating System passwords, database and file encryption, and secure user passwords / biometric logins at the application level. For questions: BD Remediation Support Phone: 1-866-583-8783 Phone Hours: 5:00am PST to 4:00pm PST (8:00am ET to 7:00pm ET) Monday - Friday Recall Customer Response Forms - email: BDRC22

• FDA enforcement recordOfficial FDA database entry for Z-2477-2025
• 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.