BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303 BD Pyxis" MedSt

FDA device recall Z-2477-2025 · posted 2025-08-28 · Open, Classified

Recall details

Recalling firm

CareFusion 303, Inc.

Reason for recall

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

Action taken

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

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

BRY

Quantity affected

8353 devices (6738 U.S. and 1615 O.U.S.)

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, MP, MS, MT, NC, ND, NE, NH, N

Date initiated

2025-05-08

Date posted

2025-08-28

Location

San Diego, CA