BD recalled 177 units of the BACTEC Blood Culture System worldwide after an unauthorized actor accessed product service credentials. The breach could allow unauthorized access to system configurations and data. Healthcare facilities should stop using the affected equipment and follow BD’s recall instructions.
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Becton Dickinson & Co. or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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The BD BACTEC Blood Culture System is an automated platform used in hospitals to analyze blood samples for bloodstream infections. It is deployed in clinical laboratories for routine diagnostic work.
Cybersecurity vulnerabilities in lab equipment can expose patient data and affect device availability and integrity. Unauthorized access could disrupt operations or expose sensitive information.
This recall aligns with growing concerns about cybersecurity in medical devices.
Hospitals may need to suspend or modify testing workflows to apply updates. Potential downtime could affect turnaround times for critical diagnoses and patient care.
BD recall notices and guidance can be found at the BD official website and the FDA enforcement report page linked in the recall notice
Remediation and replacement steps will be scheduled by BD with hospitals; typical timelines vary by facility.
Keep copies of the recall notice, correspondence with BD, inventory lists of affected catalog/serial numbers, and records of credential updates.
Catalog Numbers: 44138509; 441676; 445569; 44229609. Serial numbers include FT5675, FT5497, FT4948, FT5781, FT5120, FT3993, FT7779, FT3387, FT1993, FT5019, FT9109, FT8412, FT7176, FT7344, FT4282, FT7400, FT6093, FT0962. UDI/DI: 00382904413859. Sold worldwide to healthcare facilities. Recall Date: 2025-09-23. Status: Active. Quantity: 177 units. Distribution: Worldwide.
No injuries or incidents have been reported.
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