BD recalled 1,086 BD BACTEC Blood Culture System units worldwide after unauthorized access to product service credentials. The breach could compromise confidentiality, integrity and availability of affected devices and data. Hospitals and healthcare providers should stop using the device immediately 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 used in clinical laboratories to detect bloodstream infections by incubating blood culture bottles and signaling growth. It is deployed across hospitals and healthcare facilities to guide sepsis diagnosis.
The recall is prompted by unauthorized access to product service credentials. If exploited, this could allow access to device software or data, potentially compromising patient data and system availability.
This recall is not described as part of a broader industry pattern in the provided notice.
Hospitals may experience downtime or need to implement additional cybersecurity controls while awaiting remediation. There is potential for data exposure related to device service credentials.
FDA enforcement page and BD’s official recall notices
Remediation and replacement processes typically take weeks to months, depending on BD’s remediation plan and facility needs
Save all recall notices, emails, and vendor communications; photograph labels and serials; log dates and actions taken
Product: BD BACTEC Blood Culture System. Catalog numbers: 445570, 445702, 44557008. Serial numbers include 445570. UDI/DI: 00382904455705 (UB4523 UB3416 UB3975 UB3871A UB3753 UB4823 DB2572 UB4642 UB3414 UM1431 UB3731 UB1470 UB5555 UM1395 UB4212 UB3555 UB4159 UB4778). Distribution: Worldwide. Quantity: 1,086 units. Recall date: 2025-09-23.
No injuries or incidents have been reported.
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