Becton Dickinson & Co. recalled 1,086 units of its BACTEC Blood Culture System on September 23, 2025. Unauthorized access to product service credentials poses a risk to data security. Affected systems include the BACTEC 9120 with catalog numbers 445570 and 445702.
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 recall affects the BACTEC 9120 System, catalog numbers 445570 and 445702, and the INSTRUMENT BACTEC 9120 UNREPAIRED, catalog number 44557008. The systems were distributed worldwide, including the U.S., since their introduction.
Unauthorized access to product service credentials presents a risk to the confidentiality, integrity, and availability of the affected blood culture systems. This situation may compromise patient safety and the reliability of test results.
There are no reported incidents of injury or death associated with this recall. However, the potential for unauthorized access could lead to significant risks.
Patients and healthcare providers should stop using the device immediately. Follow the recall instructions from Becton Dickinson & Co. for further guidance.
For more information, contact Becton Dickinson & Co. or your healthcare provider. Visit the FDA recall page for updates.
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