BD MAX System recall affects 62 units distributed worldwide in 2025 after unauthorized access to service credentials. An unauthorized actor accessed credentials used by BD technical support teams. Healthcare providers should stop using the devices and follow the manufacturer’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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BD MAX System is an automated in vitro diagnostic platform used in laboratories for molecular testing. It is distributed worldwide to healthcare facilities. The recall concerns cybersecurity and credential management rather than a physical hardware defect.
Unauthorized access to service credentials could enable unauthorized actors to access or modify BD products and related data, potentially impacting patient data and system availability.
This recall is not described as part of a broader industry cybersecurity pattern in the provided information.
Labs may halt testing operations to secure credentials, review data, and implement updated credentials. There could be workflow disruption and data-access concerns until remediation steps are completed.
Recall notification channels include email, fax, letter, press release, telephone, or site visit from BD or healthcare provider
No specific remediation timeline is provided; recall is active with worldwide distribution
Keep the recall notice, device labels showing catalog numbers and UDI, correspondence with BD, and records of any remediation actions.
Catalog Numbers: 44191609; 441927. UDI/DI: 00382904419165. Sold worldwide to healthcare facilities. Date sold: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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