Becton Dickinson recalled 62 units of its BD MAX System on September 23, 2025. Unauthorized access to product service credentials poses a high risk to data confidentiality and system integrity. The recall affects worldwide distribution, including the U.S., and requires immediate action from users.
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
The recalled BD MAX System includes catalog numbers 44191609 and 441927. The system was distributed worldwide, including the U.S., Guam, and Puerto Rico, since its release. The price is not specified.
Unauthorized access to product service credentials may compromise the confidentiality, integrity, and availability of the system and associated data. This class II recall suggests a significant but not immediate danger to users.
There have been no reported injuries or incidents associated with this recall. The risk is primarily to data security rather than physical harm.
Stop using the BD MAX System immediately. Follow the manufacturer's instructions for recall actions. Contact Becton Dickinson & Co. for guidance on the recall process.
For more information, call Becton Dickinson & Co. or visit their website. Users can also check the FDA's recall page at the provided URL.
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