FDA (Devices) recall action 95636
The FDA (Devices) publishes a recall like this one as 13 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 13 pages.
BD confirmed that 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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
BD recalled its COR MX instruments after an unauthorized actor accessed service credentials. The company is updating credentials to prevent future unauthorized access to product data and systems.
Service credentials for the BD EpiCenter Data Management System were accessed by an unauthorized actor. Until credentials are updated, system data and access controls are at risk.
Becton Dickinson recalled the BACTEC 9240 System after unauthorized actors accessed product service credentials. Until credentials are updated, there is risk of unauthorized access that may compromise system security and data integrity.
Unauthorized actor accessed BD technical support credentials for the BACTEC FX40 laboratory instrument. Until credentials are updated, there is a risk of unauthorized access to the system and associated data.
Service credentials for BD EpiCenter Data Management System were accessed by an unauthorized actor. This creates a risk of unauthorized access to the software and associated data until credentials are updated.
BD is recalling the Synapsys Informatics Solution Version 444150 due to compromised service credentials used by technical support teams. Unauthorized access may compromise data confidentiality, integrity, and system availability.
BD EpiCenter software service credentials were accessed by an unauthorized actor. Until credentials are updated, there is risk of unauthorized access to the software and associated data.
Becton Dickinson recalls the BD COR GX Instrument due to unauthorized access to product service credentials. Until credentials are updated, there is a risk of unauthorized device access and potential impact to data security.
An unauthorized actor accessed service credentials for Becton Dickinson's BD MAX diagnostic systems. Until credentials are updated, there is risk of unauthorized access that may impact data confidentiality, system integrity, and availability.
BD service credentials for BACTEC FX instruments were accessed by an unauthorized actor, creating risk of unauthorized system access until credentials are updated.
Becton Dickinson reports that technical support credentials for the BD COR PX Instrument were accessed by an unauthorized actor. Users should verify credential updates with BD to mitigate unauthorized access risk.
BD recalled BACTEC 9120 Systems because technical support credentials were compromised by an unauthorized actor. Until credentials are updated, there is a risk of unauthorized access to the devices and associated data.
BD confirmed that service credentials used by technical support teams were accessed by an unauthorized actor, creating a risk of unauthorized access to BD microbiology systems and associated data.