Medical Device Breach: BACTEC 9240 System Faces Unauthorized Access 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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device where no actual unauthorized access incidents or patient harm have been reported. Although classified as FDA Class II, only a theoretical risk of compromise exists pending credential updates.
Plain-English summary
The BACTEC 9240 System, a blood culture detection device manufactured by Becton Dickinson & Co., has been recalled due to a security vulnerability in product service credentials.
BD confirmed that an unauthorized actor accessed service credentials used by BD technical support teams to access certain BD products. Until these credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity, and availability of the relevant products and associated data.
The recall affects 584 units (313 in the US and 271 internationally) distributed worldwide.
The recalled product
- Product
- BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475
- Manufacturer
- Becton Dickinson & Co.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Catalog No: 445475
- UDI-DI: 00382904454753
- Serial Numbers: DB5631
- DB 6970
- DB6857
- DB6859
- DB6122
- DB3043
- MD1710
- DB4372
- DB6043
- DB2249
- DB5030
- DB2882
- DB3090
- MD2046
- DB4927
- DB5825
- DB2828
- DB2835
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by Becton Dickinson & Co. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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