HIGH

Becton Dickinson Recalls Blood Culture Systems Over Data Breach Risk

Becton Dickinson & Co. recalled 177 units of the BD BACTEC Blood Culture System on September 23, 2025. Unauthorized access to product service credentials poses a high risk to patient data and device integrity. Healthcare providers must stop using the devices immediately and follow recall instructions.

Quick Facts at a Glance

Recall Date
September 23, 2025
Hazard Level
HIGH
Brand
Becton Dickinson &
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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.

What You Should Do

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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Product Details

The recall involves several models, including the BD BACTEC FX (Catalog Number: 44138509) and BACTEC 9240 System (Catalog Number: 445569). These products were distributed worldwide, including the U.S., Canada, and multiple countries across Europe and Asia.

The Hazard

Unauthorized access to product service credentials raises concerns about the confidentiality and integrity of patient data. This breach poses a significant risk to the security of the relevant products and associated data.

Reported Incidents

There are no specific reported injuries or incidents related to this breach. However, the potential for unauthorized access constitutes a serious risk.

What to Do

Stop using the BD BACTEC Blood Culture System immediately. Contact Becton Dickinson & Co. or your healthcare provider for further instructions.

Contact Information

For more information, contact Becton Dickinson & Co. at their official website or by phone. Detailed instructions are also available via the FDA recall announcement.

Key Facts

  • 177 units recalled
  • Unauthorized access to credentials
  • Stop use immediately
  • Contact Becton Dickinson for instructions
  • Global distribution including US and Puerto Rico

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
1. Catalog Number: 44138509
UDI/DI: 00382904413859
Serial Numbers: FT5675
FT5497
FT4948
+15 more
Affected States
ALL
Report Date
October 29, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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