HIGH

Becton Dickinson Recalls EpiCenter Microbiology System Over Data Breach

Becton Dickinson & Co. recalled 2,050 units of its EpiCenter Microbiology Data Management System on September 23, 2025. Unauthorized access to product service credentials may compromise patient data. The recall affects models distributed worldwide, including the U.S. and Puerto Rico.

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

Product Details

The recall includes the following catalog numbers: 441002, 441421, 445398, and 443971. The affected systems were sold worldwide, including the U.S., Guam, and Puerto Rico. No specific price was mentioned.

The Hazard

Unauthorized access to service credentials creates a risk of compromised data confidentiality, integrity, and availability. This could affect sensitive patient information and overall system performance.

Reported Incidents

No specific incidents or injuries have been reported related to this recall. However, the potential for unauthorized access poses a significant risk.

What to Do

Stop using the device immediately. Contact Becton Dickinson & Co. or your healthcare provider for further instructions. The company will notify affected users through various methods, including email and press release.

Contact Information

For assistance, call Becton Dickinson & Co. at 1-800-XXX-XXXX or visit their website at www.bd.com. Further details are available on the FDA's recall page.

Key Facts

  • Recall date: September 23, 2025
  • Class II recall status
  • Worldwide distribution including the U.S.
  • 2,050 units affected
  • Risk of unauthorized data access

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Safety Assessment

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

Product Classification

Product TypeMicrobiology Data Management System
Sold At
Multiple Retailers

Product Details

Model Numbers
Catalog Number: 441002
Catalog Number: 441421
Catalog Number: 445398
Catalog Number: 443971
Affected States
ALL
Report Date
October 29, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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