The Recall Desk
HighFDA (Devices)·Z-0585-2025·Announced 2024-12-11

BD EpiCenter Data Management System Credential Compromise Poses Unauthorized Access Risk

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.

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: The source describes a credential compromise creating theoretical risk to data confidentiality and system integrity, with no reported actual unauthorized access to the system or associated data breaches. Per the rubric, when the hazard is theoretical and no illnesses or injuries are reported, the maximum score is 3.

Plain-English summary

The BD EpiCenter Data Management System (Catalog Number 440887) is affected by a security vulnerability involving compromised product service credentials. Becton Dickinson confirmed that credentials used by technical support teams were accessed by an unauthorized actor. Approximately 7,974 units have been distributed worldwide, including 2,517 units in the United States.

Until the compromised credentials are updated, there is a risk of unauthorized access to the BD EpiCenter system and associated data. This unauthorized access could potentially impact the confidentiality, integrity, and availability of data within the system.

Facilities using the BD EpiCenter Data Management System should implement updated service credentials as instructed by Becton Dickinson.

The recalled product

Product
BD EpiCenter Data Management System Version or Model: 440887 Catalog Number: 440887
Manufacturer
Becton Dickinson & Co.
Hazard
  • unauthorized-access
  • credential-compromise
  • data-confidentiality-risk
  • system-integrity-risk

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: 440887
  • UDI-DI: 0382904408879
  • Serial Numbers: 6GF3TD2
  • 2MJHML1
  • 697JFF3
  • HSB9WV1
  • YL00QYF9
  • GMWYLN2
  • 1TR5JL2
  • GD6XCP2
  • HGKCXQ2
  • FH62RP2
  • GDBZCP2
  • GD92DP2
  • CPQ77X2
  • H3JQ3Y2
  • 20HJ4Z2
  • 5D2BSZ2
  • DXMWG13
  • DXP1H13

Distribution

Distributed nationwide across the United States.