The Recall Desk
HighFDA (Devices)·Z-0584-2025·Announced 2024-12-11

BD EpiCenter Medical Device Software Service Credentials Accessed by Unauthorized Party

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.

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 software product where unauthorized access to service credentials has been confirmed, but no patient harm or unauthorized system compromise has been reported. The potential exists for unauthorized actors to impact confidentiality, integrity, and availability of medical device software and patient data.

Plain-English summary

BD EpiCenter Single User Software (Version 441007, Catalog Number 441007) is being recalled due to unauthorized access to service credentials. This is medical device support software manufactured by Becton Dickinson & Co. and distributed worldwide.

Becton Dickinson & Co. 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 availability of the relevant products and associated data.

This software is distributed worldwide, including across the United States and numerous other countries. Any healthcare facility or organization using BD EpiCenter Single User Software Version 441007 may be affected by this vulnerability.

BD recommends that all users update their service credentials immediately and monitor for any unauthorized access attempts. Organizations should review system logs and contact BD technical support for guidance on credential updates and protective measures.

The recalled product

Product
BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007
Manufacturer
Becton Dickinson & Co.
Category
Medical Device — Medical Device Software
Hazard
  • credential-compromise
  • unauthorized-access
  • data-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 (2)

  • Catalog No: 441007
  • UDI-DI: 00382904410070

Distribution

Distributed nationwide across the United States.

Related recalls

Same category