The Recall Desk
ModerateFDA (Devices)·Z-0588-2025·Announced 2024-12-11

BD COR MX Instruments Affected by Unauthorized Service Credentials Access

BD recalled its COR MX instruments after an unauthorized actor accessed service credentials. The company is updating credentials to prevent future unauthorized access to product data and systems.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall addressing a cybersecurity vulnerability with no reported unauthorized access to products or patient harm. The recall is preventative, addressing the risk of future unauthorized access to product credentials and data.

Plain-English summary

BD COR MX Instrument, Catalog Number 443989, has been recalled. The recall affects 18 units distributed worldwide, including 12 in the United States and 6 distributed outside the US.

BD's service credentials—used by technical support teams to access certain BD products—were accessed by an unauthorized actor. Until these credentials are updated, there is a risk of unauthorized access that could impact the confidentiality, integrity, and availability of these products and their associated data.

Customers and healthcare facilities that have received this device should contact Becton Dickinson & Co. for information about credential updates and any recommended actions to secure their systems.

The recalled product

Product
BD COR MX Instrument Version or Model: 443989 Catalog Number: 443989
Manufacturer
Becton Dickinson & Co.
Hazard
  • unauthorized-access
  • data-breach
  • credentials-compromise

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: 443989
  • UDI-DI: 00382904439897
  • Serial Numbers: CRM0001
  • CRM0105
  • CRM0114
  • CRM0003
  • CRM0113
  • CRM0109
  • CRM0010
  • CRM0106
  • CRM0108
  • CRM0116
  • CRM0117
  • CRM0119
  • CRM0004
  • CRM0107
  • CRM0112
  • CRM0111
  • CRM0115
  • CRM0118

Distribution

Distributed nationwide across the United States.