The Recall Desk
ModerateFDA (Devices)·Z-0587-2025·Announced 2024-12-11

BD COR PX Instrument Service Credentials Compromised; Update Required

Becton Dickinson reports that technical support credentials for the BD COR PX Instrument were accessed by an unauthorized actor. Users should verify credential updates with BD to mitigate unauthorized access risk.

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 a Class II recall with no reported illnesses, injuries, or confirmed unauthorized device access. The hazard is theoretical—a potential risk of unauthorized access—rather than a documented compromise. Per the rubric, when no illnesses or injuries are reported and the hazard is theoretical, the score is at most 3. This credential security issue constitutes a precautionary recall, warranting a Moderate severity level.

Plain-English summary

The BD COR PX Instrument (Model 443988) is the subject of a recall due to a cybersecurity issue. Becton Dickinson & Co. confirmed that product service credentials used by BD technical support teams to access these instruments 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.

The recall affects 66 units total: 18 distributed in the United States and 48 units distributed internationally across numerous countries. All devices with the listed serial numbers are affected.

Users and healthcare facilities with affected BD COR PX Instruments should contact Becton Dickinson technical support to confirm that service credentials have been updated. Verify that credential updates are in place before continuing routine use of the instruments.

The recalled product

Product
BD COR PX Instrument Version or Model: 443988 Catalog Number: 443988
Manufacturer
Becton Dickinson & Co.
Hazard
  • unauthorized-access
  • credential-compromise
  • data-security-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: 443988
  • UDI-DI: 00382904439880
  • Serial Numbers: CRP0007
  • CRP0025
  • CRP0045
  • CRP0064
  • CRP0058
  • CRP0060
  • CRP0055
  • CRP0040
  • CRP0056
  • CRP0038
  • CRP0057
  • CRP0062
  • CRP0046
  • CRP0031
  • CRP0068
  • CRP0053
  • CRP0034
  • CRP0041

Distribution

Distributed nationwide across the United States.