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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
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.
Part of a larger recall action
This product is one of 13 recalled by Becton Dickinson & Co. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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