BD COR GX Instrument recalled due to compromised service credentials
Becton Dickinson recalls the BD COR GX Instrument due to unauthorized access to product service credentials. Until credentials are updated, there is a risk of unauthorized device access and potential impact to data security.
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 an FDA Class II medical device recall with confirmed unauthorized access to product credentials, creating a potential risk to device integrity and data security. No illnesses or injuries have been reported, but the confirmed credential compromise represents a real cybersecurity vulnerability affecting a medical device.
Plain-English summary
Becton Dickinson & Co. is recalling the BD COR GX Instrument (Catalog Number 443990) due to unauthorized access to product service credentials used by BD technical support teams.
BD confirmed that an unauthorized actor accessed credentials used by some BD technical support teams to support certain BD products. Until these credentials are updated, there is a potential risk of unauthorized access that could impact the confidentiality, integrity, and availability of the devices and associated data.
Approximately 70 units of this device were distributed worldwide, including 7 units in the United States and 63 units outside the US. BD is updating the compromised service credentials as a corrective action.
The recalled product
- Product
- BD COR GX Instrument Version or Model: 443990 Catalog Number: 443990
- Manufacturer
- Becton Dickinson & Co.
- Category
- Medical Device
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: 443990
- UDI-DI: 00382904439903
- Serial Numbers: CRG0023
- CRG0041
- CRG0115
- CRG0040
- CRG0106
- CRG0110
- CRG0112
- CRG0109
- CRG0047
- CRG0120
- CRG0039
- CRG0113
- CRG0035
- CRG0037
- CRG0036
- VGT0009
- CRG0020
- CRG0002
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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