The Recall Desk
HighFDA (Devices)·Z-0589-2025·Announced 2024-12-11

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.
Hazard
  • unauthorized-access
  • credential-compromise
  • data-security

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.