BD BACTEC FX40 Product Service Credentials Accessed by Unauthorized Actor
Unauthorized actor accessed BD technical support credentials for the BACTEC FX40 laboratory instrument. Until credentials are updated, there is a risk of unauthorized access to the system and associated data.
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 an FDA Class II voluntary precautionary recall due to exposed service credentials. No illnesses, injuries, or confirmed actual unauthorized access to systems or patient data have been reported. The source states only that there is a risk of unauthorized access, without confirming actual compromise.
Plain-English summary
The BD BACTEC FX40 Instrument (Model 442296, Catalog Number 442296) is a diagnostic laboratory device used in clinical settings. BD confirmed that product service credentials used by some BD technical support teams to access certain BD products 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.
Approximately 8,085 units are affected worldwide, including 838 in the United States and 7,247 units internationally across numerous countries. This precautionary recall has been issued to prevent potential unauthorized access while BD updates service credentials.
Healthcare facilities using affected BACTEC FX40 instruments should coordinate with BD regarding credential updates and security remediation measures.
The recalled product
- Product
- BD BACTEC FX40 Instrument Version or Model: 442296 Catalog Number: 442296
- 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: 442296
- UDI-DI: 00382904422967
- Serial Numbers: FF7385
- FF7425
- FF2727
- FF1261
- FF2717
- FF1262
- FF7254
- FF7365
- FF7419
- FF7374
- FF6762
- FF2759
- FF2756
- FF7380
- FF9548
- FF9544
- FF7367
- FF2745
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.
See all 13 products in this recall →Related recalls
Same manufacturer · Becton Dickinson & Co.
See all →- SevereBD Phoenix Panel NMIC-306 Recalled for Quality Control Failures
FDA (Devices) · 2026-10-21
- HighBD Phoenix Panel NMIC-312 recalled for classification error
FDA (Devices) · 2026-10-21
- ModerateBD GasPak EZ CO2 Pouch System gas generating sachets underperforming
FDA (Devices) · 2026-05-06
- ModerateBD GasPak EZ Campy Pouch System Recall for Below-Specification Gas Production
FDA (Devices) · 2026-05-06
- ModerateLaboratory cuvette arrays recalled over barcodes the analyser cannot read
FDA (Devices) · 2025-11-19
Same hazard · unauthorized access
See all →- HighBiometric Firearm Safes Recalled Due to Unauthorized-Access Hazard
CPSC · 2026-07-09
- HighFirearm chamber locks recalled because they can be forcibly removed
CPSC · 2025-09-04
- HighMUSE 5 Cardiovascular Systems Recall Administrator Credential Access
FDA (Devices) · 2025-06-18
- SevereLifeShield Infusion Safety Software Recalled for Drug Library Defects
FDA (Devices) · 2025-05-21
- HighGE Healthcare Cardiology CA1000 Security Vulnerability Could Allow Patient Data Access
FDA (Devices) · 2025-04-09
Similar recalls
- HighBACTEC FX instruments recalled after service credentials accessed by unauthorized actor
FDA (Devices) · 2025-10-29
- HighBlood culture systems recalled after service credentials were accessed by unauthorized actor
FDA (Devices) · 2025-10-29
- HighBD MAX instruments recalled after service credentials accessed by unauthorized actor
FDA (Devices) · 2025-10-29
- HighAutomated microbiology systems recalled after service credentials were accessed by unauthorized actor
FDA (Devices) · 2025-10-29
- HighMicrobiology data systems recalled after service credentials accessed by unauthorized actor
FDA (Devices) · 2025-10-29
- HighVeritor Connect software recalled after service credentials accessed by unauthorized actor
FDA (Devices) · 2025-10-29