Official recall record
BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2024-10-31
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00382904413859
- Brand on record
- Becton Dickinson & Co.
What the authority reported
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/or availability of the relevant products and associated data.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2025-09-23 · US FDA — Medical Devices
BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog Numbers: 445570, 4 - 2025-09-23 · US FDA — Medical Devices
BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/ - 2024-10-31 · US FDA — Medical Devices
BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916
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