Becton Dickinson & Co.: Device Recall

Recall #Z-2162-2025 · 06/23/2025

Class II: Risk

Recall Details

Recall Number: Z-2162-2025
Classification: Class II
Product Type: Device
Recalling Firm: Becton Dickinson & Co.
Status: Ongoing
Date Initiated: 06/23/2025
Location: Sparks, MD, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 7 systems

Reason for Recall

Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.

Product Description

BD COR System Software. Model Number: 444829.

Distribution Pattern

Worldwide - US Nationwide distribution in the states of Florida, Texas and Michigan. The countries of Sweden and Belgium.

Other Recalls by Becton Dickinson & Co.

Class II: Risk 10/23/2025

The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. As a result, the instrument enters an error state and the cuvettes cannot be used.
Class II: Risk 09/23/2025

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.
Class II: Risk 09/23/2025

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.
Class II: Risk 09/23/2025

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.
Class II: Risk 09/23/2025

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.

View all recalls by Becton Dickinson & Co. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.