Becton Dickinson & Co.: Medical Device Recall in 2025 - (Recall #: Z-2162-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

BD COR System Software. Model Number: 444829.

Product Classification:

Class II

Date Initiated: June 23, 2025

Date Posted: July 30, 2025

Recall Number: Z-2162-2025

Event ID: 97142

Reason for Recall:

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

Status: Ongoing

Product Quantity: 7 systems

Code Information:

Model Number: 444829. UDI-DI: 00382904448295. Software version 8.80 and above.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated