Class II

Medical Device Recall: BD COR System Software. Model Number: 444829.

Becton Dickinson & Co. · June 23, 2025

Reason for Recall

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

Distribution

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

States Affected

NATIONWIDE

Quantity Affected

7 systems

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2162-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Becton Dickinson & Co. Medical Device Recall: BD COR System Software. Model Number: 444829. | SafeCheck