Recall Z-2162-2025— Becton Dickinson & Co.

Name: FDA recall Z-2162-2025
Creator: U.S. Food and Drug Administration
Published: 2025-06-23

Class II · Ongoing

Class II FDA medical device recall by Becton Dickinson & Co., initiated 2025-06-23. FDA's recall record names no specific 510(k) clearance for this event. Product: BD COR System Software. Model Number: 444829.. Reason: Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results..

Recalling firm: Becton Dickinson & Co.
Classification: Class II
Status: Ongoing
Initiated: 2025-06-23
Firm location: Sparks, MD, United States

Product description

BD COR System Software. Model Number: 444829.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.