FDA Device recall Z-2162-2025

BD COR System Software

• FDA Device
• Class II
• ongoing
• Published 2025-07-30

On 2025-07-30 the FDA classified a Class II recall of BD COR System Software by Becton Dickinson And, citing potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.

Read the official FDA Device notice

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.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

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All Becton Dickinson And recalls

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2162-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.