# FDA recall Z-2162-2025

> **Becton Dickinson & Co.** · Class II · device recall initiated 2025-06-23.

## Product

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.

## Distribution

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

## Key facts

- **Recall number:** Z-2162-2025
- **Recalling firm:** Becton Dickinson & Co.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-23
- **Report date:** 2025-07-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sparks, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2162-2025

## Citation

> AI Analytics. FDA recall Z-2162-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2162-2025. Source: US FDA. Licensed CC0.

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