FDA Medical devices recall ·
BD COR System Software recall
- Recall number
- Z-2162-2025
- Date
- (initiated June 23, 2025)
- Company / brand
- Becton Dickinson & Co.
7 Loveton Cir, Sparks, MD, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 7 systems
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
BD COR System Software. Model Number: 444829.
Why was it recalled?
Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: 444829. UDI-DI: 00382904448295. Software version 8.80 and above.
Distribution
Worldwide - US Nationwide distribution in the states of Florida, Texas and Michigan. The countries of Sweden and Belgium.
States: Florida Michigan Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2162-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.