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
| Agency | FDA Device |
|---|---|
| Recall number | Z-2162-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-23 |
| Published | 2025-07-30 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Becton Dickinson And |
| Distribution | US |
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
| code_info | Model Number: 444829. UDI-DI: 00382904448295. Software version 8.80 and above. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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.