Class II — Becton Dickinson & Co.
| Recalling firm | Becton Dickinson and Company |
|---|---|
| Registered facility | View this company's 36 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results. |
| Product | BD COR System Software. Model Number: 444829. |
| Quantity | 7 systems |
| Distribution | Worldwide - US Nationwide distribution in the states of Florida, Texas and Michigan. The countries of Sweden and Belgium. |
| Initiated | 2025-06-23 |
| Classified | 2025-07-23 |
| Recall number | Z-2162-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Becton Dickinson & Co. (Z-2162-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97142/
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