BD COR System Software — Class II medical device recall Z-2162-2025
Ongoing recall by Becton Dickinson & Co., reported 2025-07-30, distributed nationwide. Potential for functionality issue that supports the Over labeling feature and could lead to possible false neg
| Recall number | Z-2162-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2025-06-23 |
| Classified | 2025-07-23 |
| Reported by FDA | 2025-07-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, SE |
| Quantity | 7 systems |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00382904448295 |
| Model numbers | 444829 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2162-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.