BD BBL CultureSwab EZ Collection and Transport System — Class II medical device recall Z-1937-2025
Ongoing recall by Copan Italia, reported 2025-06-18, distributed nationwide. Swabs for specimen collection may be prone to breakage during product usage.
| Recall number | Z-1937-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Copan Italia, Brescia, Italy |
| Recall initiated | 2025-05-02 |
| Classified | 2025-06-09 |
| Reported by FDA | 2025-06-18 |
| Distributed | Nationwide (US) |
| Quantity | 81,600 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 38053326002145 |
| Lot numbers | 2415377 |
| Model numbers | 220144 |
Product
BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only
Reason for recall
Swabs for specimen collection may be prone to breakage during product usage.
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-1937-2025. 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.