10G DIRECT SINGLE — Class II medical device recall Z-1639-2021
Terminated recall by BIOPSYBELL S.R.L., reported 2021-05-26, distributed nationwide. Products labeled as sterile were distributed, but may not have been sterilized.
| Recall number | Z-1639-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BIOPSYBELL S.R.L., Mirandola, N/A, Italy |
| Recall initiated | 2021-03-22 |
| Classified | 2021-05-19 |
| Reported by FDA | 2021-05-26 |
| Terminated | 2026-02-17 |
| Distributed | Nationwide (US) |
| Quantity | 330 units |
| Reason classes | labeling, sterility |
| Lot numbers | 2001201, 2003859, 20051288, 20061419 |
Product
10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK
Reason for recall
Products labeled as sterile were distributed, but may not have been sterilized.
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-1639-2021. 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.