Class II — BIOPSYBELL S.R.L.
| Recalling firm | BIOPSYBELL S.R.L. |
|---|---|
| Registered facility | BIOPSYBELL S.R.L. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Products labeled as sterile were distributed, but may not have been sterilized. |
| Product | 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKBD |
| Quantity | 625 units |
| Distribution | US Nationwide distribution in the states MS and KY. |
| Initiated | 2021-03-22 |
| Classified | 2021-05-19 |
| Terminated | 2026-02-17 |
| Recall number | Z-1637-2021 |
| 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 — BIOPSYBELL S.R.L. (Z-1637-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87696/
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