Class II — M.D.L. S.r.l.
| Recalling firm | M.D.L. S.r.l. |
|---|---|
| Registered facility | M.D.L. S.R.L. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Sterility assurance may be compromised. |
| Product | Bone Marrow Transplantation biopsy needle |
| Quantity | 21,518 units |
| Distribution | Nationwide |
| Initiated | 2021-08-05 |
| Classified | 2021-09-20 |
| Terminated | 2026-05-04 |
| Recall number | Z-2489-2021 |
| 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 — M.D.L. S.r.l. (Z-2489-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88430/
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