Soft Tissue Biopsy Needles — Class II medical device recall Z-2492-2021
Terminated recall by M.D.L. S.r.l., reported 2021-09-29, distributed nationwide. Sterility assurance may be compromised.
| Recall number | Z-2492-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | M.D.L. S.r.l., Delebio, Italy |
| Recall initiated | 2021-08-05 |
| Classified | 2021-09-20 |
| Reported by FDA | 2021-09-29 |
| Terminated | 2026-05-04 |
| Distributed | Nationwide (US) |
| Quantity | 20,129 units |
| Reason classes | sterility |
| Lot numbers | 0119, 0219, 0417, 0718, 0817, 0817A, 0818, 0818A, 0818B, 0918, 1119A, 1217B, 1218A, 1417A, 1417C, 1617A, 1618A, 1817, 1918A, 2117A, 2217, 2217A, 2618B, 3620D, 3620E, 4018, 4220C, 4617, 5018, 5216C |
| Model numbers | MGK11210, MGK11410, MGK11413, MGK11415, MGK11610, MGK11615, MGK11616, MGK11620, MGK11810, MGK11816, MGK11820, MGK11825, PD01415, PD01416, PD01420, PD01610, PD01615, PD01616, PD01620, PD01810, PD01816, PD01820, PD02007, PD02010, PD02016 and 47 more |
Product
Soft Tissue Biopsy Needles
Reason for recall
Sterility assurance may be compromised.
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-2492-2021. 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.