REF: 3598 SAFESCRAPER TWIST — Class II medical device recall Z-1778-2021
Terminated recall by Meta C.G.M. Spa, reported 2021-06-09, distributed in FL, TX. Sterility issues; single use devices labeled as sterile may not have been adequately sterilized
| Recall number | Z-1778-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Meta C.G.M. Spa, Correggio, Italy |
| Recall initiated | 2021-04-26 |
| Classified | 2021-06-02 |
| Reported by FDA | 2021-06-09 |
| Terminated | 2024-09-12 |
| Distributed | FL, TX |
| Quantity | 150 units |
| Reason classes | labeling, sterility |
| Lot numbers | 17-19818, 26-33118 |
| Model numbers | 3598 |
Product
REF: 3598 SAFESCRAPER TWIST, CE 0123, STERILE EO. Used in oral surgery.
Reason for recall
Sterility issues; single use devices labeled as sterile may not have been adequately 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-1778-2021. 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.