FDA Device recall Z-1778-2021
REF: 3598 SAFESCRAPER TWIST, CE 0123, STERILE EO. Used in oral surgery
- FDA Device
- Class II
- terminated
- Published 2021-06-09
On 2021-06-09 the FDA classified a Class II recall of REF: 3598 SAFESCRAPER TWIST, CE 0123, STERILE EO. Used in oral surgery by Meta C G M Spa, citing sterility issues; single use devices labeled as sterile may not have been adequately sterilized.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1778-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-04-26 |
| Published | 2021-06-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Meta C G M Spa |
| Distribution | FL, TX |
Product
REF: 3598 SAFESCRAPER TWIST, CE 0123, STERILE EO. Used in oral surgery.
Reason
Sterility issues; single use devices labeled as sterile may not have been adequately sterilized
Identifiers
| code_info | Lot number: 26-33118 and 17-19818 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1778-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.