FDA Device recall Z-0103-2023
Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10
- FDA Device
- Class II
- ongoing
- Published 2022-10-26
On 2022-10-26 the FDA classified a Class II recall of Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10 by Balt Usa, citing product pouch label does not match up with carton label.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0103-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-09-07 |
| Published | 2022-10-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Balt Usa |
| Distribution | US |
Product
Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
Reason
Product pouch label does not match up with carton label
Identifiers
| code_info | Model Number: OPTI0208CSS10 UDI-DI Code: 00818053025815 Lot Number: F220601068 Model Number: OPTI0308CSS10 UDI-DI Code: 00818053025891 Lot Number: F220601089 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0103-2023%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.