Balt Usa, Llc
Irvine, CA
This page shows every FDA and USDA recall linked to Balt Usa, Llc. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
8
Total Recalls
2022
First Recall
2025
Most Recent
Brand Name: MEGA Ballast Distal Access Platform
Product Name: Mega Ballast
Model/Catalog Number: MEGABT09180,...
Oct 24, 2025
· Device
Open, Classified
Optima Coil System REFs/UDI-DI codes:
OPTI0156BLK 00810068568875
OPTI0158BLK 00810068568882
OPTI0103BLK 008100...
Jun 18, 2025
· Device
Open, Classified
Prestige Coil System REFs/UDI-DI codes:
PRES0153CXPPLT 00810068567311
PRES1045CPKPLT 00810068567663
PRES1245CP...
Jun 18, 2025
· Device
Open, Classified
Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into...
Feb 8, 2024
· Device
Open, Classified
The Prestige Coil System is a product family of embolic coils with associated delivery system components. Thes...
Feb 8, 2024
· Device
Open, Classified
Optima Coil System
Model Number OPTI0208CSS10,
Model Number OPTI0308CSS10. Used in endovascular procedure...
Oct 20, 2022
· Device
Open, Classified
Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
Jul 26, 2022
· Device
Open, Classified
The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy att...
Jan 4, 2022
· Device
Open, Classified