BALT USA, LLC
4 recalls on record · Latest: Nov 5, 2025
FDA Devices Critical Nov 5, 2025
Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT0911…
FDA Devices Moderate Jun 25, 2025
Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT 00810068567694 PRES1445CPKPLT …
FDA Devices Moderate Oct 26, 2022
Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
FDA Devices Moderate Mar 2, 2022