Medical DeviceNov 5, 2025
Mega Ballast recall — FDA Z-0188-2026
Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
Class IFDA: OngoingBALT USA, LLC
Recall history in this database
Classification mix: Class II: 4, Class I: 1.
Medical DeviceJun 25, 2025
BALT USA Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 recall — FDA Z-1989-2025
Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.
Class IIFDA: OngoingBALT USA, LLC
Medical DeviceJun 25, 2025
BALT USA Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK recall — FDA Z-1988-2025
Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.
Class IIFDA: OngoingBALT USA, LLC
Medical DeviceFeb 14, 2024
BALT USA Neurovascular embolization device recall — FDA Z-1041-2024
Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of solder flux…
Class IIFDA: OngoingBALT USA, LLC
Medical DeviceFeb 14, 2024
BALT USA The Prestige Coil System is a product family of embolic coils with associated recall — FDA Z-1042-2024
Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of solder flux…
Class IIFDA: OngoingBALT USA, LLC
Understanding this recall history
This page summarizes recall records in which the official source identifies BALT USA, LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.