Balt USA, LLC recalls

All Balt USA, LLC recalls we track from FDA, CPSC and NHTSA data. Categories: medical devices (3).

3 recalls published between June 25, 2025 and November 5, 2025. 1 was FDA Class I, the most serious level.

• MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model recall
  FDA November 5, 2025 · Balt USA, LLC · Class I
• Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311… recall
  FDA June 25, 2025 · Balt USA, LLC · Class II
• Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875… recall
  FDA June 25, 2025 · Balt USA, LLC · Class II