Brand
BALT USA, LLC recalls
5 federal recalls on file, showing the 1 from the last 12 months. We monitor every CPSC, FDA, USDA, and NHTSA notice for BALT USA, LLC and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-11-05FDA-DeviceClass IBrand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT091110 Software Version: N/A Product Description: The Mega Ballast 091 is designed with a semi-rigid proximal shaft and a highly flexible distal shaft. The design facilitates the advancement of the Mega Ballast to access the tortuous vasculature over a guidewire and a respective dilator. The outer surface of the Mega Ballast is coated with a hydrophil
Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
Get the week's recalls, including BALT USA, LLC
Free weekly digest — every federal recall affecting your household, BALT USA, LLC included when it comes up. Track BALT USA, LLC specifically with Always-on.
Explore other recall topics
By hazard
By state
Get alerts for your household