Recall database

BALT USA, LLC recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–3 of 3 recalls

Class IOngoingZ-0188-2026

Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.

BALT USA, LLCCANov 5, 2025

Class IIOngoingZ-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.

BALT USA, LLCCAJun 25, 2025

Class IIOngoingZ-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.

BALT USA, LLCCAJun 25, 2025