BALT USA, LLC

3 FDA enforcement actions

3 Total Recalls

1 Class I

2 Class II

0 Class III

Firm Details

Product Types: device
States: CA

All Recalls

Class I: Dangerous 09/25/2025 device

Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
Class II: Risk 05/08/2025 device

Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.
Class II: Risk 05/08/2025 device

Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.