RegWardenFDA facility compliance records
Company

Balt USA, LLC

6 recall(s) on record — most severe on record: Class I.

Recalls by year

FDA actions on record by year2022: 3 recalls; 2024: 1 recalls; 2025: 2 recalls2017201820192020202132022202312024220252026
  • Recalls (6)

Registered facilities (1)

Recalls & enforcement

  • Class IOngoing2025-09-25
    Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
  • Class IIOngoing2025-05-08
    Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.
  • Class IIOngoing2024-01-03
    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 residue remaining on the hypotube component of the delivery pusher. Due to the location of …
  • Class IIOngoing2022-09-07
    Product pouch label does not match up with carton label
  • Class IIOngoing2022-07-26
    Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier.
  • Class IIOngoing2022-01-04
    Due to Label/Pouch mix-up. Pouches incorrectly labeled. Incorrect shelf carton label or pouch label due to inadequate manufacturing line clearance. As a result of this labeling mix-up, there is the possibility of inadvertently selecting the incorrect coil size for the procedure …

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Balt USA, LLC — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10041614-balt-usa-llc/

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