RegWardenFDA facility compliance records
Company

American Surgical Company, LLC

2 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2016: 1 recalls; 2024: 1 recalls1201620172018201920202021202220231202420252026
  • Recalls (2)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2024-09-18
    Product defect where the X-ray detectable barium strip (aka radio-opaque marker) becomes detached from the sponge (pattie). May delay surgical process as the surgeon may require extra time to remove the markers from the surgical field.
  • Class IITerminated2016-03-31
    Product packaging defective compromising sterility

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. “American Surgical Company, 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-10030544-american-surgical-company-llc/

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