American Surgical Company, LLC recalls Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the protection of neural tissue during surg…

Recall date

September 18, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0287-2025

FDA classification

Class II

Brand / firm

American Surgical Company, LLC

Sold / distributed

CA, IA, IL, MN, MO, NY, OH, VA Foreign: Australia, Belgium, Hungry, Italy, Netherlands, Sweden, UK Italy

Why it was recalled

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 II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the protection of neural tissue during surgery. Ref: 20-01S ¿ x ¿ inches or 6mm x 6mm) Component: N/A