Class II

Medical Device Recall: 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

American Surgical Company, LLC · September 18, 2024

Reason for Recall

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.

Distribution

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

States Affected

CA, IA, IL, MN, MO, NY, OH, VA

Quantity Affected

390 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0287-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.