Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological Recalled by American Surgical Company, LLC Due to Product defect where the X-ray detectable barium strip...

Date: September 18, 2024
Company: American Surgical Company, LLC
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact American Surgical Company, LLC directly.

Affected Products

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

Quantity: 390 units

Why Was This 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.

Where Was This Sold?

This product was distributed to 8 states: CA, IL, IA, MN, MO, NY, OH, VA

Affected (8 states)Not affected

About American Surgical Company, LLC

American Surgical Company, LLC has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report