Recall Z-0287-2025— American Surgical Company, LLC

Name: FDA recall Z-0287-2025
Creator: U.S. Food and Drug Administration
Published: 2024-09-18

Class II · Ongoing

Class II FDA medical device recall by American Surgical Company, LLC, initiated 2024-09-18. It names one FDA 510(k) clearance: K854714. Product: 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. Reason: 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..

Recalling firm: American Surgical Company, LLC
Classification: Class II
Status: Ongoing
Initiated: 2024-09-18
Firm location: Salem, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K854714 — X-RAY DETECTABLE COTTON BALLSAmerican Silk Sutures, Inc.·cleared 1985-12-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.