Americot Neurological Sponges (American Surgical) – X-Ray Marker Defect (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
American Surgical Company, LLC
Lot Codes / Batch Numbers
UDI-DI: 10749915000039 Lot Number Expiration Date: 2023/03 AQ 2028/03/31, 2023/06 AP 2028/06/30, 2023/10 BO 2028/10/31, 2023/12 AY 2028/12/31, 2024/05 AE 2029/05/31, 2024/06 AQ 2029/06/30
Products Sold
UDI-DI: 10749915000039 Lot Number Expiration Date: 2023/03 AQ 2028/03/31; 2023/06 AP 2028/06/30; 2023/10 BO 2028/10/31; 2023/12 AY 2028/12/31; 2024/05 AE 2029/05/31; 2024/06 AQ 2029/06/30
American Surgical Company, LLC is recalling Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the protection of neura due to Product defect where the X-ray detectable barium strip (aka radio-opaque marker) becomes detached from the sponge (pattie). May delay surgical process. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
American Surgical issued Urgent Medical Device Recall Letter on 9/26/24 via email. Letter states reason for recall, health risk and action to take: Effective immediately, American Surgical Company, LLC (ASC) requests your assistance. We ask that all lots listed in the table above within your inventory immediately be discontinued for use. We also ask the inventory to be quarantined, counted, and discarded. " Report any complaint to ASC Customer Service 1-800-343-0060 or email: customerservice@americansurgical.com " The product code and lot number can be found on the individual product pouch and carton. " Please respond to this request by the deadline in the form below and return the completed form to customerservice@americansurgical.com or Fax: 1-781-595-5460 even if you do not have any inventory that remains. " If you distribute this product, please forward them a copy of this communication and notify ASC Customer Service immediately. Further information and support: " For general questions regarding this communication, contact Customer Service at 800-343-0060 between the hours of 8:30 am and 5:00 pm Eastern Time, Monday through Friday.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, IL, IA, MN, MO, NY, OH, VA
Page updated: Jan 10, 2026