FDA Medical Device Recalls (openFDA)
American Surgical Company, LLC: 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
- Recall number
- Z-0287-2025
- Recalling firm
- American Surgical Company, LLC
- 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
- Status
- Open, Classified
- Initiated
- 2024-09-18
- Posted
- 2024-11-01
- Terminated
- not on file
- 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.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 390 units
- Distribution
- CA, IA, IL, MN, MO, NY, OH, VA Foreign: Australia, Belgium, Hungry, Italy, Netherlands, Sweden, UK Italy
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K854714"]
- PMA numbers
- not on file
- Product code
- HBA
- Firm FEI
- 1221144
- Firm city
- Salem
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28