Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological… recallZ-0287-2025 · American Surgical Company, LLC · initiated Sep 18, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from American Surgical Company, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Process control
What the company is doing
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: [email protected] " 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 [email protected] 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.
Recall details
- Recall number
- Z-0287-2025
- Status
- Open, Classified
- Initiated by the company
- Sep 18, 2024
- Posted by the FDA
- Nov 1, 2024
- Recalling firm
- American Surgical Company, LLC
- Quantity
- 390 units
- Product code
- HBA
- FDA submissions
- K854714
- Distribution
- CA, IA, IL, MN, MO, NY, OH, VA Foreign: Australia, Belgium, Hungry, Italy, Netherlands, Sweden, UK Italy
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
Code information (models, lots, serial 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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Americot 20-01SAmerican Surgical Company, LLC · Neurosurgical Paddie1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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