FDA Medical devices recall ·
Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use… recall
- Recall number
- Z-0287-2025
- Date
- (initiated September 18, 2024)
- Company / brand
- American Surgical Company, LLC
45 Congress St Ste 153, Salem, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 390 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot 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
Distribution
CA, IA, IL, MN, MO, NY, OH, VA Foreign: Australia, Belgium, Hungry, Italy, Netherlands, Sweden, UK Italy
States: California Iowa Illinois Minnesota Missouri New York Ohio Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0287-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.