Salem, MA, United States
American Surgical Company, LLC recalls
1 recall recorded since 2018, most recently on 18 September 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 18 September 2024
- 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.
- Distribution
- CA, IA, IL, MN, MO, NY, OH, VA Foreign: Australia, Belgium, Hungry, Italy, Netherlands, Sweden, UK Italy
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0287-2025
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.