Class II — American Surgical Company, LLC
| Recalling firm | American Surgical Company, LLC |
|---|---|
| Registered facility | AMERICAN SURGICAL COMPANY, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| 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 |
| Quantity | 390 units |
| Distribution | CA, IA, IL, MN, MO, NY, OH, VA Foreign: Australia, Belgium, Hungry, Italy, Netherlands, Sweden, UK Italy |
| Initiated | 2024-09-18 |
| Classified | 2024-11-01 |
| Recall number | Z-0287-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — American Surgical Company, LLC (Z-0287-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95464/
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