Device recall
Z-0287-2025: Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the…
FDA device recall · Class II · American Surgical Company, LLC
Key facts
| Recall number (Z-number) | Z-0287-2025 |
|---|---|
| Recall event | 95464 |
| 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 |
| Product code | HBA |
| Recalling firm | American Surgical Company, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K854714 |
| FEI number | 1221144 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database