Americot 20-01S — Class II medical device recall Z-0287-2025
Ongoing recall by American Surgical Company, LLC, reported 2024-11-13, distributed in CA, IA, IL, MN, MO, NY, OH, VA. Product defect where the X-ray detectable barium strip (aka radio-opaque marker) becomes detached from the spo
| Recall number | Z-0287-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Surgical Company, LLC, Salem, MA, United States |
| Recall initiated | 2024-09-18 |
| Classified | 2024-11-01 |
| Reported by FDA | 2024-11-13 |
| Distributed | CA, IA, IL, MN, MO, NY, OH, VA |
| Countries outside the US | AU, BE, GB, IT, NL, SE |
| Quantity | 390 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 10749915000039 |
| Lot numbers | 2023/03AQ, 2023/06AP, 2023/10BO, 2023/12AY, 2024/05AE, 2024/06AQ, 2028/03/31, 2028/06/30, 2028/10/31, 2028/12/31, 2029/05/31, 2029/06/30 |
| Model numbers | 20-01S |
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
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0287-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.