Recall archive / FDA device enforcement
Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the protection of neural tissue during su... — FDA record Z-0287-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 18, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- 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.
- Classification
- Class II
- Recalling firm
- American Surgical Company, LLC
- Quantity
- 390 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0287-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
CA, IA, IL, MN, MO, NY, OH, VA Foreign: Australia, Belgium, Hungry, Italy, Netherlands, Sweden, UK Italy
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Nov 13, 2024
- Recall initiation date
- Sep 18, 2024
- Center classification date
- Nov 1, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.