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Recall Observatory FDA recall evidence

Device 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

Z-0287-2025

September 18, 2024

Class II

Product summary

Firm
American Surgical Company, LLC
Event
Event 95464
Status
Ongoing
Classification
Class II
Quantity
390 units
Official record key
device-enforcement:Z-0287-2025

Official wording

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.

Code information: 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

Distribution pattern: CA, IA, IL, MN, MO, NY, OH, VA Foreign: Australia, Belgium, Hungry, Italy, Netherlands, Sweden, UK Italy

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.