FDA recall Z-0287-2025

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.

Distribution

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

Key facts

Status

Ongoing

Initiation date

2024-09-18

Report date

2024-11-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Salem, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0287-2025