Class II

Medical Device Recall: Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C

AMD Medicom Inc. · May 8, 2026

Reason for Recall

Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not consistently meet endotoxin specification for devices that contact the cerebrospinal fluid. Elevated endotoxin levels may lead to neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.

Distribution

US: MT, NC, VA, CA, TX, OH, TN, IL, RI

States Affected

CA, IL, MT, NC, OH, RI, TN, TX, VA

Quantity Affected

10

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2459-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

AMD Medicom Inc. Medical Device Recall: Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C | SafeCheck