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

Class II
Recalling firm
AMD Medicom Inc.
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 pattern
US: MT, NC, VA, CA, TX, OH, TN, IL, RI
Status
Ongoing
Recall number
Z-2459-2026
Recall initiated
May 8, 2026
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