Ritmed Neurological Sponges recalled for elevated endotoxin levels
Ritmed Neurological Sponges recalled for endotoxin risk
AMD Medicom Inc. is recalling Ritmed Neurological Sponges (0.75x0.75in, Sterile, REF: 85995C) used during brain surgery because some units may not meet safety standards for endotoxin—a bacterial byproduct that can cause harmful reactions in the cerebrospinal fluid. Elevated endotoxin levels could lead to fever, inflammation, low blood pressure, nausea, or neurological complications.
- If you are a healthcare facility or surgical center, check your inventory for lot 17936 (UDI-DI: 10686864044465).
- Contact AMD Medicom Inc. or your medical device supplier for guidance on affected units.
- Do not use recalled sponges for neurological procedures.
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2459-2026More AMD Medicom Inc. recalls
- FDA-Device2026-06-24Ritmed Neurological Sponges recalled for elevated endotoxin levels
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