AMD Medicom recalls Ritmed Neurological Sponges (0.5x0.5in to 1.0x3.0in) due to potential endotoxin levels that could cause neurovascular issues during surgery. Affected lots distributed after May 2022.
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.
AMD Medicom is recalling Ritmed Neurological Sponges that may not meet endotoxin safety standards for brain surgery. This could lead to serious complications like inflammation or low blood pressure if used improperly.
These sponges may contain elevated endotoxin levels when used near cerebrospinal fluid. Endotoxins can trigger inflammation, fever, low blood pressure, or nausea in sensitive patients during surgery.
Surgical teams and hospitals using these sponges for brain procedures are most at risk. Patients undergoing neurosurgery with these sponges could experience adverse reactions.
Check for sponges labeled 0.5x0.5in, 0.5x1.0in, 0.5x3.0in, 0.75x0.75in, 1.0x1.0in, 1.0x3.0in, or 0.5x1.5in with model numbers 55992C-55998C. They were distributed after May 1, 2022, with specific lot numbers listed in the recall.
Identify the sponge size and model number to confirm if it matches the recalled items listed in the recall notice.
Reach out to AMD Medicom for guidance on next steps if you have the recalled sponges.
The sponges may not consistently meet endotoxin specifications for devices that contact cerebrospinal fluid, which could lead to neurovascular issues during surgery.
Elevated endotoxin levels could cause inflammation, fever, low blood pressure, or nausea in patients during neurosurgery.
Look for sponges with sizes 0.5x0.5in to 1.0x3.0in and model numbers 55992C-55998C, distributed after May 1, 2022, with specific lot numbers listed in the recall.
We’ve drafted a message you can send AMD Medicom to request your refund or repair — edit it as you like.
Subject: Recall Z-2458-2026 — AMD Medicom AMD Medicom Hello, I own a AMD Medicom that is covered by recall Z-2458-2026 from AMD Medicom. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
