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FDA-Device2026-06-24Class IIPROCESSING DEFECT

Ritmed Neurological Sponges recalled for elevated endotoxin levels

AMD Medicom
OTHERCAILMTNCOHRITNTXVA

Ritmed Neurological Sponges recalled for endotoxin risk

Ritmed Neurological Sponges used during brain surgery may contain elevated endotoxin levels. Endotoxins are bacterial contaminants that can trigger inflammation, fever, or temporary blood pressure drops when sponges contact cerebrospinal fluid during surgery.

  • If you are a healthcare facility or surgeon, check your inventory for affected lot numbers (REF 55992C–55998C, distributed after May 1, 2022).
  • Contact AMD Medicom Inc. for instructions on handling or returning affected sponges.
  • Consider alternatives for neurological surgery until you receive guidance.
Hazard

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.

Sold states
US: MT, NC, VA, CA, TX, OH, TN, IL, RI
Affected count
7,838,200
Manufactured in
2555 Ch de L'Aviation, Montreal, Canada
Products
Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C; 0.5x1.0in, Non-Sterile/55993C; 0.5x3.0in, Non-Sterile/55994C; 0.75x0.75in, Non-Sterile/55995C; 1.0x1.0in, Non-Sterile/55996C; 1.0x3.0in, Non-Sterile/55997C; 0.5x1.5in, Non-Sterile/55998C

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2458-2026

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