FDA-Device2026-06-24Class IIPROCESSING DEFECT

Ritmed Neurological Sponges recalled for elevated endotoxin levels

OTHERCA IL MT NC OH RI TN TX VA Medical devices

What this means

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.

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The agency's original wording

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.

Intended for

Adults

Illnesses reported

None reported

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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