FDAFDA · Food and drugs·Recall number Z-2458-2026
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
Published June 24, 2026 · Recall initiated: May 8, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- AMD Medicom Inc.
- Distributor
- US: MT, NC, VA, CA, TX, OH, TN, IL, RI
- Lot
- UDI-DI: 20686864043205. Distributed After May 1st, 2022, including the following lots: 19316, 16409, 15463-7, 15463-6, 15463-5, 15463-4, 15463-3, 15463-2, 15463-1, 15463, 15192-1, 15192, 14813, 14039, 13673, 13289, 12641, 12206, 11851, 11020-1, 11020, 10586, 10392, 9243, 8160, 7784, 7748, 7044
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Canada
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