device · product 1 of 2
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
- Recall number
- Z-2458-2026
- Initiated
- May 08, 2026
- Classification
- Class II
- Status
- Ongoing
- Recalling firm
- AMD Medicom Inc.
- Quantity
- 7,838,200
App-derived interpretation
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 device-enrichment evidence · Sourced
Material/Component Contamination
Inspect official wording and provenance
Reason for recall
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.
Code information
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
Distribution pattern
US: MT, NC, VA, CA, TX, OH, TN, IL, RI