Amd Medicom Inc.: Gauze/sponge, Internal

Recall Summary AMD Medicom Inc. is recalling Ritmed Neurological Sponges in seven different sizes used during brain surgery because they may contain elevated endotoxin levels that don't meet safety standards. These sponges contact cerebrospinal fluid during neurological procedures, and high endotoxin levels could cause complications including fever, inflammation, low blood pressure, or nausea. The recall affects products distributed in nine states: California, Illinois, Montana, North Carolina, Ohio, Rhode Island, Tennessee, Texas, and Virginia.

Recalling firm: AMD Medicom Inc.
Product: 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
Reason: 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.
Category: medical device recall
Country: United States
Agency: FDA-DEVICES
Recall date: 2026-05-08
Status: Open, Classified
Areas affected: CA, IL, MT, NC, OH, RI, TN, TX, VA
Distribution: US: MT, NC, VA, CA, TX, OH, TN, IL, RI

Recall details on Nibble Recalls: https://trynibble.app/recalls/843f3f18-055a-4b8c-871f-50388c672870