Amd Medicom Inc.: Gauze/sponge, Internal
Recall Summary AMD Medicom Inc. is recalling Ritmed Neurological Sponges (0.75x0.75 inches, sterile, REF: 85995C) used during brain surgery because they may contain elevated endotoxin levels that could trigger adverse reactions including fever, inflammation, low blood pressure, or nausea in patients whose cerebrospinal fluid comes into contact with the product. The affected sponges were distributed to medical facilities in nine U.S. states: California, Illinois, Montana, North Carolina, Ohio, Rhode Island, Tennessee, Texas, and Virginia.
- Recalling firm
- AMD Medicom Inc.
- Product
- Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C
- 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
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/03812382-4352-4a61-ba0d-e43e174cbb98