AMD Medicom Inc. recalls Ritmed Neurological Sponges

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.

On 5/8/2026, recall notices were emailed to customers who were asked to do the following: 1) Discontinue use, quarantine and destroy affected devices. 2) Notify any customers or facilities to whom you have distributed this product. 3) Complete and return the response form via email to firm's customer service at Claims@medicom.ca

• FDA enforcement recordOfficial FDA database entry for Z-2458-2026
• FDA 510(k) clearance · K830269The device's official FDA premarket clearance record
• FDA device classification · EFQOfficial FDA classification for this device type
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find AMD Medicom Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.