BEUDAMED
    FDA Recall Open, Classified

    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: Z-2458-2026 · Initiated May 8, 2026

    Recall

    Recall Number
    Z-2458-2026
    Event Number
    99006
    Firm
    AMD Medicom Inc. 2555 Ch de L'Aviation Montreal Canada
    FEI Number
    3002677549
    Product Code
    EFQ
    Status
    Open, Classified
    Root Cause
    Material/Component Contamination
    Initiated
    May 8, 2026
    Posted
    June 16, 2026

    Description

    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.

    Action

    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 [email protected]

    Distribution

    US: MT, NC, VA, CA, TX, OH, TN, IL, RI

    Quantity

    7,838,200