BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported June 24, 2026

    Enforcement

    Recall Number
    Z-2458-2026
    Event ID
    99006
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    AMD Medicom Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 24, 2026
    Initiation Date
    May 8, 2026
    Classification Date
    June 16, 2026
    Address
    2555 Ch de L'Aviation, Montreal, N/A, Canada

    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.

    Code Info

    UDI-DI: 20686864043205. Distributed After May 1st, 2022

    Distribution

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

    Quantity

    7,838,200