BEUDAMED
    FDA Enforcement Class I Ongoing

    Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: No

    Recall: Z-1114-2026 · Reported February 4, 2026

    Enforcement

    Recall Number
    Z-1114-2026
    Event ID
    98208
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    SunMed Holdings, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 4, 2026
    Initiation Date
    December 15, 2025
    Classification Date
    January 28, 2026
    Address
    2710 Northridge Dr Nw Ste A, N/A, Grand Rapids, MI, 49544-9112, United States

    Description

    Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: No

    Reason

    Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.

    Code Info

    Lot Code: Lot/Serial Number(s) 0004306540 0004316209 0004328895 0004329080 0004330876 0004331254 0004332994 0004338228 0004338229 0004338230 0004339717 UDI-DI Each-10889483588970 Case-30889483588974

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.

    Quantity

    95300