BEUDAMED
    FDA Enforcement Class II Ongoing

    1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450

    Recall: Z-0585-2026 · Reported December 3, 2025

    Enforcement

    Recall Number
    Z-0585-2026
    Event ID
    97967
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Remel, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    December 3, 2025
    Initiation Date
    November 12, 2025
    Classification Date
    November 21, 2025
    Address
    12076 Santa Fe Trail Dr, N/A, Lenexa, KS, 66215-3519, United States

    Description

    1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450

    Reason

    Products may contain contamination, which may result in a darker or brown media color.

    Code Info

    1. UDI-DI 848838018831, lots 305529, 311228, 316019, 320993 2. UDI-DI 848838091353, lot 317287

    Distribution

    Worldwide - US Nationwide distribution in the states of AK, CA, FL, GA, IA, IL, IN, LA, MA, MD, ME, MI, MN, NE, NY, OH, OK, PA, RI, SD, TN, VA, WA, WI and the countries of Brazil, Canada, China, Cyprus, Finland, Great Britain, Ireland, Moldova, Norway, Singapore.

    Quantity

    1,000 US, 280 ROW