BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0585-2026 · Initiated November 12, 2025

    Recall

    Recall Number
    Z-0585-2026
    Event Number
    97967
    Firm
    Remel, Inc
    FEI Number
    1924669
    Product Code
    JTZ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    November 12, 2025
    Posted
    November 21, 2025
    Address
    12076 Santa Fe Trail Dr, Lenexa, KS, 66215-3519

    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.

    Action

    On November 13, 2025, firm began notifying customers via Urgent Medical Device Recall letters. Customers were advised to review results and destroy any remaining inventory of affected lots. Affected product should not be used for any clinical laboratory testing. Customers should complete the acknowledgement form provided by the firm indicating number of units destroyed in order to receive replacement/credit.

    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