BEUDAMED
    FDA Recall Open, Classified

    MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010

    Recall: Z-1495-2026 · Initiated January 15, 2026

    Recall

    Recall Number
    Z-1495-2026
    Event Number
    98328
    Firm
    KOB GmbH Lauterstr. 50 Wolfstein Germany
    FEI Number
    3007858639
    Product Code
    ITG
    Status
    Open, Classified
    Root Cause
    Packaging process control
    Initiated
    January 15, 2026
    Posted
    March 6, 2026

    Description

    MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010

    Reason

    Due to labeling error. Incomplete ingredients listed. Labeling did not include castor oil or calamine.

    Action

    On 01/15/2026, the firm sent a "Medical Device Recall" letter to its distributor informing them that product is being recalled due to a labeling error. The product box/package contained an incomplete ingredient statement. The ingredients castor oil and calamine were missing from the product labeling. On 02/08/2026, the firm sent an updated "URGENT Medical Device Recall" Letter. Customers are instructed to: The products of the concerned lots must be scrapped. They shall not be used, distributed or made available on the market. For questions or assistance - use email [email protected]

    Distribution

    U.S.: IL O.U.S.: Not provided as product is manufactured O.U.S.

    Quantity

    35,328