BEUDAMED
    FDA Recall Open, Classified

    Medline convenience kit: SMSC-PELVISCOPY PACK-LF DYNJ0161619M

    Recall: Z-2430-2026 · Initiated April 27, 2026

    Recall

    Recall Number
    Z-2430-2026
    Event Number
    98951
    FEI Number
    1417592
    Product Code
    MLT
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    April 27, 2026
    Posted
    June 12, 2026
    Address
    3 Lakes Dr, Medline Industries, LP, Northfield, IL, 60093-2753

    Description

    Medline convenience kit: SMSC-PELVISCOPY PACK-LF DYNJ0161619M

    Reason

    Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

    Action

    Firm began notifying consignees on 4/27/2026. Customers were instructed to request stickers to over-label affected convenience kits with a warning label. Warning label indicates for user to remove the affected component and replace it with product from supply. No kits are to be returned.

    Distribution

    US Nationwide distribution. OUS distribution pending.

    Quantity

    49,654 kits total