BEUDAMED
    FDA Recall Open, Classified

    Medline kits containing Olympus biopsy valves: 1. BRONCHOSCOPY, DYNJ900898I DYNJ901922G 2. FLEXIBLE BRONCHOSCOPY KIT, DYKM1417I DYKM1417J 3. LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146A 4. RIGID KIT, DYNDA2138A

    Recall: Z-1709-2026 · Initiated February 16, 2026

    Recall

    Recall Number
    Z-1709-2026
    Event Number
    98530
    FEI Number
    1417592
    Product Code
    OGR
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    February 16, 2026
    Posted
    April 1, 2026
    Address
    3 Lakes Dr, Medline Industries, LP, Northfield, IL, 60093-2753

    Description

    Medline kits containing Olympus biopsy valves: 1. BRONCHOSCOPY, DYNJ900898I DYNJ901922G 2. FLEXIBLE BRONCHOSCOPY KIT, DYKM1417I DYKM1417J 3. LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146A 4. RIGID KIT, DYNDA2138A

    Reason

    Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.

    Action

    Firm notified customers on 2/16/26. Consignees were provided with a copy of Olympus's notification, which includes reminders to follow the IFU. According to the firm, the component can continue to be utilized by the customer, along with the remainder of the kit.

    Distribution

    US Nationwide distribution in the states of CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, TX.

    Quantity

    14,379 kits total