BEUDAMED
    FDA Recall Open, Classified

    Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.

    Recall: Z-2209-2026 · Initiated March 23, 2026

    Recall

    Recall Number
    Z-2209-2026
    Event Number
    98654
    Firm
    TANGENT ENDOSCOPY, LLC
    FEI Number
    3041659934
    Product Code
    FBN
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    March 23, 2026
    Posted
    May 15, 2026
    Address
    2140 S Dupont Hwy, Camden, DE, 19934-1249

    Description

    Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.

    Reason

    Affected devices exhibited fractures at the distal shaft tip without complete detachment.

    Action

    On March 23, 2026, URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: Tangent requests that you discontinue use of and return all products from the lot number referenced above. We will ship you new devices and will notify you on ship date. Our records indicate that you have purchased one or more of products from these lots. Please acknowledge the email with a confirmation including the devices on hand. To find the lot number, please check the label on the package which clearly states this information. Instructions to return inventory: Please ship devices via Fedex overnight delivery, using Account 902012001. Devices must be shipped to the following address: TAG3 Engineering - Attention Scott Arp 1161 Sawgrass Corporate Parkway Sunrise, FL 33323, USA 4932-9431-8931 2 If you have any questions, please contact Shanita Shafeek at (305) 409-4946 or email [email protected]

    Distribution

    US Nationwide distribution in the states of North Carolina, Arizona, and Nevada.

    Quantity

    53 units