BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-2209-2026 · Reported May 27, 2026

    Enforcement

    Recall Number
    Z-2209-2026
    Event ID
    98654
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    TANGENT ENDOSCOPY, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 27, 2026
    Initiation Date
    March 23, 2026
    Classification Date
    May 15, 2026
    Address
    2140 S Dupont Hwy, Camden, DE, 19934-1249, United States

    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.

    Code Info

    (1) Model Number: TNG4002-IND; UDI-DI: (1) 00850061601001; Lot numbers: 2510900, 2512938, and 2601944. (2) Model Number: TNG-4007-6pk; UDI-DI: 00850061601001; Lot numbers: 2510900, 2512938, and 2601944

    Distribution

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

    Quantity

    53 units