BEUDAMED
    FDA Enforcement Class II Ongoing

    Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25

    Recall: Z-1250-2026 · Reported February 11, 2026

    Enforcement

    Recall Number
    Z-1250-2026
    Event ID
    98255
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Vortex Surgical Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 11, 2026
    Initiation Date
    December 16, 2025
    Classification Date
    February 4, 2026
    Address
    4 Research Park Dr Ste 124, N/A, Saint Charles, MO, 63304-5639, United States

    Description

    Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25

    Reason

    There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

    Code Info

    Pouch UDI 810123480456 Box UDI 810123480739 Lot 2410044

    Distribution

    Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CT, FL, HI, IA, IL, IN, KY, MA, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, WI, VA; and OUS (foreign) to countries of: Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, Vietnam.

    Quantity

    14,789 (8651 US; 6138 OUS)