BEUDAMED
    FDA Enforcement Class II Ongoing

    Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD

    Recall: Z-1244-2026 · Reported February 11, 2026

    Enforcement

    Recall Number
    Z-1244-2026
    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

    Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD

    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

    1. Flat Vitrectomy Lens Pouch UDI 810123482290 Box UDI 810123482306 Lots 2410036 2411020 2. Volk Magnifying Lens Pouch UDI 810123482825 Box UDI 810123482832 Lot 2411019

    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)