BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1244-2026 · Initiated December 16, 2025

    Recall

    Recall Number
    Z-1244-2026
    Event Number
    98255
    Firm
    Vortex Surgical Inc.
    FEI Number
    3013002167
    Product Code
    HJK
    Status
    Open, Classified
    Root Cause
    Employee error
    Initiated
    December 16, 2025
    Posted
    February 4, 2026
    Address
    4 Research Park Dr, Ste 124, Saint Charles, MO, 63304-5639

    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.

    Action

    On December 16, 2025, the firm began notifying customers via "URGENT: MEDICAL DEVICE RECALL" letters. Customers were instructed to discontinue use of affected product and to return product for Vortex Surgical to evaluate the seals; use UPS account 23623Y to ship unused products to Vortex Surgical Inc for replacement or refund at: Attn: Andrew Ritts Recall Tyvek Seal, Vortex Surgical Inc., 4 Research Park Dr., Suite 124, St. Charles, MO 63304; complete and return the Acknowledgement and Receipt Form via mail or email to: [email protected]. Actions have been implemented to improve training of individuals associated with sealing and inspecting seals to prevent reoccurrence. The sealer associated with the issue is being updated to include a guard to prevent reoccurrence. If you have any questions, contact the Director of Regulatory Affairs at 635-778-4350 or email to: [email protected] from 8am to 5pm.

    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)