BEUDAMED
    FDA Recall Open, Classified

    NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-8025 BrainPath Shephard's Hook - Sugita; NN-8026 BrainPath Shephard's Hook - Budde; NN-8042 BrainPath Shephard's Hook - Greenberg LK;

    Recall: Z-0601-2026 · Initiated October 31, 2025

    Recall

    Recall Number
    Z-0601-2026
    Event Number
    97833
    Firm
    Stryker Corporation
    FEI Number
    3015967359
    Product Code
    GEI
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    October 31, 2025
    Posted
    November 26, 2025
    Address
    1941 Stryker Way, Portage, MI, 49002-9711

    Description

    NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-8025 BrainPath Shephard's Hook - Sugita; NN-8026 BrainPath Shephard's Hook - Budde; NN-8042 BrainPath Shephard's Hook - Greenberg LK;

    Reason

    Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.

    Action

    On October 31, 2025, the firm began notifying impacted customers through Urgent Medical Device Recall letters. Customers were instructed to mark affected product with "CONTAINS LATEX" and place a copy of the notice at the product's storage location before use. Product returns are not required. However, customers who would like to receive a replacement were given options to destroy or return product for a replacement.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, England, Ireland, Italy, Kuwait, Singapore, Slovenia, Spain, and the Netherlands.

    Quantity

    39,148