BEUDAMED
    FDA Recall Open, Classified

    Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style

    Recall: Z-1943-2026 · Initiated March 12, 2026

    Recall

    Recall Number
    Z-1943-2026
    Event Number
    98627
    Firm
    Healthmark Industries Co., Inc.
    FEI Number
    1000160387
    Product Code
    OCU
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    March 12, 2026
    Posted
    April 24, 2026
    Address
    18600 Malyn Blvd, Fraser, MI, 48026-3496

    Description

    Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style

    Reason

    Product does not have FDA clearance.

    Action

    Firm began notifying customers on March 12, 2026 via email and phone call. The device has been discontinued. Customers were asked to discontinue the use of the Mesh Style Tip Protectors. Unused product may be returned for credit.

    Distribution

    US Nationwide distribution.

    Quantity

    4,291,797