BEUDAMED
    FDA Recall Open, Classified

    Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2"

    Recall: Z-1650-2026 · Initiated February 10, 2026

    Recall

    Recall Number
    Z-1650-2026
    Event Number
    98484
    FEI Number
    1417592
    Product Code
    KGN
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    February 10, 2026
    Posted
    March 27, 2026
    Address
    3 Lakes Dr, Medline Industries, LP, Northfield, IL, 60093-2753

    Description

    Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2"

    Reason

    Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory response if used, including local tissue irritation, delayed wound healing, or systemic effects such as fever and hypotension. In severe cases, septic shock may result.

    Action

    Firm began notifying customers on 2/10/26 via "Urgent Medical Device Recall" letters. Customers were instructed to immediately locate and quarantine all affected product. Affected product must be destroyed. Customer should respond to the firm to confirm quantity of affected product in inventory. The customer will receive credit from the firm once the response is submitted. Distributors should notify any of their affected downstream accounts. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected].

    Distribution

    Domestic distribution nationwide US. International distribution to Mexico and Panama.

    Quantity

    106,621 US; 2,350 OUS