BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported April 1, 2026

    Enforcement

    Recall Number
    Z-1650-2026
    Event ID
    98484
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medline Industries, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 1, 2026
    Initiation Date
    February 10, 2026
    Classification Date
    March 26, 2026
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    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.

    Code Info

    MSC8522 - Puracol UDI-DI 10080196285860 (each) 40080196285861 (case) Lot P2090 MSC8622EP - Puracol Plus UDI-DI 10080196296804 (each) 40080196296805 (case) Lot PL2107

    Distribution

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

    Quantity

    106,621 US; 2,350 OUS