BEUDAMED
    FDA Recall Open, Classified

    BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 BIPOLAR HEAD 39MM 18132 BIPOLAR HEAD 40MM 18133 BIPOLAR HEAD 41MM 18134 BIPOLAR HEAD 42MM 18135 BIPOLAR HEAD 43MM 18136 BIPOLAR HEAD 44MM 18137 BIPOLAR HEAD 45MM 18138 BIPOLAR HEAD 46MM 18139 BIPOLAR HEAD 47MM 18140 BIPOLAR HEAD 48MM 18141 BIPOLAR HEAD 49MM 18142 BIPOLAR HEAD 50MM 18143 BIPOLAR HEAD 51MM 18144 BIPOLAR HEAD 52MM 18145 BIPOLAR HEAD 53MM 18146 BIPOLAR HEAD 54MM 18147 BIPOLAR HEAD 55MM 18148 BIPOLAR HEAD 56MM 18149 BIPOLAR HEAD 57MM 18150 BIPOLAR HEAD 58MM 18151 BIPOLAR HEAD 59MM 18152 BIPOLAR HEAD 60MM

    Recall: Z-0150-2026 · Initiated September 9, 2025

    Recall

    Recall Number
    Z-0150-2026
    Event Number
    97605
    Firm
    BioPro, Inc.
    FEI Number
    1832656
    Product Code
    KWY
    Status
    Open, Classified
    Root Cause
    Package design/selection
    Initiated
    September 9, 2025
    Posted
    October 14, 2025
    Address
    2929 Lapeer Rd, Port Huron, MI, 48060-2558

    Description

    BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 BIPOLAR HEAD 39MM 18132 BIPOLAR HEAD 40MM 18133 BIPOLAR HEAD 41MM 18134 BIPOLAR HEAD 42MM 18135 BIPOLAR HEAD 43MM 18136 BIPOLAR HEAD 44MM 18137 BIPOLAR HEAD 45MM 18138 BIPOLAR HEAD 46MM 18139 BIPOLAR HEAD 47MM 18140 BIPOLAR HEAD 48MM 18141 BIPOLAR HEAD 49MM 18142 BIPOLAR HEAD 50MM 18143 BIPOLAR HEAD 51MM 18144 BIPOLAR HEAD 52MM 18145 BIPOLAR HEAD 53MM 18146 BIPOLAR HEAD 54MM 18147 BIPOLAR HEAD 55MM 18148 BIPOLAR HEAD 56MM 18149 BIPOLAR HEAD 57MM 18150 BIPOLAR HEAD 58MM 18151 BIPOLAR HEAD 59MM 18152 BIPOLAR HEAD 60MM

    Reason

    Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

    Action

    Consignees were notified on September 9, 2025, via phone, followed by formal letters with instructions for returning the inventory to BioPro.

    Distribution

    US Domestic distribution to Texas and Michigan.

    Quantity

    147 total