BEUDAMED
    FDA Recall Open, Classified

    Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.

    Recall: Z-1314-2026 · Initiated December 15, 2025

    Recall

    Recall Number
    Z-1314-2026
    Event Number
    98172
    Firm
    Hologic, Inc
    FEI Number
    1000120743
    Product Code
    KNW
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    December 15, 2025
    Posted
    February 6, 2026
    Address
    250 Campus Dr, Marlborough, MA, 01752-3020

    Description

    Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.

    Reason

    Presence of particulates in affected devices that can be deposited into breast tissue during use.

    Action

    An URGENT FIELD SAFETY NOTICE (REMOVAL) was mailed to consignees on 1/2/26. The notification instructs consignees to quarantine affected devices and return them through IQVIA per the instructions provided on the Recall Response Form. The recall notification should be forwarded within consignee locations to users and to any facility to which product was further distributed. A copy of the recall notification is to be posted for awareness at consignee locations. Questions can be directed to [email protected] or by phone at 1-877-371-4372.

    Distribution

    US Nationwide distribution.

    Quantity

    681,870 units