Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
FDA Recall #Z-1314-2026 — Class II — December 15, 2025
Product Description
Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Reason for Recall
Presence of particulates in affected devices that can be deposited into breast tissue during use.
Recalling Firm
Hologic, Inc — Marlborough, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
681,870 units
Distribution
US Nationwide distribution.
Code Information
Model No - BREVDISP09; UDI - 1540045512863; All Lots within expiry.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated