⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Hologic, Inc: Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.

Medical DevicesSource: FDA (device) · Date: 2026-02-18

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Hologic, Inc
Product
Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Reason / hazard
Presence of particulates in affected devices that can be deposited into breast tissue during use.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution.
Recall initiated
2025-12-15
Code info
Model No - BREVDISP09; UDI - 1540045512863; All Lots within expiry.
Product quantity
681,870 units
Voluntary mandated
Voluntary: Firm initiated
City
Marlborough
State
MA
Country
United States
Event id
98172
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