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Hologic, Inc recalls Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Recalled February 18, 2026 · FDA recall Z-1314-2026 · Hologic
Hazard
Presence of particulates in affected devices that can be deposited into breast tissue during use. · FDA Class II
Units
681,870 units
Sold at
US Nationwide distribution.
Description
Presence of particulates in affected devices that can be deposited into breast tissue during use.
Product
Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Manufacturer(s)
Hologic, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →