FDA-Device2026-02-18Class II
Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Hologic, Inc
Hazard
Presence of particulates in affected devices that can be deposited into breast tissue during use.
Sold states
US Nationwide distribution.
Affected count
681,870 units
Manufactured in
250 Campus Dr, N/A, Marlborough, MA, United States
Products
Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1314-2026Original summary
Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument. Presence of particulates in affected devices that can be deposited into breast tissue during use. Model No - BREVDISP09; UDI - 1540045512863; All Lots within expiry. Distribution: US Nationwide distribution. Affected quantity: 681,870 units
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