medical Class II Updated 2026-02-18

Hologic, Inc recalls Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biop

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model No - BREVDISP09; UDI - 1540045512863; All Lots within expiry.
View official government recall

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