Class IIReported 2026-02-18

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

Recalled by Hologic, Inc

Reason for Recall

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

Recall Number

Z-1314-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2025-12-15

Reported

2026-02-18

Distribution

US Nationwide distribution.

Code Info

Model No - BREVDISP09; UDI - 1540045512863; All Lots within expiry.

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.