Class II

Medical Device Recall: Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.

Hologic, Inc · December 15, 2025

Reason for Recall

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

Distribution

US Nationwide distribution.

States Affected

NATIONWIDE

Quantity Affected

681,870 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1314-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.