Recall Z-1314-2026— Hologic, Inc

Name: FDA recall Z-1314-2026
Creator: U.S. Food and Drug Administration
Published: 2025-12-15

Class II · Ongoing

Class II FDA medical device recall by Hologic, Inc, initiated 2025-12-15. It names one FDA 510(k) clearance: K163052. Product: Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.. Reason: Presence of particulates in affected devices that can be deposited into breast tissue during use..

Recalling firm: Hologic, Inc
Classification: Class II
Status: Ongoing
Initiated: 2025-12-15
Firm location: Marlborough, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K163052 — Brevera Biopsy System with Corlumina Imaging TechnologyHologic, Inc.·cleared 2017-03-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.