Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument. Recalled by Hologic, Inc Due to Presence of particulates in affected devices that can...

Date: December 15, 2025
Company: Hologic, Inc
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Hologic, Inc directly.

Affected Products

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

Quantity: 681,870 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Hologic, Inc

Hologic, Inc has 24 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report