← FDA ENFORCEMENT
Z-1314-2026Class II

Hologic, Inc

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Hologic, Inc
Product type
Device
Status
Ongoing
Report date
2026-02-18
Distribution
US Nationwide distribution.
Firm state
MA
Product quantity
681,870 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

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

Product description

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

Code / lot info

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

Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →