Hologic, Inc recalls Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.

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

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

An URGENT FIELD SAFETY NOTICE (REMOVAL) was mailed to consignees on 1/2/26. The notification instructs consignees to quarantine affected devices and return them through IQVIA per the instructions provided on the Recall Response Form. The recall notification should be forwarded within consignee locations to users and to any facility to which product was further distributed. A copy of the recall notification is to be posted for awareness at consignee locations. Questions can be directed to BreastHealth.Support@hologic.com or by phone at 1-877-371-4372.

• FDA enforcement recordOfficial FDA database entry for Z-1314-2026
• FDA 510(k) clearance · K163052The device's official FDA premarket clearance record
• FDA device classification · KNWOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.1075The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Hologic, IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.