Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
This recall is currently active, issued February 6, 2026. It was issued by Hologic, Inc.
- Company
- Hologic, Inc
- Recall Initiated
- December 15, 2025
- Posted
- February 6, 2026
- Recall Number
- Z-1314-2026
- Quantity
- 681,870 units
- Firm Location
- Marlborough, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Presence of particulates in affected devices that can be deposited into breast tissue during use.
Distribution
US Nationwide distribution.
Lot / Code Info
Model No - BREVDISP09; UDI - 1540045512863; All Lots within expiry.
Root Cause
Under Investigation by firm
Action Taken
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.