FDA Enforcement
Class II
Ongoing
Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Recall: Z-1314-2026
·
Reported February 18, 2026
Enforcement
- Recall Number
- Z-1314-2026
- Event ID
- 98172
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Hologic, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 18, 2026
- Initiation Date
- December 15, 2025
- Classification Date
- February 6, 2026
- Address
- 250 Campus Dr, N/A, Marlborough, MA, 01752-3020, United States
Description
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.
Code Info
Model No - BREVDISP09; UDI - 1540045512863; All Lots within expiry.
Distribution
US Nationwide distribution.
Quantity
681,870 units