Z-1314-2026 Class II Ongoing
FDA device recall Z-1314-2026 was initiated by Hologic, Inc on December 15, 2025 and is designated Class II. Reason for recall: Presence of particulates in affected devices that can be deposited into breast tissue during use. The recall status is ongoing. Affected quantity: 681,870 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 18, 2026
- Initiation Date
- December 15, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 681,870 units
Product Description
Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Reason for Recall
Presence of particulates in affected devices that can be deposited into breast tissue during use.
Distribution Pattern
US Nationwide distribution.
Code Information
Model No - BREVDISP09; UDI - 1540045512863; All Lots within expiry.