FDA DevicesClass II
Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Published: February 18, 2026Recall ID: Z-1314-2026Category: devicesCountry: US
Reason for Recall / Hazard
Presence of particulates in affected devices that can be deposited into breast tissue during use.
Product Description & Identification
Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Additional Source Details
| Field | Value |
|---|---|
| City | Marlborough |
| State | MA |
| Event id | 98172 |
| Address 1 | 250 Campus Dr |
| Address 2 | N/A |
| Code info | Model No - BREVDISP09; UDI - 1540045512863; All Lots within expiry. |
| Postal code | 01752-3020 |
| Report date | 20260218 |
| Product type | Devices |
| Product quantity | 681,870 units |
| Reason for recall | Presence of particulates in affected devices that can be deposited into breast tissue during use. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251215 |
| Initial firm notification | Letter |
| Center classification date | 20260206 |
Overview
- Recalling FirmHologic, Inc
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution.