FDA Device recall Z-1314-2026
Brevera Breast Biopsy System Disposable 9 Gauge Needle
- FDA Device
- Class II
- ongoing
- Published 2026-02-18
On 2026-02-18 the FDA classified a Class II recall of Brevera Breast Biopsy System Disposable 9 Gauge Needle by Hologic, citing presence of particulates in affected devices that can be deposited into breast tissue during use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1314-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-12-15 |
| Published | 2026-02-18 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Hologic |
| Distribution | US |
Product
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.
Identifiers
| code_info | Model No - BREVDISP09; UDI - 1540045512863; All Lots within expiry. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1314-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.