Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Pending LLM rewrite. Source: FDA_DEVICE Z-1314-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Presence of particulates in affected devices that can be deposited into breast tissue during use.
The recalled product
- Product
- Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
- Manufacturer
- Hologic, Inc
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model No - BREVDISP09
- UDI - 1540045512863
- All Lots within expiry.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22