FDAHealthDecember 15, 2025
Hologic, Inc — Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
⚠️ Presence of particulates in affected devices that can be deposited into breast tissue during use.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 15, 2025
US Nationwide distribution.
What's affected?
- Product
- Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
- Brand
- Hologic, Inc
- Lot code
- within
Additional details
Model No - BREVDISP09; UDI - 1540045512863; All Lots within expiry.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 681,870 units.
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