Hologic, Inc recalls Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
- Recalling company
- Hologic, Inc
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Dec 15, 2025
- Reported
- Feb 18, 2026
- Distribution
- US Nationwide distribution.
- Status
- Ongoing
- Quantity
- 681,870 units
- Lot / codes
- Model No - BREVDISP09; UDI - 1540045512863; All Lots within expiry.
- Company location
- Marlborough, MA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1314-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1314-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.