Hologic, Inc recalls Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
- Recall date
- December 15, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1314-2026
- FDA classification
- Class II
- Brand / firm
- Hologic, Inc
- Sold / distributed
- US Nationwide distribution.
Why it was recalled
Presence of particulates in affected devices that can be deposited into breast tissue during use.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
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