[pending] Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Pending LLM rewrite. Source: FDA_DEVICE Z-1314-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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.
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