Reported Feb 18, 2026 · Ongoing
Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Hologic, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hologic, Inc · 250 Campus Dr · Marlborough, MA · 01752-3020
Is this the product you have?
- Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
- Lot codes and dates
Model No - BREVDISP09UDI - 1540045512863All Lots within expiry
- Amount recalled
- 681,870 units
Where it was sold
- Nationwide
Why it was recalled
Presence of particulates in affected devices that can be deposited into breast tissue during use.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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