Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument. recall (Hologic, Inc)
Medical deviceClass IIOngoing
Summary: Hologic, Inc is recalling 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.
What is being recalled
Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Why
Presence of particulates in affected devices that can be deposited into breast tissue during use.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution.
How to tell if yours is affected
Model No - BREVDISP09; UDI - 1540045512863; All Lots within expiry.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1314-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | December 15, 2025 |
| Reported | February 18, 2026 |
| Company | Hologic, Inc |
| Company location | Marlborough, MA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 681,870 units |
More recalls from Hologic, Inc · all medical device recalls · recalls from December 2025