FDA recall, , Moderate risk
Hologic Brevera Breast Biopsy System Disposable Needle
The Brevera Breast Biopsy System Disposable 9 Gauge Needle contains particulates that can be deposited into breast tissue during use.
Summary by Recall Canary from the FDA notice
What happened
Hologic, Inc., of Marlborough, Massachusetts, recalled the Brevera Breast Biopsy System Disposable 9 Gauge Needle because of the presence of particulates in affected devices that can be deposited into breast tissue during use. The recall involved 681,870 units and was distributed nationwide in the United States.
The company began the recall on December 15, 2025, and the FDA added it to its Enforcement Report on February 6, 2026, when it was also classified.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
- UDI-DI
- 1540045512863
- Lot code
- Model No - BREVDISP09; UDI - 1540045512863; All Lots within expiry.
Recall details
- Company began the recall
- Sold in
US Nationwide distribution.
- Company
- Hologic, IncMarlborough, Massachusetts
- Hazard
- Foreign object
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98172
- Recall number
- Z-1314-2026
- Quantity recalled
- 681,870 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
