United StatesThe Brevera Breast Biopsy System Disposable 9 Gauge Needle (Model BREVDISP09; UDI 1540045512863; all lots within expiry) distributed nationwide in the United States is affected. It was recalled because particulates may be present in the devices that can be deposited into breast tissue during use.
What's being recalled
Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Recalling firm: Hologic, Inc, Marlborough, MA, United States.
How to identify it
Model No - BREVDISP09; UDI - 1540045512863; All Lots within expiry.
The hazard
Presence of particulates in affected devices that can be deposited into breast tissue during use.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)