Hologic, Inc. recalled 681,870 units of the Brevera Breast Biopsy System on December 15, 2025, due to presence of particulates that can enter breast tissue. The recall affects devices distributed nationwide in the U.S. Healthcare providers and patients must stop using the device immediately.
Presence of particulates in affected devices that can be deposited into breast tissue during use.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Hologic, Inc or your healthcare provider for instructions. Notification method: Letter
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
The Brevera Breast Biopsy System is a medical device used for breast biopsies. It aids in the accurate sampling of breast tissue for diagnostic purposes.
The device has been found to contain particulates that can enter breast tissue during a biopsy, posing potential health risks.
This recall is not part of a broader industry pattern.
Patients are advised to stop using the device immediately, which may lead to delays in necessary medical procedures.
Model numbers and UDI can typically be found on the device packaging or in the user manual.
Expect a response from Hologic within 4-6 weeks for refund processing.
Keep a record of any communication regarding the recall, including emails and letters from the manufacturer.
The Brevera Breast Biopsy System includes a Disposable 9 Gauge Needle. Model numbers affected are BREVDISP09 and UDI 1540045512863. The devices were distributed nationwide.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the manufacturer-installed settings. Modifications included disabling Barco Application Appearance Manager (AAM), altering calibration and compliance parameters, and adjusting additional display-related settings. This field correction is being conducted to restore affected system to the validated configuration and reinforce proper use in accordance with the Operator's Manual.
Hologic, Inc. recalled 3,728 units of ThinPrep CytoLyt Solution on December 12, 2025. The recall follows the discovery of fungal contamination with Parengyodontium album. Patients and healthcare providers must stop using the affected products immediately.