5 recalls found for Hologic. Check if any of your products are affected.
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 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.
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.