Skip to main content
RecallsAboutBlog

Hologic, Inc

Hologic, Inc: 5 recalls listed since January 2026 across FDA.

By year

  • 20265

By agency

  • FDA5

By category

  • Medical Device5

All recalls (5)

Hologic Selenia Dimensions and 3Dimensions Mammography Systems

Selenia Dimensions Mammography Systems can develop loose, missing, or broken internal bolts over time.

Moderate risk, FDA, , Device defect

Genius Review Station Display (Barco Monitor)

The Genius Review Station Display can be operated outside its validated configuration due to user modifications.

Moderate risk, FDA, , Device defect

Aptima HPV Assay

The Aptima HPV Assay can generate invalid or false negative results.

Moderate risk, FDA, , Device defect

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.

Moderate risk, FDA, , Foreign object

Hologic ThinPrep CytoLyt Solution Buffered Cell Wash Solution

ThinPrep CytoLyt Solution, a buffered cell wash solution, is contaminated with Parengyodontium album.

Moderate risk, FDA, , Contamination
Embed this list