Hologic, Inc. Recalls

Overview of recall records associated with Hologic, Inc., including dates, categories and classifications where available.

3recall records

May 20, 2026latest record date

Mar 25, 2026earliest record date

Recall history in this database

Classification mix: Class II: 3.

Medical DeviceMay 20, 2026

Hologic SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS recall — FDA Z-2167-2026

Complaints have been received of systems developing loose, missing, or broken internal bolts over time.

Class IIFDA: OngoingHologic, Inc

Medical DeviceMay 6, 2026

Genius" Review Station Display (Barco Monitor) recall — FDA Z-1949-2026

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.…

Class IIFDA: OngoingHologic, Inc

Medical DeviceMar 25, 2026

Aptima HPV Assay recall — FDA Z-1586-2026

Due to product exhibiting potential to generate either invalid or false negative results.

Class IIFDA: OngoingHologic, Inc.

Understanding this recall history

This page summarizes recall records in which the official source identifies Hologic, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.

Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.