fda_recall · device_recall · high

Hologic, Inc — Class II recall: 3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MO…

Event date
2026-05-20 00:00:00Z
Observed
2026-07-09 22:52:32Z
Source ID
Z-2168-2026
Payload hash
e42c467450ab6991bfbd936f

Summary

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

Entities

Informational only. Not legal, financial, or medical advice.