Recall Z-2168-2026— Hologic, Inc

Name: FDA recall Z-2168-2026
Creator: U.S. Food and Drug Administration
Published: 2026-04-08

Class II · Ongoing

Class II FDA medical device recall by Hologic, Inc, initiated 2026-04-08. FDA's recall record names no specific 510(k) clearance for this event. Product: 3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D, 3DM-SYS-INTL3D-MOB, 3DM-SYS-INTL3D-NS, 3DM-SYS-STD, 3DM-SYS-STD-MOB, 3DM-SYS-STD-NS.. Reason: Complaints have been received of systems developing loose, missing, or broken internal bolts over time..

Recalling firm: Hologic, Inc
Classification: Class II
Status: Ongoing
Initiated: 2026-04-08
Firm location: Marlborough, MA, United States

Product description

3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D, 3DM-SYS-INTL3D-MOB, 3DM-SYS-INTL3D-NS, 3DM-SYS-STD, 3DM-SYS-STD-MOB, 3DM-SYS-STD-NS.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.