Hologic, Inc.
Danbury, CT
This page shows every FDA and USDA recall linked to Hologic, Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
7
Total Recalls
2013
First Recall
2023
Most Recent
Hologic 3Dimensions/Selenia Dimensions
Models:
RM-SDM-00001-3D
SDM-00001-2D
SDM-00001-3D
SDM-05000-3D3
SDM-05...
Feb 21, 2023
· Device
Open, Classified
Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636,
Feb 18, 2020
· Device
Terminated
I-View Contrast Enhanced Digital Mammography, ASY-08109
Dec 6, 2018
· Device
Terminated
Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880
Jul 7, 2017
· Device
Terminated
Hologic M-IV Mammography System; Model M4--00001.
Intended to produce radiographic images of the breast. For...
Jun 3, 2014
· Device
Terminated
Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039.
The Seleni...
Jun 3, 2014
· Device
Terminated
Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x
The Selenia Full Field D...
Sep 30, 2013
· Device
Terminated