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    Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101

    FDA Recall
    Completed ·Hologic, Inc·Product code FZX·October 10, 2022

    Suros ATEC 0912-20 Breast Biopsy and Excision System Handpiece, REF ATEC0912-12, sterile, Hologic, Inc. 6100 Technology Center Drive Indianapolis, IN. The handpiece is inserted into the breast to the site of interest. When the proper location/position is acheived, the handpiece cuts and removes biopsy tissue.

    FDA Recall
    Terminated ·Hologic, Inc.·Product code KNW·August 11, 2010

    Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fusion Capture reagent-X 4 EA, FER-X Fusion Enhancer Reagent-X (Lithium Hydroxide Solution) 4 EA

    FDA Recall
    Open, Classified ·Hologic, Inc·Product code JTW·January 27, 2022

    ThinPrep CytoLyt Solution. Buffered Cell Wash Solution.

    FDA Recall
    Open, Classified ·Hologic, Inc·Product code LEA·December 12, 2025

    Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument.

    FDA Recall
    Terminated ·Hologic, Inc·Product code JQW·June 27, 2017

    Hologic, Inc., 10 Year Fracture Risk Questionnaire Option for QDR X-Ray Bone Densitometers Software

    FDA Recall
    Terminated ·Hologic, Inc.·Product code KGI·September 24, 2008

    Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Reagent, Promoter Reagent, Amplification Reconstitution Solution, Enzyme Reconstitution Solution, Promoter Reconstruction solution, Target capture Reagent, Reconstitution Collars.

    FDA Recall
    Open, Classified ·Hologic, Inc.·Product code PAB·September 14, 2023

    Fluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2 The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including but no limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.

    FDA Recall
    Terminated ·Hologic, Inc.·Product code JAA·April 25, 2013

    Hologic M-IV Mammography System; Model M4--00001. Intended to produce radiographic images of the breast. For screening and diagnostic imaging of the breast.

    FDA Recall
    Terminated ·Hologic, Inc.·Product code IZH·May 13, 2014

    Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including but no limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.

    FDA Recall
    Terminated ·Hologic, Inc.·Product code JAA·April 25, 2013

    Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer.

    FDA Recall
    Terminated ·Hologic, Inc.·Product code MUE·May 13, 2014

    Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-2DC SDM-00001-M3D SDM-05000-3DC SDM-SYS-6000-3D SDM-05000-2D3 SDA-SYS-3000-2D SDM-00001 SDM-SYS-9000-2D SDM-00001-M2D 3DM-SYS-STD 3DM-SYS-STD-NS SDM-05000-2AC SDM-05000-2A2 SDA-SYS-3000-3D SDA-SYS-3000-3D-UPS SDM-SYS-6000-3D-HTC SDM-05000-2D2 SDM-05000-3D2 SDM-SYS-6000-2D SDM-SYS-9000-3D

    FDA Recall
    Open, Classified ·Hologic, Inc.·Product code OTE·January 16, 2023

    Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer. The Selenia Full Field Digital Mammography System is intended for use in the same clinical applications as traditional screen-film mammography systems. Mammography images can be interpreted on either hard copy film or soft copy review workstations, cleared for mammography

    FDA Recall
    Terminated ·Hologic, Inc.·Product code MUE·September 6, 2013

    Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.

    FDA Recall
    Terminated ·Hologic, Inc·Product code NUA·March 31, 2016

    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.

    FDA Recall
    Open, Classified ·Hologic, Inc·Product code OTE·April 8, 2026

    Hologic Explorer Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate of bone mineral density, comparison of measured variables obtained from a given scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics.

    FDA Recall
    Terminated ·Hologic, Inc.·Product code KGI·June 27, 2008

    Hologic Oasis Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate of bone mineral density, comparison of measured variables obtained from a given scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics.

    FDA Recall
    Terminated ·Hologic, Inc.·Product code KGI·June 27, 2008

    Hologic Discovery Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate of bone mineral density, comparison of measured variables obtained from a given scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics.

    FDA Recall
    Terminated ·Hologic, Inc.·Product code KGI·June 27, 2008

    Hologic QDR4500 Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate of bone mineral density, comparison of measured variables obtained from a given scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics.

    FDA Recall
    Terminated ·Hologic, Inc.·Product code KGI·June 27, 2008

    Hologic Delphi Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate of bone mineral density, comparison of measured variables obtained from a given scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition analysis, and discrimination of bone from prosthetics.

    FDA Recall
    Terminated ·Hologic, Inc.·Product code KGI·June 27, 2008