Brand

Hologic, Inc. Recalls

25 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Hologic, Inc..

25Total Recalls
2Critical
83,064Units Affected
Mar 23, 2026Most Recent
All Recalls

Every Hologic, Inc. Recall

Sorted by most recent. Click any recall for full details.

25 recalls
High RiskFDA
Hologic, Inc
Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Softwa...
Diagnostic Devices·1,200 affected·Mar 23, 2026
High RiskFDA
Hologic, Inc.
Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Compon...
Diagnostic Devices·306 affected·Feb 18, 2026
High RiskFDA
Hologic, Inc
ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
Medical Devices·3,728 affected·Dec 12, 2025
High RiskFDA
Hologic, Inc.
The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 71738-001). The Colle...
Diagnostic Devices·1,351 affected·Jan 8, 2025
High RiskFDA
Hologic, Inc.
Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
Diagnostic Devices·380 affected·Dec 13, 2024
High RiskFDA
Hologic, Inc.
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
Diagnostic Devices·3 affected·Nov 8, 2024
CriticalFDA
Hologic, Inc
BioZorb Marker. Radiographic soft tissue marker.
Medical Devices·12,710 affected·Oct 10, 2024
CriticalFDA
Hologic, Inc
BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZorb Marker 4cm x ...
Medical Devices·53,492 affected·Mar 13, 2024
High RiskFDA
Hologic, Inc.
PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully automates all steps...
Diagnostic Devices·771 affected·Dec 15, 2023
High RiskFDA
Hologic, Inc.
Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-2DC SDM-00001-M3...
Medical Devices·797 affected·Jan 16, 2023
High RiskFDA
Hologic, Inc
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
Surgical Devices·178 affected·Oct 10, 2022
High RiskFDA
Hologic, Inc
The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb LP Marker i...
Medical Implants·233 affected·Aug 9, 2022
High RiskFDA
Hologic, Inc
Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.
Diagnostic Devices·2,061 affected·Mar 18, 2022
High RiskFDA
Hologic, Inc.
Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636,
Medical Devices·72 affected·Jan 21, 2020
High RiskFDA
Hologic, Inc
Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture Reagent - S, Nucleic Acid in a bu...
Diagnostic Devices·47 affected·Oct 10, 2019
High RiskFDA
Hologic, Inc
Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 Product Usage: The Panther instrument is a fully automated sample-to-result i...
Diagnostic Devices·103 affected·Jan 20, 2018
High RiskFDA
Hologic, Inc.
Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200
Medical Devices·165 affected·Nov 29, 2017
High RiskFDA
Hologic, Inc
Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
Diagnostic Devices·1 affected·Sep 15, 2017
High RiskFDA
Hologic, Inc
Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument.
Medical Devices·164 affected·Jun 27, 2017
High RiskFDA
Hologic, Inc
SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-12-OB (9G Introducer Localization Set (OB Model) for...
Medical Devices·535 affected·Aug 2, 2016
High RiskFDA
Hologic, Inc
SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for...
Medical Devices·1,440 affected·Aug 2, 2016
High RiskFDA
Hologic, Inc
Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.
Medical Devices·2,580 affected·Mar 31, 2016
High RiskFDA
Hologic, Inc.
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 provi...
Surgical Devices·287 affected·Apr 25, 2013
High RiskFDA
Hologic, Inc.
Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2 The device is a Mini C-arm Fluoroscopic Imaging S...
Surgical Devices·46 affected·Sep 14, 2012
High RiskFDA
Hologic, Inc.
Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4.0.1 The device is a Mini C-arm Fluoroscopic Imaging Sys...
Surgical Devices·414 affected·Sep 14, 2012