Hologic, Inc.
26 recalls on record · Latest: Jan 21, 2026
FDA Devices Moderate Jan 21, 2026
ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
FDA Devices Moderate Feb 12, 2025
The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 71738-001). The Collection Tube (…
FDA Devices Moderate Jan 22, 2025
Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
FDA Devices Moderate Jan 1, 2025
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
FDA Devices Moderate Dec 18, 2024
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
FDA Devices Critical Dec 4, 2024
BioZorb Marker. Radiographic soft tissue marker.
FDA Devices Critical May 15, 2024
BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZorb Marker 4cm x 5cm 2) F040…
FDA Devices Moderate Jan 31, 2024
PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully automates all steps necessary t…
FDA Devices Moderate Mar 1, 2023
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…
FDA Devices Moderate Oct 12, 2022
The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb LP Marker is comprised …
FDA Devices Moderate Apr 13, 2022
Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.
FDA Devices Moderate Jun 3, 2020
Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture Reagent - S, Nucleic Acid in a buffered solut…
FDA Devices Moderate Mar 4, 2020
Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636,
FDA Devices Moderate Feb 28, 2018
Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200
FDA Devices Moderate Feb 28, 2018
Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Q
FDA Devices Moderate Feb 21, 2018
Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 Product Usage: The Panther instrument is a fully automated sample-to-result instrument, e…
FDA Devices Moderate Oct 25, 2017
Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
FDA Devices Moderate Aug 9, 2017
Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument.
FDA Devices Moderate Sep 14, 2016
SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-12-OB (9G Introducer Localization Set (OB Model) for ATEC0914-12…
FDA Devices Moderate Sep 14, 2016
SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for ATEC0914-20…
FDA Devices Moderate May 4, 2016
Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432.
FDA Devices Moderate Mar 5, 2014
NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller, Model Number: 71978-001 Catalog Number: RFC2009 Product Us…
FDA Devices Moderate May 22, 2013
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 physician…
FDA Devices Moderate May 22, 2013
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…
FDA Devices Moderate Oct 3, 2012
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 System design…
FDA Devices Moderate Oct 3, 2012