Hologic recalls
Hologic appears in 48 official U.S. recall notices indexed by RecallRadar, most recently on 2026-05-20.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- 3DIMENSIONS MAMMOGRAPHY SYSTEM
FDA Device · Class II · 2026-05-20 · Hologic - SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D…
FDA Device · Class II · 2026-05-20 · Hologic - Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software Ve…
FDA Device · Class II · 2026-05-06 · Hologic - Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No
FDA Device · Class II · 2026-03-25 · Hologic - Brevera Breast Biopsy System Disposable 9 Gauge Needle
FDA Device · Class II · 2026-02-18 · Hologic - ThinPrep¿ CytoLyt¿ Solution
FDA Device · Class II · 2026-01-21 · Hologic - Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Descri…
FDA Device · Class II · 2025-02-19 · Hologic - The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 71738-001)
FDA Device · Class II · 2025-02-12 · Hologic - Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD
FDA Device · Class II · 2025-01-22 · Hologic - Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
FDA Device · Class II · 2025-01-01 · Hologic - Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
FDA Device · Class II · 2024-12-18 · Hologic - BioZorb Marker
FDA Device · Class I · 2024-12-04 · Hologic - Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0 system software as fo…
FDA Device · Class II · 2024-10-02 · Hologic - Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI, Horizon-A-CN, Horizon-W-CN, Horizon-…
FDA Device · Class II · 2024-07-24 · Hologic - BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZorb Marker 4cm x 5cm…
FDA Device · Class I · 2024-05-15 · Hologic - Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Reagent, Promoter Rea…
FDA Device · Class II · 2024-04-03 · Hologic - PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully automates all steps necess…
FDA Device · Class II · 2024-01-31 · Hologic - Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14
FDA Device · Class II · 2023-07-05 · Hologic - 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-0500…
FDA Device · Class II · 2023-03-01 · Hologic - The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site
FDA Device · Class II · 2022-10-12 · Hologic - Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus
FDA Device · Class II · 2022-04-13 · Hologic - Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fusion Capture reagen…
FDA Device · Class II · 2022-03-23 · Hologic - Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to the Panther Fusion S…
FDA Device · Class II · 2021-04-14 · Hologic - Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000
FDA Device · Class II · 2020-09-30 · Hologic - Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture Reagent - S, Nucleic Acid in a buff…
FDA Device · Class II · 2020-06-03 · Hologic - Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636
FDA Device · Class II · 2020-03-04 · Hologic - I-View¿ Contrast Enhanced Digital Mammography, ASY-08109
FDA Device · Class II · 2019-01-02 · Hologic - Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200
FDA Device · Class II · 2018-02-28 · Hologic - Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Q
FDA Device · Class II · 2018-02-28 · Hologic - Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 Product Usage: The Panther instrument is a fully automated sample-to-result instrum…
FDA Device · Class II · 2018-02-21 · Hologic - Affirm Lateral Arm Upright Biopsy Accessory
FDA Device · Class II · 2018-01-24 · Hologic - Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
FDA Device · Class II · 2017-10-25 · Hologic - Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument
FDA Device · Class II · 2017-08-09 · Hologic - SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices
FDA Device · Class II · 2016-11-30 · Hologic - Sertera Biopsy Device, Sterile
FDA Device · Class II · 2016-09-28 · Hologic - SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for AT…
FDA Device · Class II · 2016-09-14 · Hologic - SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-12-OB (9G Introducer Localization Set (OB Model) for AT…
FDA Device · Class II · 2016-09-14 · Hologic - ATEC CANISTER. Suction Canister with Lid 490 cc., RX Only
FDA Device · Class II · 2016-07-27 · Hologic - CF InPlex ASR Card
FDA Device · Class II · 2016-05-04 · Hologic - Hologic InPlex CF Molecular Test (IVD)
FDA Device · Class II · 2016-05-04 · Hologic - Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039
FDA Device · Class II · 2014-06-11 · Hologic - Hologic M-IV Mammography System
FDA Device · Class II · 2014-06-11 · Hologic - NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller, Model Number: 71978-001 Catalog Number: RFC2009 Produc…
FDA Device · Class II · 2014-03-05 · Hologic - Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field Digital Mammography system gene…
FDA Device · Class II · 2013-10-09 · Hologic - 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…
FDA Device · Class II · 2013-05-22 · Hologic - 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 ph…
FDA Device · Class II · 2013-05-22 · Hologic - 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…
FDA Device · Class II · 2012-10-03 · Hologic - 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 System de…
FDA Device · Class II · 2012-10-03 · Hologic