Hologic, Inc

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Top device categories

• Device, Thermal Ablation, EndometrialMNB1,095
• Instrument, BiopsyKNW722
• Digital Breast TomosynthesisOTE589
• Hysteroscope (And Accessories)HIH401
• Marker, Radiographic, ImplantableNEU332
• Full Field Digital, System, X-Ray, MammographicMUE246
• Coagulator, Laparoscopic, Unipolar (And Accessories)HFG116
• System, X-Ray, MammographicIZH96
• Processor, Cervical Cytology Slide, AutomatedMKQ45
• Insufflator, HysteroscopicHIG43

Recent recalls

• 2026-05-12Open, ClassifiedDevice Design

  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, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2, SDM-05000-2A3, SDM-05000-2AC, SDM-05000-2D2, SDM-05000-2D3, SDM-05000-2DC, SDM-05000-3D2, SDM-05000-3D3, SDM-05000-3DC, SDM-SYS-9000-2D, SDM-SYS-9000-3D.

  Complaints have been received of systems developing loose, missing, or broken internal bolts over time.

• 2026-05-12Open, ClassifiedDevice Design

  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.

  Complaints have been received of systems developing loose, missing, or broken internal bolts over time.

• 2026-04-24Open, ClassifiedSoftware design

  Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software Version: N/A - not software version specific Component: Yes, the Genius" Review Station is a component of the Genius" Digital Diagnostics System with the Genius" Cervical AI Algorithm cleared under DEN210035.

  It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the manufacturer-installed settings. Modifications included disabling Barco Application Appearance Manager (AAM), altering calibration and compliance parameters, and adjusting additional display-related settings. This field correction is being conducted to restore affected system to the validated configuration and reinforce proper use in accordance with the Operator's Manual.

• 2026-03-19Open, ClassifiedUnder Investigation by firm

  Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No

  Due to product exhibiting potential to generate either invalid or false negative results.

• 2026-02-06Open, ClassifiedUnder Investigation by firm

  Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.

  Presence of particulates in affected devices that can be deposited into breast tissue during use.

• 2026-01-15Open, ClassifiedUnder Investigation by firm

  ThinPrep CytoLyt Solution. Buffered Cell Wash Solution.

  Fungal contamination of affected lot with Parengyodontium album.

• 2025-02-13Open, ClassifiedProcess control

  Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Description: Instrument, Biopsy Component: N/A

  Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.

• 2025-02-04Open, ClassifiedNonconforming Material/Component

  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 (PN: 71550-001) is manufactured by a third-party supplier, MML Diagnostics Packaging, and includes the transport tube, cap, and extraction buffer. Tubes are packaged into PN: 71738-00 at Hologic prior to kit release.

  Three lots of Rapid fFN Specimen Collection kit (901164, 901165, and 904850) contain Rapid fFN Specimen Collection Tubes which may be empty, underfilled, or overfilled with extraction buffer. The transport tubes are used with the Fetal Fibronectin Enzyme Immunoassay and Rapid fFN for the TLiIQ System which aids in assessing the risk of preterm delivery. The use of empty transport tubes or transport tubes containing insufficient extraction buffer volume may result in invalid results and/or delays in obtaining results. Additionally, the use of underfilled tubes may result in false positive results and the use of overfilled tubes may result in false negative results.

• 2025-01-14Open, ClassifiedProcess control

  Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.

  Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment.

• 2024-12-20Open, ClassifiedUnknown/Undetermined by firm

  Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400

  SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results.