Hologic, Inc.
171 devices · 2,699 adverse event reports · 14 deaths reported · 41 devices named in recalls
Counts reflect reports that name each device's exact identifier. Larger companies sell more devices, so totals should not be read as a safety ranking.
- BioZorb F0202MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls192 reports
- BioZorb F0221MARKER, RADIOGRAPHIC, IMPLANTABLE3 recalls15 reports
- Brevera Breast Biopsy System BREVDISP09INSTRUMENT, BIOPSY154 reports
- NovaSure SureSound 2013DEVICE, THERMAL ABLATION, ENDOMETRIAL151 reports
- BioZorb F0203MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls51 reports
- Selenia Dimensions ASY-04160Full field digital,system,x-ray,mammographic2 recalls47 reports
- EVIVA_0913-20INSTRUMENT, BIOPSY145 reports
- Fluent Fluid Management System FLT-112SINSUFFLATOR, HYSTEROSCOPIC140 reports
- Selenia Dimensions ASY-01966Full field digital,system,x-ray,mammographic131 reports
- BioZorb F0303MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls19 reports
- BioZorb F0304MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls19 reports
- BioZorb F0231MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls19 reports
- Sertera Biopsy Device Sertera-14INSTRUMENT, BIOPSY2 recalls14 reports
- NovaSure NS2013USDEVICE, THERMAL ABLATION, ENDOMETRIAL112 reports
- 3Dimensions 3DM-SYS-STDDigital breast tomosynthesis1 recall57 reports
- BioZorb F0404MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls6 reports
- BioZorb F0331MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls4 reports
- BioZorb F0405MARKER, RADIOGRAPHIC, IMPLANTABLE2 recalls1 report
- Panther Fusion® KIT, GBS ASSAY CARTRIDGES, 96-TEST, FUSION, IVDreal time Nucleic acid amplification system2 recalls0 reports
- Myosure Reach Tissue Removal Device 10-401FCHYSTEROSCOPE (AND ACCESSORIES)4 deaths99 reports
- NovaSure V5Device, thermal ablation, endometrial2 deaths92 reports
- Aptima® KIT, HPV, APTIMA, 250 TEST, REFRIG, IVDKit, rna detection, human papillomavirus1 recall32 reports
- Selenia Dimensions SDM-SYS-6000-3DDigital breast tomosynthesis1 recall29 reports
- NovaSure NS2000USDEVICE, THERMAL ABLATION, ENDOMETRIAL77 reports
- Brevera Breast Biopsy System BREV100INSTRUMENT, BIOPSY74 reports
- Selenia Dimensions SDM-SYS-9000-3DDigital breast tomosynthesis1 recall16 reports
- Brevera Breast Biopsy System BREVDRVINSTRUMENT, BIOPSY61 reports
- MyoSure Tissue Removal Device 30-401LITEHYSTEROSCOPE (AND ACCESSORIES)1 death60 reports
- NovaSure V5Device, thermal ablation, endometrial60 reports
- Panther Fusion® KIT, SARS/FLU A/B/RSV REAG CARTRDG, 96T, FUS, IVDMulti-target respiratory specimen nucleic acid test including SARS-CoV-2 and other microbial agents1 recall7 reports
- 3Dimensions 3DM-SYS-INTL3DDigital breast tomosynthesis1 recall5 reports
- 3Dimensions 3DM-SYS-INTL2D-MOBDigital breast tomosynthesis1 recall5 reports
- Selenia Dimensions SDM-SYS-6000-2DDigital breast tomosynthesis1 recall5 reports
- Selenia Dimensions SDA-SYS-3000-2DDigital breast tomosynthesis1 recall4 reports
- Horizon ADensitometer, bone1 recall3 reports
- Affirm Lateral Arm Upright Biopsy Accessory ASY-03723System, x-ray, mammographic1 recall3 reports
- Selenia Dimensions SDM-SYS-9000-2DDigital breast tomosynthesis1 recall2 reports
- Aptima® KIT, MAIN ASSAY, CMV, 100-TEST, IVDCytomegalovirus (cmv) dna quantitative assay1 recall2 reports
- Horizon CiDensitometer, bone1 recall1 report
- Horizon WDensitometer, bone1 recall1 report
- ThinPrep® ThinPrep® CytoLyt® Sol'n 946mlPRESERVATIVE, CYTOLOGICAL1 recall1 report
- Aptima® KIT,HPV,APTIMA,250 TEST,ROOM TEMP, IVDKit, rna detection, human papillomavirus1 recall0 reports
- Horizon CDensitometer, bone1 recall0 reports
- Horizon WiDensitometer, bone1 recall0 reports
- 3Dimensions ASY-10559Digital breast tomosynthesis1 recall0 reports
- 3Dimensions 3DM-SYS-STD-NSDigital breast tomosynthesis1 recall0 reports
- 3Dimensions 3DM-SYS-INTL3D-NSDigital breast tomosynthesis1 recall0 reports
- 3Dimensions 3DM-SYS-INTL3D-MOBDigital breast tomosynthesis1 recall0 reports
- 3Dimensions 3DM-SYS-INTL2D-NSDigital breast tomosynthesis1 recall0 reports
- 3Dimensions ASY-11748-CHDDigital breast tomosynthesis1 recall0 reports
- I -View™ Contrast Enhanced Digital Mammography ASY-08109Full field digital, system, x-ray, mammographic1 recall0 reports
- DIGITAL DIAGNOSTICS SYSTEM DISPLAY, 27IN, 8MPDigital cervical cytology slide imaging system with artificial intelligence algorithm1 recall0 reports
- Sizer Set ASY-16190Guide, surgical, instrument1 recall0 reports
- Rapid fFN FFN SPECIMEN COLLECTION KIT, 25PKDevice, specimen collection1 recall0 reports
- Aptima Combo 2® KIT APTIMA COMBO 2 TIGRIS-REF (IVD)-CEDNA-REAGENTS, NEISSERIA39 reports
- Myosure XL for Fluent Device 50-601XLHYSTEROSCOPE (AND ACCESSORIES)1 death35 reports
- Acessa ProVu System 7300COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)1 death35 reports
- ATEC 0912-20INSTRUMENT, BIOPSY32 reports
- NovaSure SureSound 2007DEVICE, THERMAL ABLATION, ENDOMETRIAL31 reports
- EVIVA 0913-12TINSTRUMENT, BIOPSY29 reports
- CoolSeal™ Trinity CSL-TR105-37Electrosurgical, cutting & coagulation & accessories28 reports
- Omni Hysteroscope 60-200HYSTEROSCOPE (AND ACCESSORIES)28 reports
- ATEC SAPPHIRE 100INSTRUMENT, BIOPSY25 reports
- Affirm Breast Biopsy Guidance System STLC-00004System, x-ray, mammographic24 reports
- Affirm Prone Biopsy System PBX-SYS-AFFIRM-3DSystem, x-ray, mammographic23 reports
- Panther® PANTHER, INSTRUMENT SYSTEMInstrumentation for clinical multiplex test systems22 reports
- MyoSure Tissue Removal Device 50-501XLHYSTEROSCOPE (AND ACCESSORIES)1 death20 reports
- Aptima® MULTITEST SWAB COLLECTION KIT,APTIMA,IVDHerpes simplex virus nucleic acid amplification assay19 reports
- ATEC SAPPHIREINSTRUMENT, BIOPSY18 reports
- CoolSeal™ Reveal CSL-RV105-10Electrosurgical, cutting & coagulation & accessories1 death17 reports
- ATEC 0914-20MRINSTRUMENT, BIOPSY17 reports
- Selenia Dimensions 3D System 3D softwareDigital breast tomosynthesis14 reports
- EVIVA_1213-20INSTRUMENT, BIOPSY14 reports
- ATEC Introducer ILS 0914-20INSTRUMENT, BIOPSY13 reports
- Fluent Console FLT-100INSUFFLATOR, HYSTEROSCOPIC1 death13 reports
- TruNode Surgical Gamma Probe 120-807605Probe, uptake, nuclear11 reports
- SecurMark MRI SMARK-M-SS1MARKER, RADIOGRAPHIC, IMPLANTABLE10 reports
- CELERO-12INSTRUMENT, BIOPSY10 reports
- SecurMark SMARK-EVIVA-13MARKER, RADIOGRAPHIC, IMPLANTABLE9 reports
- APTIMA® KIT, MAIN ASSAY, HIV QUANT, 100T, US IVDTest, hiv detection9 reports
- Tomcat® TOMCAT SYSTEMSTATION, PIPETTING AND DILUTING, FOR CLINICAL USE9 reports
- TriMark TRIMARK TD 3609MARKER, RADIOGRAPHIC, IMPLANTABLE8 reports
- ATEC PEARLINSTRUMENT, BIOPSY8 reports
- OMNI OMNI-S-001Hysteroscope accessories8 reports
- ATEC 1212-20INSTRUMENT, BIOPSY7 reports
- Brevera Breast Biopsy System BREV200INSTRUMENT, BIOPSY7 reports
- CoolSeal™ Trinity CSL-TR105-30Electrosurgical, cutting & coagulation & accessories1 death6 reports
- Selenia Dimensions ASY-07460Full field digital,system,x-ray,mammographic6 reports
- CERVICAL SEAL ASSY DEVICE OLK-100Seal, cervical, mechanical, unpowered6 reports
- Aptima Combo 2® KIT,APTIMACOMBO2,250T,REF,CEIVD-UPDATEDNucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections6 reports
- CoolSeal™ Trinity CSL-TR105-44Electrosurgical, cutting & coagulation & accessories5 reports
- CoolSeal™ Mini CSL-MN103-20Electrosurgical, cutting & coagulation & accessories5 reports
- ATEC SAPPHIRE25INSTRUMENT, BIOPSY5 reports
- EVIVA 0913-12INSTRUMENT, BIOPSY5 reports
- Selenia Dimensions ASY-08483Full field digital,system,x-ray,mammographic5 reports
- Discovery WiDensitometer, bone5 reports
- Selenia FFDM ASY-00676Full field digital,system,x-ray,mammographic5 reports
- Myosure Manual Tissue Removal Device 20-401MLHYSTEROSCOPE (AND ACCESSORIES)5 reports
- Fluent Pro Fluid Management System FLT-200Insufflator, hysteroscopic1 death5 reports
- ATEC Introducer ILS 0914-12INSTRUMENT, BIOPSY4 reports