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Hologic, Inc FDA Recalls
23 recalls on file across devices, 2 of them Class I and 22 still open. Matched by name to HOLX.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
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| 3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D, 3DClass IIApr 8, 2026Complaints have been received of systems developing loose, m |
| SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-60Class IIApr 8, 2026Complaints have been received of systems developing loose, m |
| Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: Class IIMar 23, 2026It was identified that certain devices were being operated o |
| Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima Class IIFeb 18, 2026Due to product exhibiting potential to generate either inval |
| Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.Class IIDec 15, 2025Presence of particulates in affected devices that can be dep |
| ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.Class IIDec 12, 2025Fungal contamination of affected lot with Parengyodontium al |
| Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software VersiClass IIJan 15, 2025Devices presented a condition in which the inner needle sepa |
| The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 7173Class IIJan 8, 2025Three lots of Rapid fFN Specimen Collection kit (901164, 901 |
| Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.Class IIDec 13, 2024Potential weak pouch seal on Panther Fusion GBS assay cartri |
| Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400Class IINov 8, 2024SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SAR |
| BioZorb Marker. Radiographic soft tissue marker.Class IOct 10, 2024Firm received reports of adverse events/complications that i |
| Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0 sClass IIAug 19, 2024Identified an issue with Selenia Dimensions 1.12.0 and 3Dime |
| Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI, Horizon-A-CN, Class IIJun 13, 2024Non-conformance pertains to electromagnetic compatibility re |
| BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZClass IMar 13, 2024Safety Information: Complaints describe complications/advers |
| PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully auClass IIDec 15, 2023Due to potential false positive Flu B results when a sample |
| Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme ReClass IISep 14, 2023Use of assay along with plasma specimen may result in error |
| Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the brClass IIMay 2, 2023The inner needle of the Sertera device is either detaching o |
| Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-Class IIJan 16, 2023C-Arm unexpected movement may cause blunt trauma should the |
| Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog NuClass IIOct 10, 2022IFU was not provided with the Sizer Set sterilization tray |
| The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BiClass IIAug 9, 2022Hologic BioZorb LP Marker, (Product number F0221), lot numbe |
| Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptocoClass IIMar 18, 2022Samples, run on a GBS Assay, that have analyte concentration |
| Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X FuClass IIJan 27, 2022Failed stability specifications for reagent kits that may re |
| Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to tClass IIFeb 26, 2021There is a potential for tube trays to leak which could pot |