Hologic, Inc
FDA Regulatory Profile
Hologic, Inc appears in FDA public data with 48 recalls — including 2 Class I (most serious) —, 118 510(k) clearances, 41 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-2168-2026, Class II) was initiated on April 8, 2026. Its most recent 510(k) clearance was granted on June 17, 2026.
Summary
- Total Recalls
- 48 (2 Class I)
- 510(k) Clearances
- 118
- Inspections
- 41
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2168-2026 | Class II | 3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS | April 8, 2026 |
| Z-2167-2026 | Class II | SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS | April 8, 2026 |
| Z-1949-2026 | Class II | Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Mo | March 23, 2026 |
| Z-1586-2026 | Class II | Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product | February 18, 2026 |
| Z-1314-2026 | Class II | Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument. | December 15, 2025 |
| Z-1093-2026 | Class II | ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution. | December 12, 2025 |
| Z-1170-2025 | Class II | Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Serter | January 15, 2025 |
| Z-1095-2025 | Class II | The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Coll | January 8, 2025 |
| Z-0907-2025 | Class II | Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD. | December 13, 2024 |
| Z-0694-2025 | Class II | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400 | November 8, 2024 |
| Z-0328-2025 | Class I | BioZorb Marker. Radiographic soft tissue marker. | October 10, 2024 |
| Z-3248-2024 | Class II | Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and | August 19, 2024 |
| Z-2373-2024 | Class II | Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizo | June 13, 2024 |
| Z-1733-2024 | Class I | BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft ti | March 13, 2024 |
| Z-0782-2024 | Class II | PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing s | December 15, 2023 |
| Z-1371-2024 | Class II | Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplificatio | September 14, 2023 |
| Z-2035-2023 | Class II | Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue | May 2, 2023 |
| Z-1144-2023 | Class II | Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-0 | January 16, 2023 |
| Z-0669-2025 | Class II | Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument gui | October 10, 2022 |
| Z-1858-2022 | Class II | The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft | August 9, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K253634 | CoolSeal Generator® (CSL-200-90) | June 17, 2026 |
| K251993 | Panther Fusion GI Expanded Bacterial Assay | September 25, 2025 |
| K251868 | Panther Fusion GI Bacterial Assay | September 25, 2025 |
| K243341 | Genius AI Detection 2.0 | July 31, 2025 |
| K243396 | Aptima SARS-CoV-2 Assay | February 13, 2025 |
| K243935 | Aptima CMV Quant Assay | January 17, 2025 |
| K243345 | Aptima BV Assay; Aptima CV/TV Assay | November 25, 2024 |
| K242465 | Panther Fusion SARS-CoV-2/Flu A/B/RSV assay | November 15, 2024 |
| K240886 | Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedur | July 25, 2024 |
| K233352 | Aptima HCV Quant Dx Assay | July 24, 2024 |
| K241240 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay | July 18, 2024 |
| DEN210035 | Genius Digital Diagnostics System with the Genius Cervical AI algorithm | January 31, 2024 |
| K231329 | Aptima Neisseria gonorrhoeae Assay | January 26, 2024 |
| K230451 | Aptima® Chlamydia trachomatis Assay | November 16, 2023 |
| K231316 | Aptima Trichomonas vaginalis Assay | November 6, 2023 |
| K230096 | Genius AI Detection 2.0 with CC-MLO Correlation | May 23, 2023 |
| K222736 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay | May 16, 2023 |
| K231017 | Panther Fusion AdV/hMPV/RV Assay | May 5, 2023 |
| K221449 | Genius AI Detection 2.0 | October 6, 2022 |
| K220321 | Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Tric | June 3, 2022 |