FDA recall record · openFDA

Hologic, Inc

18 FDA recalls on record (2023–2026) — 18 device. 18 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Complaints have been received of systems developing loose, missing, or broken internal bolts over time. 2

It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration d 1

Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results lead 1

Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migratio 1

Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, devi 1

Recalls

BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZ Class I 2024-03-13 BioZorb Marker. Radiographic soft tissue marker. Class I 2024-10-10 Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: Class II 2026-03-23 SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-60 Class II 2026-04-08 Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima Class II 2026-02-18 3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D, 3D Class II 2026-04-08 The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 7173 Class II 2025-01-08 ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution. Class II 2025-12-12 Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument. Class II 2025-12-15 Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Versi Class II 2025-01-15 Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD. Class II 2024-12-13 Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400 Class II 2024-11-08 Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI, Horizon-A-CN, Class II 2024-06-13 Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0 s Class II 2024-08-19 Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000- Class II 2023-01-16 PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully au Class II 2023-12-15 Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the br Class II 2023-05-02 Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Re Class II 2023-09-14

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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