Hologic recalls

Hologic has 48 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 20 May 2026. 23 are still ongoing. 6 were reported in the last 12 months.

Total recalls48since 2012

Last 12 months6reported

Class I24% of total

Ongoing23latest 20 May 2026

Recalls per month, last 24 months

click a bar for that month

1Oct '24 0 2 2Jan '25 2 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 1Jan '26 1 1 0Apr 3 0 0Jul 0 0

Severity split

Class I 2 4%Class II 46 96%Class III 0 0%

Why hologic is recalled

Product types

By year

2026613%
202548%
2024715%
202324%
202236%
202112%
202036%
201912%
201848%
201724%

Ongoing hologic recalls

23 active

Reported	Class	Recall	Company	Reason	Where
20 May 2026Device	CLASS II	3dimensions Mammography System recalled by Hologic	Hologic	Other	Nationwide
20 May 2026Device	CLASS II	Selenia Dimensions Mammography Systems recalled by Hologic	Hologic	Other	Nationwide
6 May 2026Device	CLASS II	Genius" Review Station Display (Barco Monitor) recalled by Hologic	Hologic	Device Malfunction	Nationwide
25 Mar 2026Device	CLASS II	Aptima HPV Assay recalled by Hologic	Hologic	Potency & Assay	Nationwide
18 Feb 2026Device	CLASS II	Brevera Breast Biopsy System Disposable Needle recalled by Hologic	Hologic	Particulate Matter	Nationwide
21 Jan 2026Device	CLASS II	ThinPrep¿ CytoLyt¿ Solution recalled by Hologic	Hologic	Other	Nationwide

All hologic recalls, newest first

48 total

Reported	Class	Recall	Company	Reason	Where
20 May 2026Device	CLASS II	3dimensions Mammography System recalled by Hologic	Hologic	Other	Nationwide
20 May 2026Device	CLASS II	Selenia Dimensions Mammography Systems recalled by Hologic	Hologic	Other	Nationwide
6 May 2026Device	CLASS II	Genius" Review Station Display (Barco Monitor) recalled by Hologic	Hologic	Device Malfunction	Nationwide
25 Mar 2026Device	CLASS II	Aptima HPV Assay recalled by Hologic	Hologic	Potency & Assay	Nationwide
18 Feb 2026Device	CLASS II	Brevera Breast Biopsy System Disposable Needle recalled by Hologic	Hologic	Particulate Matter	Nationwide
21 Jan 2026Device	CLASS II	ThinPrep¿ CytoLyt¿ Solution recalled by Hologic	Hologic	Other	Nationwide
19 Feb 2025Device	CLASS II	Sertera Biopsy Device recalled by Hologic	Hologic	Device Malfunction	Nationwide
12 Feb 2025Device	CLASS II	The Rapid fFN Specimen Collection Tube (PN recalled by Hologic	Hologic	Potency & Assay	Nationwide
22 Jan 2025Device	CLASS II	Panther Fusion GBS Assay recalled by Hologic	Hologic	Potency & Assay	20 states
1 Jan 2025Device	CLASS II	Panther Fusion Sars-CoV-2/Flu A/B/RSV Assay recalled by Hologic	Hologic	Potency & Assay	AK

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.