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. The most frequent reason is device malfunction.

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

0Nov '24 2 2 2Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 1 1Feb 1 0 3May 0 0 0Aug 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
18 Dec 2024Device	CLASS II	Sizer Set- sterilization tray and 6 individual sizers recalled	Hologic	Sterility	Nationwide
4 Dec 2024Device	CLASS I	BioZorb Marker recalled by Hologic	Hologic	Other	Nationwide
2 Oct 2024Device	CLASS II	Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis recalled	Hologic	Device Malfunction	Nationwide
24 Jul 2024Device	CLASS II	Horizon X-Ray Bone Densitometer (DXA) recalled by Hologic	Hologic	Other	Nationwide
15 May 2024Device	CLASS I	BioZorb Marker-BioZorb 3D Bioabsorbable Marker recalled by Hologic	Hologic	Other	Nationwide
3 Apr 2024Device	CLASS II	Aptima CMV Quant Assay, Reference numbers: AW recalled by Hologic	Hologic	Potency & Assay	Nationwide
31 Jan 2024Device	CLASS II	Panther Fusion System recalled by Hologic	Hologic	Potency & Assay	Nationwide
5 Jul 2023Device	CLASS II	Sertera Biopsy Device-intended to obtain percutaneous core recalled	Hologic	Other	Nationwide
1 Mar 2023Device	CLASS II	3Dimensions/Selenia Dimensions recalled by Hologic	Hologic	Other	Nationwide
12 Oct 2022Device	CLASS II	The BioZorb LP Marker is an implantable radiopaque marker recalled	Hologic	Other	Nationwide
13 Apr 2022Device	CLASS II	Panther Fusion GBS Assay Cartridges 96 Tests recalled by Hologic	Hologic	Potency & Assay	21 states
23 Mar 2022Device	CLASS II	Panther Fusion Extraction Reagent-X recalled by Hologic	Hologic	Potency & Assay	Nationwide
14 Apr 2021Device	CLASS II	Panther Fusion Tube Tray recalled by Hologic	Hologic	Packaging Defects	Nationwide
30 Sep 2020Device	CLASS II	Panther Fusion Tube Tray, Part: FAB recalled by Hologic	Hologic	Potency & Assay	26 states
3 Jun 2020Device	CLASS II	Panther Fusion Extraction Reagent-S recalled by Hologic	Hologic	Other	14 states
4 Mar 2020Device	CLASS II	Selenia Dimensions Mammography System recalled by Hologic	Hologic	Other	19 states
2 Jan 2019Device	CLASS II	I-View¿ Contrast Enhanced Digital Mammography, ASY recalled by Hologic	Hologic	Other	Nationwide
28 Feb 2018Device	CLASS II	Rapid for the TLiIQ(R) System, Hologic(R) recalled	Hologic	Other	CA
28 Feb 2018Device	CLASS II	Rapid for the TLiIQ(R) System, Hologic(R) recalled	Hologic	Other	CA
21 Feb 2018Device	CLASS II	Panther(R) Fusion(TM) recalled by Hologic	Hologic	Foreign Material	CA

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.