Recall Register

Food, drugs, devices › Firms

Hologic, Inc

FDA recalling firm · 41 enforcement events · 48 product records · 2012–2026 · MA, CA

Hologic, Inc has 41 FDA enforcement events on this register (48 product records) between 2012 and 2026: 41 device; the busiest year was 2024 with 6.

5% of its events are Class I; the most common class is Class II (39). 22 events are listed as ongoing; the recalling firm's address is in MA and CA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
8 Apr 2026SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2, SDM-05000-2A3, SDM-05000-2AC, SDM-05000-2D2, SDM-05000-2D3, SDM-05000-2DC, SDM-05000-3D2, SDM-05000-3D3,…DeviceClass II2Ongoing
23 Mar 2026Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software Version: N/A - not software version specific Component: Yes, the Genius" Review Station is a component of the Genius" Digital Diagnostics System with the Genius" Cervical AI…DeviceClass II1Ongoing
18 Feb 2026Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: NoDeviceClass II1Ongoing
15 Dec 2025Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.DeviceClass II1Ongoing
12 Dec 2025ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.DeviceClass II1Ongoing
15 Jan 2025Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Description: Instrument, Biopsy Component: N/ADeviceClass II1Ongoing
8 Jan 2025The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 71738-001). The Collection Tube (PN: 71550-001) is manufactured by a third-party supplier, MML Diagnostics Packaging, and includes the transport tube, cap, and extraction buffer. Tubes are packaged into…DeviceClass II1Ongoing
13 Dec 2024Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.DeviceClass II1Ongoing
8 Nov 2024Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400DeviceClass II1Ongoing
10 Oct 2024BioZorb Marker. Radiographic soft tissue marker.DeviceClass I1Ongoing
19 Aug 2024Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0 system software as follows Model/Catalog Number: 1. ASY-16824 FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.11.1 SYSTEMS 2. ASY-16825 FMI UPGRADE KIT, 3DIMENSIONS 2.3.0.3 SYSTEM…DeviceClass II1Ongoing
13 Jun 2024Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI, Horizon-A-CN, Horizon-W-CN, Horizon-WI-CN, Horizon-CI-CNDeviceClass II1Ongoing
13 Mar 2024BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZorb Marker 4cm x 5cm 2) F0404 BioZorb Marker 4cm x 4cm 3) F0331 BioZorb Marker 1cm x 3cm x 3cm 4) F0231 BioZorb Marker 1cm x 3cm x 2cm 5) F0221 BioZorb Marker 1cm x 3cm x 2cm 6) F0304 BioZorb Marker…DeviceClass I1Ongoing
15 Dec 2023PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully automates all steps necessary to perform Aptima assays from sample processing through amplification, detection, and data reduction. The Panther Fusion System is an integrated, fully automated, in vitro…DeviceClass II1Ongoing
14 Sep 2023Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Reagent, Promoter Reagent, Amplification Reconstitution Solution, Enzyme Reconstitution Solution, Promoter Reconstruction solution, Target capture Reagent, Reconstitution Collars.DeviceClass II1Ongoing
2 May 2023Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14DeviceClass II1Ongoing
16 Jan 2023Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-2DC SDM-00001-M3D SDM-05000-3DC SDM-SYS-6000-3D SDM-05000-2D3 SDA-SYS-3000-2D SDM-00001 SDM-SYS-9000-2D SDM-00001-M2D 3DM-SYS-STD 3DM-SYS-STD-NS SDM-05000-2AC SDM-05000-2A2 SDA-SYS-3000-3D…DeviceClass II1Ongoing
10 Oct 2022Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101DeviceClass II1Completed
9 Aug 2022The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb LP Marker is comprised of a bioabsorbable PLA (polylactic acid) component which resorbs completely in 1 year or more and a permanent component (titanium). The BioZorb LP Marker is provided…DeviceClass II1Ongoing
18 Mar 2022Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.DeviceClass II1Ongoing
27 Jan 2022Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fusion Capture reagent-X 4 EA, FER-X Fusion Enhancer Reagent-X (Lithium Hydroxide Solution) 4 EADeviceClass II1Ongoing
26 Feb 2021Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to the Panther Fusion System that is used to contain the PCR and RT-PCR steps of the assay processing.DeviceClass II1Ongoing
4 Aug 2020Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000DeviceClass II1Terminated
21 Jan 2020Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636,DeviceClass II1Terminated
10 Oct 2019Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture Reagent - S, Nucleic Acid in a buffered solution and FER-S Fusion Enhancer Reagent-S (Lithium Hydroxide Solution), UDI: 15420045509214DeviceClass II1Ongoing
6 Dec 2018I-View¿ Contrast Enhanced Digital Mammography, ASY-08109DeviceClass II1Terminated
20 Jan 2018Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 Product Usage: The Panther instrument is a fully automated sample-to-result instrument, eliminating the need for batch processing and automates all aspects of nucleic acid testing on a single, integrated platform. The Panther can be test samples with random…DeviceClass II1Terminated
29 Nov 2017Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200DeviceClass II2Terminated
15 Sep 2017Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic UseDeviceClass II1Terminated
7 Jul 2017Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880DeviceClass II1Terminated
27 Jun 2017Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument.DeviceClass II1Terminated
28 Oct 2016SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices. SURESOUND22 Multipack (OUS Distribution) containing 2 packs of six devices. For uterine soundDeviceClass II1Terminated
22 Aug 2016Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.DeviceClass II1Terminated
2 Aug 2016SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for ATEC0914-20MR Handpiece)DeviceClass II2Terminated
31 May 2016ATEC CANISTER. Suction Canister with Lid 490 cc., RX Only; Suction canister used to collect fluid during a breast biopsy.DeviceClass II1Terminated
31 Mar 2016CF InPlex ASR Card; Catalog Number: 95-0501.DeviceClass II2Terminated
13 May 2014Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer.DeviceClass II2Terminated
24 Jan 2014NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller, Model Number: 71978-001 Catalog Number: RFC2009 Product Usage: The NovaSure Impedance Controlled Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in premenopausal women with mehorrhagia…DeviceClass II1Terminated
6 Sep 2013Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer. The Selenia Full Field Digital Mammography System is intended for use in the same…DeviceClass II1Terminated
25 Apr 2013Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including but no limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light…DeviceClass II2Terminated
14 Sep 2012Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4.0.1 The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic visualization of a patient, including but not limited to surgical orthopedic and podiatry use, critical and emergency…DeviceClass II2Terminated

By type and class

Device41
Class II39
Class I2

Class I: 5% of this firm's events; 18% of all events on the register.

Events by year

12
14
16
18
20
22
24
26
Enforcement events for Hologic, Inc by year initiated.

Questions and answers

How many FDA recalls has Hologic, Inc had?

41 enforcement events (48 product records) on this register, 2012–2026: 41 device.

Are any Hologic, Inc recalls ongoing?

22 events are listed as ongoing in the current openFDA export.

What class are Hologic, Inc recalls?

39 Class II, 2 Class I. 5% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.