Hologic recalls
Hologic appears in 48 official U.S. recall notices indexed by RecallRadar, most recently on 2026-05-20.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 48 |
|---|---|
| Published | 2012-10-03 to 2026-05-20 |
| By agency | FDA Device (48) |
| By classification | Class II (46), Class I (2) |
| By status | terminated (24), ongoing (23), completed (1) |
| Distribution named in notices | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, US, UT, VA, VT, WA, WI, WV, WY |
Recalls
- 3DIMENSIONS MAMMOGRAPHY SYSTEM
FDA Device · Class II · 2026-05-20 · Hologic
Reason: Complaints have been received of systems developing loose, missing, or broken internal bolts over time. - SELENIA 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…
FDA Device · Class II · 2026-05-20 · Hologic
Reason: Complaints have been received of systems developing loose, missing, or broken internal bolts over time. - Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software Ve…
FDA Device · Class II · 2026-05-06 · Hologic
Reason: It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the manufacturer-installed settings. Modifications included disabling Ba… - Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No
FDA Device · Class II · 2026-03-25 · Hologic
Reason: Due to product exhibiting potential to generate either invalid or false negative results. - Brevera Breast Biopsy System Disposable 9 Gauge Needle
FDA Device · Class II · 2026-02-18 · Hologic
Reason: Presence of particulates in affected devices that can be deposited into breast tissue during use. - ThinPrep¿ CytoLyt¿ Solution
FDA Device · Class II · 2026-01-21 · Hologic
Reason: Fungal contamination of affected lot with Parengyodontium album. - Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Descri…
FDA Device · Class II · 2025-02-19 · Hologic
Reason: Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement. - The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection kit (PN: 71738-001)
FDA Device · Class II · 2025-02-12 · Hologic
Reason: Three lots of Rapid fFN Specimen Collection kit (901164, 901165, and 904850) contain Rapid fFN Specimen Collection Tubes which may be empty, underfilled, or overfilled with extraction buffer. The transport tubes are use… - Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD
FDA Device · Class II · 2025-01-22 · Hologic
Reason: Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment. - Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400
FDA Device · Class II · 2025-01-01 · Hologic
Reason: SARS-CoV-2/Flu A/B/RSV Assay Kit may erroneously produce SARS-CoV-2 false positive results. - Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
FDA Device · Class II · 2024-12-18 · Hologic
Reason: IFU was not provided with the Sizer Set sterilization tray Revised Sterilization Instructions for Sizer Set - BioZorb Marker
FDA Device · Class I · 2024-12-04 · Hologic
Reason: Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort. - Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0 system software as fo…
FDA Device · Class II · 2024-10-02 · Hologic
Reason: Identified an issue with Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when used in combination with C-View software in which the quality of the final C-View synthesized 2D image is impacted and may ap… - Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI, Horizon-A-CN, Horizon-W-CN, Horizon-…
FDA Device · Class II · 2024-07-24 · Hologic
Reason: Non-conformance pertains to electromagnetic compatibility requirements according to the international technical standard IEC 60601-1-2 for the safety and essential performance of medical electrical equipment, where the… - BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZorb Marker 4cm x 5cm…
FDA Device · Class I · 2024-05-15 · Hologic
Reason: Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the breast… - Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Reagent, Promoter Rea…
FDA Device · Class II · 2024-04-03 · Hologic
Reason: Use of assay along with plasma specimen may result in error code which would invalidate sample. - PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully automates all steps necess…
FDA Device · Class II · 2024-01-31 · Hologic
Reason: Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive. - Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14
FDA Device · Class II · 2023-07-05 · Hologic
Reason: The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery - Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D SDM-05000-3D3 SDM-05000-2DC SDM-00001-M3D SDM-0500…
FDA Device · Class II · 2023-03-01 · Hologic
Reason: C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual - The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site
FDA Device · Class II · 2022-10-12 · Hologic
Reason: Hologic BioZorb LP Marker, (Product number F0221), lot number 22A0RL, contained removable labels with an expiration date that indicated the product had already expired. The expiration date on the removable label is actu… - Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus
FDA Device · Class II · 2022-04-13 · Hologic
Reason: Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results. - Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion System, IVD, Rx only, Contents: FCR-X Fusion Capture reagen…
FDA Device · Class II · 2022-03-23 · Hologic
Reason: Failed stability specifications for reagent kits that may result in false negative test results. - Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to the Panther Fusion S…
FDA Device · Class II · 2021-04-14 · Hologic
Reason: There is a potential for tube trays to leak which could potentially result in false positive results, false negative results or invalid patient results. - Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000
FDA Device · Class II · 2020-09-30 · Hologic
Reason: Tube trays may leak which could invalidate patient results or assay worklists, causing delayed results for any assays with which they are used. A possibility exists of false negative result with flu A/B/RSV assay or par… - Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture Reagent - S, Nucleic Acid in a buff…
FDA Device · Class II · 2020-06-03 · Hologic
Reason: Reagent component included in flu test kit may cause both high background signal in a true negative sample leading to false positive and/or false negative results. This could result in false positive and/or false negati… - Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636
FDA Device · Class II · 2020-03-04 · Hologic
Reason: The recalling firm has received reports from the field of the C-arm on the Selenia Dimensions system seizing or dropping during field repairs and cleaning of the systems. - I-View¿ Contrast Enhanced Digital Mammography, ASY-08109
FDA Device · Class II · 2019-01-02 · Hologic
Reason: Calibration issue not possible to visualize contrast uptake in the subtracted mammography images - Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200
FDA Device · Class II · 2018-02-28 · Hologic
Reason: Rapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). The products were distributed to customers before FDA approved the change to use the material from SDIX. - Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200Q
FDA Device · Class II · 2018-02-28 · Hologic
Reason: Rapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). The products were distributed to customers before FDA approved the change to use the material from SDIX. - Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 Product Usage: The Panther instrument is a fully automated sample-to-result instrum…
FDA Device · Class II · 2018-02-21 · Hologic
Reason: The Panther or the Panther Fusion glass panel separates from the 19 inch touch screen monitor and could potentially fall and hit an operator. - Affirm Lateral Arm Upright Biopsy Accessory
FDA Device · Class II · 2018-01-24 · Hologic
Reason: The firm is implementing a product correction involving its Affirm¿ Lateral Arm Upright Biopsy Accessory, ASY-09880. The correction has been initiated due to a component (the Left-hand Guide or the Blue Needle Guide) is… - Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
FDA Device · Class II · 2017-10-25 · Hologic
Reason: An incorrect incubator was installed on one Panther System which potentially led to incorrect Aptima Combo 2(R) assay (AC2) results. - Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument
FDA Device · Class II · 2017-08-09 · Hologic
Reason: A Tomcat Instrument software anomaly that causes the pipettor arm to make physical contact with the mucous shelf which could potentially lead to incorrect patient results. - SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices
FDA Device · Class II · 2016-11-30 · Hologic
Reason: Breach in sterile barrier compromising product sterility - Sertera Biopsy Device, Sterile
FDA Device · Class II · 2016-09-28 · Hologic
Reason: Incorrect label on the Sertera Biopsy Kit - SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for AT…
FDA Device · Class II · 2016-09-14 · Hologic
Reason: Tip Breakage at the glue joint between the obturator body and tip - SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-12-OB (9G Introducer Localization Set (OB Model) for AT…
FDA Device · Class II · 2016-09-14 · Hologic
Reason: Tip Breakage at the glue joint between the obturator body and tip - ATEC CANISTER. Suction Canister with Lid 490 cc., RX Only
FDA Device · Class II · 2016-07-27 · Hologic
Reason: Cracks ATEC Canister Lids. - CF InPlex ASR Card
FDA Device · Class II · 2016-05-04 · Hologic
Reason: Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing during pregnancy and the associated risks of such invasive testing. - Hologic InPlex CF Molecular Test (IVD)
FDA Device · Class II · 2016-05-04 · Hologic
Reason: Complaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing during pregnancy and the associated risks of such invasive testing. - Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039
FDA Device · Class II · 2014-06-11 · Hologic
Reason: Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which could result in patient injury - Hologic M-IV Mammography System
FDA Device · Class II · 2014-06-11 · Hologic
Reason: Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which could result in patient injury - NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller, Model Number: 71978-001 Catalog Number: RFC2009 Produc…
FDA Device · Class II · 2014-03-05 · Hologic
Reason: NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC 60601-1, - Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field Digital Mammography system gene…
FDA Device · Class II · 2013-10-09 · Hologic
Reason: Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the most recently dated images - Fluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2 The device is a Mini C-arm Fluroscopic Imaging System designed to…
FDA Device · Class II · 2013-05-22 · Hologic
Reason: The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is not accurate and the total cumulative irradiation time is not accurate. - Fluoroscan 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 ph…
FDA Device · Class II · 2013-05-22 · Hologic
Reason: The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is not accurate and the total cumulative irradiation time is not accurate. - Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2 The device is a Mini C-arm Fluoroscopic Imaging System…
FDA Device · Class II · 2012-10-03 · Hologic
Reason: Fluoroscan Mini C-Arm models -InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180¿around vertical axis. InSight FD, version 5.0.1 and 5.0.2 - DICOM images stored in PACS may be lipped 180¿ a… - Hologic 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 de…
FDA Device · Class II · 2012-10-03 · Hologic
Reason: InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180¿around vertical axis. InSight FD, version 5.0.1 and 5.0.2 - DICOM images stored in PACS may be lipped 180¿ around vertical axis as well as…