Medical DeviceMay 20, 2026
Hologic SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS recall — FDA Z-2167-2026
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
Class IIFDA: OngoingHologic, Inc
Recall history in this database
Classification mix: Class II: 20, Class I: 1.
Medical DeviceMay 6, 2026
Genius" Review Station Display (Barco Monitor) recall — FDA Z-1949-2026
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.…
Class IIFDA: OngoingHologic, Inc
Medical DeviceMar 25, 2026
Aptima HPV Assay recall — FDA Z-1586-2026
Due to product exhibiting potential to generate either invalid or false negative results.
Class IIFDA: OngoingHologic, Inc.
Medical DeviceFeb 19, 2025
Sertera Biopsy Device recall — FDA Z-1170-2025
Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.
Class IIFDA: OngoingHologic, Inc.
Medical DeviceFeb 12, 2025
Hologic The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid recall — FDA Z-1095-2025
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…
Class IIFDA: OngoingHologic, Inc.
Medical DeviceJan 22, 2025
Hologic Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent recall — FDA Z-0907-2025
Potential weak pouch seal on Panther Fusion GBS assay cartridge, causing potential for invalid or incorrect results leading to a possible delay of treatment.
Class IIFDA: OngoingHologic, Inc.
Medical DeviceOct 2, 2024
Hologic Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version recall — FDA Z-3248-2024
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…
Class IIFDA: OngoingHologic Inc.
Medical DeviceJul 24, 2024
Hologic Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI recall — FDA Z-2373-2024
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…
Class IIFDA: OngoingHologic Inc.
Medical DeviceMay 15, 2024
Hologic BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of recall — FDA Z-1733-2024
Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from…
Class IFDA: OngoingHologic, Inc.
Medical DeviceApr 3, 2024
Hologic Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and recall — FDA Z-1371-2024
Use of assay along with plasma specimen may result in error code which would invalidate sample.
Class IIFDA: OngoingHologic, Inc.
Medical DeviceJan 31, 2024
Hologic PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic recall — FDA Z-0782-2024
Due to potential false positive Flu B results when a sample was also SARS-CoV-2 positive.
Class IIFDA: OngoingHologic, Inc.
Medical DeviceJul 5, 2023
Hologic Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples recall — FDA Z-2035-2023
The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery
Class IIFDA: OngoingHologic, Inc.
Medical DeviceMar 1, 2023
Hologic 3Dimensions/Selenia Dimensions Models: RM-SDM-00001-3D SDM-00001-2D SDM-00001-3D recall — FDA Z-1144-2023
C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual
Class IIFDA: OngoingHologic, Inc.
Medical DeviceOct 12, 2022
Hologic The BioZorb LP Marker is an implantable radiopaque marker used to facilitate recall — FDA Z-1858-2022
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…
Class IIFDA: OngoingHologic, Inc.
Medical DeviceApr 13, 2022
Hologic Panther Fusion GBS Assay Cartridges 96 Tests recall — FDA Z-0877-2022
Samples, run on a GBS Assay, that have analyte concentrations that are at or near the limit of detection may produce false negative results.
Class IIFDA: OngoingHologic, Inc.
Medical DeviceMar 23, 2022
Hologic Panther Fusion Extraction Reagent-X, REF PRD-04477, For use with Panther Fusion recall — FDA Z-0750-2022
Failed stability specifications for reagent kits that may result in false negative test results.
Class IIFDA: OngoingHologic, Inc.
Medical DeviceApr 14, 2021
Hologic Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product recall — FDA Z-1369-2021
There is a potential for tube trays to leak which could potentially result in false positive results, false negative results or invalid patient results.
Class IIFDA: OngoingHologic, Inc.
Medical DeviceSep 30, 2020
Hologic Panther Fusion Tube Tray, Part: FAB-15004, REF: PRD-04000 recall — FDA Z-2990-2020
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…
Class IIFDA: TerminatedHologic, Inc.
Medical DeviceJun 3, 2020
Hologic Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of recall — FDA Z-2163-2020
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…
Class IIFDA: OngoingHologic, Inc.
Medical DeviceMar 4, 2020
Hologic Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions recall — FDA Z-1343-2020
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.
Class IIFDA: TerminatedHologic, Inc.
Medical DeviceJan 2, 2019
Hologic I-View Contrast Enhanced Digital Mammography, ASY-08109 recall — FDA Z-0685-2019
Calibration issue not possible to visualize contrast uptake in the subtracted mammography images
Class IIFDA: TerminatedHologic, Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Hologic, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.