Hologic, Inc
Marlborough, MA
This page shows every FDA and USDA recall linked to Hologic, Inc. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
14
Total Recalls
2014
First Recall
2026
Most Recent
Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Feb 6, 2026
· Device
Open, Classified
ThinPrep CytoLyt Solution. Buffered Cell Wash Solution.
Jan 15, 2026
· Device
Open, Classified
Brand Name: Sertera Biopsy Device
Product Name: Sertera Biopsy Device
Model/Catalog Number: Sertera-14
Softwar...
Feb 13, 2025
· Device
Open, Classified
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide
Model/C...
Dec 11, 2024
· Device
Completed
BioZorb Marker. Radiographic soft tissue marker.
Nov 26, 2024
· Device
Open, Classified
BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue.
1) F...
May 3, 2024
· Device
Open, Classified
Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors...
Jun 29, 2023
· Device
Open, Classified
The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue si...
Sep 30, 2022
· Device
Open, Classified
SURESOUND22US Multipack (US Distribution) containing 2 packs of six devices.
SURESOUND22 Multipack (OUS Distri...
Nov 22, 2016
· Device
Terminated
Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.
Sep 21, 2016
· Device
Terminated
SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI.
ILS-0914-20-OB (9G Introducer Local...
Sep 8, 2016
· Device
Terminated
SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI.
ILS-0914-12-OB (9G Introducer Local...
Sep 8, 2016
· Device
Terminated
ATEC CANISTER. Suction Canister with Lid 490 cc., RX Only; Suction canister used to collect fluid during a bre...
Jul 19, 2016
· Device
Terminated
NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller, Model Number: 71978-001
C...
Feb 26, 2014
· Device
Terminated