Medical device recalls
Device recalls are the largest single group in this archive, because the FDA logs corrections and removals as well as outright withdrawals. Many are handled entirely between the manufacturer and a hospital and need nothing from a patient. Each notice states who has to act.
13,634 stored notices, reported between Jun 20, 2012 and Sep 9, 2026. Newest first.
Reported Oct 16, 2024
iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Atrium Medical Corporation
FDA (openFDA device enforcement)
Reported Oct 16, 2024
Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Auris Health Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 16, 2024
Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
FDA (openFDA device enforcement)
Reported Oct 16, 2024
BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
FDA (openFDA device enforcement)
Reported Oct 16, 2024
Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Incorporated
FDA (openFDA device enforcement)
Reported Oct 16, 2024
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers: a)¿¿¿¿¿ 2089507-120;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
FDA (openFDA device enforcement)
Reported Oct 16, 2024
Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 16, 2024
Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Inspire Medical Systems Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 16, 2024
MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
FDA (openFDA device enforcement)
Reported Oct 16, 2024
NxTAG Respiratory Pathogen Panel, REF: I051C0447
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Luminex Molecular Diagnostics Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 16, 2024
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
3 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 16, 2024
StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
FDA (openFDA device enforcement)
Reported Oct 16, 2024
IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
FDA (openFDA device enforcement)
Reported Oct 16, 2024
Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America
FDA (openFDA device enforcement)
Reported Oct 16, 2024
FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Qualigen Inc.
FDA (openFDA device enforcement)
Reported Oct 16, 2024
The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Quantum Surgical Sas
FDA (openFDA device enforcement)
Reported Oct 16, 2024
The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Neurovascular
FDA (openFDA device enforcement)
Reported Oct 16, 2024
Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Windstone Medical Packaging, Inc.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 16, 2024
Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Zyno Medical LLC
FDA (openFDA device enforcement)
Reported Oct 9, 2024
DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alcon Research LLC
FDA (openFDA device enforcement)
Reported Oct 9, 2024
BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton, Dickinson and Company, BD Bio Sciences
FDA (openFDA device enforcement)
Reported Oct 9, 2024
BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.CooperVision, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 9, 2024
DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Feng Chun Yuan Medical Equipment (shenzhen)co.,Ltd.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 9, 2024
Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip. Each pad is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Healgen Scientific LLC
FDA (openFDA device enforcement)
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RecallNow is not a government agency. Every notice above was published by the FDA, USDA FSIS or CPSC and links back to its source. Browse the whole archive.