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.
13,791 stored notices, reported between Jun 20, 2012 and Oct 28, 2026. Newest first.
Reported Oct 23, 2024
KINOVA Jaco assistive robot. Model Numbers: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, KR MJ2 0001. Jaco…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Kinova Inc.
FDA (openFDA device enforcement)
Reported Oct 23, 2024
Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, for freezing and sectioning tissue samples
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Leica Biosystems Nussloch GmbH
5 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 23, 2024
MEDLINE HEART CABG CDS, REF CDS983376R
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
5 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 23, 2024
Vanta Implantable Neurostimulator (INS), Model 977006
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
FDA (openFDA device enforcement)
Reported Oct 23, 2024
Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Merit Medical Systems, Inc.
15 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 23, 2024
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/Catalog Number: 4329BL Product Description:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nova Ortho-Med Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 23, 2024
EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Oct 23, 2024
The Graft Tube is an optional instrument which, as designed, can be filled with flowable graft material, then advanced…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Spineology, Inc.
FDA (openFDA device enforcement)
Reported Oct 23, 2024
1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shaping and smoothing of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
FDA (openFDA device enforcement)
Reported Oct 23, 2024
Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wilson-Cook Medical Inc.
FDA (openFDA device enforcement)
Reported Oct 23, 2024
Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045
Moderate riskThis product could cause temporary or reversible health problems — stop using it.XTANT Medical Holdings, Inc.
FDA (openFDA device enforcement)
Reported Oct 16, 2024
3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Moderate riskThis product could cause temporary or reversible health problems — stop using it.3M Company - Health Care Business
FDA (openFDA device enforcement)
Reported Oct 16, 2024
Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Agfa Healthcare NV
FDA (openFDA device enforcement)
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)
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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.