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 30, 2024
A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Oct 30, 2024
Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Shimadzu Corporation Medical Systems Division
FDA (openFDA device enforcement)
Reported Oct 30, 2024
CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD Inc.
13 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 30, 2024
medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Smiths Medical ASD, Inc.
23 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 30, 2024
Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Spectrum Medical Ltd.
FDA (openFDA device enforcement)
Reported Oct 23, 2024
IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter Inc.
FDA (openFDA device enforcement)
Reported Oct 23, 2024
Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Beckman Coulter, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 23, 2024
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO+ BRIDGE TO INTEGRATED KIT; the system utilizes an…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
21 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 23, 2024
Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Change Healthcare Canada Company
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 23, 2024
Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cue Health Inc.
FDA (openFDA device enforcement)
Reported Oct 23, 2024
GE Heathcare Giraffe OmniBed; neo natal incubator
High riskUsing this product could cause serious injury, illness or death — stop using it now.Datex--Ohmeda, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
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)
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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.