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 May 29, 2024
IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System, Test, Thyroid Autoantibody.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 29, 2024
8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Leibinger GmbH & Co. KG
FDA (openFDA device enforcement)
Reported May 29, 2024
Stryker Blueprint Software, Catalog #BPUE001.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Tornier S.A.S.
FDA (openFDA device enforcement)
Reported May 29, 2024
Yamaha Surface Mounter YR series, YS series, i-Pulse series, Sigma series, S series, M series. Affected models: YSM10,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Yamaha Motor Corporation
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 22, 2024
Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Andover Healthcare Inc.
FDA (openFDA device enforcement)
Reported May 22, 2024
Spectrum IQ Infusion pump, Product Code 357009
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported May 22, 2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR3.5 (5PK), REF H74908526012; cardiac catheter
High riskUsing this product could cause serious injury, illness or death — stop using it now.Boston Scientific Corporation
47 more products in this recall
FDA (openFDA device enforcement)
Reported May 22, 2024
CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9.5 cm), Model 44102, Sterile,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cardinal Health 200, LLC
FDA (openFDA device enforcement)
Reported May 22, 2024
EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Cook Medical Incorporated
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 22, 2024
Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fisher & Paykel Healthcare, Ltd.
FDA (openFDA device enforcement)
Reported May 22, 2024
Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
FDA (openFDA device enforcement)
Reported May 22, 2024
HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P
Moderate riskThis product could cause temporary or reversible health problems — stop using it.HeartSine Technologies Ltd.
FDA (openFDA device enforcement)
Reported May 22, 2024
LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Karl Storz Endoscopy
FDA (openFDA device enforcement)
Reported May 22, 2024
Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.LeMaitre Vascular, Inc.
FDA (openFDA device enforcement)
Reported May 22, 2024
Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketones, Ascorbic Acid, Glucose, pH, Specific…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Macherey Nagel GmbH & Co. Kg
FDA (openFDA device enforcement)
Reported May 22, 2024
CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Medical Systems USA
FDA (openFDA device enforcement)
Reported May 22, 2024
APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medartis Inc.
FDA (openFDA device enforcement)
Reported May 22, 2024
namic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT, REF 60011045; b) 3V MANIFOLD KIT ON WITH NAMIC DT & WASTE MANAGEMENT,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 22, 2024
Medtronic Arterial Cannulae packaged as: a) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80020; b) DLP¿…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
12 more products in this recall
FDA (openFDA device enforcement)
Reported May 22, 2024
RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ossur H / F
3 more products in this recall
FDA (openFDA device enforcement)
Reported May 22, 2024
Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips North America LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 22, 2024
VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantitative measurement of free triiodothyronine…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Quidelortho
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 22, 2024
The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sophysa S.A.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 22, 2024
TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Threaded IM Nail 3.6mm,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.TriMed Inc.
1 more product 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.