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 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)
Reported May 22, 2024
WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wishbone Medical, Inc.
FDA (openFDA device enforcement)
Reported May 15, 2024
DURAFLOW 2, 24CM STRAIGHT BASIC KIT -Indicated for use in attaining Long-Term vascular access for Hemodialysis and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Angiodynamics, Inc.
14 more products in this recall
FDA (openFDA device enforcement)
Reported May 15, 2024
Baxter Spectrum IQ Infusion Pump, Product Code 3570009
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported May 15, 2024
GE Healthcare Innova IGS 5, computed tomography x-ray system
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, SCS
6 more products in this recall
FDA (openFDA device enforcement)
Reported May 15, 2024
BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Hologic, Inc.
FDA (openFDA device enforcement)
Reported May 15, 2024
Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Navigation, Inc.
FDA (openFDA device enforcement)
Reported May 15, 2024
Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nrt X-Ray A/s
FDA (openFDA device enforcement)
Reported May 15, 2024
5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/795143, 5500 W/795144, 5500 G/795145, and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Ultrasound, Inc.
FDA (openFDA device enforcement)
Reported May 15, 2024
Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Randox Laboratories Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 15, 2024
PERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TLF-DS 45 40-S TLF-DS 45 45-S TLF-DS 55 30-S…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Spineart Sa
FDA (openFDA device enforcement)
Reported May 15, 2024
Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Leibinger GmbH & Co. KG
FDA (openFDA device enforcement)
Reported May 15, 2024
t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
High riskUsing this product could cause serious injury, illness or death — stop using it now.Tandem Diabetes Care, Inc.
FDA (openFDA device enforcement)
Reported May 15, 2024
Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Vyaire Medical, Inc.
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.