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 Mar 29, 2023
Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Vapotherm
FDA (openFDA device enforcement)
Reported Mar 29, 2023
Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Withings
FDA (openFDA device enforcement)
Reported Mar 22, 2023
BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Avanos Medical, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 22, 2023
Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816MSK
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bard Peripheral Vascular Inc.
FDA (openFDA device enforcement)
Reported Mar 22, 2023
Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
FDA (openFDA device enforcement)
Reported Mar 22, 2023
BD Ultra-Fine Insulin Syringe 0.5mL, 6mm, 31G - Insulin Syringes are designed for administering insulin in the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
7 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 22, 2023
In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147
Moderate riskThis product could cause temporary or reversible health problems — stop using it.BioFire Diagnostics, LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 22, 2023
Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Brainlab AG
FDA (openFDA device enforcement)
Reported Mar 22, 2023
Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platform
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fenwal Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 22, 2023
Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Intuitive Surgical, Inc.
FDA (openFDA device enforcement)
Reported Mar 22, 2023
TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Limacorporate S.p.A
FDA (openFDA device enforcement)
Reported Mar 22, 2023
Fusion Bioline Vascular Graft, Part number M00201503046B0
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
FDA (openFDA device enforcement)
Reported Mar 22, 2023
Recreo Hair Growth Laser Comb
Moderate riskThis product could cause temporary or reversible health problems — stop using it.OMM Imports, Inc. dba Zero Gravity
FDA (openFDA device enforcement)
Reported Mar 22, 2023
Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Scientia Vascular, Inc.
FDA (openFDA device enforcement)
Reported Mar 22, 2023
Arial mobile application, model #54630 and #54640 for Android devices downloaded from the Google Play Store as part of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Securitas Healthcare LLC
FDA (openFDA device enforcement)
Reported Mar 22, 2023
Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative measurement of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Mar 22, 2023
Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency location.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Medical Division
FDA (openFDA device enforcement)
Reported Mar 22, 2023
TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Synthes (USA) Products LLC
2 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 15, 2023
BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human citrated plasma.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aniara Diagnostica LLC
FDA (openFDA device enforcement)
Reported Mar 15, 2023
Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Baxter Healthcare Corporation
FDA (openFDA device enforcement)
Reported Mar 15, 2023
LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Corporation
FDA (openFDA device enforcement)
Reported Mar 15, 2023
CD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog number and product name: 1. CD5-3B,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Carefusion 2200 Inc.
FDA (openFDA device enforcement)
Reported Mar 15, 2023
Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien, LP
FDA (openFDA device enforcement)
Reported Mar 15, 2023
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Datascope Corp.
7 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.