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 Jun 19, 2024
EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien, LLC
FDA (openFDA device enforcement)
Reported Jun 19, 2024
US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
FDA (openFDA device enforcement)
Reported Jun 19, 2024
MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and H3912BD, dedicated cardiac SPECT…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ge Medical Systems Israel, Functional Imaging
FDA (openFDA device enforcement)
Reported Jun 19, 2024
CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Integra LifeSciences Corp.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 19, 2024
Coviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into or withdraw fluids from the body MMS Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Mckesson Medical-Surgical Inc. Corporate Office
FDA (openFDA device enforcement)
Reported Jun 19, 2024
VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Jun 19, 2024
OMTech Desktop Laser Engraver
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Rygel Advanced Machines d/b/a Omtech Laser
FDA (openFDA device enforcement)
Reported Jun 19, 2024
Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Thoratec Corp.
FDA (openFDA device enforcement)
Reported Jun 19, 2024
Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Wondfo USA Co. Ltd.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 19, 2024
Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Young Dental Manufacturing I, LLC
FDA (openFDA device enforcement)
Reported Jun 12, 2024
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS
High riskUsing this product could cause serious injury, illness or death — stop using it now.ARROW INTERNATIONAL Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 12, 2024
ADVANTA VXT, 5X40, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Atrium Medical Corporation
67 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 12, 2024
Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 SmartSite Y Sites REF 10013072 Tubing set…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Bd Switzerland Sarl
FDA (openFDA device enforcement)
Reported Jun 12, 2024
BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal, nasopharyngeal, oropharyngeal…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Co.
FDA (openFDA device enforcement)
Reported Jun 12, 2024
LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Corentec Co., Ltd.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 12, 2024
GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ONE-A1-1B, ONE-CUF, SMALL ADULT, 1 TB BAYONET,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems Information Technologies Inc.
FDA (openFDA device enforcement)
Reported Jun 12, 2024
Vaporizer Sevoflurane Maquet Filling, Product code/REF number (6682282), Component of: Flow-i C20, Flow-i C30,Flow-i…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Getinge USA Sales Inc.
FDA (openFDA device enforcement)
Reported Jun 12, 2024
IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ion Beam Applications S.A.
FDA (openFDA device enforcement)
Reported Jun 12, 2024
Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Leica Biosystems Nussloch GmbH
FDA (openFDA device enforcement)
Reported Jun 12, 2024
Syringes labeled as: a) SYR 10ML L/L CONTROL, Item Numbers: 1. DNSC91881, 2. DYNJSYRPPC10; b) SYRINGE 20ML BLUE L/L LOW…
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)
Reported Jun 12, 2024
O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.-Littleton
FDA (openFDA device enforcement)
Reported Jun 12, 2024
MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patients weighing…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Megadyne Medical Products, Inc.
FDA (openFDA device enforcement)
Reported Jun 12, 2024
Newport s N-LHP-928(j) units if sold as a laser head/power supply set, and N5-LPL-944-080 and N6-LPL-944-080 if sold as…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Newport Corp.
FDA (openFDA device enforcement)
Reported Jun 12, 2024
BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Series Bedside Monitoring System is intended to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nihon Kohden America 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.