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 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)
Reported Jun 12, 2024
OES 4000 Hysteroscope, Model/Catalog Number: A4674A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
FDA (openFDA device enforcement)
Reported Jun 12, 2024
VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly. For use in verifying the…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Ortho-Clinical Diagnostics, Inc.
FDA (openFDA device enforcement)
Reported Jun 12, 2024
HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system,…
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 Jun 12, 2024
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Remote Diagnostic Technologies Ltd.
FDA (openFDA device enforcement)
Reported Jun 12, 2024
Arial mobile application, model numbers 54640, 54630, and 54630-SMA, that utilizes Apple iOS 17.4 and Apple iOS 17.5, a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Securitas Healthcare LLC
FDA (openFDA device enforcement)
Reported Jun 12, 2024
The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip. The outside diameter of the Synchro…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Neurovascular
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 12, 2024
Brand Name: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 Product Description: Serialized Monitor
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Verathon, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 12, 2024
WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruction Manual and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.WAVi Co.
FDA (openFDA device enforcement)
Reported Jun 5, 2024
Brand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: CoverStainer, CoverStainer CPO Model/Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Agilent Technologies
FDA (openFDA device enforcement)
Reported Jun 5, 2024
20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Alcon Research LLC
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 5, 2024
Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Boston Scientific Neuromodulation Corporation
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.