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 Apr 13, 2022
Alinity m HBV Application Specification File (US and CE)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Molecular, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 13, 2022
Amplatzer Steerable Delivery Sheath
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott
FDA (openFDA device enforcement)
Reported Apr 13, 2022
Brius Pontics (components in a set of custom metal orthodontic devices);BRIUS , RX Only, Non-Sterile, Custom Made…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Brius Technologies Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 13, 2022
Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917;…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Cook Medical Incorporated
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 13, 2022
DeRoyal ST Neonatal Dressing Change Kit, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DeRoyal Industries Inc.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 13, 2022
Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Draeger Medical, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 13, 2022
C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DRG International, Inc.
FDA (openFDA device enforcement)
Reported Apr 13, 2022
Revolution Apex, Revolution CT with Apex Edition
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
5 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 13, 2022
Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Hologic, Inc.
FDA (openFDA device enforcement)
Reported Apr 13, 2022
Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Maquet Cardiovascular, LLC
FDA (openFDA device enforcement)
Reported Apr 13, 2022
Cardiohelp-i Transport Guard with Transport Guard (701072525): is a 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 Apr 13, 2022
Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
FDA (openFDA device enforcement)
Reported Apr 13, 2022
Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Philips Healthcare
FDA (openFDA device enforcement)
Reported Apr 13, 2022
Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model…
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 Apr 13, 2022
Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Remote Diagnostic Technologies Ltd.
FDA (openFDA device enforcement)
Reported Apr 13, 2022
Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sa3, LLC
FDA (openFDA device enforcement)
Reported Apr 13, 2022
MODEL: X-RAY R/F SYSTEM FLUOROspeed X1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Shimadzu Medical Systems
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 13, 2022
Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Apr 13, 2022
YSIO X.Pree
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Medical Solutions USA, Inc.
FDA (openFDA device enforcement)
Reported Apr 13, 2022
Surgicare Neuro Pack - Neurological Kit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stradis Medical, LLC dba Stradis Healthcare
4 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 13, 2022
BenchMark ULTRA and DISCOVERY ULTRA Instruments
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ventana Medical Systems Inc.
FDA (openFDA device enforcement)
Reported Apr 13, 2022
SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Volcano Corporation
FDA (openFDA device enforcement)
Reported Apr 13, 2022
First SIGN SARS-CoV-2 Antigen Test
Moderate riskThis product could cause temporary or reversible health problems — stop using it.WHPM Inc.
FDA (openFDA device enforcement)
Reported Apr 6, 2022
Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ansell Healthcare Products LLC
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.