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 Jan 22, 2025
nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Nuwellis Inc.
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Olympus Corporation of the Americas
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Quidel Ortho
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sin Sistema de Implante Nacional S.a
FDA (openFDA device enforcement)
Reported Jan 22, 2025
ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE" BUCK EAR CUR BL STR#0STRLCS/25, Model Number…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sklar Instruments
29 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Tornier S.A.S.
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Trokamed GmbH
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 15, 2025
Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot Model / Catalog Number: O2U2012 Lot…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.3B Medical, Inc.
FDA (openFDA device enforcement)
Reported Jan 15, 2025
Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Aerin Medical, Inc.
FDA (openFDA device enforcement)
Reported Jan 15, 2025
AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Applied Medical Technology Inc.
FDA (openFDA device enforcement)
Reported Jan 15, 2025
Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Beckman Coulter, Inc.
FDA (openFDA device enforcement)
Reported Jan 15, 2025
EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio Patient Pad…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Elucent Medical Inc.
FDA (openFDA device enforcement)
Reported Jan 15, 2025
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
FDA (openFDA device enforcement)
Reported Jan 15, 2025
Dialyzer Optiflux 160NRe
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Medical Care Holdings, Inc.
FDA (openFDA device enforcement)
Reported Jan 15, 2025
GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3) A0659MB
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Medical Systems, LLC
7 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 15, 2025
VACUETTE SAFELINK, REF: 450210
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Greiner Bio-One GmbH
FDA (openFDA device enforcement)
Reported Jan 15, 2025
Smaxel Fractional CO2 Laser, a Class IV medical laser system.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ids Ltd.
FDA (openFDA device enforcement)
Reported Jan 15, 2025
JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L
High riskUsing this product could cause serious injury, illness or death — stop using it now.Jiangsu Jumao X-Care Medical Equipment Co. Ltd.
FDA (openFDA device enforcement)
Reported Jan 15, 2025
VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Maquet Cardiovascular, LLC
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 15, 2025
Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Nipro Renal Soultions USA, Corporation
FDA (openFDA device enforcement)
Reported Jan 15, 2025
The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Qualigen Inc.
FDA (openFDA device enforcement)
Reported Jan 15, 2025
Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Spacelabs Healthcare, Inc.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 15, 2025
100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-000) 230V NEPTUNE 3 ROVER ENGLISH…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Corporation
FDA (openFDA device enforcement)
Reported Jan 8, 2025
3M Unitek Transbond Plus Self-Etching Primer REF 712-090 (100 unit box) 712-091 (20 unit box) Transbond Plus Self…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.3M Unitek 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.