FDA Device · 2021
FDA Device recalls in 2021
RecallRadar indexes 2,303 FDA Device recall notices published in 2021. By classification: 179 Class I, 2,098 Class II, 26 Class III.
- REGARD Stereotactic Tray
FDA Device · Class II · 2021-11-24 · Roi Cps - SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the b…
FDA Device · Class II · 2021-11-24 · Cordis - QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200
FDA Device · Class II · 2021-11-17 · Z Medica - Ellume COVID-19 Home Test
FDA Device · Class I · 2021-11-17 · Ellume - Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, 722068, 722078, 722…
FDA Device · Class II · 2021-11-17 · Philips North America - T4 EIA Kit, Cat No: BC-1007, Store at 2-8C, For in vitro diagnostic use only This product s intended use is For the quantitative determinat…
FDA Device · Class II · 2021-11-17 · Biocheck - HENRY SCHEIN Safety Blood Collection Needle 22Gx 1 1/4 Inch, REF 570-2068, 100pcs/box 1000pcs/ctn 350*210*350mm
FDA Device · Class II · 2021-11-17 · Zhejiang Kindly Medical Devices - McKesson PREVENT HT Safety Blood Collection Needles, 22G 1 1/4 inch, MFR # 16-NBC22GS
FDA Device · Class II · 2021-11-17 · Zhejiang Kindly Medical Devices - Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1
FDA Device · Class II · 2021-11-17 · Covidien - McKesson PREVENT HT Safety Blood Collection Needles, 21G 1 1/4 inch, MFR # 16-NBC21GS
FDA Device · Class II · 2021-11-17 · Zhejiang Kindly Medical Devices - McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, MFR # 16-NBCH21GS
FDA Device · Class II · 2021-11-17 · Zhejiang Kindly Medical Devices - Hemodialysis Delivery System, Software Version 2.x
FDA Device · Class II · 2021-11-17 · Baxter Healthcare - THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA
FDA Device · Class II · 2021-11-17 · Therakos - McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, MFR # 16-NBCH22GS
FDA Device · Class II · 2021-11-17 · Zhejiang Kindly Medical Devices - HENRY SCHEIN Safety Blood Collection Needle 21Gx 1 1/4 Inch, REF 570-2067, 100pcs/box 1000pcs/ctn 350*210*350mm
FDA Device · Class II · 2021-11-17 · Zhejiang Kindly Medical Devices - 3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape, Catalog No. 2244, (3M ID (SKU): 70-2011-8506-6, SAP ID: 7100212989)…
FDA Device · Class II · 2021-11-10 · 3m Health Care Business - Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical Solutions Custom Conven…
FDA Device · Class I · 2021-11-10 · Windstone Medical Packaging - Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
FDA Device · Class II · 2021-11-10 · Fujifilm Healthcare Americas - ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform
FDA Device · Class II · 2021-11-10 · Implant Direct Sybron Manufacturing - Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G09908 The introducer sheath incorporates a hydrophilic coated Flex…
FDA Device · Class II · 2021-11-10 · Cook - Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW) CENa_3-1-0-1 and lower
FDA Device · Class II · 2021-11-10 · Siemens Healthcare Diagnostics - ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform
FDA Device · Class II · 2021-11-10 · Implant Direct Sybron Manufacturing - FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)
FDA Device · Class II · 2021-11-10 · Karl Storz Endoscopy - Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following workplace/system application s…
FDA Device · Class II · 2021-11-10 · Siemens Medical Solutions Usa - Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069 The introducer sheath incorporate…
FDA Device · Class II · 2021-11-10 · Cook - Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
FDA Device · Class II · 2021-11-10 · Fujifilm Healthcare Americas - Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
FDA Device · Class II · 2021-11-10 · Siemens Healthcare Diagnostics - Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
FDA Device · Class II · 2021-11-10 · Fujifilm Healthcare Americas - COVENA PICC Sleeve
FDA Device · Class II · 2021-11-10 · Queen Comfort Products - Clinician Programmer Application (CPA) model A610 Clinician Software Application
FDA Device · Class II · 2021-11-10 · Medtronic Neuromodulation - GM Helix Acqua Implant 3.5x10, Article No. 140.944
FDA Device · Class II · 2021-11-10 · Jjgc Industria E Comercio De Materials Dentarios - Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
FDA Device · Class II · 2021-11-10 · Fujifilm Healthcare Americas - Aspiration Syringe Kit, REF: MVSK60
FDA Device · Class II · 2021-11-10 · Microvention - The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear polycarbonate material and is an access…
FDA Device · Class II · 2021-11-10 · Bayer Medical Care - ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866
FDA Device · Class II · 2021-11-10 · Siemens Healthcare Diagnostics - IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063)
FDA Device · Class I · 2021-11-10 · Lumenis - Bivona Uncuffed Wire Endotracheal Tubes
FDA Device · Class II · 2021-11-03 · Smiths Medical Asd - REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERI…
FDA Device · Class II · 2021-11-03 · W L Gore And Associates - REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERI…
FDA Device · Class II · 2021-11-03 · W L Gore And Associates - ASC PneumoLiner device, Part No. WA90500US (US market only) The Pneumoliner device is intended for use as a multiple instrument port and ti…
FDA Device · Class II · 2021-11-03 · Olympus - REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STER…
FDA Device · Class II · 2021-11-03 · W L Gore And Associates - Pneupac paraPac plus 300 ventilator kit, REF P300NGB
FDA Device · Class III · 2021-11-03 · Smiths Medical Asd - Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543
FDA Device · Class II · 2021-11-03 · Siemens Healthcare Diagnostics - REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERI…
FDA Device · Class II · 2021-11-03 · W L Gore And Associates - RAPTAR Laser Range Finders
FDA Device · Class II · 2021-11-03 · Potomac River Group - Bivona Aire-Cuf Endotracheal Tube
FDA Device · Class II · 2021-11-03 · Smiths Medical Asd - REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERI…
FDA Device · Class II · 2021-11-03 · W L Gore And Associates - Cliquid MD version 3.4 software used in conjunction with Analyst MD software on SCIEX Citrine & 4500MD series liquid chromatography-tandem…
FDA Device · Class II · 2021-11-03 · Ab Sciex - ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to…
FDA Device · Class I · 2021-11-03 · Medtech Sas - Concerto User Interface Software provided with the following systems: (1) Xstrahl 100 Electronic Brachytherapy - 100kV Superficial X-Ray Th…
FDA Device · Class II · 2021-11-03 · Xstrahl - REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERI…
FDA Device · Class II · 2021-11-03 · W L Gore And Associates - C315-HIS Delivery Catheter
FDA Device · Class II · 2021-11-03 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151
FDA Device · Class II · 2021-11-03 · Siemens Healthcare Diagnostics - REF/Catalogue Number GSXE0020, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERI…
FDA Device · Class II · 2021-11-03 · W L Gore And Associates - REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STER…
FDA Device · Class II · 2021-11-03 · W L Gore And Associates - Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00
FDA Device · Class II · 2021-11-03 · Elekta - REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERI…
FDA Device · Class II · 2021-11-03 · W L Gore And Associates - BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton
FDA Device · Class II · 2021-11-03 · Becton Dickinson And - Atellica IM 1600 Analyzer, SMN 11066000
FDA Device · Class II · 2021-10-27 · Siemens Healthcare Diagnostics - Easi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths)
FDA Device · Class II · 2021-10-27 · Kinsman Enterprises - Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the…
FDA Device · Class II · 2021-10-27 · Medtronic Xomed - Medtronic sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the…
FDA Device · Class II · 2021-10-27 · Medtronic Xomed - Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097
FDA Device · Class I · 2021-10-27 · Datascope - HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular we…
FDA Device · Class II · 2021-10-27 · Instrumentation Laboratory - REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845
FDA Device · Class II · 2021-10-27 · Limacorporate S P A - Discovery MR750w 3.0T nuclear magnetic resonance imaging system
FDA Device · Class II · 2021-10-27 · Ge Healthcare - Herniatome, 17G x 15cm, Lumbar Type with with 20ga-30cm Introducer, Model Number 5091715
FDA Device · Class II · 2021-10-27 · Adria Srl - MPR Slotted Mallet, labeling etched onto devices as follows: Medical Products Resource 800.524.5194 www.m-p-r.com MPR-1120-1000 (01)0084000…
FDA Device · Class II · 2021-10-27 · Implant Resource - SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051
FDA Device · Class II · 2021-10-27 · Diasorin Molecular - EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232
FDA Device · Class II · 2021-10-27 · Philips Ultrasound - SIGNA Pioneer nuclear magnetic resonance imaging system
FDA Device · Class II · 2021-10-27 · Ge Healthcare - SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system
FDA Device · Class II · 2021-10-27 · Ge Healthcare - Tenaculum, Plastic
FDA Device · Class II · 2021-10-27 · Stradis Medical - VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monitoring the performance of the VITROS ECi/E…
FDA Device · Class II · 2021-10-27 · Ortho Clinical Diagnostics - Discovery MR750 3.0T nuclear magnetic resonance imaging system
FDA Device · Class II · 2021-10-27 · Ge Healthcare - IUD Insertion Kit
FDA Device · Class II · 2021-10-27 · Stradis Medical - REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852
FDA Device · Class II · 2021-10-27 · Limacorporate S P A - P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641
FDA Device · Class II · 2021-10-27 · Fort Defiance Industries - CADD Administration Sets, Model #21-7346-24
FDA Device · Class II · 2021-10-27 · Smiths Medical Asd - Herniatome, 17G x 9cm, Cervical Type, Model Number 5091749
FDA Device · Class II · 2021-10-27 · Adria Srl - medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 081-101GE c. 081-101GEE d. 081-101NE e. 081-102NE f. 081-102RE g.…
FDA Device · Class II · 2021-10-27 · Smiths Medical Asd - Herniatome, 17G x 15cm, Lumbar Type, Model Number 5091745
FDA Device · Class II · 2021-10-27 · Adria Srl - smiths medical portex Loss of Resistance Device, REF 100/398/000
FDA Device · Class II · 2021-10-27 · Smiths Medical Asd - Atellica IM 1300 Analyzer, SMN 11066001
FDA Device · Class II · 2021-10-27 · Siemens Healthcare Diagnostics - HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular we…
FDA Device · Class II · 2021-10-27 · Instrumentation Laboratory - CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e.…
FDA Device · Class I · 2021-10-27 · Smiths Medical Asd - Kit: Central Line Dres Change 20/Cs
FDA Device · Class II · 2021-10-27 · Medical Action Industries 306 - Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
FDA Device · Class II · 2021-10-27 · Canon Medical System Usa - SIGNA Artist nuclear magnetic resonance imaging system
FDA Device · Class II · 2021-10-27 · Ge Healthcare - SIGNA Voyager nuclear magnetic resonance imaging system
FDA Device · Class II · 2021-10-27 · Ge Healthcare - 6.5MMX165MM CANNULATED SCREW
FDA Device · Class II · 2021-10-27 · Smith And Nephew - Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G X 4"Biopsy/Aspiration needle, 15 G Aspiration Nee…
FDA Device · Class II · 2021-10-27 · Bard Peripheral Vascular - SIGNA Architect nuclear magnetic resonance imaging system
FDA Device · Class II · 2021-10-27 · Ge Healthcare - Optima MR450w 1.5T nuclear magnetic resonance imaging system
FDA Device · Class II · 2021-10-27 · Ge Healthcare - 1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system
FDA Device · Class II · 2021-10-27 · Ge Healthcare - Foundation Kit
FDA Device · Class II · 2021-10-27 · Stradis Medical - Medtronic Sterile single-use blades that are components of the StraightShot M Series Handpiece and Fusion ENT Navigation Software, and the…
FDA Device · Class II · 2021-10-27 · Medtronic Xomed - SIGNA Premier nuclear magnetic resonance imaging system
FDA Device · Class II · 2021-10-27 · Ge Healthcare - IUD Insertion Pack
FDA Device · Class II · 2021-10-27 · Stradis Medical - HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical laboratories
FDA Device · Class II · 2021-10-27 · Instrumentation Laboratory
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