FDA Device · 2016
FDA Device recalls in 2016
RecallRadar indexes 3,246 FDA Device recall notices published in 2016. By classification: 116 Class I, 3,050 Class II, 80 Class III.
- Alcon AcrySof IQ IOL with ULTRASERT Delivery System Product Usage: The Alcon AcrySof IQ Intraocular Lens (IOL) is an acrylic foldable singl…
FDA Device · Class II · 2016-09-07 · Alcon Research - Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, Custom surgical kit
FDA Device · Class II · 2016-09-07 · Deroyal Industries - Diamond Coated Tips and Burs are accessories to the air powered dental handpiece (S-MAX pico) The intended use of the tips is based on the…
FDA Device · Class II · 2016-09-07 · Nakanishi - CURVED-TIP STAPLER 30,IS4000
FDA Device · Class II · 2016-09-07 · Intuitive Surgical - Monaco RTP System Used to make treatment plans for patients with prescriptions for external beam radiation therapy
FDA Device · Class II · 2016-09-07 · Elekta - UNIQ 1.0: UNIQ FD10, 722026
FDA Device · Class II · 2016-09-07 · Philips Electronics North America - SMR allen wrench 5 mm, product code 9013.50.210
FDA Device · Class II · 2016-09-07 · Limacorporate S P A - MAQUET Servo Humidifier 163, Inmed Mfg
FDA Device · Class II · 2016-09-07 · Teleflex Medical - The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas, Electrolyte and Metabolite Analysis
FDA Device · Class II · 2016-09-07 · Cardinal Health - A7 Anesthesia Delivery System, a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic an…
FDA Device · Class II · 2016-09-07 · Mindray Ds Usa - HexaPOD evo RT System Product Usage: The intended use of the device is the control of accurate patient positioning with assistance of a 3D…
FDA Device · Class II · 2016-09-07 · Elekta - Diamond Coated Tips and Burs are accessories to the Ultrasonic Scaler (VARIOS 350 LUX, VARIOS 350, VARIOS 150 LUX, VARIOS 150)
FDA Device · Class II · 2016-09-07 · Nakanishi - STAPLER,IS4000
FDA Device · Class II · 2016-09-07 · Intuitive Surgical - NIO-A / NIO-P is an instant IO access device comprises housing with spring load mechanism that injects a trocar needle into the bone marrow…
FDA Device · Class II · 2016-09-07 · Waismed - Allura Xper with release R8.2: Allura Xper FD10, 722026
FDA Device · Class II · 2016-09-07 · Philips Electronics North America - Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled containing Coated Tubing as follows: This product is intended for…
FDA Device · Class II · 2016-09-07 · Terumo Cardiovascular Systems - Centricity Laboratory Core Lab System 4.1 The Centricity Laboratory System is intended to be an information system designed to support the…
FDA Device · Class II · 2016-09-07 · Ge Healthcare It - FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY) The Fujifilm Digital Mammography System, A…
FDA Device · Class II · 2016-09-07 · Fujifilm Medical Systems U - RadSuite software
FDA Device · Class II · 2016-09-07 · Merge Healthcare - Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 (91 cm), Volume 0.32 mL
FDA Device · Class II · 2016-09-07 · Baxter Healthcare - STAPLER 30,IS4000
FDA Device · Class II · 2016-09-07 · Intuitive Surgical - Philips DuraDiagnost stationary X-ray system
FDA Device · Class II · 2016-09-07 · Philips Electronics North America - UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 775222 UniCel DxH Slidemaker Stainer (DxH SMS) Instructions for…
FDA Device · Class II · 2016-09-07 · Beckman Coulter - BD Vacutainer Push Button Blood Collection Set, Sterile, Rx only, 0.6 x 19 mm x 305 mm, 23G x 3/4" x 12", REF 367342
FDA Device · Class II · 2016-09-07 · Becton Dickinson And - iConnect Enterprise Archive
FDA Device · Class II · 2016-09-07 · Merge Healthcare - Merge Cardio software
FDA Device · Class II · 2016-09-07 · Merge Healthcare - PCR Compano Basic Reader using 100-127V as mains voltage
FDA Device · Class II · 2016-09-07 · Philips Electronics North America - Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems
FDA Device · Class II · 2016-09-07 · Invivo - Diamond Coated Tips and Burs are accessories to the air powered Bone drill (VARIOSURG with and without light) The intended use of the tips…
FDA Device · Class II · 2016-09-07 · Nakanishi - DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO
FDA Device · Class II · 2016-09-07 · Deroyal Industries - INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile
FDA Device · Class II · 2016-09-07 · Integra Lifesciences D B A Integra Pain Management - ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment (A1c_3) res…
FDA Device · Class II · 2016-09-07 · Siemens Healthcare Diagnostics - SPECULAR MICROSCOPE CEM-530
FDA Device · Class II · 2016-09-07 · Nidek - Double Pump RF Patient Cassette
FDA Device · Class II · 2016-09-07 · Medical Vision Ab - Adult Dual Dispersive Electrodes (for patients >15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6400,…
FDA Device · Class II · 2016-08-31 · Conmed - Liver Access and Biopsy Needle Set Biopsy needle kit Intended for use in obtaining liver histology samples via a jugular vein approach
FDA Device · Class II · 2016-08-31 · Cook - Panacea Air Pro Mattress Control Unit, Model: Platinum 5000, US Model Number 5000
FDA Device · Class II · 2016-08-31 · American National Mfg - CARESCAPE VC150 Vital Signs Monitor
FDA Device · Class II · 2016-08-31 · Innokas Medical Oy - Alere INRatio PT/INR System Professional Model Numbers: 0100004 Product Usage: Alere INRatio ¿ 2 PT/INR Monitoring System (Professional Use…
FDA Device · Class I · 2016-08-31 · Alere San Diego - Ingenuity Core128, Model number 728323 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the b…
FDA Device · Class II · 2016-08-31 · Philips Medical Systems Cleveland - Ziehm Vision RFD, Mobile C-arm for Mobile Fluoroscopic Imaging
FDA Device · Class II · 2016-08-31 · Ziehm Imaging - TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528
FDA Device · Class II · 2016-08-31 · Vision Rt - FluoroSet Radiographic Tubal Assessment Set Cannula, Manipulator/ Injector, Uterine Used for instillation of contrast media into the uterin…
FDA Device · Class II · 2016-08-31 · Cook - Tecan Infinite M1000 PRO The Tecan Infinite M1000 PRO is a multifunctional monochromator-based microplate reader that provides high perform…
FDA Device · Class II · 2016-08-31 · Tecan Us - Neff DAgostino Percutaneous Access Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an…
FDA Device · Class II · 2016-08-31 · Cook - RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 3L, REF 90-SRK-312300, QTY: 1, STERILE R
FDA Device · Class II · 2016-08-31 · Medtronic Sofamor Danek Usa - Brilliance BigBore Radiology CT Model number 728244 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional im…
FDA Device · Class II · 2016-08-31 · Philips Medical Systems Cleveland - Medtronic, Evera Implantable Cardioverter Defibrillators: Product Model EVERA XT DDBB1D1, DDBB1D4, DDBB2D1, DDBB2D4, DVBB2D4, DVBB1D1. EVER…
FDA Device · Class II · 2016-08-31 · Medtronic Cardiac Rhythm And Heart Failure - Alere INRatio2 PT/INR Home Monitoring System Model Number: 0200432, 0200433 Product Usage: Alere INRatio 2 PT/INR Home Monitoring System: T…
FDA Device · Class I · 2016-08-31 · Alere San Diego - SOMATOM Definition Edge with software version VA48A-SP2
FDA Device · Class II · 2016-08-31 · Siemens Medical Solutions Usa - BVX-330NR Bovie Precise 360 Handpiece 33cm, needle Product is used for the delivery of helium gas plasma for cutting, coagulation, and abla…
FDA Device · Class II · 2016-08-31 · Bovie Medical - Selective Salpingography Catheter with Beacon Tip Cannula, Manipulator/ Injector, Uterine Used for injection of contrast medium into the fa…
FDA Device · Class II · 2016-08-31 · Cook - Alere INRatio2 Replacement Monitor (Home) Model Number: 0200457 Product Usage: Alere INRatio 2 PT/INR Home Monitoring System: The Alere INR…
FDA Device · Class I · 2016-08-31 · Alere San Diego - BVX-450BR Bovie Precise 360 Handpiece 45cm, blade Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablat…
FDA Device · Class II · 2016-08-31 · Bovie Medical - Alere INRatio PT/INR Test Strips Model Number: 0100071, 0100139 Product Usage: The INRatio/INRatio2 Test Strips perform a modified version…
FDA Device · Class I · 2016-08-31 · Alere San Diego - Brilliance CT 16 Power, Model number 728240 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of…
FDA Device · Class II · 2016-08-31 · Philips Medical Systems Cleveland - RESPONSIVE, KNEE: FEMORAL COMPONENT CR/CS, SIZE 3R, REF 90-SRK-311300, QTY: 1, STERILE R
FDA Device · Class II · 2016-08-31 · Medtronic Sofamor Danek Usa - Shuttle Select Slip-Cath Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians tr…
FDA Device · Class II · 2016-08-31 · Cook - Brilliance CT Big Bore Oncology, Model number 728243 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional i…
FDA Device · Class II · 2016-08-31 · Philips Medical Systems Cleveland - Pediatric Dual Dispersive Electrodes (for patients 5-15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000,…
FDA Device · Class II · 2016-08-31 · Conmed - Kumpe Access Catheter Cathether, Ureteral, General & Plastic Surgery Used in combination with a HiWire, Bentson, or other flexible-tipped w…
FDA Device · Class II · 2016-08-31 · Cook - Brilliance 16, Model number 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body…
FDA Device · Class II · 2016-08-31 · Philips Medical Systems Cleveland - Siemens RAPIDPoint¿ 500 v2.2.2A Software Upgrade Kit
FDA Device · Class III · 2016-08-31 · Siemens Healthcare Diagnostics - Beacon Tip Torcon NB Advantage Catheter Catheter, Intravascular, Diagnostic
FDA Device · Class II · 2016-08-31 · Cook - Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product Model VIVAXTCRT-D DTBA1D1, DTBA1D4 VIVASCRT-D DTBB1D1, DTBB1D4…
FDA Device · Class II · 2016-08-31 · Medtronic Cardiac Rhythm And Heart Failure - Alere INRatio2 PT/INR Professional Testing System Model Number: 0200431 Product Usage: The INRatio 2 PT Monitoring system is used for the q…
FDA Device · Class I · 2016-08-31 · Alere San Diego - Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics
FDA Device · Class II · 2016-08-31 · Merz North America - Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only, Product Usage: The QWIX Positioning screw is indicated for fixati…
FDA Device · Class II · 2016-08-31 · Integra Lifesciences - NovaPACS versions 8.4.7, 8.5.3, and 8.5.6. Distributed by Novarad Corporation
FDA Device · Class II · 2016-08-31 · Novarad - SOMATOM Definition Flash with software version VA48A-SP2
FDA Device · Class II · 2016-08-31 · Siemens Medical Solutions Usa - AlignRT¿ Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the p…
FDA Device · Class II · 2016-08-31 · Vision Rt - Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging
FDA Device · Class II · 2016-08-31 · Ziehm Imaging - SUNRISE instrument
FDA Device · Class II · 2016-08-31 · Tecan Us - Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), No Cable, Catalog Number 51-7410
FDA Device · Class II · 2016-08-31 · Conmed - Alere INRatio Replacement Monitor Model Number: 0100137 Usage: The INRatio 2 PT Monitoring system is used for the quantitative measurement…
FDA Device · Class I · 2016-08-31 · Alere San Diego - BVX-450NR Bovie Precise 360 Handpiece 45cm, needle Product is used for the delivery of helium gas plasma for cutting, coagulation, and abla…
FDA Device · Class II · 2016-08-31 · Bovie Medical - Cobalt HV Bone Cement Product Usage: Cobalt HV Bone Cement provides two separate, pre-measured and sterilized components which when mixed f…
FDA Device · Class II · 2016-08-31 · Encore Medical - RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 4R, REF 90-SRK-311400, QTY: 1, STERILE R
FDA Device · Class II · 2016-08-31 · Medtronic Sofamor Danek Usa - TIBIAL TRAY , SIZE 2, REF 90-SRK-200200, QTY: 1, STERILE R, total knee replacement
FDA Device · Class II · 2016-08-31 · Medtronic Sofamor Danek Usa - TIBIAL TRAY , SIZE 5, REF 90-SRK-200500, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
FDA Device · Class II · 2016-08-31 · Medtronic Sofamor Danek Usa - Aprima Access Nonvascular Introducer Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of…
FDA Device · Class II · 2016-08-31 · Cook - 120 V Neptune 3 Rover, Model Number: 0703-001-000
FDA Device · Class II · 2016-08-31 · Stryker Instruments Div - Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well microplates
FDA Device · Class II · 2016-08-31 · Tecan Us - INRatio Prothrombin Time (PT) Monitoring System Model Number: 0100007 Product Usage: The INRatio Prothrombin Time Monitoring System uses a…
FDA Device · Class I · 2016-08-31 · Alere San Diego - DBS Pocket Adaptor, Model 64001 and Model 64002
FDA Device · Class II · 2016-08-31 · Medtronic Neuromodulation - Ziehm Vision R, Mobile C-arm for Mobile Fluoroscopic Imaging
FDA Device · Class II · 2016-08-31 · Ziehm Imaging - Pediatric ThermoGard¿ Dual Dispersive Electrodes (for patients 5-15 kg.), 10' (3.05m) Cable, Catalog Number 51-7710
FDA Device · Class II · 2016-08-31 · Conmed - Infinite F50 instrument
FDA Device · Class II · 2016-08-31 · Tecan Us - RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 5R, REF 90-SRK-311500, QTY: 1, STERILE R
FDA Device · Class II · 2016-08-31 · Medtronic Sofamor Danek Usa - TIBIAL TRAY , SIZE 4, REF 90-SRK-200400, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
FDA Device · Class II · 2016-08-31 · Medtronic Sofamor Danek Usa - SOMATOM Definition AS with software version VA48A-SP2
FDA Device · Class II · 2016-08-31 · Siemens Medical Solutions Usa - Beacon Tip Centimeter Sizing Catheter Beacon Tip White Vessel Sizing Catheter Beacon Tip Vessel Sizing Catheter Catheter, Intravascular, Di…
FDA Device · Class II · 2016-08-31 · Cook - Tecan Infinite 200
FDA Device · Class II · 2016-08-31 · Tecan Us - TIBIAL TRAY , SIZE 3, REF 90-SRK-200300, QTY: 1, STERILE R, total knee replacement
FDA Device · Class II · 2016-08-31 · Medtronic Sofamor Danek Usa - RadSuite software
FDA Device · Class II · 2016-08-31 · Merge Healthcare - Alere INRatio/ INRatio2 PT/INR Test Strips Model Number: 99007EU, 99007G1, 99007G3, 99007G5, 99007G7, 99008EU, 99008G1, 99008G3, 99008G5, 9…
FDA Device · Class I · 2016-08-31 · Alere San Diego - OEC UroView 2800, fluoroscopic x-ray system
FDA Device · Class II · 2016-08-31 · Ge Oec Medical Systems - Beacon Tip Royal Flush Plus High-Flow Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic proce…
FDA Device · Class II · 2016-08-31 · Cook - Alere INRatio2 PT/INR Professional Monitoring System Model Number: 55128A Product Usage: The Alere INRatio¿/INRatio¿2 system uses a modifie…
FDA Device · Class I · 2016-08-31 · Alere San Diego - Slip-Cath Beacon Tip Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicia…
FDA Device · Class II · 2016-08-31 · Cook
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