FDA Device · 2014
FDA Device recalls in 2014
RecallRadar indexes 3,059 FDA Device recall notices published in 2014. By classification: 558 Class I, 2,441 Class II, 60 Class III.
- HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Angled Tip, 180 CM Length
FDA Device · Class I · 2014-07-02 · Nitinol Devices And Components - ANSPACH***REF 98-0022***8 mm Coarse Headless Screw with Driver***Rx Only*** This device is intended to be used with Anspach Systems
FDA Device · Class II · 2014-07-02 · The Anspach Effort - FirmArray Blood Culture Identification (BCID) Panel, Model 2.0 The FilmArray Blood Culture Identification (BCID) Panel is a qualitative mul…
FDA Device · Class II · 2014-07-02 · Biofire Diagnostics - HydroFinity Hydrophilic guidewire
FDA Device · Class I · 2014-07-02 · Nitinol Devices And Components - ANSPACH***REF 98-0033***Custom Autolube Food Guard***Rx Only*** This device is intended to be used with Anspach Systems
FDA Device · Class II · 2014-07-02 · The Anspach Effort - ANSPACH***REF SP-4604-00***3mm Fluted Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with Anspach…
FDA Device · Class II · 2014-07-02 · The Anspach Effort - Spacelabs Healthcare Qube Compact Monitor, Model 91390
FDA Device · Class II · 2014-07-02 · Spacelabs Healthcare - ANSPACH***REF SP-4602-00***2mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with…
FDA Device · Class II · 2014-07-02 · The Anspach Effort - Siemens Dimension LOCI TNI Troponin I Calibrator RC 621
FDA Device · Class II · 2014-07-02 · Siemens Healthcare Diagnostics - HydroFinity Hydrophilic guidewire
FDA Device · Class I · 2014-07-02 · Nitinol Devices And Components - ANSPACH***REF SP-4605-00***Arthroscopic Suture Anchor assembly with Suture Threader***Rx Only*** This device is intended to be used with An…
FDA Device · Class II · 2014-07-02 · The Anspach Effort - iGUIDE System Product Usage: The intended use of the device is the control of accurate patient positioning with the assistance of a 30 Trac…
FDA Device · Class II · 2014-06-25 · Elekta - EZPass Passer, Sterile single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft…
FDA Device · Class II · 2014-06-25 · Biomet - G7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis
FDA Device · Class II · 2014-06-25 · Biomet - Tytin Regular Set, Double Spill, 50 Capsules, Part Number 29948, Lot Number 3-1294
FDA Device · Class II · 2014-06-25 · Kerr - Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a component of the Puritan Bennett 840 Ventilator: The Backlight Invert…
FDA Device · Class II · 2014-06-25 · Nellcor Puritan Bennett Dba Covidien - VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory sample-management system
FDA Device · Class III · 2014-06-25 · Siemens Medical Solutions Diagnostics - cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat
FDA Device · Class II · 2014-06-25 · Roche Diagnostics Operations - Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02
FDA Device · Class II · 2014-06-25 · Roche Diagnostics Operations - VITROS (R) Chemistry Products Calibrator Kit 17, Product Code/ Catalog Number 6801701 -- For in vitro diagnostic use only --- VITROS Chemis…
FDA Device · Class II · 2014-06-25 · Ortho Clinical Diagnostics - IntellaTip MiFi XP Temperature Ablation Catheter
FDA Device · Class II · 2014-06-25 · Boston Scientific - IntellaTip MiFi XP Temperature Ablation Catheter
FDA Device · Class II · 2014-06-25 · Boston Scientific - Altrus Thermal Tissue Fusion Handpieces under the following specifications: 1) 10mm x 16 cm Catalog Number: 60-9510-001, 2) 10 mm x 23 cm C…
FDA Device · Class II · 2014-06-25 · Conmed - Philips MR systems: Trolley Variable Height IRF (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System
FDA Device · Class II · 2014-06-25 · Philips Medical Systems - Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System
FDA Device · Class II · 2014-06-25 · Ebi - IntellaTip MiFi XP Temperature Ablation Catheter
FDA Device · Class II · 2014-06-25 · Boston Scientific - RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy
FDA Device · Class II · 2014-06-25 · Raysearch Laboratories Ab - G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110003458
FDA Device · Class II · 2014-06-25 · Biomet - EZPass Nylon Monofilament Single Pack, Part number 110007379, Orthopedic Manual Surgical Instrument Sterile, single use arthroscopic instru…
FDA Device · Class II · 2014-06-25 · Biomet - Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components
FDA Device · Class II · 2014-06-25 · Synthes - GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CA…
FDA Device · Class II · 2014-06-25 · Ge Healthcare - RUSH81 Prosthetic Foot Product Usage: Prosthetic foot for human use
FDA Device · Class II · 2014-06-25 · Ability Dynamics - Synergy XVI Intended for radiation therapy treatment
FDA Device · Class II · 2014-06-25 · Elekta - Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 Product Usage:For use to manage fecal incontinence through the colle…
FDA Device · Class I · 2014-06-25 · Convatec - IntellaTip MiFi XP Temperature Ablation Catheter
FDA Device · Class II · 2014-06-25 · Boston Scientific - IntellaTip MiFi XP Temperature Ablation Catheter
FDA Device · Class II · 2014-06-25 · Boston Scientific - VITROS (R) Chemistry Products FS Calibrator 1, Product Code/ Catalog Number 6801873 -- For in vitro diagnostic use only --- VITROS Chemistr…
FDA Device · Class II · 2014-06-25 · Ortho Clinical Diagnostics - Safety glasses made with "Rage" frames manufactured between February 20, 2014 and February 25, 2014
FDA Device · Class II · 2014-06-25 · Wal Mart Stores - EZPass Suture Retriever, Nitinol, Single Pack, Part number 10007380
FDA Device · Class II · 2014-06-25 · Biomet - MOSAIQ, an oncology information system used to manage workflows for treatment planning and delivery
FDA Device · Class II · 2014-06-25 · Elekta - APTIMA Urine Collection Kit
FDA Device · Class III · 2014-06-25 · Gen Probe - Spacelabs Healthcare Ventilator Flexport Interface, Model 90436A-07
FDA Device · Class II · 2014-06-25 · Spacelabs Healthcare - cobas 6000 analyzer series Operators Manual Roche cobas
FDA Device · Class II · 2014-06-25 · Roche Diagnostics Operations - NIPRO Safe Touch Safety Scalp Vein Set
FDA Device · Class II · 2014-06-25 · Nipro Medical - Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor
FDA Device · Class II · 2014-06-25 · Childrens Medical Ventures - Philips MR systems: Ingenia HA FLEX TRAK Trolley (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System
FDA Device · Class II · 2014-06-25 · Philips Medical Systems - IntellaTip MiFi XP Temperature Ablation Catheter
FDA Device · Class II · 2014-06-25 · Boston Scientific - HLD Systems Model 610 Washer/High Level Disinfector
FDA Device · Class II · 2014-06-18 · Cenorin - Philips IntellVue Info Center iX 866023
FDA Device · Class II · 2014-06-18 · Philips Healthcare - Stryker 5.0mm Barrel Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery…
FDA Device · Class II · 2014-06-18 · Stryker Instruments Div - BioDerm Liberty 3.0 External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes)
FDA Device · Class II · 2014-06-18 · Bioderm - Stryker 5.0mm Barrel Bur Sterile
FDA Device · Class II · 2014-06-18 · Stryker Instruments Div - Stryker 1.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neuros…
FDA Device · Class II · 2014-06-18 · Stryker Instruments Div - Stryker 6.0mm Egg Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, i…
FDA Device · Class II · 2014-06-18 · Stryker Instruments Div - Stryker 6.0mm Acorn Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery,…
FDA Device · Class II · 2014-06-18 · Stryker Instruments Div - Stryker 3.0mm Round Fluted Bur Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue du…
FDA Device · Class II · 2014-06-18 · Stryker Instruments Div - Stryker 5.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue du…
FDA Device · Class II · 2014-06-18 · Stryker Instruments Div - Ultrasonic Transducer Kits For use with the Access Family of Immunoassay Systems*. *The Access Family of Immunoassay Systems includes the A…
FDA Device · Class II · 2014-06-18 · Beckman Coulter - Stryker 2.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue d…
FDA Device · Class II · 2014-06-18 · Stryker Instruments Div - enGen (TM) Laboratory Automation System Configured with TCAutomation" Software v3.5 -- For in vitro quantitative measurement of a variety o…
FDA Device · Class II · 2014-06-18 · Ortho Clinical Diagnostics - VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Refurbished, Product Codes/Catalog Numbers 6801375, 6801890 for in vitro diagnostic use
FDA Device · Class II · 2014-06-18 · Ortho Clinical Diagnostics - Stryker 2.5mm x 3.6mm Neuro Drill Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue…
FDA Device · Class II · 2014-06-18 · Stryker Instruments Div - Stryker 1.3mm Wire Pass Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosu…
FDA Device · Class II · 2014-06-18 · Stryker Instruments Div - IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX)
FDA Device · Class II · 2014-06-18 · Philips Medical Systems - BioDerm Liberty Pouch Clean & Dry External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective w…
FDA Device · Class II · 2014-06-18 · Bioderm - Stryker 3.5mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue d…
FDA Device · Class II · 2014-06-18 · Stryker Instruments Div - enGen Laboratory Automation Systems (enGen) with TCAutomation -- For in vitro quantitative measurement of a variety of analytes of clinical…
FDA Device · Class II · 2014-06-18 · Ortho Clinical Diagnostics - Tissue-Tek PARAFORM PROC/EMB/MEDIUM, FORMULA 3 - 8x1Kg. for diagnostic chemistry use
FDA Device · Class II · 2014-06-18 · Sakura Finetek Usa - Horizon Medical Imaging Horizon Medical Imaging is a medical image and information management application that is intended to receive trans…
FDA Device · Class II · 2014-06-18 · Mckesson Medical Immaging - Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactured…
FDA Device · Class II · 2014-06-18 · Neo Metrics - Stryker 5.0mm Egg Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, i…
FDA Device · Class II · 2014-06-18 · Stryker Instruments Div - Stryker 5.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue d…
FDA Device · Class II · 2014-06-18 · Stryker Instruments Div - RUSCH Easy Cath Coude Kit, 10 FR, Rx Only, Sterile, Distributed by: Teleflex Medical, Research Triangle Park, NC 27708
FDA Device · Class II · 2014-06-18 · Teleflex Medical - Stryker 5.0mm Acorn Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery,…
FDA Device · Class II · 2014-06-18 · Stryker Instruments Div - Cooper Surgical TAMPA CATHETER 5 French 33 cm
FDA Device · Class II · 2014-06-18 · Coopersurgical - BioDerm Safe n' Dry 21006 (Component: SKIN-PREP Protective wipes)
FDA Device · Class II · 2014-06-18 · Bioderm - Stryker 4.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neuros…
FDA Device · Class II · 2014-06-18 · Stryker Instruments Div - Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01, Sterilized by Ethylene Oxide, Rx Only
FDA Device · Class II · 2014-06-18 · Summit Medical - Maquet PowerLED 700
FDA Device · Class II · 2014-06-18 · Maquet Medical Systems Usa - Stryker 5.5mm Round Fluted Bur Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue du…
FDA Device · Class II · 2014-06-18 · Stryker Instruments Div - Stryker 2.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neuros…
FDA Device · Class II · 2014-06-18 · Stryker Instruments Div - Stryker 3.0mm x 3.8mm Neuro Drill Less Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related t…
FDA Device · Class II · 2014-06-18 · Stryker Instruments Div - Stryker 3.0mm x 3.8mm Precision Neuro Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue…
FDA Device · Class II · 2014-06-18 · Stryker Instruments Div - Leica Ceiling Mount MSF-1 for use with M841 and M501 operating microscopes
FDA Device · Class II · 2014-06-18 · Leica Microsystems - Stryker 0.5mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neuros…
FDA Device · Class II · 2014-06-18 · Stryker Instruments Div - bluephase style Light probe Pin-point 6>2 mm black REF # 636 241
FDA Device · Class II · 2014-06-18 · Ivoclar Vivadent - Leica Ceiling Mount MS-1F & MC-1F for use with the M500 N operating microscope
FDA Device · Class II · 2014-06-18 · Leica Microsystems - VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use
FDA Device · Class II · 2014-06-18 · Ortho Clinical Diagnostics - Portex Low Dead Space Connector with Sideport, 3.5mm Product Usage: The connector is used to attach the endotracheal tube to the patient br…
FDA Device · Class I · 2014-06-18 · Smiths Medical Asd - Stryker 3.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue du…
FDA Device · Class II · 2014-06-18 · Stryker Instruments Div - Stryker 1.5mm Wire Pass Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosu…
FDA Device · Class II · 2014-06-18 · Stryker Instruments Div - Stryker 5.5mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue du…
FDA Device · Class II · 2014-06-18 · Stryker Instruments Div - Beekley Spots Light Image O-Spots for Mammography Catalog Number: 252 Product Usage: To identify raised moles in Mammography
FDA Device · Class III · 2014-06-18 · Beekley - Synthes Matrix Mandible Short Cut Plate Cutter Synthes Matrix Mandible Short Cut Plate Cutter is intended for oral, maxillofacial surgery
FDA Device · Class II · 2014-06-18 · Synthes - Stryker 4.0mm x 5.1mm Neuro Drill Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue…
FDA Device · Class II · 2014-06-18 · Stryker Instruments Div - NaturaLyte¿ Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit
FDA Device · Class III · 2014-06-18 · Fresenius Medical Care Holdings - Stryker 3.0mm x 3.8mm Neuro Drill Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue…
FDA Device · Class II · 2014-06-18 · Stryker Instruments Div - Stryker 3.0mm x 3.8mm Neuro Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neu…
FDA Device · Class II · 2014-06-18 · Stryker Instruments Div - Stryker 2.0mm Tapered Round Elite Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during…
FDA Device · Class II · 2014-06-18 · Stryker Instruments Div - Lindemann Drill Short, 1.6mm Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosur…
FDA Device · Class II · 2014-06-18 · Stryker Instruments Div
Other years
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