FDA Device · 2013
FDA Device recalls in 2013
RecallRadar indexes 2,249 FDA Device recall notices published in 2013. By classification: 177 Class I, 1,944 Class II, 128 Class III.
- RoboCouch Patient Positioning System Product Usage: is intended for use in the support and positioning of a patient during radiosurgery and…
FDA Device · Class II · 2013-05-01 · Accuray - ORTHOCORD One Violet and One Blue Braided Composite Suture with OS-6 Reverse Cutting Needles, Product Code: 223116
FDA Device · Class II · 2013-05-01 · Depuy Mitek A Johnson And Johnson - ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223111
FDA Device · Class II · 2013-05-01 · Depuy Mitek A Johnson And Johnson - ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-6 Taper Needles, Product Code: 223115
FDA Device · Class II · 2013-05-01 · Depuy Mitek A Johnson And Johnson - ORTHOCORD ONE VIOLET AND ONE BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223113
FDA Device · Class II · 2013-05-01 · Depuy Mitek A Johnson And Johnson - VITROS¿ Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B surface antigen (anti-HBs)) Reagent Packs For the quantitative in…
FDA Device · Class III · 2013-05-01 · Ortho Clinical Diagnostics - AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry analyzer that measures…
FDA Device · Class II · 2013-05-01 · Beckman Coulter - All OneTouch Verio IQ Blood Glucose Meters sold as: Verio IQ System Kits - Meter
FDA Device · Class I · 2013-04-24 · Lifescan - Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300)
FDA Device · Class II · 2013-04-24 · Toshiba American Medical Systems - IS3000 USER MANUAL for Intuitive Surgical da Vinci Si Surgical System and da Vinci Si-e Surgical System, Model SI3000
FDA Device · Class II · 2013-04-24 · Intuitive Surgical - VITROS 5600 Integrated System, Product Code 6802413
FDA Device · Class II · 2013-04-24 · Ortho Clinical Diagnostics - ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended to be used as patient-specific surgical instrumentation…
FDA Device · Class I · 2013-04-24 · Stryker Howmedica Osteonics - HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic CO status System Only
FDA Device · Class II · 2013-04-24 · Transonic Systems - The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere elec…
FDA Device · Class II · 2013-04-24 · Hospira - ADVIA Centaur Vitamin D Calibrator 6-pack
FDA Device · Class II · 2013-04-24 · Siemens Healthcare Diagnostics - LifeScan brand OneTouch¿ Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603
FDA Device · Class II · 2013-04-24 · Lifescan - REF 32-422760 Oxford Uni Knee System,Toffee Hammer, non-sterile, found in REF 32-422763 Oxford Mlcroplasty Knee System Tibial instrument Tr…
FDA Device · Class II · 2013-04-24 · Biomet U K - TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc
FDA Device · Class II · 2013-04-24 · Smith And Nephew - SR Instruments FG3105 Patient Scales Used on various Joerns Healthcare Patient Lifters
FDA Device · Class II · 2013-04-24 · Sr Instruments - Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass graft of the ELANA technique
FDA Device · Class II · 2013-04-24 · Elana - Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power sup…
FDA Device · Class II · 2013-04-24 · Carefusion - Edwards Lifesciences Duraflo coated Femoral Cannula
FDA Device · Class II · 2013-04-24 · Edwards Lifesciences - Instrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators
FDA Device · Class II · 2013-04-24 · Instrumentation Industries - OsteoSelect DBM Putty Product Usage: Orthopedic bone filler
FDA Device · Class II · 2013-04-24 · Bacterin International - IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model IS2000
FDA Device · Class II · 2013-04-24 · Intuitive Surgical - Clinical Chemistry Phenobarbital, list number 1E08
FDA Device · Class II · 2013-04-24 · Abbott Laboratories - Duane Reade TRUEtrack monitor kit, UPC# 6 39194 01679 7 Part # A4006-81 The TRUEtrack Blood Glucose System is intended for the quantitative…
FDA Device · Class II · 2013-04-24 · Nipro Diagnostics - EVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004 Designed to automatically clean and high-level disinfect flexible, submersible vi…
FDA Device · Class II · 2013-04-24 · Advanced Sterilization Products - VITROS 5,1 FS Chemistry System, Product Code 6801375 and VITROS 5,1 FS Chemistry System Refurbished, Product Code 6801890
FDA Device · Class II · 2013-04-24 · Ortho Clinical Diagnostics - Integra XKnife¿ Stereotactic Radiosurgery and Radiotherapy Treatment Planning, Software Versions 5.0.1 and 5.0.2. Intended for use in stere…
FDA Device · Class II · 2013-04-24 · Integra Lifesciences - EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004
FDA Device · Class II · 2013-04-24 · Advanced Sterilization Products - Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-cli…
FDA Device · Class II · 2013-04-24 · Philips Medical Systems Cleveland - ACIST Medical Systems Inc
FDA Device · Class II · 2013-04-24 · Acist Medical Systems - HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE110US02, All Serial Numbers, Software Versions 5.0.7 and Below
FDA Device · Class II · 2013-04-24 · Horiba Instruments - Edwards Lifesciences Crimpers, Model 9100CR26
FDA Device · Class II · 2013-04-24 · Edwards Lifesciences - Pressure Monitoring sets with VAMP Plus closed blood sampling system model # T001691A, PXVP0566, PXVP2260, PXVP0826, PXVP0827, PXVP2284AT3,…
FDA Device · Class II · 2013-04-24 · Edwards Lifesciences - Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power sup…
FDA Device · Class I · 2013-04-24 · Carefusion - ADVIA Centaur Vitamin D Assay (100 tests)
FDA Device · Class II · 2013-04-24 · Siemens Healthcare Diagnostics - GE Healthcare, AW Server
FDA Device · Class II · 2013-04-24 · Ge Healthcare - The Oxford Partial Knee
FDA Device · Class II · 2013-04-24 · Synvasive Technology - Heritage Labs Path Study Extra Supplies Kit, Product # A 2376, kit contains 3 zippered plastic bags which hold support supplies for health…
FDA Device · Class II · 2013-04-24 · Heritage Labs International - Siemens Dimension Vista(R) System Vista Drug 4 Calibrator
FDA Device · Class II · 2013-04-24 · Siemens Healthcare Diagnostics - MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0) Product Usage: The Cardiohelp System is a blood oxygenation…
FDA Device · Class II · 2013-04-24 · Maquet Cardiovascular - GE Healthcare Muse v7 cardiology information system
FDA Device · Class II · 2013-04-24 · Ge Healthcare - Philips Healthcare Computed Tomography X-Ray System
FDA Device · Class II · 2013-04-24 · Philips Healthcare - The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere elec…
FDA Device · Class II · 2013-04-24 · Hospira - CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner
FDA Device · Class II · 2013-04-24 · Roche Diagnostics Operations - VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Product Code 6802445
FDA Device · Class II · 2013-04-24 · Ortho Clinical Diagnostics - ADVIA Centaur Vitamin D Calibrator 2-pack
FDA Device · Class II · 2013-04-24 · Siemens Healthcare Diagnostics - Vitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea version 5.2 (Vitrea Enterprise Suite 1.3 and Vitrea fX 3.1) and s…
FDA Device · Class II · 2013-04-24 · Vital Images - LifeScan brand OneTouch¿ Select Control Solution, Part Number/Model #: 02168902
FDA Device · Class II · 2013-04-24 · Lifescan - Siemens syngo WorkFlow SLR, Radiological Information System, Version VA31A SP1/SP2/SP3 The information system syngo(R) Workflow SLR is a di…
FDA Device · Class II · 2013-04-24 · Siemens Medical Solutions Usa - IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma)
FDA Device · Class III · 2013-04-24 · Alere San Diego - Alere Cholestech LDX ALT AST Test Cassette, Model #12-788
FDA Device · Class II · 2013-04-24 · Alere San Diego - GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ, Cardiovascular and Interventional Imaging System
FDA Device · Class II · 2013-04-24 · Ge Healthcare - Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado Hills, CA) & manufactured under Synvasive Technolo…
FDA Device · Class II · 2013-04-24 · Synvasive Technology - ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner
FDA Device · Class II · 2013-04-24 · Roche Diagnostics Operations - Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged-particle radiation therapy system, Model: Iris Va…
FDA Device · Class II · 2013-04-24 · Accuray - Edwards Lifesciences Crimpers, Model 9100CR23
FDA Device · Class II · 2013-04-24 · Edwards Lifesciences - DeGotzen XRay unit XGenus Dental X-ray unit
FDA Device · Class II · 2013-04-24 · Degotzen - ADVIA Centaur Vitamin D Assay (500 tests)
FDA Device · Class II · 2013-04-24 · Siemens Healthcare Diagnostics - EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories Part number C02033-01
FDA Device · Class II · 2013-04-24 · Endogastric Solutions - G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood
FDA Device · Class III · 2013-04-17 · Tosoh Bioscience - LHB, First Aid Type I Individual Kit, NSN: 6545-00-656-1092, antiseptics, Kit number: 2114002
FDA Device · Class III · 2013-04-17 · Lighthouse For The Blind - LHB, Antiseptic Kit, Povidone Swab, Gauze Pads, and non-stick pads
FDA Device · Class III · 2013-04-17 · Lighthouse For The Blind - Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc
FDA Device · Class II · 2013-04-17 · Arrow International - LHB, First Aid Type III, NSN # 6545-00-656-1094, Kit number: 2114011
FDA Device · Class III · 2013-04-17 · Lighthouse For The Blind - Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that contains version 4 of the MPI board 10434200
FDA Device · Class II · 2013-04-17 · Siemens Medical Solutions Usa - GE Healthcare Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera
FDA Device · Class II · 2013-04-17 · Ge Healthcare - Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc
FDA Device · Class II · 2013-04-17 · Arrow International - MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System Product Usage: MRI System
FDA Device · Class II · 2013-04-17 · Toshiba American Medical Systems - GE Healthcare, Discovery MR750w 3.0T System
FDA Device · Class II · 2013-04-17 · Ge Healthcare - LHB, First Aid Type IV Belt Type, NSN #6545-01-010-7754
FDA Device · Class III · 2013-04-17 · Lighthouse For The Blind - Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bracket Buccal Tubes are intended to hold in orthodontic wires used to mo…
FDA Device · Class II · 2013-04-17 · Ormco Sybronendo - Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm Product Code: 030450 Applications in abdominal, gynecologic, pediatric anti…
FDA Device · Class II · 2013-04-17 · Covidien - LHB, Perishable Items Pack Type IV. Kit number: 2114016-100
FDA Device · Class III · 2013-04-17 · Lighthouse For The Blind - Torrent" irrigation tubing
FDA Device · Class II · 2013-04-17 · Us Endoscopy Group - Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fusion or Luminos Select
FDA Device · Class II · 2013-04-17 · Siemens Medical Solutions Usa - TSX-IOI: AQUILION 32/64
FDA Device · Class II · 2013-04-17 · Toshiba American Medical Systems - GE Healthcare LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) and LOGIQ S7 (with software revisions R1.0.1, R1.0.2 and R1.0.3) diagnos…
FDA Device · Class II · 2013-04-17 · Ge Healthcare - LHB, Type I First Aid Kit Perishable, Non-Aspirin 4/pg, Aspirin 4/pg and Povidone Iodine, antiseptic towelette
FDA Device · Class III · 2013-04-17 · Lighthouse For The Blind - LHB, Perishable Items Pack Type I , Kit Number: 2114002-100
FDA Device · Class III · 2013-04-17 · Lighthouse For The Blind - The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators
FDA Device · Class II · 2013-04-17 · Physio Control - LHB, Perishable Item Pack Type III. Kit number: 2114011-100
FDA Device · Class III · 2013-04-17 · Lighthouse For The Blind - VMX, VMX Plus Mobile Radiographic Unit with the following models: 45296139
FDA Device · Class II · 2013-04-17 · Ge Healthcare - Giraffe OmniBed¿ and Giraffe Incubator p/n 6600-0723-700 (rev A and B) labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723…
FDA Device · Class I · 2013-04-17 · Ge Healthcare - Dade(R) Actin(R) FSL Activated PTT Reagent
FDA Device · Class II · 2013-04-17 · Siemens Healthcare Diagnostics - Flexible Grip which is part of the Synthes Universal Nail System
FDA Device · Class II · 2013-04-17 · Synthes Usa Hq - Medtronic MiniMed Paradigm Insulin Infusion Pumps Model Numbers: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K,…
FDA Device · Class II · 2013-04-17 · Medtronic Minimed - Posey Biothane Restraint Cuffs, Catalog Number 2900
FDA Device · Class II · 2013-04-17 · J T Posey - Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray
FDA Device · Class II · 2013-04-17 · Toshiba American Medical Systems - IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting
FDA Device · Class II · 2013-04-17 · Agfa - Kerr Maxcem Elite, self-etch/self-adhesive resin cement
FDA Device · Class II · 2013-04-17 · Kerr Pentron - Precise Treatment Table
FDA Device · Class II · 2013-04-17 · Elekta - ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator…
FDA Device · Class II · 2013-04-17 · Siemens Medical Solutions Usa - Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and SC3460-52
FDA Device · Class II · 2013-04-17 · Stelkast - Respironics SealFlex Single Port Ribbed Mask (Infant)
FDA Device · Class I · 2013-04-17 · Engineered Medical Systems - CO2 Incubators (General Purpose Incubator), model numbers 370, 371, 380, 381, 3307, 3308, 3310, 3311, 3540, 3541, 3542, 3543, 3584, 3585, 3…
FDA Device · Class II · 2013-04-17 · Thermo Fisher Scientific Asheville - IMPAX CV 7.8 SU3 - OCR Service
FDA Device · Class II · 2013-04-17 · Agfa - Stryker Orthopaedics Baseplate Impactor Extractor TRIATHLON Instruments
FDA Device · Class II · 2013-04-17 · Stryker Howmedica Osteonics
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