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.
- ILLICO Straight CP TI Rod, -5.5MM x 110M
FDA Device · Class II · 2013-03-27 · Alphatec Spine - Biomet Spine Polaris 5.5 Button Lock Screw Inserter
FDA Device · Class II · 2013-03-27 · Ebi - 3.75mm x 12mm Fixed Cervical Screws
FDA Device · Class II · 2013-03-20 · Genesys Orthopedic Systems - ACUSON S2000 Automated Breast Volume Scanner (ABVS)
FDA Device · Class II · 2013-03-20 · Siemens Medical Solutions Usa - Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072
FDA Device · Class II · 2013-03-20 · Synthes Usa Hq - Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead models are indicated for ventricular antitachycardia…
FDA Device · Class II · 2013-03-20 · Sorin Group Usa - Cynch Lordotic T-PLlF Implant
FDA Device · Class II · 2013-03-20 · Spine Smith Partners - INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 75 MM, TITANIUM, Smith &…
FDA Device · Class II · 2013-03-20 · Smith And Nephew - Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system
FDA Device · Class II · 2013-03-20 · Siemens Medical Solutions Usa - Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray S…
FDA Device · Class II · 2013-03-20 · Philips Medical Systems Cleveland - GOPump Elastometric infusion PumpKit with/ and without accesssories all containing Dual GOPump, part number 510076: One infusion pump compr…
FDA Device · Class I · 2013-03-20 · Symbios Medical Products - Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATEST VWF:Ag Latex + 4 ml R3 Diagnostica Stago 3) LIATEST VWF:Ag Latex D…
FDA Device · Class II · 2013-03-20 · Diagnostica Stago - Genesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment Part Number: G71205 Genesis implant for single stage or two stage surgical procedures…
FDA Device · Class II · 2013-03-20 · Keystone Dental - Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T Signa HDe MR System
FDA Device · Class II · 2013-03-20 · Ge Healthcare - Draeger Infinity Acute Care System (IACS) Monitoring Solution
FDA Device · Class II · 2013-03-20 · Draeger Medical - Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile
FDA Device · Class II · 2013-03-20 · Medtronic Navigation - Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: Synthes Large External Fixation is intended for…
FDA Device · Class II · 2013-03-20 · Synthes Usa Hq - REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surgical instrument
FDA Device · Class II · 2013-03-20 · Biomet - Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver Sulfadiazine STERILE, Box…
FDA Device · Class II · 2013-03-20 · Bacterin International - GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, Innova3100IQ, and Innova4100IQ equipped with Video Monitor Suspens…
FDA Device · Class II · 2013-03-20 · Ge Healthcare - INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 80 MM, TITANIUM, Smith &…
FDA Device · Class II · 2013-03-20 · Smith And Nephew - Siemens Total Iron Binding Capacity (IBCT) Flex Reagent Cartridge
FDA Device · Class III · 2013-03-20 · Siemens Healthcare Diagnostics - Brilliance 6, 10, 16, 40, 64, Big Bore and the iCT, iCT SP, Ingenuity CT and MX8000 Dual v. EXP are Computed Tomography X-Ray Systems
FDA Device · Class II · 2013-03-20 · Philips Medical Systems Cleveland - Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blade is intended to release A-1 pulley in endoscopic trigger release…
FDA Device · Class II · 2013-03-20 · Instratek - ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960
FDA Device · Class II · 2013-03-20 · Innominata - Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Genesis implant for single stage or two stage surgical procedures al…
FDA Device · Class II · 2013-03-20 · Keystone Dental - Elekta Synergy XVI. Radiation Therapy Digital Imager
FDA Device · Class II · 2013-03-20 · Elekta - Integra CUSA excel
FDA Device · Class II · 2013-03-20 · Integra Lifesciences - Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982
FDA Device · Class II · 2013-03-20 · Synthes Usa Hq - TotalCare SpO2RT2 bed
FDA Device · Class II · 2013-03-20 · Hill Rom - AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with OptiEdge Product Usage: These are ultraviolet-absorbing posteri…
FDA Device · Class II · 2013-03-20 · Abbott Medical Optics Amo - Churchill Medical Systems, Inc
FDA Device · Class II · 2013-03-20 · Vygon - Nicolet EEG Wireless Amplifier 32/64 Channel
FDA Device · Class II · 2013-03-20 · Natus Neurology - Command Instrument Broach Handle
FDA Device · Class II · 2013-03-20 · Stryker Howmedica Osteonics - GE Healthcare, Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ. Cardiovascular X-ray imaging systems
FDA Device · Class II · 2013-03-20 · Ge Healthcare - AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities
FDA Device · Class II · 2013-03-13 · Steris - Synthes Multi-Vector Distractor Body, Part Number 487.931
FDA Device · Class II · 2013-03-13 · Synthes Usa Hq - Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable po…
FDA Device · Class II · 2013-03-13 · Churchill Medical Systems - Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967
FDA Device · Class II · 2013-03-13 · Synthes Usa Hq - BD Vacutainer PST Gel and Lithium Heparin (LH)
FDA Device · Class III · 2013-03-13 · Becton Dickinson And - D3000I Advantage Drive System, 230v, surgical instrument motor
FDA Device · Class III · 2013-03-13 · Linvatec - GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x (Advantage Workstation 4.1) Volume Analysis (Advantage W…
FDA Device · Class II · 2013-03-13 · Ge Healthcare - Century Console Base, Model #043625051b
FDA Device · Class II · 2013-03-13 · Salyer Prn Biomedical - Hickman 9.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (pediatric product…
FDA Device · Class II · 2013-03-13 · Bard Access Systems - Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopulmonary bypass procedures
FDA Device · Class II · 2013-03-13 · Medtronic Cardiac Rhythm Disease Management - Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Part Number 487.966
FDA Device · Class II · 2013-03-13 · Synthes Usa Hq - Ad-Tech Medical Instrument Corporation Macro Micro Subdural Electrode
FDA Device · Class I · 2013-03-13 · Ad Tech Medical Instrument - D3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpie…
FDA Device · Class III · 2013-03-13 · Linvatec - Beckman Coulter AU5800 Clinical Chemistry Analyzer
FDA Device · Class II · 2013-03-13 · Beckman Coulter - Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography X-Ray System
FDA Device · Class II · 2013-03-13 · Philips Medical Systems Cleveland - Philips Digital Diagnost Stationary radiographic system
FDA Device · Class II · 2013-03-13 · Philips Healthcare - SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear accelerators, MOSAIQ OIS syste…
FDA Device · Class II · 2013-03-13 · Siemens Medical Solutions Usa - Atricure Inc., Max1 Isolator Transpolar Pen
FDA Device · Class II · 2013-03-13 · Atricure - PSX PROXIMATE Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC. For routine skin closure in a wide variety of surgical procedures
FDA Device · Class II · 2013-03-13 · Ethicon Endo Surgery - Leonard 10.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (product code 060…
FDA Device · Class II · 2013-03-13 · Bard Access Systems - Stryker XIA 3 Iliac Screwdriver, 3-PCS. The XIA 3 Iliac Screwdriver is used to drive XIA 3 closed head Monoaxial and closed head Polyaxial…
FDA Device · Class II · 2013-03-06 · Stryker Spine - GE Healthcare Definium 5000/5220493-2 X-Ray System
FDA Device · Class II · 2013-03-06 · Ge Healthcare - BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Length: 100mm
FDA Device · Class II · 2013-03-06 · Baylis Medical - Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Avex CX ceramic brackets are formed with 99.9% pure alumina oxide
FDA Device · Class III · 2013-03-06 · Ultradent Products - KY SENSITIVE TM JELLY Personal Lubricant
FDA Device · Class II · 2013-03-06 · Mc Neil Ppc - REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product Usage: Power injectable infusion PICC insertion kits
FDA Device · Class II · 2013-03-06 · Medical Components - QuietCare-Networked product, Facility Server/model: QC101601
FDA Device · Class II · 2013-03-06 · Intel Ge Care Innovations - Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips Medical Systems, Highland Heights, OH 44143 The Brilliance Sc…
FDA Device · Class II · 2013-03-06 · Philips Medical Systems Cleveland - Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore, Model #728243
FDA Device · Class II · 2013-03-06 · Philips Medical Systems Cleveland - Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260
FDA Device · Class II · 2013-03-06 · Philips Medical Systems Cleveland - KY SilkE Vaginal Moisturizer and Personal Lubricant
FDA Device · Class II · 2013-03-06 · Mc Neil Ppc - Philips Medical Systems, GEMINI LXL - Model #882412
FDA Device · Class II · 2013-03-06 · Philips Medical Systems Cleveland - Philips MX 16-Slice CT Scanner System, a whole-body computed tomography X-ray system
FDA Device · Class II · 2013-03-06 · Philips Medical Systems Cleveland - Philips Medical Systems, GEMINI TF Big Bore, Model #882476, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning…
FDA Device · Class II · 2013-03-06 · Philips Medical Systems Cleveland - Versafitcup Impacting Ring Model Number: 01.26.10.0133 (46mm), 01.26.10.0134 (48mm), 01.26.10.0135 (50mm), 01.26.10.0136 (52mm), 01.26.10.0…
FDA Device · Class II · 2013-03-06 · Medacta Usa - Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator
FDA Device · Class II · 2013-03-06 · Advanced Neuromodulation Systems - VACUETTE Cellestis 1 ml QuantiFERON¿ - TB ANTIGEN
FDA Device · Class II · 2013-03-06 · Cellestis - GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System
FDA Device · Class II · 2013-03-06 · Ge Healthcare - Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medical
FDA Device · Class II · 2013-03-06 · Myco Medical Supplies - Atrapro Antipruritic Hydrogel, 1.5 oz gel tube, 4 Net wt/ 1.5 oz.. RX only, Professional Sample, Not for Sale
FDA Device · Class II · 2013-03-06 · Oculus Innovative Sciences - Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226, for electrosurgical cutting and coagulation
FDA Device · Class II · 2013-03-06 · Aesculap - Vacuette Cellestis 1 ml QuantiFERON¿ TB ANTIGEN (HA) High Altitude: Shake 10x
FDA Device · Class II · 2013-03-06 · Cellestis - Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod Connector (52-6700)
FDA Device · Class II · 2013-03-06 · Orthofix - Orthofix ISKD Limb Lengthener
FDA Device · Class II · 2013-03-06 · Orthofix - Ingenuity TF PET/CT. Diagnostic imaging system
FDA Device · Class II · 2013-03-06 · Philips Medical Systems Cleveland - GE Healthcare Definium 5000 / 5220493 X-Ray System
FDA Device · Class II · 2013-03-06 · Ge Healthcare - Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290)
FDA Device · Class II · 2013-03-06 · Integra Lifesciences - KY TINGLING JELLY Personal Lubricant
FDA Device · Class II · 2013-03-06 · Mc Neil Ppc - Elekta, Apex add-on Micro MLC, collimator for radiation therapy
FDA Device · Class II · 2013-03-06 · Elekta - Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022, and 712082 Product Usage: Digital radiographic…
FDA Device · Class II · 2013-03-06 · Philips Healthcare - NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMC61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravasc…
FDA Device · Class II · 2013-02-27 · Codman And Shurtleff - NEUROPATH 6Fx100 GUIDING CATH MC Product Code: GCB61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravasc…
FDA Device · Class II · 2013-02-27 · Codman And Shurtleff - Varian Eclipse Treatment Planning System for Radiotherapy
FDA Device · Class II · 2013-02-27 · Varian Medical Systems Oncology Systems - Vascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide, Rx Only, Model numbers 5300 - 5307, 5324, 5325, 5329, 5332,…
FDA Device · Class II · 2013-02-27 · Vascular Solutions - NEUROPATH 6Fx100 GUIDING CATH ST Product Code: GST61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravasc…
FDA Device · Class II · 2013-02-27 · Codman And Shurtleff - ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORP…
FDA Device · Class II · 2013-02-27 · Conmed - NEUROPATH 5Fx90 GUIDING CATH S2 Product Code: GSM50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascu…
FDA Device · Class II · 2013-02-27 · Codman And Shurtleff - CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into…
FDA Device · Class II · 2013-02-27 · Carefusion 303 - NEUROPATH 5Fx90 GUIDING CATH ST Product Code: GST50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascu…
FDA Device · Class II · 2013-02-27 · Codman And Shurtleff - Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO) for the treatment of respiratory insufficiency in infants
FDA Device · Class II · 2013-02-27 · Maquet Cardiovascular Us Sales - NEUROPATH 6Fx100 GUIDING CATH MPD Product Code: GMD60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravas…
FDA Device · Class II · 2013-02-27 · Codman And Shurtleff - NEUROPATH 5Fx90 GUIDING CATH MCV Product Code: GCB50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravasc…
FDA Device · Class II · 2013-02-27 · Codman And Shurtleff - MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures
FDA Device · Class II · 2013-02-27 · Medrad - LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an end-stage revision knee product t…
FDA Device · Class I · 2013-02-27 · Depuy Orthopaedics - NEUROPATH 6Fx90 GUIDING CATH S2 Product Code: GSM60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascu…
FDA Device · Class II · 2013-02-27 · Codman And Shurtleff
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