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.
- STAR Excimer Laser System, Model: STAR S2, Catalog Number: 0030-1479, Product is manufactured and distributed by AMO Manufacturing USA, LLC…
FDA Device · Class II · 2013-10-30 · Abbott Medical Optics - Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2_EU Rx Only, Manufacturer GMS- Gesellschaft fur medizinis…
FDA Device · Class II · 2013-10-30 · Integra Lifesciences - STERRAD 200 Sterilizer (Single Door), Part Number: 10201
FDA Device · Class II · 2013-10-30 · Advanced Sterilization Products - STAR ActiveTrak Excimer Laser System, Model: STAR S3, Catalog Number: 0030-2450, Product is manufactured and distributed by AMO Manufacturi…
FDA Device · Class II · 2013-10-30 · Abbott Medical Optics - STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moistur…
FDA Device · Class II · 2013-10-30 · Advanced Sterilization Products - Integra Licox Brain Tissue Oxygen Monitoring 1 x Dual Lumen Introducer Kit REF IM2.S_.EU Rx Only, Manufacturer GMS- Gesellschaft fur medizi…
FDA Device · Class II · 2013-10-30 · Integra Lifesciences - Inegra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Tunneling Probe Kit REF IT2 Rx Only, Manufacturer GMS- Gesellschaft fur medi…
FDA Device · Class II · 2013-10-30 · Integra Lifesciences - IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS)
FDA Device · Class II · 2013-10-30 · Agfa - Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IP2.P Rx Only, Manufacturer GMS- Gesellschaft fur medizinisch…
FDA Device · Class II · 2013-10-30 · Integra Lifesciences - Integra Licox Brain Tissue Oxygen Monitoring
FDA Device · Class II · 2013-10-30 · Integra Lifesciences - Merit Medical Performa Angiographic Catheter 5F Multipack
FDA Device · Class II · 2013-10-30 · Merit Medical Systems - VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL13011000 *…
FDA Device · Class II · 2013-10-30 · Varian Medical Systems - Acuson SC2000 volume imaging ultrasound systems at software version 3.0. Mfg name: Siemens Medical Solutions USA, Inc
FDA Device · Class II · 2013-10-30 · Siemens Medical Solutions Usa - Synergetics 25 gauge Soft Tip Cannula, packaged in 6 units per box
FDA Device · Class II · 2013-10-30 · Synergetics - UNITRAC Pneumatic Retraction Arm
FDA Device · Class II · 2013-10-30 · Aesculap - Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical Cassettes are consumable used in the OPTI LION Electro…
FDA Device · Class II · 2013-10-30 · Opti Medical Systems - BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled in part Product Usage: The Myc…
FDA Device · Class II · 2013-10-30 · Becton Dickinson And - Integra Licox Brain Tissue Oxygen Monitoring
FDA Device · Class II · 2013-10-30 · Integra Lifesciences - ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, D…
FDA Device · Class II · 2013-10-23 · Siemens Healthcare Diagnostics - GE, Optima CT660
FDA Device · Class II · 2013-10-23 · Ge Healthcare - Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) Brilliance CT Big Bore Oncology, Brilliance CT…
FDA Device · Class II · 2013-10-23 · Philips Medical Systems Cleveland - Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F1…
FDA Device · Class II · 2013-10-23 · Boston Scientific Crm - Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for Europe)
FDA Device · Class II · 2013-10-23 · Sekisui Diagnostics - GE PET Discovery 610, PET Discovery 710
FDA Device · Class II · 2013-10-23 · Ge Healthcare - Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product Usage: The washer disinfector is used in healthcare facilities whe…
FDA Device · Class II · 2013-10-23 · Getinge Disinfection - GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ. Intended for general purpose di…
FDA Device · Class II · 2013-10-23 · Ge Healthcare - MX 16-Slice CT Scanner System
FDA Device · Class II · 2013-10-23 · Philips Medical Systems Cleveland - GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation
FDA Device · Class I · 2013-10-23 · Ge Healthcare - Synthes Midfoot Fusion Bolt 6.5 mm
FDA Device · Class II · 2013-10-23 · Synthes Usa Hq - Harvest Graft Delivery System
FDA Device · Class II · 2013-10-23 · Harvest Technologies - GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom
FDA Device · Class I · 2013-10-23 · Ge Healthcare - Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119
FDA Device · Class II · 2013-10-23 · Boston Scientific Crm - P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal a…
FDA Device · Class II · 2013-10-23 · Sonosite - Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for the quantitation of phosphorus in human serum, plasma, or urine
FDA Device · Class II · 2013-10-23 · Abbott Laboratories - Dimension Vista (R) Urinary/Cerebrospinal Fluid Protein (UCFP) Flex (R) Reagent Cartridge Lot 11349BB The Urinary / Cerebrospinal Fluid Pro…
FDA Device · Class II · 2013-10-23 · Siemens Healthcare Diagnostics - GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. This table is intended for use in a diagnostic X-ray system to support patients duri…
FDA Device · Class II · 2013-10-23 · Ge Healthcare - Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product Usage: used to administer anesthesia and ventilation to patients…
FDA Device · Class I · 2013-10-16 · Draeger Medical - Bard LifeStent Solo Vascular Stent, Item Numbers: EX062001CL, EX072001CL, EX062003CL, EX072003CL. The LifeStent Solo Vascular Stent System…
FDA Device · Class I · 2013-10-16 · Bard Peripheral Vascular - Advanta VXT Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access
FDA Device · Class II · 2013-10-09 · Atrium Medical - Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field Digital Mammography system gene…
FDA Device · Class II · 2013-10-09 · Hologic - H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573-0692), vacuum sealed and packaged in a 5 mil poly bags, label…
FDA Device · Class I · 2013-10-09 · H And H Associates - DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML DISP Container w/6'…
FDA Device · Class II · 2013-10-09 · Devilbiss Healthcare - Flixene IFG with Assisted Delivery Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular a…
FDA Device · Class II · 2013-10-09 · Atrium Medical - Solitaire-35 Peek Solitaire Anterior Spinal System
FDA Device · Class II · 2013-10-09 · Ebi - Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood
FDA Device · Class II · 2013-10-09 · Radiometer America - Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access
FDA Device · Class II · 2013-10-09 · Atrium Medical - Advanta SuperSoft Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access
FDA Device · Class II · 2013-10-09 · Atrium Medical - Advanta VS Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access
FDA Device · Class II · 2013-10-09 · Atrium Medical - McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medical image and inform…
FDA Device · Class II · 2013-10-09 · Mckesson Information Solutions - Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access
FDA Device · Class II · 2013-10-09 · Atrium Medical - MedStream Programmable Pump
FDA Device · Class I · 2013-10-09 · Codman And Shurtleff - Advanta SuperSoft Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular ac…
FDA Device · Class II · 2013-10-09 · Atrium Medical - SHOPKO Waterproof Adhesive Pads Antibacterial
FDA Device · Class II · 2013-10-09 · Aso - Advanta VS Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access
FDA Device · Class II · 2013-10-09 · Atrium Medical - Flixene Trumpet Grafts >or= 6mm Flixene GW and GWT Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass,…
FDA Device · Class II · 2013-10-09 · Atrium Medical - The product is labeled in part "***Surgical Laser Technologies, Inc
FDA Device · Class II · 2013-10-09 · Photomedex - Advanta VXT Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular…
FDA Device · Class II · 2013-10-09 · Atrium Medical - Ultima OPCAB System, Sterile, Rx Only, Product Usage: Intended for use during performance of minimally invasive cardiac surgery through a s…
FDA Device · Class II · 2013-10-09 · Maquet Cardiovascular - Product Name: AVEA¿ Ventilator
FDA Device · Class I · 2013-10-09 · Carefusion 211 - GE Healthcare, Discovery MR750 3.0T, Optima MR450w 1.5T, and Discovery MR450 1.5T . scanner designed to support high resolution, high signa…
FDA Device · Class II · 2013-10-09 · Ge Healthcare - Advanta SST Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access
FDA Device · Class II · 2013-10-09 · Atrium Medical - Advanta SST Bifurcated Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascul…
FDA Device · Class II · 2013-10-09 · Atrium Medical - Flixene IFG Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular…
FDA Device · Class II · 2013-10-09 · Atrium Medical - MedStream Refill Kit (1 unit), EMEA: 91-4289 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Bac…
FDA Device · Class I · 2013-10-09 · Codman And Shurtleff - Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the corona…
FDA Device · Class II · 2013-10-09 · Cordis - Universal Flex2 Breathing Circuit Class I 510(k) Exempt An anesthesia breathing circuit is a device that is intended to administer medical…
FDA Device · Class I · 2013-10-09 · King Systems - MedStream Refill Kit (6 units), EMEA: 91-4290 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Ba…
FDA Device · Class I · 2013-10-09 · Codman And Shurtleff - MedStream Programmable Pump
FDA Device · Class I · 2013-10-09 · Codman And Shurtleff - King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ve…
FDA Device · Class II · 2013-10-09 · King Systems - Flixene Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access
FDA Device · Class II · 2013-10-09 · Atrium Medical - MedStream Refill Kit, U.S (6 units): 91-4288 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Bac…
FDA Device · Class I · 2013-10-09 · Codman And Shurtleff - MedStream Programmable Pump
FDA Device · Class I · 2013-10-09 · Codman And Shurtleff - NC Sprinter
FDA Device · Class II · 2013-10-09 · Medtronic Vascular - MedStream Programmable Pump
FDA Device · Class I · 2013-10-09 · Codman And Shurtleff - MedStream Refill Kit, U.S: 91-4287 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in t…
FDA Device · Class I · 2013-10-09 · Codman And Shurtleff - ENDOPLUS
FDA Device · Class II · 2013-10-02 · Endoplus - Smiths Medical, Deltec: REF 21-8011-24 Port-A-Cath Dual-Lumen
FDA Device · Class II · 2013-10-02 · Smiths Medical Asd - Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intended for fixation of fractures of the dista…
FDA Device · Class II · 2013-10-02 · Synthes Usa Hq - Synthes Oracle Spacer System Slap Hammer, Part Number 03.809.690, Lot Number 3723847 The Oracle Spacer is indicated for use in patients wit…
FDA Device · Class II · 2013-10-02 · Synthes Usa Hq - Stryker Vision Mounting Arm, for use with other Stryker Endoscopy medical device products for human patients
FDA Device · Class II · 2013-10-02 · Stryker Endoscopy - Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe
FDA Device · Class II · 2013-10-02 · Medtronic Xomed - GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model numbers: 2395001, 2395001-2, 2395001-3, 2395001-4…
FDA Device · Class II · 2013-10-02 · Ge Healthcare - Invacare Power Wheelchair, one per box To provide mobility to a person restricted to a sitting position
FDA Device · Class II · 2013-10-02 · Invacare - Reliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060-1834 USA www.steris.com
FDA Device · Class II · 2013-10-02 · Steris - Monaco RTP System Radiation Therapy Treatment Planning System
FDA Device · Class II · 2013-10-02 · Elekta - Smith Medical, Deltec, REF 21-2386-24, 11 Fr Introducer Set with Peel-Away Sheath, Sterile EO, Rx Only PORT-A-CATH¿ and PORT-A-CATH¿ II imp…
FDA Device · Class II · 2013-10-02 · Smiths Medical Asd - SmartSite Low Sorbing Infusion Set, Model#72313E The SmartSite Low Sorbing Infusion Sets are used to administer fluid and medications throu…
FDA Device · Class II · 2013-10-02 · Carefusion 303 - TEGRIS system Four labels of the Tegris System include: Emergency button (1703.72) MAQUET GmbH & Co. KG Kehler-Strabe 31 Baden-Wuerttemberg…
FDA Device · Class II · 2013-10-02 · Maquet Cardiovascular Us Sales - CareFusion Gravity Set, Model #44000-07 The CareFusion Gravity Sets are used to administer fluid and medication through a needle or cathete…
FDA Device · Class II · 2013-10-02 · Carefusion 303 - The FL23SE Bed is an AC-powered adjustable hospital bed with four built-in electric DC motors and remote controls that is intended for medi…
FDA Device · Class II · 2013-10-02 · Stryker Medical Division - SmartSite Low Sorbing Infusion Set, Model# 10015048
FDA Device · Class II · 2013-10-02 · Carefusion 303 - Monaco RTP System Radiation treatment planning
FDA Device · Class II · 2013-10-02 · Elekta - QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator
FDA Device · Class II · 2013-10-02 · Maquet Cardiovascular Us Sales - DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott Laboratories. 100 ml, IVD Mfg by: Microgenics Corporation, 4636…
FDA Device · Class II · 2013-10-02 · Microgenics - BD Epilor Syringe BD Franklin Lakes, NJ 07417 BD EDC Laagstraat 57, B-9140 Temse-Belgium The Epilor syringe is used in conjunction with an…
FDA Device · Class II · 2013-10-02 · Becton Dickinson And - ABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essential role in many cell functions: intracellularly in muscle contract…
FDA Device · Class III · 2013-10-02 · Horiba Instruments - Terumo Pall AL6X Arterial Blood Line Filter, labeled in part Terumo Cardiovascular Systems Corporation, packaged as part of a Terumo Cardio…
FDA Device · Class II · 2013-10-02 · Terumo Cardiovascular Systems - ENDOPLUS
FDA Device · Class II · 2013-10-02 · Endoplus - OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black
FDA Device · Class II · 2013-09-25 · Smith And Nephew Endoscopy Division - TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue
FDA Device · Class II · 2013-09-25 · Smith And Nephew Endoscopy Division
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