FDA Device · 2012
FDA Device recalls in 2012
RecallRadar indexes 1,310 FDA Device recall notices published in 2012. By classification: 95 Class I, 1,162 Class II, 53 Class III.
- Beekley A-Spots Floral Skin Markers -Order Number: 751 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses o…
FDA Device · Class II · 2012-08-08 · Beekley - Arm and Hammer Spinbrush Pro Clean Sonic Recharge Made in China
FDA Device · Class II · 2012-08-08 · Church And Dwight - I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 cartridge is intended to be used for quantitatively measure sodiu…
FDA Device · Class II · 2012-08-08 · Abbott Point - UroView 2800
FDA Device · Class II · 2012-08-08 · Ge Oec Medical Systems - BridgePoint Medical, Stingray Catheter, REF M - 1000, Sterilized with Ethylene Oxide Gas, Prescription Only, Manufacturer BridgePoint Medic…
FDA Device · Class II · 2012-08-01 · Bridgepoint Medical - Product is labeled in part: "***OPTETRAK RBK***TIBIAL TRAY***FINNED, CEMENTED***CoCr Alloy***SIZE 2F/1T***REF 260-04-21***Exactech Gainesvi…
FDA Device · Class II · 2012-08-01 · Exactech - 4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.019.038S Manufactured or Distributed by Synthes (USA) 1101 Synthe…
FDA Device · Class II · 2012-08-01 · Synthes Usa Hq - Product is labeled in part: "***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED***Ti Alloy*** SIZE 1F/1T, 2F/1T***FOR CEMENTED USE ONLY***Exact…
FDA Device · Class II · 2012-08-01 · Exactech - Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy systems provides continuous or intermittent ventilatory support f…
FDA Device · Class I · 2012-08-01 · Respironics - OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures
FDA Device · Class I · 2012-08-01 · Ge Oec Medical Systems - ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ OIS Systems and Multiple-X, Manufactured by SIEMENS…
FDA Device · Class II · 2012-08-01 · Siemens Medical Solutions Usa - Hospira LifeShield Latex-Free 100 mL Burette Set, Convertible Pin, 77 inch with 2 Prepierced Injection Sites and Option-Lok Microdrip Solus…
FDA Device · Class II · 2012-08-01 · Hospira - IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating of digital structured…
FDA Device · Class II · 2012-08-01 · Agfa - Tibial Punch Tower Assembly
FDA Device · Class II · 2012-08-01 · Stryker Howmedica Osteonics - ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp
FDA Device · Class II · 2012-08-01 · Stryker Howmedica Osteonics - Siemens syngo.plaza
FDA Device · Class II · 2012-08-01 · Siemens Medical Solutions Usa - VITROS 5,1 FS System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes o…
FDA Device · Class II · 2012-08-01 · Ortho Clinical Diagnostics - Getinge brand --- large capacity, floor loading jet spray, washers for mechanical washing, intermediate level, thermal disinfection and dry…
FDA Device · Class II · 2012-08-01 · Getinge Usa - PrepStain Kit: 1.2 DiTi Cone
FDA Device · Class II · 2012-08-01 · Tripath Imaging - PrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone
FDA Device · Class II · 2012-08-01 · Tripath Imaging - PrepStain Slide Processor
FDA Device · Class II · 2012-08-01 · Tripath Imaging - System 1 Base 220/240V The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of…
FDA Device · Class II · 2012-08-01 · Terumo Cardiovascular Systems - PrepStain PM Kit, T-AG (Catalog 490588)
FDA Device · Class II · 2012-08-01 · Tripath Imaging - Oto Ease by Westone, labeled as a bacteria free, greaseless lubricant
FDA Device · Class II · 2012-08-01 · Westone Laboratories - Universal Spinal System Lamina Hooks Synthes Medium TI Lamina Hook - Right 498.320 Non sterile LOT 6876785 Noncervical spinal fixation devi…
FDA Device · Class II · 2012-08-01 · Synthes Usa Products - VITROS 5600 Integrated System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of a…
FDA Device · Class II · 2012-08-01 · Ortho Clinical Diagnostics - OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right
FDA Device · Class II · 2012-08-01 · Orthopediatrics - 4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 REF 04.019.028S Manufactured or Distributed by Synthes (USA) 1101 Synthe…
FDA Device · Class II · 2012-08-01 · Synthes Usa Hq - VITROS 4600 Chemistry System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of an…
FDA Device · Class II · 2012-08-01 · Ortho Clinical Diagnostics - Bella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30cm, Product Code: 311
FDA Device · Class II · 2012-08-01 · Beekley - .***ANSPACH***Sterile
FDA Device · Class II · 2012-08-01 · The Anspach Effort - Rejuvenate Modular Stems Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland Rejuvenate Modular Necks Stryke…
FDA Device · Class II · 2012-08-01 · Stryker Howmedica Osteonics - OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system Product Usage: The 8800 Flexview is designed to provide fluoroscopi…
FDA Device · Class I · 2012-08-01 · Ge Oec Medical Systems - Affinity Four Birthing Bed P3700 Product Usage: The Affinity, Four Birthing Bed is intended to be used as birthing beds for women of child…
FDA Device · Class II · 2012-08-01 · Hill Rom - OEC 9800
FDA Device · Class I · 2012-08-01 · Ge Oec Medical Systems - NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501
FDA Device · Class II · 2012-08-01 · Philips And Neusoft Medical Systems - The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inches in length, with a "J" shaped curve that proje…
FDA Device · Class II · 2012-08-01 · Mallinckrodt - Alaris PC unit model 8015 Product Usage: The device is labeled for prescription use only
FDA Device · Class I · 2012-08-01 · Carefusion 303 - System 1 Base 100/120V The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of…
FDA Device · Class II · 2012-08-01 · Terumo Cardiovascular Systems - Leica M525 F50 Surgical Microscope
FDA Device · Class II · 2012-08-01 · Leica Microsystems - BD Gram Stain Kit, containing 1- 250 mL bottle of Gram Crystal Violet, and additional reagents: Gram Iodine (Stabilized), Gram Decolorizer,…
FDA Device · Class II · 2012-07-25 · Becton Dickinson And - Sarns Modular Perfusion System 8000 base, 5 pump 115V. The Sarns Modular Perfusion Systern 8000 is indicated for use for up to 6 hours on t…
FDA Device · Class II · 2012-07-25 · Terumo Cardiovascular Systems - EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112
FDA Device · Class II · 2012-07-25 · Ekos - Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments
FDA Device · Class II · 2012-07-25 · Integra - Sarns Modular Perfusion System 8000 base, 4 pump 220/240V. The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours o…
FDA Device · Class II · 2012-07-25 · Terumo Cardiovascular Systems - CareFusion EnVe Ventilator Designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5…
FDA Device · Class I · 2012-07-25 · Carefusion 203 - Alere Triage Tox+MTD Drug Screen, PN 94400 Product Usage: The Alere Triage TOX Drug Screen is a fluorescence immunoassay to be used with th…
FDA Device · Class II · 2012-07-25 · Alere San Diego - OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV used as an aid to locate anatomical structures during open or…
FDA Device · Class II · 2012-07-25 · Ge Oec Medical Systems - Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with Option C. It is a patient monitor with arrhythmia detection or…
FDA Device · Class II · 2012-07-25 · Spacelabs Healthcare - System 1 Base, 220/240V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of…
FDA Device · Class II · 2012-07-25 · Terumo Cardiovascular Systems - MicroCool Breathable Impervious Surgical Gown, (Large and X-Large), Sterile, Made in Honduras
FDA Device · Class II · 2012-07-25 · Kimberly Clark - Terumo Advanced Perfusion System 1. System 1 base 220/240V. The Terumo Advanced Perfusion System I is indicated for use in extracorporeal c…
FDA Device · Class II · 2012-07-25 · Terumo Cardiovascular Systems - MicroCool Breathable Impervious Gown with Secure Fit Surgical, (Large and X-Large), Made in Honduras
FDA Device · Class II · 2012-07-25 · Kimberly Clark - Stryker T2 Arthrodesis Nailing System
FDA Device · Class II · 2012-07-25 · Stryker Howmedica Osteonics - Gram Crystal Violet 250 mL, catalog #212525, in cartons of 4 bottles
FDA Device · Class II · 2012-07-25 · Becton Dickinson And - Sarns Modular Perfusion System 9000, 115V with color screen
FDA Device · Class II · 2012-07-25 · Terumo Cardiovascular Systems - Bipolar Forceps model number: S02-XXX, S03-XXX, P02-XXX, and P03-XXX. "Instructions For Use" (QF7.5.1A.R01 thru QF7.5.1A.R06 Care and Handl…
FDA Device · Class II · 2012-07-25 · Stingray Surgical Products - Abbott Molecular Bar Code Scanner User's Guide
FDA Device · Class II · 2012-07-25 · Abbott Molecular - System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of…
FDA Device · Class II · 2012-07-25 · Terumo Cardiovascular Systems - epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System Product Usage: Usage: epoc Blood Analysis BGEM Test Card…
FDA Device · Class II · 2012-07-25 · Epocal - OEC 8800 Flexiview designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional pro…
FDA Device · Class II · 2012-07-25 · Ge Oec Medical Systems - OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, OEC 9800 MD Motorized C-arm System designed to provide fluoroscopic and spot-film imagin…
FDA Device · Class II · 2012-07-25 · Ge Oec Medical Systems - Sarns Modular Perfusion System 8000 base, 4 pump 115V. The Sarns Modular Perfusion system 8000 is indicated for use for up to 6 hours on th…
FDA Device · Class II · 2012-07-25 · Terumo Cardiovascular Systems - Philips Brilliance 6, 16, 40, 64, Big Bore, iCT and iCT SP are Computed Tomography X-Ray Systems
FDA Device · Class II · 2012-07-25 · Philips Medical Systems Cleveland - Etac¿ Ono Walker, Etac¿ Avant Walker, and Etac¿ Salsa Walker
FDA Device · Class II · 2012-07-25 · Etac Supply Center Ab - GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink
FDA Device · Class II · 2012-07-25 · Gulf Fiberoptics - Sarns Modular Perfusion System 9000, 100V with color screen
FDA Device · Class II · 2012-07-25 · Terumo Cardiovascular Systems - Sarns Modular Perfusion System 9000, 220/240V with color screen
FDA Device · Class II · 2012-07-25 · Terumo Cardiovascular Systems - Sarns Modular Perfusion System 8000 base, 5 pump 100V. he Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the…
FDA Device · Class II · 2012-07-25 · Terumo Cardiovascular Systems - Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E. The Critical Diagnostics Presage ST2 Assay kit is an in vitro diagnostic device th…
FDA Device · Class III · 2012-07-25 · Critical Diagnostics - SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software
FDA Device · Class III · 2012-07-25 · Sigma - Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED TOTAL HIP PACK, REF 89-6664.03 surgical kits
FDA Device · Class II · 2012-07-25 · Deroyal Industries - Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours o…
FDA Device · Class II · 2012-07-25 · Terumo Cardiovascular Systems - LMA Esophageal Intubation Detector (EID), Catalog Number EID100 The device is used to assist verification of placement of the endotracheal…
FDA Device · Class II · 2012-07-25 · Lma North America - Terumo Advanced Perfusion System 1. System 1 base 100/120V. The Terumo Advanced Perfusion System I is indicated for use in extracorporeal c…
FDA Device · Class II · 2012-07-25 · Terumo Cardiovascular Systems - Hitachi Scenaria CT System Software Product Usage: The Scenaria system is indicated to acquire axial volumes of the whole body including th…
FDA Device · Class II · 2012-07-25 · Hitachi Medical Systems America - Hudson RCI Concha Therm Neptune Humidifier, Rx Only, Product Usage: Usage: Device that is intended to add moisture to, and sometime to warm…
FDA Device · Class II · 2012-07-25 · Teleflex Medical - Sarns Modular Perfusion System 8000 base, 4 pump 100V. The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on th…
FDA Device · Class II · 2012-07-25 · Terumo Cardiovascular Systems - Varian brand Varian Eclipse Treatment Planning System for radiotherapy
FDA Device · Class II · 2012-07-25 · Varian Medical Systems Oncology Systems - Infusomat(R) Space Pump (US Version) with software version 686G030103 (commonly termed 'G03'), 686E030003, 686F030005, 686F030007, 686G0300…
FDA Device · Class I · 2012-07-25 · B Braun Medical - GE Healthcare Optima Mobile X-ray System
FDA Device · Class II · 2012-07-25 · Ge Healthcare - Terumo Advanced Perfusion System 1 System 1 Base, 220/240V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours o…
FDA Device · Class II · 2012-07-25 · Terumo Cardiovascular Systems - Sarns Modular Perfusion System 8000 base, 5 pump 220/240V. The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours o…
FDA Device · Class II · 2012-07-25 · Terumo Cardiovascular Systems - Stryker AVS Navigator Trials 6mm-15mm Manufactured by: Stryker Spine SAS Z.1 Marticot-33610-Cestas -France +33 (0) 5.57.97.06.30 http;//www…
FDA Device · Class II · 2012-07-25 · Stryker Spine - GE Healthcare, Invasive Blood Pressure Care Cables
FDA Device · Class II · 2012-07-25 · Ge Healthcare - Military Kit Portable Clinical Analyzer
FDA Device · Class II · 2012-07-18 · Abbott Point - Terumo Advanced Perfusion System 1 Electronic O2 Blender/Analyzer
FDA Device · Class II · 2012-07-18 · Terumo Cardiovascular Systems - superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the tracheobronchial tree to a…
FDA Device · Class II · 2012-07-18 · Superdimension - Button Switchpens, w/Extendable Needle Electrode 10 mm Exposure, Single Use device, Electrosurgical./Extendable Pencils, 510(k)#K936304, Mo…
FDA Device · Class II · 2012-07-18 · Psc Industries - System 1 Base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of b…
FDA Device · Class II · 2012-07-18 · Terumo Cardiovascular Systems - CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S. Sterilized with Ethylene Oxide
FDA Device · Class II · 2012-07-18 · Cardiovascular Systems - Bayonet Forceps 8.25 (209.6 mm) 0.5mm Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-13420, 510 (k) #K884175
FDA Device · Class II · 2012-07-18 · Psc Industries - i-STAT1 Abaxis Analyzer
FDA Device · Class II · 2012-07-18 · Abbott Point - Bayonet Forceps 7.75" (196.9 mm) 0.5 mm Tips Non-Stick Electrosurgical/Bipolar Forceps/Reusable, Model #90-7004 (k) #K982705
FDA Device · Class II · 2012-07-18 · Psc Industries - enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL…
FDA Device · Class II · 2012-07-18 · Vital Signs Devices A Ge Healthcare - System 1 Base, 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of…
FDA Device · Class II · 2012-07-18 · Terumo Cardiovascular Systems - FLOW-I Anesthesia System The system is intended for use in administrating anesthesia while controlling the entire ventilation for patients…
FDA Device · Class I · 2012-07-18 · Maquet Cardiovascular Us Sales - Alere Triage CardioProfiler Panel PN 97100CP Used for the quantitative determination of creatine kinase MB, myoglobin, troponin I and B-typ…
FDA Device · Class I · 2012-07-18 · Alere San Diego - Safedraw Venous Close Loop System, Blood Sampling Set, packaged in a tyvek bag, Model/Part Number 688695, Argon Critical Care Systems, Sing…
FDA Device · Class II · 2012-07-18 · Argon Medical Devices - IntelliSpace Portal software and Extended Brillance Workspace software Intellispace Portal is a multimodality thin-client applications serv…
FDA Device · Class II · 2012-07-18 · Philips Medical Systems Cleveland
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