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.
- IsoGel AIR 84, Support Surface
FDA Device · Class II · 2013-08-21 · Stryker Medical Division - epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium Potassium , Ionized Calcium…
FDA Device · Class II · 2013-08-21 · Epocal - Siemens syngo.plaza SW version VA20 with Mammography license. image processing, radiological system
FDA Device · Class II · 2013-08-21 · Siemens Medical Solutions Usa - GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ray system is intended to produce cross-sectional images of the bod…
FDA Device · Class II · 2013-08-21 · Ge Healthcare - 3.2mm Drill Bit
FDA Device · Class II · 2013-08-21 · Orthopediatrics - Nova Max Plus Monitor System (Kit w/10 Count Vials) Catalog Number: 43435 Product usage: The Nova Max Glucose Test Strips are for use with…
FDA Device · Class I · 2013-08-21 · Nova Biomedical - Siemens AXIOM Artis zeego x-ray, angiographic system
FDA Device · Class II · 2013-08-21 · Siemens Medical Solutions Usa - Nova Max Glucose Test Strips (50 Count International Catalog Number: 45512 Product usage: The Nova Max Glucose Test Strips are for use with…
FDA Device · Class I · 2013-08-21 · Nova Biomedical - Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1512, IVS17512, IVS2012, IVS2512, IVS3012, IVS1530, IVS2030 and…
FDA Device · Class II · 2013-08-21 · Edwards Lifesciences - GE Healthcare, LOGIQ S8 Ultrasound System The device is intended for use by a qualified physician for ultrasound evaluation of Fetal
FDA Device · Class II · 2013-08-21 · Ge Healthcare - Nova Max Glucose Test Strips (50 Count Retail) Catalog Number: 43437 Product Usage: The Nova Max Glucose Test Strips are for use with the N…
FDA Device · Class I · 2013-08-21 · Nova Biomedical - Nova Max Glucose Test Strips (100 Count Retail Canada)Catalog Number: 43955 Product Usage: The Nova Max Glucose Test Strips are for use wit…
FDA Device · Class I · 2013-08-21 · Nova Biomedical - 220/240V AC, Advanced Perfusion System 1 Product Usage: The Terumo¿ Advanced Perfusion System 1 is indicated for use in extracorporeal circ…
FDA Device · Class II · 2013-08-21 · Terumo Cardiovascular Systems - Edwards EndoReturn Arterial Cannula, model ER21B and ER23B Product Usage: The ThruPort EndoReturn arterial cannula kit (with or without hem…
FDA Device · Class II · 2013-08-21 · Edwards Lifesciences - C-QUR V-Patch Mesh (All sizes and shapes)
FDA Device · Class II · 2013-08-21 · Atrium Medical - CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below
FDA Device · Class II · 2013-08-21 · Veridex - 1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask
FDA Device · Class II · 2013-08-21 · Carefusion 2200 - Fisherbrand Sterile Swab, Calcium Alginate Fiber Tipped, Wood Applicator Swab 100 pouches/boxes, 10 boxes/case
FDA Device · Class II · 2013-08-21 · Fisher Scientific - Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system is a permanently installed diagnostic x-ray system for generatio…
FDA Device · Class II · 2013-08-21 · Carestream Health - C-QUR Mesh (All Sizes, shapes)
FDA Device · Class II · 2013-08-21 · Atrium Medical - Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized using ethylene oxide
FDA Device · Class II · 2013-08-21 · Medtronic Cardiac Rhythm Disease Management - Terumo¿ Advanced Perfusion System 1: 220/240V AC, Advanced Perfusion System 1 The Terumo¿ Advanced Perfusion System 1 is indicated for use…
FDA Device · Class II · 2013-08-21 · Terumo Cardiovascular Systems - Nova Max Glucose Test Strips (50 Count DME) Catalog Number: 43523 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova…
FDA Device · Class I · 2013-08-21 · Nova Biomedical - GE Healthcare, Optima XR220amx, Optima XR200amx, and Brivo XR285amx
FDA Device · Class II · 2013-08-21 · Ge Healthcare - Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in
FDA Device · Class II · 2013-08-21 · Vital Signs Devices A Ge Healthcare - SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM GE SIGNA 3.0T WITH EXCITE MR SYSTEM…
FDA Device · Class II · 2013-08-21 · Ge Healthcare - Nova Max Glucose Test Strips (10 Count Boxed) Catalog Number: 43590 Product Usage: The Nova Max Glucose Test Strips are for use with the No…
FDA Device · Class I · 2013-08-21 · Nova Biomedical - Nova Max Glucose Test Strips (10 Count Vials) Catalog Number: 43604 These strips are kitted into Nova Max Glucose Test Strip System Kits 43…
FDA Device · Class I · 2013-08-21 · Nova Biomedical - Remel X/pect Flu A&B Control Swabs, For In Vitro Diagnostic Use, Ref R246003, each package contains 20 Flu A Control Swabs and 20 Flu B Con…
FDA Device · Class III · 2013-08-21 · Remel - ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack)
FDA Device · Class III · 2013-08-21 · Siemens Healthcare Diagnostics - 5.0mm Unit Rod 270mm 5.0mm Unit Rod 290mm 5.0mm Unit Rod 310mm 5.0mm Unit Rod 330mm 5.0mm Unit Rod 350mm 5.0mm Unit Rod 370mm 5.0mm Unit Ro…
FDA Device · Class II · 2013-08-21 · Synthes Usa Hq - Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C)
FDA Device · Class II · 2013-08-21 · Spinefrontier - Nova Max Glucose Test Strips (10 Count Canada)Catalog Number: 43877 Product The Nova Max Glucose Test Strips are for use with the Nova Max…
FDA Device · Class I · 2013-08-21 · Nova Biomedical - Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L)
FDA Device · Class II · 2013-08-21 · Biomet 3i - Colorimetric (CM)/ Rate (RT) incubator wear pads
FDA Device · Class II · 2013-08-21 · Ortho Clinical Diagnostics - Terumo¿ Advanced Perfusion System 1: 100/120V AC, Advanced Perfusion System 1 The Terumo¿ Advanced Perfusion System 1 is indicated for use…
FDA Device · Class II · 2013-08-21 · Terumo Cardiovascular Systems - Sonopet Ultrasonic Aspirator Console (Console 110V with Pedal & Pole) Product Usage: The Sonopet Console is indicated for use in surgical p…
FDA Device · Class II · 2013-08-14 · Stryker Instruments Div - IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T, L2KTS6 - 600T). Intended to quantitatively measure hu…
FDA Device · Class II · 2013-08-14 · Siemens Healthcare Diagnostics - TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Br¿nsh¿j, Denmark, www.radiometer.com
FDA Device · Class II · 2013-08-14 · Radiometer America - Leader Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in
FDA Device · Class II · 2013-08-14 · Aso - bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system
FDA Device · Class II · 2013-08-14 · Biomerieux - bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system
FDA Device · Class II · 2013-08-14 · Biomerieux - Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within the case, a variety of shapes and sizes of plates a…
FDA Device · Class II · 2013-08-14 · Spinefrontier - TopCare Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in
FDA Device · Class II · 2013-08-14 · Aso - Mobiletta Mira Mobile X-ray System
FDA Device · Class II · 2013-08-14 · Siemens Medical Solutions Usa - HEB Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in
FDA Device · Class II · 2013-08-14 · Aso - bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system
FDA Device · Class II · 2013-08-14 · Biomerieux - MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier
FDA Device · Class II · 2013-08-14 · Mitsubishi Heavy Industries Hiroshima Machinery Work - List No. 14219-28
FDA Device · Class I · 2013-08-14 · Hospira - Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(…
FDA Device · Class II · 2013-08-14 · Spinefrontier - Sonopet Ultrasonic Aspirator Console 5450-852-000 (Console 230V) Product Usage: The Sonopet Console is indicated for use in surgical proced…
FDA Device · Class II · 2013-08-14 · Stryker Instruments Div - IMMULITE Systems Rapid TSH (REF LKRT1 - 100T, LKRT5 - 500 T, L2KRT2 - 200T, L2KRT6 - 600T). Intended to quantitatively measure human thyroi…
FDA Device · Class II · 2013-08-14 · Siemens Healthcare Diagnostics - List No. 14203-28
FDA Device · Class I · 2013-08-14 · Hospira - VENTANA (a member of the Roche Group) BenchMark ULTRA
FDA Device · Class II · 2013-08-14 · Ventana Medical Systems - Enterprise 9000 Bed
FDA Device · Class II · 2013-08-14 · Arjo - Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat
FDA Device · Class I · 2013-08-14 · Cordis - bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system
FDA Device · Class II · 2013-08-14 · Biomerieux - MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the MRidium 3860+MR Infusion Pump System)
FDA Device · Class I · 2013-08-14 · Iradimed - R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 60 MM OD, QTY: (1), STERILE H2O2, REF 71335760
FDA Device · Class II · 2013-08-14 · Smith And Nephew - R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: (1), STERILE H2O2, REF 71335762
FDA Device · Class II · 2013-08-14 · Smith And Nephew - Non-sterile Viscot Surgical Skin Markers Part Number 1437-100 Non-sterile Viscot Part Number 143-100 Surgical Skin Markers are pen-like dev…
FDA Device · Class II · 2013-08-14 · Precision Dynamics - bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system
FDA Device · Class II · 2013-08-14 · Biomerieux - List No. 14206-28
FDA Device · Class I · 2013-08-14 · Hospira - Premier Value Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in
FDA Device · Class II · 2013-08-14 · Aso - List No. 14207-28
FDA Device · Class I · 2013-08-14 · Hospira - bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system
FDA Device · Class II · 2013-08-14 · Biomerieux - bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system
FDA Device · Class II · 2013-08-14 · Biomerieux - Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserters are instruments which capture, hold and drive pedicle screw asse…
FDA Device · Class II · 2013-08-14 · Spinefrontier - bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system
FDA Device · Class II · 2013-08-14 · Biomerieux - Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107) Product Usage: The TACR method is an in vitro diagnostic…
FDA Device · Class II · 2013-08-14 · Siemens Healthcare Diagnostics - Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev
FDA Device · Class II · 2013-08-14 · Spinefrontier - CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in
FDA Device · Class II · 2013-08-14 · Aso - List No. 14212-28
FDA Device · Class I · 2013-08-14 · Hospira - VENTANA (a member of the Roche Group) DISCOVERY ULTRA
FDA Device · Class II · 2013-08-14 · Ventana Medical Systems - Beckman Coulter AU5800 Clinical Chemistry Analyzer, All Serial Numbers
FDA Device · Class II · 2013-08-14 · Beckman Coulter - BD Vacutainer Multiple Sample and Direct Draw Luer Adapter BD Franklin Lakes, NJ 07417 USA A sterile non-invasive device used to connect ve…
FDA Device · Class II · 2013-08-14 · Becton Dickinson And - List No. 14210-28
FDA Device · Class I · 2013-08-14 · Hospira - Dimension TSH Flex Reagent Cartridge (REF RF412)
FDA Device · Class II · 2013-08-14 · Siemens Healthcare Diagnostics - bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system
FDA Device · Class II · 2013-08-14 · Biomerieux - bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system
FDA Device · Class II · 2013-08-14 · Biomerieux - List No. 14211-28
FDA Device · Class I · 2013-08-14 · Hospira - Sonopet Ultrasonic Aspirator Console 5450-851-000(Console 100V) Product Usage: The Sonopet Console is indicated for use in surgical procedu…
FDA Device · Class II · 2013-08-14 · Stryker Instruments Div - bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system
FDA Device · Class II · 2013-08-14 · Biomerieux - Discount Drug Mart Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in
FDA Device · Class II · 2013-08-14 · Aso - List No. 14217-28
FDA Device · Class I · 2013-08-14 · Hospira - bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system
FDA Device · Class II · 2013-08-14 · Biomerieux - bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system
FDA Device · Class II · 2013-08-14 · Biomerieux - Medtronic Mullins Transseptal Adult 7F, REF 008551
FDA Device · Class II · 2013-08-14 · Medtronic Cardiac Rhythm Disease Management - Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612)
FDA Device · Class II · 2013-08-14 · Siemens Healthcare Diagnostics - ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06491080 - 500 Tests, REF 04862625 - 2500T). Intended to quantit…
FDA Device · Class II · 2013-08-14 · Siemens Healthcare Diagnostics - Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass Creatine Kinase MB isozyme Calibrator is an in vitro diagnostic pr…
FDA Device · Class II · 2013-08-14 · Siemens Healthcare Diagnostics - T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are silicone handled instruments that have a quick release end
FDA Device · Class II · 2013-08-14 · Spinefrontier - bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system
FDA Device · Class II · 2013-08-14 · Biomerieux - Dimension Vista System TSH Flex Reagent Cartridge (REF K6412)
FDA Device · Class II · 2013-08-14 · Siemens Healthcare Diagnostics - Walgreens ("W" and "Well at Walgreens") Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in
FDA Device · Class II · 2013-08-14 · Aso - Meijer Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in
FDA Device · Class II · 2013-08-14 · Aso - bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system
FDA Device · Class II · 2013-08-14 · Biomerieux - Duane Reade (DR) Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in
FDA Device · Class II · 2013-08-14 · Aso - Enterprise 8000 Bed
FDA Device · Class II · 2013-08-14 · Arjo - Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly part number TC10006584
FDA Device · Class I · 2013-08-14 · Carefusion 303
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