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.
- STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the perfor…
FDA Device · Class II · 2012-11-14 · Diagnostica Stago - Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broaches the…
FDA Device · Class II · 2012-11-14 · Medacta Usa - S5 Single Roller Pump 150, Item Number: 10-80-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for p…
FDA Device · Class II · 2012-11-14 · Sorin Group Usa - Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is an in vitro diagnostic test for the quantitative measurement of t…
FDA Device · Class III · 2012-11-14 · Siemens Healthcare Diagnostics - Sunquest Laboratory, version 7.0 not available
FDA Device · Class II · 2012-11-14 · Sunquest Information Systems - NCB¿-PH Plate
FDA Device · Class II · 2012-11-14 · Zimmer - Dynesys¿ HA Pedicle + set screw
FDA Device · Class II · 2012-11-14 · Zimmer - Sysmex XE-2100C Automated Hematology System
FDA Device · Class II · 2012-11-14 · Sysmex America - 0.7/1.3U163CS-36 In combination with below systems MobileArt Evolution, MobileDaRt Evolution Product Usage: The device is a mobile X-ray sy…
FDA Device · Class II · 2012-11-14 · Shimadzu Medical Systems - "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2740***" Ophthalmic surgery
FDA Device · Class II · 2012-11-14 · Surgical Specialties Puerto Rico - Biolox¿ delta Ceramic Femoral Head Rx only, sterile
FDA Device · Class II · 2012-11-14 · Zimmer - MS-30¿ Stem
FDA Device · Class II · 2012-11-14 · Zimmer - SCP Pump Control Panel, Product Code: 60-02-50, Serial Numbers: 60S09131, 60S09133-60S09135, 60S09140-60S09142, 60S08954
FDA Device · Class II · 2012-11-07 · Sorin Group Usa - Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with…
FDA Device · Class II · 2012-11-07 · Oscor - Adult Resuscitator, Pro-5000 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is intended t…
FDA Device · Class I · 2012-11-07 · Ventlab - Hip Components: INSERT MOBILE "COLLEGIA" TAILLE 58*28, OT22C58, Lot Numbers: W07335080 and X06391225 INSERT MOBILE "COLLEGIA" TAILLE 60*28,…
FDA Device · Class II · 2012-11-07 · Wright Medical Technology - ARIA Radiation Oncology, Version 11
FDA Device · Class II · 2012-11-07 · Varian Medical Systems Oncology Systems - AirFlow, Small Adult Resuscitator, AF5000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 Th…
FDA Device · Class I · 2012-11-07 · Ventlab - QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator
FDA Device · Class II · 2012-11-07 · Maquet Cardiovascular Us Sales - Knee Components: ROTULE "913" D=32 , Part Number PGA00030, Lot Number X02383380 INSERT TIBIAL "913 PCR" T.1 - EP.10-, PGA00050, Lot Numbers…
FDA Device · Class II · 2012-11-07 · Wright Medical Technology - Safe Spot Infant Resuscitator, SS3200 Series, Single Patient Use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028
FDA Device · Class I · 2012-11-07 · Ventlab - Software for Vitrea, Vitrea fX, and Vitrea Enterprise Suite (VES): VPMC-09293C Vitrea . Model Number Vitrea 5.2, 6.0, 6.1, and 6.2 VPMC-093…
FDA Device · Class II · 2012-11-07 · Vital Images - Ventlab Premium Small Adult Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028
FDA Device · Class I · 2012-11-07 · Ventlab - Extremity Components: PROTHESE A EXPANSION COMPLETE D=6 LG 12 MM, Part Number PPO90000, Lot Numbers: U11113596, W12372884, W12376849, X0138…
FDA Device · Class II · 2012-11-07 · Wright Medical Technology - Aviator Drill Bit (10 mm, 12 mm, 14 mm, 16 mm, Manufactured by: Stryker Spine SAS Z.1 Marticot -33610- Cestas France +33 (0) 5.57.97.06.30…
FDA Device · Class II · 2012-11-07 · Stryker Spine - ILLlCO¿ MIS Posterior Fixation System, Bone-screw Internal Spinal Fixation System, Orthosis, Spinal Pedical Fixation Orthosis, Spondylolist…
FDA Device · Class II · 2012-11-07 · Alphatec Spine - "***All in one CrossFT***Punch***PFT-00M***4.5mm to 6.5mm***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***" To create pathw…
FDA Device · Class II · 2012-11-07 · Linvatec - Safe Spot Infant Resuscitator, Pro-1900 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is…
FDA Device · Class I · 2012-11-07 · Ventlab - Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged…
FDA Device · Class II · 2012-11-07 · Progressive Medical - V*Care Resuscitator Infant Resuscitator, VN 3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 2…
FDA Device · Class I · 2012-11-07 · Ventlab - West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG…
FDA Device · Class III · 2012-11-07 · Focus Diagnostics - cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, Inc., Product Usage: The primary use of the cobas 4…
FDA Device · Class III · 2012-11-07 · Roche Molecular Systems - MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management
FDA Device · Class II · 2012-11-07 · Elekta - Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50 Tests)
FDA Device · Class II · 2012-11-07 · Siemens Healthcare Diagnostics - Ventlab Premium Small Child Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028
FDA Device · Class I · 2012-11-07 · Ventlab - AirFlow, Infant Resuscitator, AF3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Dis…
FDA Device · Class I · 2012-11-07 · Ventlab - Ventlab Rescue Med Infant Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028
FDA Device · Class I · 2012-11-07 · Ventlab - SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139
FDA Device · Class II · 2012-11-07 · Sorin Group Usa - AirFlow Resuscitator, Adult Resuscitator, AF1000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 2…
FDA Device · Class I · 2012-11-07 · Ventlab - Breath Tech, Safe Spot Infant Resuscitator, BT2000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC…
FDA Device · Class I · 2012-11-07 · Ventlab - Stat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E. /Stat-Check CO2 Indicator, SC 9000 Series, Single use, Manufacture…
FDA Device · Class I · 2012-11-07 · Ventlab - HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917
FDA Device · Class I · 2012-11-07 · Heartsine Technologies - Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 h…
FDA Device · Class II · 2012-10-31 · Terumo Cardiovascular Systems - Symbiq One Channel Infuser
FDA Device · Class I · 2012-10-31 · Hospira - Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped wit…
FDA Device · Class II · 2012-10-31 · Optovue - GE Healthcare innova 3131-IQ Mobile X-ray system
FDA Device · Class II · 2012-10-31 · Ge Healthcare - AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Stiff
FDA Device · Class II · 2012-10-31 · Nipro Medical - SpiraLok 6.5mm with Ethibond without needles Product Number: 222966 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in…
FDA Device · Class II · 2012-10-31 · Depuy Mitek A Johnson And Johnson - SpiraLok 5.0mm with Ethibond without needles Product Number: 222964 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in…
FDA Device · Class II · 2012-10-31 · Depuy Mitek A Johnson And Johnson - SpiraLok 6.5mm with Ethibond and needles Product Number: 222962 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rot…
FDA Device · Class II · 2012-10-31 · Depuy Mitek A Johnson And Johnson - Pulset Arterial Blood Gas (ABG) sampling kit
FDA Device · Class II · 2012-10-31 · Westmed - Perfusion System 8000, base 4 pump, 115V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 h…
FDA Device · Class II · 2012-10-31 · Terumo Cardiovascular Systems - SpiraLok 6.5mm with Panacryl and needles Product Number: 222963 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rot…
FDA Device · Class II · 2012-10-31 · Depuy Mitek A Johnson And Johnson - SpiraLok 5.0 w/out Needles with Orthocord Product Number: 222969 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in ro…
FDA Device · Class II · 2012-10-31 · Depuy Mitek A Johnson And Johnson - Pulset Arterial Blood Gas (ABG) sampling kit
FDA Device · Class II · 2012-10-31 · Westmed - GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 A medical image review station that allows easy select…
FDA Device · Class II · 2012-10-31 · Ge Healthcare - AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Regular
FDA Device · Class II · 2012-10-31 · Nipro Medical - SpiraLok 6.5 w/out Needles with Orthocord Product Number: 222971 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in ro…
FDA Device · Class II · 2012-10-31 · Depuy Mitek A Johnson And Johnson - Pulset Arterial Blood Gas (ABG) sampling kit
FDA Device · Class II · 2012-10-31 · Westmed - Pulset Arterial Blood Gas (ABG) sampling kit
FDA Device · Class II · 2012-10-31 · Westmed - Pulset Arterial Blood Gas (ABG) sampling kit
FDA Device · Class II · 2012-10-31 · Westmed - Pulset Arterial Blood Gas (ABG) sampling kit
FDA Device · Class II · 2012-10-31 · Westmed - GE Healthcare innova 3100, Mobile X-ray system
FDA Device · Class II · 2012-10-31 · Ge Healthcare - Perfusion System 8000, base 4 pump, 100V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 h…
FDA Device · Class II · 2012-10-31 · Terumo Cardiovascular Systems - Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up t…
FDA Device · Class II · 2012-10-31 · Terumo Cardiovascular Systems - Biosense Webster MobiCath Bi-Directional Guiding Sheath
FDA Device · Class II · 2012-10-31 · Greatbatch Medical - Osseotite Tapered Certain Implant 5 X 10mm Model INT510 Biomet 3i Dental Implants are intended for surgical placement in the upper or lower…
FDA Device · Class II · 2012-10-31 · Biomet 3i - AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit for Escherichia coli and Pseudomonas aeruginosa Cata…
FDA Device · Class II · 2012-10-31 · Advandx - Pulset Arterial Blood Gas (ABG) sampling kit
FDA Device · Class II · 2012-10-31 · Westmed - Pulset Arterial Blood Gas (ABG) sampling kit
FDA Device · Class II · 2012-10-31 · Westmed - DePuy Mitek VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece Catalog Number: 227305 The DePuy Mitek VAPR Electrodes for u…
FDA Device · Class II · 2012-10-31 · Depuy Mitek A Johnson And Johnson - Pulset Arterial Blood Gas (ABG) sampling kit
FDA Device · Class II · 2012-10-31 · Westmed - Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number 442600
FDA Device · Class III · 2012-10-31 · Beckman Coulter - Pulset Arterial Blood Gas (ABG) sampling kit
FDA Device · Class II · 2012-10-31 · Westmed - EVICEL Fibrin Sealant (Human) Rx Only
FDA Device · Class II · 2012-10-31 · Ethicon - Screw, fixation, boneProduct Number: 222967 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair sur…
FDA Device · Class II · 2012-10-31 · Depuy Mitek A Johnson And Johnson - Pulset Arterial Blood Gas (ABG) sampling kit
FDA Device · Class II · 2012-10-31 · Westmed - The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket
FDA Device · Class III · 2012-10-31 · Ormco Sybronendo - Gish 3/8 x 1/2" Reducer Connector with Luer fitting, Item Numbers: EC2180S, Lot Numbers: 1108900099, 1119900091, 1203700129, 1208600013, 12…
FDA Device · Class II · 2012-10-31 · Sorin Group Usa - SpiraLok 6.5 w/out Needles with violet and blue Orthocord Product Number: 222988 SPIRALOK Anchors are primarily used to re-attach soft tiss…
FDA Device · Class II · 2012-10-31 · Depuy Mitek A Johnson And Johnson - AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Stiff
FDA Device · Class II · 2012-10-31 · Nipro Medical - 6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair
FDA Device · Class II · 2012-10-31 · Encore Medical - GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1: Seno Advantage is…
FDA Device · Class II · 2012-10-31 · Ge Healthcare - SpiraLok 5.0 w/Needles with Orthocord Product Number: 222968 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotato…
FDA Device · Class II · 2012-10-31 · Depuy Mitek A Johnson And Johnson - Pulset Arterial Blood Gas (ABG) sampling kit
FDA Device · Class II · 2012-10-31 · Westmed - Pulset Arterial Blood Gas (ABG) sampling kit
FDA Device · Class II · 2012-10-31 · Westmed - GE Healthcare innova 3100-IQ, Mobile X-ray system The innova systems are indicated for use in generating fluoroscopic images of human anato…
FDA Device · Class II · 2012-10-31 · Ge Healthcare - AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit for Escherichia coli,and/or Klebsiella pneumoniae an…
FDA Device · Class II · 2012-10-31 · Advandx - SpiraLok 6.5 w/Needles with Orthocord Product Number: 222970 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotato…
FDA Device · Class II · 2012-10-31 · Depuy Mitek A Johnson And Johnson - Perfusion System 8000, base 4 pump, 220V/240V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up t…
FDA Device · Class II · 2012-10-31 · Terumo Cardiovascular Systems - SpiraLok 5.0mm with Ethibond and needles Product Number: 222960 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rot…
FDA Device · Class II · 2012-10-31 · Depuy Mitek A Johnson And Johnson - SpiraLok 6.5 w/Needles with violet and blue Orthocord Product Number: 222987 SPIRALOK Anchors are primarily used to re-attach soft tissue t…
FDA Device · Class II · 2012-10-31 · Depuy Mitek A Johnson And Johnson - AquaLiner Hydrophilic Guidewire 0.035" X 180cm, Angle / Regular
FDA Device · Class II · 2012-10-31 · Nipro Medical - Repeater Pump, Class II device used for facilitating repeatable drug dosage distribution and reconstitution in hospital pharmacies
FDA Device · Class II · 2012-10-31 · Baxa - Gish 3/8 x 3/8" Straight Connector with Luer fitting, Item Numbers: EC2160B, EC2160S, Lot Numbers: 1210100010, 1215100026, 1217000138, Exp
FDA Device · Class II · 2012-10-31 · Sorin Group Usa - GE Discovery NM/CT670
FDA Device · Class II · 2012-10-31 · Ge Healthcare - SpiraLok 5.0 w/out Needles with violet and blue Orthocord Product Number: 222986 SPIRALOK Anchors are primarily used to re-attach soft tiss…
FDA Device · Class II · 2012-10-31 · Depuy Mitek A Johnson And Johnson - Perfusion System 8000, base 5 pump, 100V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 h…
FDA Device · Class II · 2012-10-31 · Terumo Cardiovascular Systems - HiRes 90K devices with Helix Electrodes Model CI 1400-02H The HiResolution Bionic Ear System is a cochlear implant system designed to provi…
FDA Device · Class II · 2012-10-31 · Advanced Bionics - SpiraLok 5.0mm with Panacryl without needles Product Number: 222965 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in…
FDA Device · Class II · 2012-10-31 · Depuy Mitek A Johnson And Johnson
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