FDA Device · 2016
FDA Device recalls in 2016
RecallRadar indexes 3,246 FDA Device recall notices published in 2016. By classification: 116 Class I, 3,050 Class II, 80 Class III.
- American Surgical Cotton Balls-Strung 3/8" Ref Number: 30-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Device · Class II · 2016-06-01 · American Surgical - Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566
FDA Device · Class II · 2016-06-01 · Leica Microsystems - American Surgical Telfa 1" x 1" Ref Number: 80-12 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Device · Class II · 2016-06-01 · American Surgical - American Surgical Ray-Cot 1/2" x 3" Ref Number: 60-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Device · Class II · 2016-06-01 · American Surgical - American Surgical Delicot-J 15 mm x 20 mm Ref Number: 63-04J (Japan Only) Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Device · Class II · 2016-06-01 · American Surgical - American Surgical Ray-Cot 1/2" x 1/2" Ref Number: 60-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Device · Class II · 2016-06-01 · American Surgical - American Surgical Delicot 5 mm x 13 mm Ref Number: 63-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Device · Class II · 2016-06-01 · American Surgical - American Surgical Cotton Balls-Non-Strung 3/4" Ref Number: 31-03 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Device · Class II · 2016-06-01 · American Surgical - American Surgical Policot 1/2" x 2" Ref Number: 90-29 Product Usage: Neurosurgical and Nonneurosurgical Sponges
FDA Device · Class II · 2016-06-01 · American Surgical - Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing Fiber (LDF) and the Visualase…
FDA Device · Class II · 2016-05-25 · Medtronic Navigation - VersaFx Femoral Fixation System Hex head compression screw 4.7 mm dia. 2 inch (51 mm) length 47116202400
FDA Device · Class II · 2016-05-25 · Zimmer Manufacturing B V - Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 20 mm Length 00114205020 Mini M…
FDA Device · Class II · 2016-05-25 · Zimmer Manufacturing B V - 1) 24 G x 0.75 in
FDA Device · Class II · 2016-05-25 · Becton Dickinson And - Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular cup bone screw selftap 6.5x20mm 00662406520 Hgp ii acetabul…
FDA Device · Class II · 2016-05-25 · Zimmer Manufacturing B V - Alcon 23G and 25G Valved Entry System provides access into the posterior segment of the eye for surgical instruments within the frame of 23…
FDA Device · Class II · 2016-05-25 · Alcon Research - Diamedix Is-Mumps IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detect…
FDA Device · Class II · 2016-05-25 · Diamedix - Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm length 47493501801
FDA Device · Class II · 2016-05-25 · Zimmer Manufacturing B V - Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971)
FDA Device · Class II · 2016-05-25 · Lumenis - LenSx Laser System
FDA Device · Class II · 2016-05-25 · Alcon Research - Periarticular plating system, cancellous bone screw, partially threaded, hex head, 4.0 mm diameter, 16 mm length 47234702116
FDA Device · Class II · 2016-05-25 · Zimmer Manufacturing B V - Diamedix Is-CMV IgG Test Kit
FDA Device · Class II · 2016-05-25 · Diamedix - Diamedix Is-EBV-EA-D IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative det…
FDA Device · Class II · 2016-05-25 · Diamedix - Trilogy self-tapping bone screw Bone screw 4.5x25 selftap 00625004525 Bone screw 4.5x50 selftap 00625004550 Bone screw 6.5x15 selftap 00625…
FDA Device · Class II · 2016-05-25 · Zimmer Manufacturing B V - NeuroBlate System SideFire Select 2.2 mm Directional Laser Probe, Sterile EO. Model #s SFS000-01,SFS002-01, SFS122-01, SFS222-01, SFS322-01…
FDA Device · Class I · 2016-05-25 · Monteris Medical - Zimmer Plates and Screws (ZPS) 4.0 mm Cancellous Screw Fully Threaded, 12 mm Length 47484001200 4.0 mm Cancellous Screw Fully Threaded, 14…
FDA Device · Class II · 2016-05-25 · Zimmer Manufacturing B V - 23G and 25G Constellation Totalplus Paks provides access into the posterior segment of the eye for surgical instruments within the frame of…
FDA Device · Class II · 2016-05-25 · Alcon Research - Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02
FDA Device · Class II · 2016-05-25 · Valeant Pharmacueticals International - ADVIA Chemistry Triglyceride_2, concentrated
FDA Device · Class II · 2016-05-25 · Siemens Healthcare Diagnostics - AB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257
FDA Device · Class II · 2016-05-25 · Ab Sciex - M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 mm Length 00225304542 M/DN Intramedullary Fixation 4.2 mm…
FDA Device · Class II · 2016-05-25 · Zimmer Manufacturing B V - ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 2.0 MM, Part # OCM7-2SD Product Usage: The Otologic Curved Micro (OCCM) A…
FDA Device · Class II · 2016-05-25 · The Anspach Effort - ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part # OCM7-15SD Product Usage: The Otologic Curved Micro (OCCM)…
FDA Device · Class II · 2016-05-25 · The Anspach Effort - ITST intertrochanteric/subtrochanteric fixation 4.5 mm diameter cortical screw, 3.5 mm hex head, 57 mm length 00225305745
FDA Device · Class II · 2016-05-25 · Zimmer Manufacturing B V - Zimmer Plates and Screws (ZPS) 3.5 mm Cortical Screw SelfTapping, 10 mm Length 47483501001 3.5 mm Cortical Screw SelfTapping, 14 mm Length…
FDA Device · Class II · 2016-05-25 · Zimmer Manufacturing B V - Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 45 mm Length 47115504507 Herbert Cannulated Bone Screw System, Bone Screw, 6…
FDA Device · Class II · 2016-05-25 · Zimmer Manufacturing B V - Diamedix Is-EBV-VCA IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative dete…
FDA Device · Class II · 2016-05-25 · Diamedix - Custom Paks containing 23G and 25G valved trocar cannula provide access into the posterior segment of the eye for surgical instruments with…
FDA Device · Class II · 2016-05-25 · Alcon Research - Zimmer Plates and Screws (ZPS) 2.7 mm Cortical Screw SelfTapping, 14 mm Length 47482701401
FDA Device · Class II · 2016-05-25 · Zimmer Manufacturing B V - Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 584400 (OUS) Intended to provide enteral nutrition to a patient for hospital an…
FDA Device · Class II · 2016-05-18 · Medtronic - Vitek 2 Gram Positive Susceptibility Test Cards (AST-P636 REF 417951), 20 cards/kit
FDA Device · Class I · 2016-05-18 · Biomerieux - NovaPACS Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation
FDA Device · Class II · 2016-05-18 · Novarad - Ascom Mobile Monitoring Gateway (versions 4.1.1 and 4.2.0) and Ascom Unite Connect for Nurse Call (version 2.2.0)
FDA Device · Class II · 2016-05-18 · Ascom Us - Dimension Assays: Triglycerides (TGL)
FDA Device · Class II · 2016-05-18 · Siemens Healthcare Diagnostics - Vitek 2 Gram Positive Susceptibility Test Cards (AST-P643 REF 418671), 20 cards/kit
FDA Device · Class I · 2016-05-18 · Biomerieux - Dimension Vista Assays: Triglycerides (TRIG)
FDA Device · Class II · 2016-05-18 · Siemens Healthcare Diagnostics - Advia Chemistry Assay: LDL Cholesterol, Direct
FDA Device · Class II · 2016-05-18 · Siemens Healthcare Diagnostics - Dimension Assays: ENZYMATIC CREATININE
FDA Device · Class II · 2016-05-18 · Siemens Healthcare Diagnostics - Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411-36C, CD1411-36Q, CD1411-36C Product Usage: Ellipse ICD device…
FDA Device · Class II · 2016-05-18 · St Jude Medical - Given Imaging Bravo¿ pH capsule delivery device, 5-pack
FDA Device · Class II · 2016-05-18 · Covidien - Vitek 2 Gram Positive Susceptibility Test Cards (AST-P641 REF 418590), 20 cards/kit
FDA Device · Class I · 2016-05-18 · Biomerieux - Dimension Vista Assays: Uric Acid (URCA)
FDA Device · Class II · 2016-05-18 · Siemens Healthcare Diagnostics - Vitek 2 Gram Positive Susceptibility Test Cards (AST-P646 REF 420144), 20 cards/kit
FDA Device · Class I · 2016-05-18 · Biomerieux - Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN method is an in vitro diagnostic test for the quantitative measure…
FDA Device · Class II · 2016-05-18 · Siemens Healthcare Diagnostics - GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2754-FC Product Usage: The FlowCOUPLER Device is a single use,…
FDA Device · Class II · 2016-05-18 · Baxter Healthcare - Axial Torque Limiting Driver (1st generation) Product Usage: The Bradshaw Medical Axial Torque Limiting Driver is a reusable surgical instr…
FDA Device · Class II · 2016-05-18 · Bradshaw Medical - Advia Chemistry Assay: Lactate
FDA Device · Class II · 2016-05-18 · Siemens Healthcare Diagnostics - Advia Chemistry Assays - Cholesterol_2 concentrated and Cholesterol, LDL Cholesterol
FDA Device · Class II · 2016-05-18 · Siemens Healthcare Diagnostics - Given Imaging Bravo¿¿ pH capsule delivery device, 1-pack
FDA Device · Class II · 2016-05-18 · Covidien - Vitek 2 Gram Positive Susceptibility Test Cards (AST-P639 REF 418662), 20 cards/kit
FDA Device · Class I · 2016-05-18 · Biomerieux - Dimension Vista Assays: Enzymatic Creatine (ECRE)
FDA Device · Class II · 2016-05-18 · Siemens Healthcare Diagnostics - Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL)
FDA Device · Class II · 2016-05-18 · Siemens Healthcare Diagnostics - Vitek 2 Gram Positive Susceptibility Test Cards (AST-P645 REF 419602), 20 cards/kit
FDA Device · Class I · 2016-05-18 · Biomerieux - ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATION NAME: Immunoassay Analyzers
FDA Device · Class III · 2016-05-18 · Siemens Healthcare Diagnostics - Dimension Vista Assays: Direct HDL Cholesterol (AHDL)
FDA Device · Class II · 2016-05-18 · Siemens Healthcare Diagnostics - Vitek 2 Gram Positive Susceptibility Test Cards (AST-P644 REF 418673), 20 cards/kit
FDA Device · Class I · 2016-05-18 · Biomerieux - Arctic Sun Temperature Management System, 5000, 100-120V and 220-240V The product is a thermal regulating system indicated for monitoring a…
FDA Device · Class II · 2016-05-18 · C R Bard - GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2752-FC Product Usage: The FlowCOUPLER Device is a single use,…
FDA Device · Class II · 2016-05-18 · Baxter Healthcare - GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2753-FC. Product Usage: The FlowCOUPLER Device is a single use,…
FDA Device · Class II · 2016-05-18 · Baxter Healthcare - GEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2755-FC Product Usage: The FlowCOUPLER Device is a single use,…
FDA Device · Class II · 2016-05-18 · Baxter Healthcare - GEM(TM), FLOWCOUPLER(R), 4.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2756-FC Product Usage: The FlowCOUPLER Device is a single use,…
FDA Device · Class II · 2016-05-18 · Baxter Healthcare - Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures
FDA Device · Class II · 2016-05-18 · Applied Medical Resources - Vitek 2 Gram Positive Susceptibility Test Cards (AST-P640 REF 418579), 20 cards/kit
FDA Device · Class I · 2016-05-18 · Biomerieux - Dimension Assays: Direct HDL Cholesterol (AHDL)
FDA Device · Class II · 2016-05-18 · Siemens Healthcare Diagnostics - CinchLock SS Knotless Anchor with Inserter
FDA Device · Class II · 2016-05-18 · Stryker - CinchLock Flex Knotless Anchor with Inserter
FDA Device · Class II · 2016-05-18 · Stryker - NeuViz 64 Multi-Slice CT Scanner System (consist if two variants: NeuViz 64e, NeuViz 64i)
FDA Device · Class II · 2016-05-18 · Neusoft Medical Systems - ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA Chemistry Glucose & Concentrated Glucose Oxidase Assay and ADVIA Chemistry Glucose
FDA Device · Class II · 2016-05-18 · Siemens Healthcare Diagnostics - Dimension Assays: Uric Acid (URCA)
FDA Device · Class II · 2016-05-18 · Siemens Healthcare Diagnostics - Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position
FDA Device · Class II · 2016-05-18 · Atlas Spine - Distal Femoral Replacement (patient specific, custom made orthopedic implant device)
FDA Device · Class II · 2016-05-18 · Stanmore Implants Worldwide - Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 384400 (US) Intended to provide enteral nutrition to a patient for hospital and…
FDA Device · Class II · 2016-05-18 · Medtronic - Hamilton G5 with software version between v2.41, v2.42, v2.50
FDA Device · Class II · 2016-05-18 · Hamilton Medical - Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor, Battery Packs Model Number - 016400, 010520
FDA Device · Class I · 2016-05-18 · Medtronic - Syva Emit Methotrexate Assay, is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of methotrexate in human se…
FDA Device · Class II · 2016-05-18 · Siemens Healthcare Diagnostics - ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT & ADVIA CHEMISTRY TRIGLYCERIDES_2 Concentrated (TRIG_c) REAGENT
FDA Device · Class II · 2016-05-18 · Siemens Healthcare Diagnostics - ADVIA CHEMISTRY ENZYMATIC CREATININE_2
FDA Device · Class II · 2016-05-18 · Siemens Healthcare Diagnostics - Vitek 2 Gram Positive Susceptibility Test Cards (AST-P642 REF 418604), 20 cards/kit
FDA Device · Class I · 2016-05-18 · Biomerieux - Mallinckrodt Evac Tracheal Tubes Model #124170-MALLINCKRODT & 124175
FDA Device · Class II · 2016-05-18 · Stryker Sustainability Solutions - Advia Chemistry Assay: Uric Acid and Uric Acid, concentrated
FDA Device · Class II · 2016-05-18 · Siemens Healthcare Diagnostics - Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lot EB6064, Open Well Instability The SIR…
FDA Device · Class II · 2016-05-18 · Siemens Healthcare Diagnostics - Launcher Guiding Catheter Model #LA6EBU30
FDA Device · Class II · 2016-05-18 · Stryker Sustainability Solutions - Alaris PC unit, Model 8015 The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System
FDA Device · Class II · 2016-05-11 · Carefusion 303 - MAKOplasty Hip Array Kit Laminate 150230
FDA Device · Class II · 2016-05-11 · Mako Surgical - Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL Product Code # 710200S Serial # >200805 and <204001 The Dialog+ can be used…
FDA Device · Class I · 2016-05-11 · B Braun Medical - CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490
FDA Device · Class II · 2016-05-11 · Carestream Health - Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, Model 4500
FDA Device · Class II · 2016-05-11 · Nuvectra - TCM CombiM Modules 903-111
FDA Device · Class II · 2016-05-11 · Radiometer America - Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A The Dialog+ can be used for implementing and monitoring hemodialys…
FDA Device · Class I · 2016-05-11 · B Braun Medical - Syngo Dynamics
FDA Device · Class II · 2016-05-11 · Siemens Medical Solutions Usa - Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do No…
FDA Device · Class II · 2016-05-11 · Applied Medical Technology
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