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.
- Ingenuity Core Computed Tomography X-ray system, Model 728321
FDA Device · Class III · 2016-11-23 · Philips Medical Systems Cleveland - Cath Lab Kit w/03 ml Intraflo, 2 Port Manifold Right OFF Rotator and TP4, Item No. 46098-19 The Transpac Disposable Straight Pressure Trans…
FDA Device · Class II · 2016-11-23 · Icu Medical - TRIPLE PRESSURE KIT WITH 03ML FLUSH DEVICE FOR METHODIST M.C. OF ILLINOIS, Item No. 46072-51 The Transpac Disposable Straight Pressure Tran…
FDA Device · Class II · 2016-11-23 · Icu Medical - Atrium Medical 28 Fr Trocar catheter, Sterile Model Number: 8428 Intended to facilitate the evacuation of air and/or fluid from the chest c…
FDA Device · Class II · 2016-11-23 · Atrium Medical - Covidien Devon Light Glove sub-assembly non-sterile For Kit Packers Product Usage: A disposable, sterile, single-use cover for compatible s…
FDA Device · Class II · 2016-11-16 · Covidien - SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum OD 2.6mm
FDA Device · Class II · 2016-11-16 · Akita Sumitomo Bakelite - Professional Hospital Supply, Inc Custom Packaging containing the Devon Light Glove Item Number Description 380789003 SURE SET SINGLE BASIN…
FDA Device · Class II · 2016-11-16 · Covidien - Covidien Devon Light Glove packaged in sterile surgical kits Reference: 31140208 Product Usage: A disposable, sterile, single-use cover for…
FDA Device · Class II · 2016-11-16 · Covidien - Symbiq Two Channel Infuser
FDA Device · Class II · 2016-11-16 · Hospira - OR Table, Top U26 H V, Model # 1909793
FDA Device · Class II · 2016-11-16 · Trumpf Medical Systems - SOMATOM Definition Flash system, x-ray, tomography, computed
FDA Device · Class II · 2016-11-16 · Siemens Medical Solutions Usa - NRG Transseptal Needle and NRG RF Transseptal Kit
FDA Device · Class II · 2016-11-16 · Baylis Medical - Zimmer¿ Air Dermatome II Handpiece Loaner, item number 01-8851-001-00
FDA Device · Class II · 2016-11-16 · Zimmer Surgical - SOMATOM Definition AS system, x-ray, tomography, computed
FDA Device · Class II · 2016-11-16 · Siemens Medical Solutions Usa - X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-0601-350V10 103-0602-350V06 103-0601-300V01 103-0602-300 103-0602-3…
FDA Device · Class I · 2016-11-16 · Micro Therapeutics - ReShape Integrated Dual Balloon System, Gen 1, Model No. 01-0013-001, Catalog No. RSM110 product Usage: The ReShape Integrated Dual Balloon…
FDA Device · Class II · 2016-11-16 · Reshape Medical - Pipeline Embolization Device (Pipeline Classic) The device is indicated for the endovascular treatment of adults (22 year of age or older)…
FDA Device · Class I · 2016-11-16 · Micro Therapeutics - TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device software that is installed on bone densitometers for analysis of…
FDA Device · Class II · 2016-11-16 · Medimaps Group - Replacement floor locking cylinders for the Schaerer model 7300 surgical tables
FDA Device · Class II · 2016-11-16 · Schaerer Medical Usa - The surgical table is a stand alone unit
FDA Device · Class II · 2016-11-16 · Schaerer Medical Usa - AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusion of the heart's left atrial appendage,…
FDA Device · Class II · 2016-11-16 · Atricure - Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use Product Usage: The Roche COBAS INTEGRA c111 analyzer…
FDA Device · Class II · 2016-11-16 · Roche Diagnostics Operations - X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE Sheath, 8 mm x 15 cm, Product Code 996081 The product is a du…
FDA Device · Class II · 2016-11-16 · C R Bard - Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera…
FDA Device · Class I · 2016-11-16 · Micro Therapeutics - Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body removal
FDA Device · Class I · 2016-11-16 · Micro Therapeutics - SB (Sumitomo Bakelite Co.,) Electrosurgical Knife Size: Working Length 1.8M Maximum OD 2.6mm
FDA Device · Class II · 2016-11-16 · Akita Sumitomo Bakelite - Accessory Adapter Part number 600525A0 Product Usage: designed for the mounting of MAQUET accessories with the dovetail guide interface imm…
FDA Device · Class II · 2016-11-16 · Maquet Medical Systems Usa - LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236
FDA Device · Class II · 2016-11-16 · Stryker Howmedica Osteonics - GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max dialyzer is a single us…
FDA Device · Class II · 2016-11-16 · Baxter Healthcare - FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use in the cardiovascular system for introduction and posi…
FDA Device · Class I · 2016-11-16 · Sentreheart - Reprocessed Daig Steerable and Daig Supreme Fixed Curve Diagnostic Electrophysiology Catheters Model Numbers: 401940, 402004 UPC Code: 0088…
FDA Device · Class II · 2016-11-16 · Stryker Sustainability Solutions - Symbiq One Channel Infuser
FDA Device · Class II · 2016-11-16 · Hospira - catalog # 405612 BD Spinal Anesthesia Tray 22G x 3.5 in
FDA Device · Class II · 2016-11-16 · Becton Dickinson And - ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic acid in human plasma
FDA Device · Class II · 2016-11-16 · Abbott Laboratories - AC TenderLink 13/30 10 pcs
FDA Device · Class II · 2016-11-09 · Unomedical As - Model 055: Thermophore Classic, Professional Quality, Deep-Heat Therapy, Model 055 Large 14' x 27", Model 056: Thermophore Classic, Profess…
FDA Device · Class II · 2016-11-09 · Battle Creek Equipment - TD60 display Telemetry Transmitter, SHENZHEN Mindray Bio-Medical Electronics Co., LTD, Mindray Building, Keji 12th Road South, Hi-Tech Indu…
FDA Device · Class II · 2016-11-09 · Mindray Ds Usa - TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71322040, 71322041, 71322042, 71322043, 71322044, 71322045, 71322046, 71322047, 7…
FDA Device · Class II · 2016-11-09 · Smith And Nephew - 15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the epidural placement, directly or through an epidural catheter, of a…
FDA Device · Class II · 2016-11-09 · Epimed International - Silhouette Paradigm 13mm, 18"
FDA Device · Class II · 2016-11-09 · Unomedical As - Guider Softip XF
FDA Device · Class II · 2016-11-09 · Stryker Neurovascular - Guider Softip XF
FDA Device · Class II · 2016-11-09 · Stryker Neurovascular - Guider Softip XF
FDA Device · Class II · 2016-11-09 · Stryker Neurovascular - Visualase Body Accessory Kit PN 020-3000
FDA Device · Class II · 2016-11-09 · Medtronic Navigation - Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling installed rail systems: Multirall 200, Likorall 200, 242, 243, 25…
FDA Device · Class II · 2016-11-09 · Hill Rom - Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies temperature-controlled water for cardioplegia heat exchangers and for bl…
FDA Device · Class II · 2016-11-09 · Maquet Cardiovascular Us Sales - Fruit Punch Glucose, 100 Gram Concentration, Liquid, 4/Pack of 6 Bottles, 24/cs Accessory to an In Vitro Diagnostic Oral Glucose Tolerance…
FDA Device · Class II · 2016-11-09 · Azer Scientific - Rigid Suction Canister 3000 CC and 2000 CC
FDA Device · Class II · 2016-11-09 · Medline Industries - Guider Softip XF
FDA Device · Class II · 2016-11-09 · Stryker Neurovascular - Guider Softip XF
FDA Device · Class II · 2016-11-09 · Stryker Neurovascular - Contact Detach, 8mm, 23", G29
FDA Device · Class II · 2016-11-09 · Unomedical As - Guider Softip XF
FDA Device · Class II · 2016-11-09 · Stryker Neurovascular - HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD thermodilution catheter enclosed in a contamination shield (Arro…
FDA Device · Class II · 2016-11-09 · Arrow International - SureT G29 6mm, 18", Paradigm
FDA Device · Class II · 2016-11-09 · Unomedical As - TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71324038, 71324039, 71324040, 71324041, 71324042, 71324043, 71324044, 713240…
FDA Device · Class II · 2016-11-09 · Smith And Nephew - Visualase Visualization Stylets PN 020-2301
FDA Device · Class II · 2016-11-09 · Medtronic Navigation - Guider Softip XF
FDA Device · Class II · 2016-11-09 · Stryker Neurovascular - Xhibit Central Station, Model 96102
FDA Device · Class II · 2016-11-09 · Spacelabs Healthcare - Comfort 5+5 Pack w/110cm Tube & 17mm Cann
FDA Device · Class II · 2016-11-09 · Unomedical As - Infusion Set, Comfort, 23" Hosp 10
FDA Device · Class II · 2016-11-09 · Unomedical As - Symbiq Two Channel Infuser
FDA Device · Class II · 2016-11-09 · Hospira - Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system v…
FDA Device · Class II · 2016-11-09 · Stryker Sustainability Solutions - Affected Pain Control Tray Component (5% Lidocaine Hydrochloride and 7.5% DExtrose Injection, USP) Injection of anesthetics to provide regi…
FDA Device · Class II · 2016-11-09 · B Braun Medical - Glucose Tolerance Beverage- Orange 50 gram Concentration, Liquid 4/Pack of 6 bottles, 24/case Accessory to an In Vitro Diagnostic Oral Gluc…
FDA Device · Class II · 2016-11-09 · Azer Scientific - Guider Softip XF
FDA Device · Class II · 2016-11-09 · Stryker Neurovascular - Guider Softip XF
FDA Device · Class II · 2016-11-09 · Stryker Neurovascular - Guider Softip XF
FDA Device · Class II · 2016-11-09 · Stryker Neurovascular - Guider Softip XF
FDA Device · Class II · 2016-11-09 · Stryker Neurovascular - Guider Softip XF
FDA Device · Class II · 2016-11-09 · Stryker Neurovascular - Guider Softip XF
FDA Device · Class II · 2016-11-09 · Stryker Neurovascular - Symbiq One Channel Infuser
FDA Device · Class II · 2016-11-09 · Hospira - Guider Softip XF
FDA Device · Class II · 2016-11-09 · Stryker Neurovascular - Empowr PS Knee System Box Cut Guide
FDA Device · Class II · 2016-11-09 · Encore Medical - Guider Softip XF
FDA Device · Class II · 2016-11-09 · Stryker Neurovascular - PhoenixSpec AP Calibrator is used to calibrate the PhoenixSpec &
FDA Device · Class III · 2016-11-02 · Becton Dickinson And - SimpliRED D-Dimer, Product Code DSRK4 The SimpliRED D-dimer assay is a rapid, qualitative test for the detection of cross-linked fibrin deg…
FDA Device · Class II · 2016-11-02 · Bbi Solutions Oem - Fortify VR, Model No. CD1231-40, CD1231-40Q. Fortify ST VR, Model No. CD1241-40, CD1241-40Q. Fortify Assura VR, Model No. CD1257-40, CD1257…
FDA Device · Class I · 2016-11-02 · St Jude Medical - Unify, Model No. CD3231-40, CD3231-40Q. Unify Quadra, Model No. CD3249-40, CD3249-40Q. Unify Assura, Model No. CD3257-40, CD3357-40C, CD335…
FDA Device · Class I · 2016-11-02 · St Jude Medical - The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringes
FDA Device · Class II · 2016-11-02 · Accessclosure A Cardinal Health - Symbiq One Channel Infuser
FDA Device · Class II · 2016-11-02 · Hospira - URISYS 2400 Urine Analyzer Automated Urinalysis System Product Usage: The RSD 800 is a computer-controlled stand-alone sorting system for s…
FDA Device · Class II · 2016-11-02 · Roche Diagnostics Operations - cobas p 612 Pre-Analytical Instrument calculator/data processing module, for clinical use Product Usage: The cobas 6000 series is a fully a…
FDA Device · Class II · 2016-11-02 · Roche Diagnostics Operations - cobas p 501 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The MODULAR PRE-ANALYTICS system is a f…
FDA Device · Class II · 2016-11-02 · Roche Diagnostics Operations - Keystone Dental PrimaConnex¿ Straight Implant TC, RD Internal Connection 4.0 x 11.5mm
FDA Device · Class II · 2016-11-02 · Keystone Dental - cobas e411 Immunoassay Analyzer e411: Immunoassay Analyzer Product Usage: The cobas p501/p701 instrument stores primary and secondary sampl…
FDA Device · Class II · 2016-11-02 · Roche Diagnostics Operations - enGen Laboratory Automation System (Product Code ENGEN) configured with Thermo Scientific Centrifuge Module and TCAutomation Software Versi…
FDA Device · Class II · 2016-11-02 · Ortho Clinical Diagnostics - da Vinci¿ Xi" Surgical System, model number IS4000, A70_P5x with P5 Software
FDA Device · Class II · 2016-11-02 · Intuitive Surgical - cobas 6000 Series system c6000, Chemistry (Photometric, Discrete), for clinical Use
FDA Device · Class II · 2016-11-02 · Roche Diagnostics Operations - ReTurn 7500/7500 Aid, transfer
FDA Device · Class II · 2016-11-02 · Handicare Usa - Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fort…
FDA Device · Class I · 2016-11-02 · St Jude Medical - Roche/Hitachi MODULAR Analytics Combination Systems Modular D/P: Clinical Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinica…
FDA Device · Class II · 2016-11-02 · Roche Diagnostics Operations - VIA 27 Microcatheter, Part No. FG27-154-01, Model No. VIA-27-154-01 The VIA 27 is intended for the introduction of non-liquid interventiona…
FDA Device · Class II · 2016-11-02 · Sequent Medical - FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional treatments in gynecolo…
FDA Device · Class II · 2016-11-02 · Lumenis - cobas 6800/8800 system Hepatitis Viral B DNA Detection Product Usage: The cobas p512 pre-analytical system is a computer controlled fully a…
FDA Device · Class II · 2016-11-02 · Roche Diagnostics Operations - cobas p 512 Pre-Analytical Instrument calculator/data processing module, for clinical use Product Usage: The cobas 6800/8800 systems suppor…
FDA Device · Class II · 2016-11-02 · Roche Diagnostics Operations - 4205 Journey Rolling Walker Product Usage: used to assist people in walking
FDA Device · Class II · 2016-11-02 · Nova Ortho Med - RSD 800A Aliquoting System calculator/data processing module, for clinical use Product Usage: The Roche/Hitachi MODULAR Analytics System is…
FDA Device · Class II · 2016-11-02 · Roche Diagnostics Operations - Zimmer¿ Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece
FDA Device · Class II · 2016-11-02 · Zimmer Biomet - Symbiq Two Channel Infuser
FDA Device · Class II · 2016-11-02 · Hospira - RSD 800 Sorting System calculator/data processing module, for clinical use Product Usage: The cobas 8000 Modular Analyze Series is a fully…
FDA Device · Class II · 2016-11-02 · Roche Diagnostics Operations
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