FDA Device · 2017
FDA Device recalls in 2017
RecallRadar indexes 2,615 FDA Device recall notices published in 2017. By classification: 51 Class I, 2,510 Class II, 54 Class III.
- Halo One 5F Introducer Sheath 90 cm Product Code: HAL590 Product Usage: The Halo One Thin-Walled Guiding Sheath is designed to perform as b…
FDA Device · Class I · 2017-01-25 · Bard Peripheral Vascular - Merge Cardio software
FDA Device · Class II · 2017-01-25 · Merge Healthcare - NucliSENS magnetic extraction reagents, For in vitro diagnostic use, Product Usage: NucliSENS miniMAG¿ is intended to be used for the extra…
FDA Device · Class I · 2017-01-25 · Biomerieux - AFX Endovascular AAA System, Endoleak Type IIIB
FDA Device · Class II · 2017-01-25 · Endologix - AFX Endovascular AAA System, Endoleak Type IIIA
FDA Device · Class II · 2017-01-25 · Endologix - Alcon Monarch III (1) "C" Cartridge The device is used for implanting AcrySof intraocular lenses in the eye following cataract removal
FDA Device · Class II · 2017-01-18 · Alcon Research - REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116
FDA Device · Class II · 2017-01-18 · Smith And Nephew - Biograph mCT S(40)-4R, Material Number 10248671 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomograp…
FDA Device · Class II · 2017-01-18 · Siemens Medical Solutions Usa - 133" 60 Drop 24 Hour Primary Set w/2 Bravo24¿, 2 Gang 1o2¿ Manifold, Rotating Luer, 1 Ext, Item No. B59006 Product Usage: The intravascular…
FDA Device · Class II · 2017-01-18 · Icu Medical - SCREW 02.7-12MM LOCKING, REF W27 ST112: a) DRP, b) NEO, In2Bones, 28 chemin du petit bois, 69130 Ecully - France The NEOVIEW¿ Plating Syste…
FDA Device · Class II · 2017-01-18 · In2bones Sas - Merge Eye Station f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Ima…
FDA Device · Class II · 2017-01-18 · Merge Healthcare - Artis zee/zeego, Angiographic x-ray system Stand alone system The Artis systems are a family of dedicated angiography systems developed for…
FDA Device · Class II · 2017-01-18 · Siemens Medical Solutions Usa - Femoral and Tibial Cutting Block Adapter Base
FDA Device · Class II · 2017-01-18 · Brainlab Ag - DxH 600 Coulter Cellular Analysis System, Catalog No. B23858
FDA Device · Class II · 2017-01-18 · Beckman Coulter - Biograph mCT X-4R, Material Number 10248670 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (…
FDA Device · Class II · 2017-01-18 · Siemens Medical Solutions Usa - Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analyze and plan radiatio…
FDA Device · Class II · 2017-01-18 · Elekta - Straumann Drill 1, short, ¿ 2.2mm, l 33.0mm, SS-Non sterile
FDA Device · Class II · 2017-01-18 · Straumann Manufacturing - Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free Intended use: For the administration of drugs and solutions to…
FDA Device · Class II · 2017-01-18 · Hospira - Natus Warmette Blanket Cabinet and Warmette Dual Cabinet The Natus Warmette Blanket Cabinet is designed to store and warm blankets and hosp…
FDA Device · Class II · 2017-01-18 · Natus Manufacturing - MiniLoc¿ Safety Infusion Set Winged without Y-Injection Site
FDA Device · Class II · 2017-01-18 · Bard Access Systems - Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Sterile, The product is placed into an Aluminum Oxide coated PET…
FDA Device · Class II · 2017-01-18 · Zimmer Biomet - Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a component of a system indicated for the fixati…
FDA Device · Class II · 2017-01-18 · Trilliant Surgical - StatLock¿ CV Plus w/Pigtail
FDA Device · Class II · 2017-01-18 · Bard Access Systems - UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B68304
FDA Device · Class II · 2017-01-18 · Beckman Coulter - NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, In2Bones, 28 chemin du petit bois, 69130 Ecully - France The NEOVIEW¿ Plating System is intende…
FDA Device · Class II · 2017-01-18 · In2bones Sas - ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal¿ PS Knee Replacement System is intended for use as a tota…
FDA Device · Class II · 2017-01-18 · Conformis - StatLock¿ PICC Plus Crescent Foam
FDA Device · Class II · 2017-01-18 · Bard Access Systems - Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed T…
FDA Device · Class II · 2017-01-18 · Siemens Medical Solutions Usa - Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation Knowledge Based Contouring version 2.3 [2.3.12] Radiolog…
FDA Device · Class II · 2017-01-18 · Varian Medical Systems - symmetry surgical ULTRA(R) Sterrad container, REF numbers: C131310-SP, C13134-SP, C13135-SP, C13136-SP, C13139-SP, C13854-SP, C13855-SP, C1…
FDA Device · Class II · 2017-01-18 · Symmetry Surgical - NEOVIEW(R) SCREWS SET, REF W27 ST900, STERILE R The NEOVIEW¿ Plating System is intended for fixation of intra-articular and extraarticular…
FDA Device · Class II · 2017-01-18 · In2bones Sas - Reunion TSA Peg Alignment Sound Catalog #5901-1038 The Peg Alignment Sound (PIN 5901-1038, Revision A) is an instrument used in the ReUnion…
FDA Device · Class II · 2017-01-18 · Stryker Howmedica Osteonics - i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System Device Listing Number E454448
FDA Device · Class II · 2017-01-18 · Health Robotics S R L - Biograph mCT Flow Edge-4R, Material Number 10528955 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomo…
FDA Device · Class II · 2017-01-18 · Siemens Medical Solutions Usa - symmetry surgical ULTRA(R) Gravity container, REF numbers: C131310-G, C13134-G, C13135-G, C13136-G, C13139-G, C13854-G, C13855-G, C13856-G,…
FDA Device · Class II · 2017-01-18 · Symmetry Surgical - Reprocessed Electrophysiology Catheter Cables Catalog Number: CB3434CT, D134401, CB3410CT, CB3412CT Electrophysiology catheter cables are d…
FDA Device · Class II · 2017-01-18 · Stryker Sustainability Solutions - AxIEM Touch N Go Pointer Probe
FDA Device · Class II · 2017-01-18 · Medtronic Navigation - SIEMENS IMMULITE 2000/2000 Xpi Systems Intact PTH (Parathyroid Hormone) Test Code iPTH, REF/Catalog Number L2KPP2, Siemens Material Number…
FDA Device · Class II · 2017-01-18 · Siemens Healthcare Diagnostics - Reprocessed Ablation Catheter Cable Catalog Number: CR3425CT, CR3434CT Ablation catheter cables are designed as electrode cables with a mul…
FDA Device · Class II · 2017-01-18 · Stryker Sustainability Solutions - BIOGRAPH mCT 20 Excel, Material Number 10507786 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomograp…
FDA Device · Class II · 2017-01-18 · Siemens Medical Solutions Usa - FV-RF (Clinix RF Plus) Product Usage: A Stationary X-ray System, a device intended for radiographic/fluoroscopic examinations of various an…
FDA Device · Class II · 2017-01-18 · Philips Medical Systems Cleveland - Brilliance iCT Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstr…
FDA Device · Class II · 2017-01-18 · Philips Medical Systems Cleveland - Halo Closed System Transfer Device, closed syringe adaptor, REF CSA100, Rx only, Sterile, packaged as individual units, packed and shipped…
FDA Device · Class II · 2017-01-18 · J And J Solutions - OEC 9800
FDA Device · Class II · 2017-01-18 · Ge Oec Medical Systems - Biograph mCT-X w/TrueV Upgrade, Material Number 10250745 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed…
FDA Device · Class II · 2017-01-18 · Siemens Medical Solutions Usa - Tego Connector, Item No. D1000, NM1000 The Tego¿ Needle Free Access Device is intended for use as an accessory to a vascular access device…
FDA Device · Class II · 2017-01-18 · Icu Medical - symmetry surgical ULTRA(R) Steam container, REF numbers: C131310, C13134, C13135, C13136, C13139, C13854, C13855, C13856, C181310, C18134,…
FDA Device · Class II · 2017-01-18 · Symmetry Surgical - Artis Q/Q.zen, Angiographic x-ray system Stand alone system The Artis systems are a family of dedicated angiography systems developed for s…
FDA Device · Class II · 2017-01-18 · Siemens Medical Solutions Usa - EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disi…
FDA Device · Class II · 2017-01-18 · Advanced Sterilization Products - IQon Spectral CT with software version 4.7.0 Product Usage: The IQon Spectral CT is a Computed Tomography X-Ray System intended to produce…
FDA Device · Class II · 2017-01-18 · Philips Medical Systems Cleveland - VOCO Futurabond M+ adhesive, RF 1515, Manufactured by VOCO GmbH, Futurabond M+ is a dental adhesive for use with methacrylate-based restora…
FDA Device · Class II · 2017-01-18 · Voco - Straumann Twist Drill PRO ¿4.2mm,long,41mm,SS-Non sterile
FDA Device · Class II · 2017-01-18 · Straumann Manufacturing - Ceres-C Standalone Cervical Interbody The product is a stand-alone anterior cervical interbody fusion device indicated for use in skeletall…
FDA Device · Class II · 2017-01-18 · Amendia - Biograph mCT X-3R, Material Number 10248673 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (…
FDA Device · Class II · 2017-01-18 · Siemens Medical Solutions Usa - The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surg…
FDA Device · Class II · 2017-01-18 · Ge Oec Medical Systems - Biograph mCT Flow 40-4R, Material Number 10529159 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomogr…
FDA Device · Class II · 2017-01-18 · Siemens Medical Solutions Usa - Biograph mCT S(64)-3R, Material Number 10248669 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomograp…
FDA Device · Class II · 2017-01-18 · Siemens Medical Solutions Usa - SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stabilization Device
FDA Device · Class II · 2017-01-18 · C R Bard - Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria MRI" CRT -D SureScan", Claria MRI" Quad CRT -D SureScan. implantabl…
FDA Device · Class II · 2017-01-18 · Medtronic Cardiac Rhythm And Heart Failure - Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy
FDA Device · Class II · 2017-01-18 · Elekta - Biograph mCT S(64)-4R, Material Number 10248672 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomograp…
FDA Device · Class II · 2017-01-18 · Siemens Medical Solutions Usa - Biograph mCT S(40)-3R, Material Number 10248668 The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomograp…
FDA Device · Class II · 2017-01-18 · Siemens Medical Solutions Usa - OPT Croutons is a synthetic bone substitute designed for the repair of bony defects and is made of pure beta-tricalcium phosphate
FDA Device · Class II · 2017-01-18 · Acumed - Infant Warmer System (IWS)
FDA Device · Class II · 2017-01-18 · Ge Healthcare - OEC MiniView 6800
FDA Device · Class II · 2017-01-18 · Ge Oec Medical Systems - SafeStep¿ Huber Needle Set with Y-Injection Site
FDA Device · Class II · 2017-01-18 · Bard Access Systems - Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies from the eye of the p…
FDA Device · Class II · 2017-01-18 · Bausch And Lomb - Medline E-Z Lubricating Jelly
FDA Device · Class II · 2017-01-18 · Medline Ind - GoDirect Screw-Retaining Top Part Numbers: 4500-61
FDA Device · Class II · 2017-01-18 · Implant Direct Sybron Manufacturing - G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9180-06, 9180-07, 9180-17, 9101-00, 9101-06 The Opticage Expand…
FDA Device · Class II · 2017-01-11 · Interventional Spine - GalaSHAPE 3D
FDA Device · Class II · 2017-01-11 · Tepha - Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly
FDA Device · Class II · 2017-01-11 · Boston Scientific - Modular SMF(TM) The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surger…
FDA Device · Class II · 2017-01-11 · Smith And Nephew - PreludeEASE Hydrophilic Sheath Introducer Dilator The Merit PreludeEASE Hydrophilic Sheath Introducer is intended to provide access and fac…
FDA Device · Class II · 2017-01-11 · Merit Medical Systems - Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ml fill and 10 ml fill
FDA Device · Class I · 2017-01-11 · Nurse Assist - Gomco Circumcision Clamps with separate O-Ring Component: The device is packaged non-sterile and has no shelf-life The Gomco clamp is inten…
FDA Device · Class II · 2017-01-11 · Aesculap Implant Systems - Modular REDAPT(TM) Hip Systems The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and…
FDA Device · Class II · 2017-01-11 · Smith And Nephew - DR Systems Unity PACS software, now known as Merge Unity PACS software
FDA Device · Class II · 2017-01-11 · Merge Healthcare - Modular Necks: The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery…
FDA Device · Class II · 2017-01-11 · Smith And Nephew - PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Orthopedics, Arlington, TN Instruments support the implantation of…
FDA Device · Class II · 2017-01-11 · Microport Orthopedics - TRU-Balance 3 Power Positioning Systems, TB3 Lift/Tilt/Recline (Gen 1)
FDA Device · Class II · 2017-01-11 · Pride Mobility Products - TVC Imaging System model TVC-MC9 , for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiogra…
FDA Device · Class II · 2017-01-11 · Infraredx - Sterling Diagnostics, Inc., SGPT Colorimetric for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes
FDA Device · Class III · 2017-01-04 · Sterling Diagnostics - SFX
FDA Device · Class II · 2017-01-04 · Ge Healthcare - Prestige VH
FDA Device · Class II · 2017-01-04 · Ge Healthcare - Precision 500D
FDA Device · Class II · 2017-01-04 · Ge Healthcare - Prestige II
FDA Device · Class II · 2017-01-04 · Ge Healthcare - Shimadzu X-ray TV System, Catalog No. SONIALVISION G4
FDA Device · Class II · 2017-01-04 · Shimadzu Medical Systems - SOMATOM Scope Power, Computed tomography x-ray system
FDA Device · Class II · 2017-01-04 · Siemens Medical Solutions Usa - Creatinine/Endpoint [Modified Heinegard-Tiderstrom] for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes
FDA Device · Class III · 2017-01-04 · Sterling Diagnostics - Sterling Diagnostics, Inc.Colorimetric SGOT for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes
FDA Device · Class III · 2017-01-04 · Sterling Diagnostics - Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0 Specimen Gate Laboratory is intended for use as…
FDA Device · Class II · 2017-01-04 · Perkinelmer Health Sciences - NeuViz 64 Multi-slice CT Scanner Systems
FDA Device · Class II · 2017-01-04 · Neusoft Medical Systems - SOMATOM Perspective, Computed tomography x-ray system
FDA Device · Class II · 2017-01-04 · Siemens Medical Solutions Usa - Sterling Diagnostics, Inc., Enzymatic Uric Acid (Uricase Trinder) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes
FDA Device · Class III · 2017-01-04 · Sterling Diagnostics - NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only
FDA Device · Class II · 2017-01-04 · Medtronic Xomed - ADVANTX LCA
FDA Device · Class II · 2017-01-04 · Ge Healthcare - Enzymatic Cholesterol (Trinder/COD-CEH) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes
FDA Device · Class III · 2017-01-04 · Sterling Diagnostics - NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version
FDA Device · Class II · 2017-01-04 · Neusoft Medical Systems - Arthex S3 Arm Sleeve Connector
FDA Device · Class II · 2017-01-04 · Allen Medical Systems
Other years
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