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.
- FastPack Free T4 Immunoassay Chemilunescence assay for the determination of Free T4 The FastPack free T4 Immunoassay is a paramagnetic part…
FDA Device · Class II · 2013-12-25 · Qualigen - Stryker brand GDC-18 360 18MM X 30CM, Catalog Number: M00334818300
FDA Device · Class II · 2013-12-25 · Stryker Neurovascular - Stryker brand COMPLIANT 5MM X 30MM, Catalog Number: M003SRC05300
FDA Device · Class II · 2013-12-25 · Stryker Neurovascular - Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS method is an in vitro diagnostic test for the quantitative measurement…
FDA Device · Class II · 2013-12-25 · Siemens Healthcare Diagnostics - Stryker brand COMPLIANT 4MM X 10MM, Catalog Number: M003SRC04100
FDA Device · Class II · 2013-12-25 · Stryker Neurovascular - Mega Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000
FDA Device · Class II · 2013-12-25 · Intuitive Surgical - Stryker brand COMPLIANT 4MM X 20MM, Catalog Number: M003SRC04200
FDA Device · Class II · 2013-12-25 · Stryker Neurovascular - Stryker brand EXCELSIOR SL-10 PRE-SHAPED J 15OCM
FDA Device · Class II · 2013-12-25 · Stryker Neurovascular - Continuous Peripheral Nerve Block Catheter Kit and Set Continuous Peripheral Nerve Block Catheter Kit and Set permits placement of catheter…
FDA Device · Class II · 2013-12-25 · Arrow International - Access Immunoassay Systems Reaction Vessels
FDA Device · Class II · 2013-12-25 · Beckman Coulter - outer box: Ref 906768, CurvTek Eye Needle 22 MM X-large Stainless Steel, Single Use Gamma Sterilized, Rx inner incorrect label: CurvTek 7 M…
FDA Device · Class II · 2013-12-25 · Biomet - Stryker brand EXCELSIOR SL-10 PRE-SHAPED 45 150CM, Catalog Number: M0031681900, Product is manufactured by Stryker Neurovascular, Cork, Ire…
FDA Device · Class II · 2013-12-25 · Stryker Neurovascular - HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220
FDA Device · Class II · 2013-12-25 · Instrumentation Laboratory - Broncho Flexible Fiberscope, models: 11001BN1, 11002BD1, 11004BC1, and 11009BC1. " Examination and treatment of the tracheobronchial tree C…
FDA Device · Class II · 2013-12-25 · Karl Storz Endoscopy America - Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog Number 100018, Product is manufactured and distributed by Mic…
FDA Device · Class II · 2013-12-25 · Microgenics - Nephros SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue, River Edge, NJ 07661 Assembled at : MEDICA 41036 Medolla, Italy Filters are p…
FDA Device · Class I · 2013-12-25 · Nephros - ABACUS TPN Calculation Software, Baxa: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-004…
FDA Device · Class II · 2013-12-25 · Baxter Englewood - Medfusion¿ 4000 Syringe Infusion Pumps Medfusion¿ 4000 Syringe Infusion Pumps are designed for use in care areas for the administration of…
FDA Device · Class II · 2013-12-25 · Smiths Medical Asd - VITROS CA 125 II Calibrators For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic Syste…
FDA Device · Class II · 2013-12-25 · Ortho Clinical Diagnostics - Nephros Dual Stage Ultra Filter (DSU) Brochure Document 60-3003 Revisions: 0, 1, 2 Product Usage: A disposable point of use water ultrafilt…
FDA Device · Class I · 2013-12-25 · Nephros - Intubation Flexible Fiberscope, Models: 11301AA1, 11301BN1, 11302BD1, 11302BD2, 11304BC1, 11340BC1, 11301BND1, 11302BDD1, and 11302BDD2. "…
FDA Device · Class II · 2013-12-25 · Karl Storz Endoscopy America - PedFuse Reset Screw
FDA Device · Class II · 2013-12-25 · Spinefrontier - Stryker brand EXCELSIOR SL-10 PRE-SHAPED S 15OCM
FDA Device · Class II · 2013-12-25 · Stryker Neurovascular - 3M ESPE Imprint II Regular Body , Catalog Number 9379, and Paradigm Regular Body VPS, Catalog Number 5315, Impression Material that are int…
FDA Device · Class II · 2013-12-25 · 3m Health Care Business - Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7
FDA Device · Class II · 2013-12-25 · Aesculap - Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacro…
FDA Device · Class II · 2013-12-25 · Siemens Healthcare Diagnostics - Stryker brand EXCELSIOR SL-10 PRE-SHAPED J 15OCM, Catalog Number: M0031681920
FDA Device · Class II · 2013-12-25 · Stryker Neurovascular - Stryker brand EXCELSIOR 1018 PRE-SHAPED 45 150CM, Catalog Number: M0031441900
FDA Device · Class II · 2013-12-25 · Stryker Neurovascular - Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal grouping, IVD. The kit contains reagent groups A, B, C, D, F, G, a co…
FDA Device · Class II · 2013-12-25 · Remel - Stryker brand COMPLIANT 4MM X 15MM, Catalog Number: M003SRC04150
FDA Device · Class II · 2013-12-25 · Stryker Neurovascular - Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg, 50 discs per cartridge, 5 cartridges per box
FDA Device · Class III · 2013-12-25 · Remel - Kimberly-Clark Single Shot Epidural Pain Management Trays containing the BD LOR Syringe (BD Code 405198) Product Usage: The device is desig…
FDA Device · Class II · 2013-12-25 · Kimberly Clark - Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box
FDA Device · Class II · 2013-12-25 · Remel - Stryker brand SUPER COMPLIANT 7MM X 15MM, Catalog Number: M003SSC07150
FDA Device · Class II · 2013-12-25 · Stryker Neurovascular - FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescence assay for the determination of Vitamin D The FastPack Vitamin D…
FDA Device · Class II · 2013-12-25 · Qualigen - ClearSight(TM) Toric 1 day (ocufilcon D), 30 daily disposable contact lenses for astigmatism, STERILE, Rx only --- CooperVision Hamble, SO3…
FDA Device · Class II · 2013-12-25 · Coopervision - HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120
FDA Device · Class II · 2013-12-25 · Instrumentation Laboratory - Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Disposable, package of 6 pcs, GE Healthcare Finland Oy Made in US Rx…
FDA Device · Class I · 2013-12-25 · Ge Healthcare - Stryker brand SUPER COMPLIANT 4MM X 7MM, Catalog Number: M003SSC04070
FDA Device · Class II · 2013-12-25 · Stryker Neurovascular - Stryker brand COMPLIANT 4MM X 30MM, Catalog Number: M003SRC04300
FDA Device · Class II · 2013-12-25 · Stryker Neurovascular - Stryker brand EXCELSIOR SL-10 PRE-SHAPED 90 150CM, Catalog Number: M0031681910
FDA Device · Class II · 2013-12-25 · Stryker Neurovascular - Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only Product Usage: The Integra kits which contain a…
FDA Device · Class II · 2013-12-25 · Integra Lifesciences D B A Integra Pain Management - SEAC Advanced Dental System, Model A591561 The SEAC Advanced Dental System is a self-contained dental delivery system with a built-in air c…
FDA Device · Class II · 2013-12-25 · Asi Medical - remel RapID Yeast Plus System, 20 tests, Ref: R8311007, IVD, containing a 15-ml bottle of RapID Yeast Plus Reagent A and a 10-ml bottle of…
FDA Device · Class II · 2013-12-25 · Remel - 1) Nephros SafeShower FH - 15 filters per box
FDA Device · Class I · 2013-12-25 · Nephros - Stryker brand EXCELSIOR SL-10 PRE-SHAPED C 15OCM
FDA Device · Class II · 2013-12-25 · Stryker Neurovascular - HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320
FDA Device · Class II · 2013-12-25 · Instrumentation Laboratory - MagNA Pure 96 System Version 1.0 Software Version 2.0 Robotic workstation for automated isolation of nucleic acids from different kinds of…
FDA Device · Class II · 2013-12-25 · Roche Diagnostics Operations - Stryker brand GDC-10 ULTRA SOFT 2MM X 3CM, Catalog Number: M0033432030
FDA Device · Class II · 2013-12-25 · Stryker Neurovascular - Stryker brand GDC VORTX 2MM X 3MM, Catalog Number: M00335302340
FDA Device · Class II · 2013-12-25 · Stryker Neurovascular - Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses, STERILE, Rx ONLY --- Coopervision Shamble, SO 31 4 RF, UK - S…
FDA Device · Class II · 2013-12-25 · Coopervision - KayserBetten model IDA beds Product Usage: BED, AC-POWERED ADJUSTABLE HOSPITAL
FDA Device · Class II · 2013-12-25 · Mobility Unlimited - InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENTrakTM Computer-Assisted Navigation Systems (USA)
FDA Device · Class II · 2013-12-25 · Ge Oec Medical Systems - Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000
FDA Device · Class II · 2013-12-25 · Intuitive Surgical - Stryker brand EXCELSIOR SL-10 150CM 2 TIP, Catalog Number: M0031681890, Product is manufactured by Stryker Neurovascular, Cork, Ireland and…
FDA Device · Class II · 2013-12-25 · Stryker Neurovascular - FastPack Testosterone Immunoassay Chemilunescence assay for the determination of Testosterone The FastPack Testo Immunoassay is a paramagne…
FDA Device · Class II · 2013-12-25 · Qualigen - FreeStyle Lite Blood Glucose Test Strips
FDA Device · Class I · 2013-12-25 · Abbott Diabetes Care - FreeStyle Blood Glucose Test Strips
FDA Device · Class I · 2013-12-25 · Abbott Diabetes Care - FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. FastPack Total PSA Immunoassay is a paramagnetic p…
FDA Device · Class II · 2013-12-25 · Qualigen - Stryker brand COMPLIANT 5MM X 15MM, Catalog Number: M003SRC05150
FDA Device · Class II · 2013-12-25 · Stryker Neurovascular - Centurion Sterile # 84 Rubber Bands Reorder EB84, Caution: This product contains natural rubber latex which may cause allergic reactions
FDA Device · Class II · 2013-12-18 · Centurion Medical Products - Vasoview Hemopro Endoscopic Vessel Harvesting System Maquet Cardiovascular LLC 45 Barbour Pond Drive Wayne, NJ 07470 Indicated for use in m…
FDA Device · Class II · 2013-12-18 · Maquet Cardiovascular - Helion S Exam Light or H300 The device is intended to locally illuminate an examination area of the patient's body with high intensity ligh…
FDA Device · Class II · 2013-12-18 · Trumpf Medical Systems - NexGen Complete Knee Solution CR Articular Surface Provisional-Striped Green 9mm Height Nonsterile Devices are used in total knee arthropla…
FDA Device · Class II · 2013-12-18 · Zimmer - Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp
FDA Device · Class II · 2013-12-18 · Stryker Howmedica Osteonics - 1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, Size #5 Howmedica Osteonics Corp. 325 Corporate Dr…
FDA Device · Class II · 2013-12-18 · Stryker Howmedica Osteonics - NexGen Complete Knee Solution CR Articular Surface Provisional-Yellow 9mm Height Nonsterile Devices are used in total knee arthroplasty and…
FDA Device · Class II · 2013-12-18 · Zimmer - VerifyNow IIb/IIIa Test, 10-Test Kit, Catalog No. 85310, 10 tests/box
FDA Device · Class II · 2013-12-18 · Accumetrics - Axillent Debakey Grasping Forceps, Part No. 33821DYD In general the surgeons use 33821DYD Debakey forceps to grasp tissue
FDA Device · Class II · 2013-12-18 · Karl Storz Endoscopy America - Zimmer Trabecular Metal Total Ankle Talar Component Left Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited m…
FDA Device · Class II · 2013-12-18 · Zimmer - Opal Orthodontics by Ultradent
FDA Device · Class III · 2013-12-18 · Ultradent Products - Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio frequency induced heat, Product is manufactured and distributed…
FDA Device · Class II · 2013-12-18 · Cutera - NexGen Complete Knee Solution Porous Patella Drill Guide-26mm dia./10mm thickness Non sterile, Rx Only Devices are used in total knee arthr…
FDA Device · Class II · 2013-12-18 · Zimmer - AMSCO¿ Evolution¿ steam sterilizer Transfer Carriage
FDA Device · Class II · 2013-12-18 · Steris - Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable…
FDA Device · Class II · 2013-12-18 · Synthes Usa Hq - Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous introduction of devices into th…
FDA Device · Class II · 2013-12-18 · Arrow International - Coulter LH 750 Hematology Analyzer, Part No. 6605632, A85570 Product Usage: The Coulter LH 750 Hematology Analyzer is a quantitative, autom…
FDA Device · Class II · 2013-12-18 · Beckman Coulter - Zimmer Trabecular Metal Total Ankle Talar Component Right Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited…
FDA Device · Class II · 2013-12-18 · Zimmer - iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological
FDA Device · Class II · 2013-12-18 · Iba Dosimetry - Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is used for open and closed wedge osteotomies of the medial proximal ti…
FDA Device · Class II · 2013-12-18 · Synthes Usa Hq - Digital Pathology System (DPS) Software version 1.1 The Omnyx" Integrated Digital Pathology system, which consists of a whole slide scanner…
FDA Device · Class II · 2013-12-18 · Omnyx - NexGen¿ Complete Knee Solutions Stemmed Tibial Component Precoat NexGen Tibial Baseplates are part of the NexGen systems of semi-constraine…
FDA Device · Class II · 2013-12-18 · Zimmer - NexGen Complete Knee Solution CR Articular Surface Provisional-Purple 9mm Height Nonsterile Devices are used in total knee arthroplasty and…
FDA Device · Class II · 2013-12-18 · Zimmer - Product is labeled in part: LIST NO. 43449
FDA Device · Class II · 2013-12-18 · Hospira - HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40 K122253 (Procare Monitor B20): The PROCARE Mo…
FDA Device · Class II · 2013-12-18 · Ge Healthcare - Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969
FDA Device · Class II · 2013-12-18 · Ethicon - Coulter LH 780 Hematology Analyzer, Part No. 723585, A90728 Product Usage: Coulter LH 780 Hematology Analyzer is a is a quantitative, autom…
FDA Device · Class II · 2013-12-18 · Beckman Coulter - NexGen Complete Knee Solution Porous Patella Drill Guide-29mm dia./10mm thickness Non sterile, Rx Only Devices are used in total knee arthr…
FDA Device · Class II · 2013-12-18 · Zimmer - Aesculap GNI161 Bipolar Foot Control Product Usage: The Aesculap Bipolar Coagulator is intended for use in surgery to generate electrical p…
FDA Device · Class II · 2013-12-18 · Aesculap - Zimmer Trabecular Metal Total Ankle Tibial Base Component Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited…
FDA Device · Class II · 2013-12-18 · Zimmer - Blanketrol III Data Export Software Version 1.10 The Blanketrol III Data Export Software is intended for use in the electronic transfer of…
FDA Device · Class II · 2013-12-11 · Cincinnati Sub Zero Products - GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 13 MM QTY: (1), REF 71420820, STERILE EO, Smith & Nephew, Inc
FDA Device · Class II · 2013-12-11 · Smith And Nephew - VersaSafe Extension Set, Model No. 21000M-007
FDA Device · Class II · 2013-12-11 · Carefusion 303 - The GE Centricity Web
FDA Device · Class II · 2013-12-11 · Ge Healthcare It - SIEMENS brand ONCOR series Linear Accelerator Linac systems with component: any photon unflat beam option(Multiple X feature) in combinatio…
FDA Device · Class II · 2013-12-11 · Siemens Medical Solutions Usa - Assembly, Patient Side Manipulator on da Vinci Surgical Systems: da Vinci S Surgical System
FDA Device · Class II · 2013-12-11 · Intuitive Surgical - Synthes Soft Tissue Retractor Small Extendible
FDA Device · Class II · 2013-12-11 · Synthes Usa Hq - Navigator HD l3F/15F x 46cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog M0062502290, Sterile
FDA Device · Class II · 2013-12-11 · Boston Scientific - STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902
FDA Device · Class III · 2013-12-11 · Advanced Sterilization Products - Navigator HD l3F/15F x 36cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog No 250-228, Sterile
FDA Device · Class II · 2013-12-11 · Boston Scientific
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