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.
- VITROS Chemistry Products GLU Slides packaged as 300 slides/pack catalog number 1707801 VITROS GLU Slides quantitatively measure glucose (G…
FDA Device · Class II · 2013-11-27 · Ortho Clinical Diagnostics - VITROS Chemistry Products URIC Slides packaged as 300 slides/pack catalog number 1943927 VITROS URIC Slides quantitatively measure uric aci…
FDA Device · Class II · 2013-11-27 · Ortho Clinical Diagnostics - Siemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct Bilirubin_2 Reagent, Siemens Material Number (SMN) 10312279, REF 09…
FDA Device · Class II · 2013-11-27 · Siemens Healthcare Diagnostics - VITROS Chemistry Products TRIG Slides packaged as 300 slides/pack catalog number 1336544 and packaged as 90 slides/pack catalog number 8329…
FDA Device · Class II · 2013-11-27 · Ortho Clinical Diagnostics - ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental adhesive for restorations
FDA Device · Class II · 2013-11-27 · Ivoclar Vivadent - ALTRUS¿ THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 36 cm Shaft, REF 60-9522-001, STERILE -- CONMED CORPORATION 525 FRENCH R…
FDA Device · Class II · 2013-11-27 · Conmed - ADVIA 2400 System Software V4.01
FDA Device · Class II · 2013-11-27 · Siemens Healthcare Diagnostics - VITROS Chemistry Products THEO Slides packaged as 300 slides/pack catalog number 8301764 and packaged as 90 slides/pack catalog number 1307…
FDA Device · Class II · 2013-11-27 · Ortho Clinical Diagnostics - VITROS Chemistry Products DGXN Slides packaged as 90 slides/pack catalog number 8343386 VITROS DGXN Slides quantitatively measure digoxin (…
FDA Device · Class II · 2013-11-27 · Ortho Clinical Diagnostics - Model FL14E Rose BedsThe Rose Bed is an AC-powered adjustable long-term care bed intended for medical purposes that consists of a bed with…
FDA Device · Class II · 2013-11-27 · Stryker Medical Division - TruSystem Surgical Table (TS7000) Leg Section One Part Light HU Use of the Leg Section One Part Light HU is permitted only with the TRUMP…
FDA Device · Class II · 2013-11-27 · Trumpf Medical Systems - Spacelabs Healthcare qube Compact Patient Monitor, Model 91390
FDA Device · Class II · 2013-11-27 · Spacelabs Healthcare - ARTAS Disposable and Reuseable Kit ( Contains Skin Tensioner FP-45384
FDA Device · Class II · 2013-11-27 · Restoration Robotics - VITROS Chemistry Products CRBM Slides packaged as 90 slides/pack catalog number 8892382
FDA Device · Class II · 2013-11-27 · Ortho Clinical Diagnostics - ZINGER¿ Steerable Guidewire
FDA Device · Class I · 2013-11-27 · Medtronic Vascular - Vascutek Gelsoft Vascular Graft (peripheral) Labeling reads in part, "***Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis***STRAIGHT…
FDA Device · Class II · 2013-11-27 · Terumo Cardiovascular Systems - VITROS Chemistry Products AST Slides packaged as 300 slides/pack catalog number 8433815 VITROS AST Slides quantitatively measure aspartate…
FDA Device · Class II · 2013-11-27 · Ortho Clinical Diagnostics - VITROS Chemistry Products PHBR Slides packaged as 90 slides/pack catalog number 8221384 VITROS PHBR Slides quantitatively measure phenobarb…
FDA Device · Class II · 2013-11-27 · Ortho Clinical Diagnostics - VITROS Chemistry Products ECO2 Slides packaged as 300 slides/pack catalog number 8262396 VITROS ECO2 Slides quantitatively measure total ca…
FDA Device · Class II · 2013-11-27 · Ortho Clinical Diagnostics - VITROS Chemistry Products CHE Slides packaged as 300 slides/pack catalog number 1914605 and packaged as 90 slides/pack catalog number 80047…
FDA Device · Class II · 2013-11-27 · Ortho Clinical Diagnostics - Trinica Anterior Lumbar Plate (ALP) system, part 07.01058.001
FDA Device · Class II · 2013-11-27 · Zimmer - CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseFocus Anesthesia Workstation with the following par…
FDA Device · Class I · 2013-11-27 · Del Mar Reynolds Medical - Polyglycolic-Lactic Acid Absorbable Surgical Suture Label reads in part "Coated VILET *** (Polyglacin 910) Suture UNDYED BRANDED V423 *** R…
FDA Device · Class II · 2013-11-27 · Riverpoint Medical - VITROS Chemistry Products Li Slides packaged as 300 slides/pack catalog number 8318925 and packaged as 90 slides/pack catalog number 163266…
FDA Device · Class II · 2013-11-27 · Ortho Clinical Diagnostics - ADVIA 1800 System Software V2.01
FDA Device · Class II · 2013-11-27 · Siemens Healthcare Diagnostics - VITROS Chemistry Products SALI Slides packaged as 90 slides/pack catalog number 1314343 VITROS SALI Slides quantitatively measure salicylat…
FDA Device · Class II · 2013-11-27 · Ortho Clinical Diagnostics - VITROS Chemistry Products CREA Slides packaged as 300 slides/pack catalog number 6802584 VITROS CREA Slides quantitatively measure creatini…
FDA Device · Class II · 2013-11-27 · Ortho Clinical Diagnostics - The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere elec…
FDA Device · Class I · 2013-11-27 · Hospira - VITROS Chemistry Products UPRO Slides packaged as 90 slides/pack catalog number 6800120 VITROS UPRO Slides quantitatively measure protein (…
FDA Device · Class II · 2013-11-27 · Ortho Clinical Diagnostics - Sterile Disposable Kit ( Contains Skin Tensioner ASY-25067
FDA Device · Class II · 2013-11-27 · Restoration Robotics - ADVIA 1650 System Software: 1) V4.01, 2) V3.52
FDA Device · Class II · 2013-11-27 · Siemens Healthcare Diagnostics - Dura Guard, Dural Repair Patch with Apex Processing
FDA Device · Class II · 2013-11-27 · Synovis Surgical Innovations - GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615
FDA Device · Class II · 2013-11-27 · Ge Healthcare - VITROS Chemistry Products BuBc Slides packaged as 300 slides/pack catalog number 8383051 and packaged as 90 slides/pack catalog number 1612…
FDA Device · Class II · 2013-11-27 · Ortho Clinical Diagnostics - Cougar¿ Nitinol Workhorse Guidewire: Models: CGRLS190HJ, CGRLS190HS, CGRLS190S, CGRLS300HS, CGRLS300S. CGRXT190HJ, CGRXT190HS, CGRXT190J, C…
FDA Device · Class I · 2013-11-27 · Medtronic Vascular - The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities ass…
FDA Device · Class II · 2013-11-27 · Ge Healthcare It - THUNDER¿ Steerable Guidewire
FDA Device · Class I · 2013-11-27 · Medtronic Vascular - GE Vivid E9 ultrasound system
FDA Device · Class II · 2013-11-27 · Ge Healthcare - COUGAR¿ Steerable Guidewire
FDA Device · Class I · 2013-11-27 · Medtronic Vascular - VITROS Chemistry Products AcP Slides, 90 slides/pack
FDA Device · Class II · 2013-11-27 · Ortho Clinical Diagnostics - ATTAIN HYBRID¿ Guide Wire
FDA Device · Class I · 2013-11-27 · Medtronic Vascular - VITROS Chemistry Products CRP Slides packaged as 90 slides/pack catalog number 8097990 VITROS CRP Slides quantitatively measure C-reactive…
FDA Device · Class II · 2013-11-27 · Ortho Clinical Diagnostics - VITROS Chemistry Products PROT Slides packaged as 90 slides/pack catalog number 8208431 VITROS PROT Slides quantitatively measure protein (…
FDA Device · Class II · 2013-11-27 · Ortho Clinical Diagnostics - Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)
FDA Device · Class II · 2013-11-27 · Aesculap - VITROS Chemistry Products CK Slides packaged as 300 slides/pack catalog number 8479396 and packaged as 90 slides/pack catalog number 847803…
FDA Device · Class II · 2013-11-27 · Ortho Clinical Diagnostics - VITROS Chemistry Products Mg Slides packaged as 300 slides/pack catalog number 8255093 and packaged as 90 slides/pack catalog number 192120…
FDA Device · Class II · 2013-11-27 · Ortho Clinical Diagnostics - VITROS Chemistry Products BUN/UREA Slides packaged as 300 slides/pack catalog number 8102204 VITROS BUN/UREA Slides quantitatively measure…
FDA Device · Class II · 2013-11-27 · Ortho Clinical Diagnostics - Stryker 1) XIA Torque Wrench 2) XIA 3 Torque Wrench 3) XIA Elegance Short Torque Wrench Manufactured by: Stryker Spine SAS Z.I. Marticot -3…
FDA Device · Class II · 2013-11-27 · Stryker Spine - Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade is used to…
FDA Device · Class II · 2013-11-27 · Synthes Usa Hq - *** 1) SYMBIQ One-Channel Infuser
FDA Device · Class II · 2013-11-27 · Hospira - ADVIA 1200 System Software: 1) V2.00, 2) V2.01
FDA Device · Class II · 2013-11-27 · Siemens Healthcare Diagnostics - VITROS Chemistry Products LIPA Slides packaged as 300 slides/pack catalog number 1668409 and packaged as 90 slides/pack catalog number 8297…
FDA Device · Class II · 2013-11-27 · Ortho Clinical Diagnostics - VITROS Chemistry Products LAC Slides packaged as 300 slides/pack catalog number 8433880 and packaged as 90 slides/pack catalog number 81501…
FDA Device · Class II · 2013-11-27 · Ortho Clinical Diagnostics - Vascu Guard, Peripheral Vascular Patch with Apex Processing
FDA Device · Class II · 2013-11-27 · Synovis Surgical Innovations - VITROS Chemistry Products ACET Slides, 90 slides/pack
FDA Device · Class II · 2013-11-27 · Ortho Clinical Diagnostics - BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System
FDA Device · Class II · 2013-11-27 · Ebi - VITROS Chemistry Products Ca Slides packaged as 300 slides/pack catalog number 1450261 VITROS Ca Slides quantitatively measure calcium (Ca)…
FDA Device · Class II · 2013-11-27 · Ortho Clinical Diagnostics - VITROS Chemistry Products Fe Slides packaged as 300 slides/pack catalog number 1515808 and packaged as 90 slides/pack catalog number 192454…
FDA Device · Class II · 2013-11-27 · Ortho Clinical Diagnostics - Brilliance iCT Computed Tomography X-Ray System, Product Usage: The Brilliance iCT is a Computed Tomography X-Ray System intended to produc…
FDA Device · Class II · 2013-11-27 · Philips Medical Systems Cleveland - Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma
FDA Device · Class II · 2013-11-27 · Restoration Robotics - VITROS Chemistry Products AMON Slides packaged as 300 slides/pack catalog number 1721869 and packaged as 90 slides/pack catalog number 1726…
FDA Device · Class II · 2013-11-27 · Ortho Clinical Diagnostics - Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zei…
FDA Device · Class II · 2013-11-27 · Carl Zeiss Meditec - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - Sarns" Venous Return Cannulae, 20 Fr with 1/4" flare, 14.5" (37 cm) long
FDA Device · Class II · 2013-11-20 · Terumo Cardiovascular Systems - Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation
FDA Device · Class II · 2013-11-20 · Medtronic Neuromodulation - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - Product Catalog (part number 20-0020) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor…
FDA Device · Class II · 2013-11-20 · The Anspach Effort - Acetabular Pressurizer
FDA Device · Class II · 2013-11-20 · Stryker Instruments Div - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - Combiset Blood Line Hemodialysis use Catalog Number: 03-2622-3. Intended for use as the extracorporeal blood circuit during Hemodialysis an…
FDA Device · Class II · 2013-11-20 · Fresenius Medical Care Holdings - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms
FDA Device · Class II · 2013-11-20 · Spacelabs Healthcare - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - DeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, MADE IN…
FDA Device · Class II · 2013-11-20 · Deroyal Industries - SIGMA SPECTRUM Infusion Pump with Master Drug Library
FDA Device · Class II · 2013-11-20 · Baxter Healthcare - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - Sterrad 100NX, Product Code: 10104
FDA Device · Class II · 2013-11-20 · Advanced Sterilization Products - SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen, 55074-2 revision B) Product Usage: Intended to be used a…
FDA Device · Class II · 2013-11-20 · Baxter Healthcare - Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medic…
FDA Device · Class II · 2013-11-20 · Synthes Usa Hq - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - The Plum A+ Hyperbaric Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can…
FDA Device · Class II · 2013-11-20 · Hospira - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - Medtronic Activa PC, model 37601, and Activa RC, model 37612, Activa SC, models 37602 and 37603
FDA Device · Class II · 2013-11-20 · Medtronic Neuromodulation - Access 2 Immunoassay System, Part Number: 81600N The Access Immunoassay System is an in vitro diagnostic device used for the quantitative,…
FDA Device · Class II · 2013-11-20 · Beckman Coulter - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - DePuy Mitek FMS Outflow Tubing with One-Way valve Product Code:284649 Product Usage: The Intermediary Tubing for FMS¿ Fluid Management Syst…
FDA Device · Class II · 2013-11-20 · Depuy Mitek A Johnson And Johnson - Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free Sweetened with xylitol and sor…
FDA Device · Class II · 2013-11-20 · Glaxosmithkline - Siemens syngo.plaza image processing system image processing radiological system
FDA Device · Class II · 2013-11-20 · Siemens Medical Solutions Usa - Artis zee systems x-ray, angiographic system
FDA Device · Class II · 2013-11-20 · Siemens Medical Solutions Usa - Titan 3T MRI System, MRT-3010A/5. Product Usage: Usage: MRI system
FDA Device · Class II · 2013-11-20 · Toshiba American Medical Systems - Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with the Pneumatic Motor Systems including: BlackMax Motor Systems, Micr…
FDA Device · Class II · 2013-11-20 · The Anspach Effort - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - Plum A+ Infusion Pump
FDA Device · Class II · 2013-11-20 · Hospira - Cutting Bur Chart (part number 20-0019) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Moto…
FDA Device · Class II · 2013-11-20 · The Anspach Effort - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used fo…
FDA Device · Class II · 2013-11-20 · Hospira - Prostiva RF Therapy Hand Piece Kit, REF 8929, Rx only, sterilized using Ethylene Oxide
FDA Device · Class II · 2013-11-20 · Urologix - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health
Other years
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