FDA Device · 2014
FDA Device recalls in 2014
RecallRadar indexes 3,059 FDA Device recall notices published in 2014. By classification: 558 Class I, 2,441 Class II, 60 Class III.
- Reusable laparoscopic instruments are packaged as non-sterile
FDA Device · Class II · 2014-10-08 · Instrumed International - Reusable laparoscopic instruments are packaged as non-sterile
FDA Device · Class II · 2014-10-08 · Instrumed International - Siemens Ysio Max system The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices
FDA Device · Class II · 2014-10-08 · Siemens Medical Solutions Usa - SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids
FDA Device · Class II · 2014-10-08 · Baxter Healthcare - LAP-BAND AP SYSTEM AP Large with Access Port, Allergan, LAP-BAND AP SYSTEM Access Port I. Product was distributed for both the AP Large and…
FDA Device · Class II · 2014-10-08 · Apollo Endosurgery - Reusable laparoscopic instruments are packaged as non-sterile
FDA Device · Class II · 2014-10-08 · Instrumed International - Verigene BC-GP Kit (Catalog number 20-005-018)
FDA Device · Class II · 2014-10-08 · Nanosphere - The Rejuvenator Chamber manufactured by Baro-Therapies, Inc
FDA Device · Class II · 2014-10-08 · Baro Therapies - Hudson RCI¿ Pediatric Anesthesia Breathing Circuits, Single Patient Use, Rx Only, Product Usage: To administer medical gases to a patient d…
FDA Device · Class I · 2014-10-08 · Teleflex Medical - Reusable laparoscopic instruments are packaged as non-sterile
FDA Device · Class II · 2014-10-08 · Instrumed International - Siemens Uroskop Omnia Max system The Uroskop Omnia is a solid state detector fluoroscopic X-Ray system, primarily for urological applicatio…
FDA Device · Class II · 2014-10-08 · Siemens Medical Solutions Usa - VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD. For in vitro diagnostic use only
FDA Device · Class II · 2014-10-08 · Ortho Clinical Diagnostics - ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500
FDA Device · Class III · 2014-10-08 · Elitech Clinical Systems Sas - Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead)
FDA Device · Class II · 2014-10-08 · St Jude Medical - The Symbia T Series consists of the T16, T6, T2, and T. The Symbia T integrates state-of-the-art SPECT and high quality spiral CT to provid…
FDA Device · Class II · 2014-10-08 · Siemens Medical Solutions Usa - CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50
FDA Device · Class II · 2014-10-08 · Kci Usa - Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead)
FDA Device · Class II · 2014-10-08 · St Jude Medical - Siemens Dimension Vista¿ CHEM 1 CAL, lot 3GM081
FDA Device · Class II · 2014-10-08 · Siemens Healthcare Diagnostics - Philips Expression MR200 MRI Patient Monitoring System Model 866120
FDA Device · Class II · 2014-10-08 · Invivo - The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are Computed Tomography X-ray systems intended to produce cross-sectional…
FDA Device · Class II · 2014-10-08 · Philips Medical Systems Cleveland - GE Healthcare Precision 500D, Classical R&F System
FDA Device · Class II · 2014-10-08 · Ge Healthcare - ADVIA Centaur Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment on…
FDA Device · Class II · 2014-10-08 · Siemens Healthcare Diagnostics - Persona The Personalized Knee System 2.5 mm Female Screw 48 mm Length Sterile Qty-2. Sterilized using irradiation, single use
FDA Device · Class II · 2014-10-08 · Zimmer - Verigene BC-GN Kit (Catalog number 20-005-021)
FDA Device · Class II · 2014-10-08 · Nanosphere - ADVIA Centaur XP Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment…
FDA Device · Class II · 2014-10-08 · Siemens Healthcare Diagnostics - RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as t…
FDA Device · Class II · 2014-10-01 · Smith And Nephew - Vapotherm Precision Flow, Disposable Patient Circuit PF-DPC-High
FDA Device · Class II · 2014-10-01 · Vapotherm - Vapotherm Precision Flow,Disposable Patient Circuit PF-DPC-Low
FDA Device · Class II · 2014-10-01 · Vapotherm - UltraStream Exchange Kit Model Numbers 32001524 (24 cm), 32001528 (28cm), 32001532 (32 cm), and 32001536 (36 cm) and 32002540 (40 cm)
FDA Device · Class II · 2014-10-01 · Argon Medical Devices - The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of c…
FDA Device · Class II · 2014-10-01 · Nanosphere - UltraStream Peel Away Kit
FDA Device · Class II · 2014-10-01 · Argon Medical Devices - Vapotherm Precision Flow,Disposable Patient Circuit PFNODPC-High
FDA Device · Class II · 2014-10-01 · Vapotherm - The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed using the sample-to-result Verigene System is a qualitative, m…
FDA Device · Class II · 2014-10-01 · Nanosphere - AXIOM Artis or Artis zee system Product Usage: Axiom Artis and Artis zee / zeego are dedicated angiography systems developed for single and…
FDA Device · Class II · 2014-10-01 · Siemens Medical Solutions Usa - Vapotherm Precision Flow,Disposable Patient Circuit PF-NODPC-Low
FDA Device · Class II · 2014-10-01 · Vapotherm - DePuy Synthes TI Vectra Plates: TI Vectra-One" Plate 2 Level / 34 mm part 04.613.184 3337672 TI Vectra" Plate 3 Level / 57 mm part 04.613.2…
FDA Device · Class II · 2014-10-01 · Synthes - ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 Product Usage: ABX PENTRA Magnesium RTU reagent with associated calibrators and contro…
FDA Device · Class II · 2014-10-01 · Horiba Instruments - BD PosiFlush SF Saline Flush Syringe 0.9 Sodium Chloride Injection, USP 10 mL REF 306553
FDA Device · Class II · 2014-10-01 · Becton Dickinson And - The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative…
FDA Device · Class II · 2014-10-01 · Nanosphere - Brilliance CT System 6/10/16/16P/40 configuration
FDA Device · Class II · 2014-10-01 · Philips Medical Systems Cleveland - CareFusion AirLife Heated Infant Breathing Circuit Product Usage: Respiratory breathing circuits are used with a ventilator when mechanical…
FDA Device · Class II · 2014-10-01 · Carefusion 2200 - Minstrel (with scale) Product Usage: is a mobile passive hoist
FDA Device · Class II · 2014-10-01 · Arjohuntleigh Polska Sp Z O O - STAT 2 Flow Controller
FDA Device · Class I · 2014-10-01 · Icu Medical - Artis zee and Artis zeego systems. x-ray, angiographic system
FDA Device · Class II · 2014-10-01 · Siemens Medical Solutions Usa - No packaging
FDA Device · Class II · 2014-10-01 · Philips Medical Systems Cleveland - Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-High
FDA Device · Class II · 2014-10-01 · Vapotherm - Vapotherm Precision Flow,Disposable Patient Circuit PFH-DPC-High
FDA Device · Class II · 2014-10-01 · Vapotherm - eye-pak 7407 Tray Support Cover REF 8065740745
FDA Device · Class II · 2014-10-01 · Alcon Research - Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS480 Product Usage: For in vitro diagnostic use
FDA Device · Class II · 2014-10-01 · Dako North America - Justright Surgical, JustRight 5mm Stapler, REF JR-ST25-2.0, Sterile, EO, Rx Only, JR-ST25-2.0 product is packaged in cases of 6. The JustRi…
FDA Device · Class II · 2014-10-01 · Justright Surgical - Vapotherm Precision Flow,Disposable Patient Circuit PFHDPC-Low
FDA Device · Class II · 2014-10-01 · Vapotherm - VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection of immunoglobulin G antibody to hepatitis C virus…
FDA Device · Class II · 2014-10-01 · Ortho Clinical Diagnostics - UltraStream Chronic Hemodialysis Catheter Standard Kit
FDA Device · Class II · 2014-10-01 · Argon Medical Devices - EZ-IO 45mm (40kg & up) Needle Set, part number 9079-VC-005
FDA Device · Class II · 2014-10-01 · Vidacare - 98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow Controller, Rotating Luer, Item No. Z2648
FDA Device · Class I · 2014-10-01 · Icu Medical - CareFusion EnVe and ReVel Ventilators
FDA Device · Class I · 2014-10-01 · Carefusion 203 - The Ysio Systems with software version VC10 The Ysio enables radiographic and tomographic exposures of the whole Body including: skull, che…
FDA Device · Class II · 2014-10-01 · Siemens Medical Solutions Usa - 0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe 10 mL REF#306553 used in Centurion Convenience Kits
FDA Device · Class II · 2014-10-01 · Centurion Medical Products - The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester [poly(ethylene terephtalate)] braids, with or without P…
FDA Device · Class II · 2014-10-01 · Peters Surgical - The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a qualitative nucleic acid multiplex test intended to…
FDA Device · Class II · 2014-10-01 · Nanosphere - Fuze Manual Tilt Wheelchair
FDA Device · Class II · 2014-10-01 · Pdg Product Design Group - The synthetic non-absorbable surgical sutures CARDIOFLON Evolution are composed of polyester [poly(ethylene terephtalate)] braids, coated,…
FDA Device · Class II · 2014-10-01 · Peters Surgical - STAT 2 Flow Controller
FDA Device · Class I · 2014-10-01 · Icu Medical - The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed in vitro diagnostic test for the rapid detection o…
FDA Device · Class II · 2014-10-01 · Nanosphere - Circular Lock Screws, part # G826, lot # 11406
FDA Device · Class II · 2014-10-01 · Genesys Orthopedics Systems - Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000-LB The concentrate is formulated to be used with a three steam…
FDA Device · Class II · 2014-10-01 · Fresenius Medical Care Holdings - Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-Low
FDA Device · Class II · 2014-10-01 · Vapotherm - UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative, or qualitative dete…
FDA Device · Class II · 2014-10-01 · Beckman Coulter - Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 mm countersink/depth gauges in the Mini Screw Set/System
FDA Device · Class II · 2014-10-01 · Instratek - Justright Surgical, JustRight 5mm Reload, REFJR-REL25-2.0, Sterile, EO, Rx Only It is a replacement cartridge used when more than one firin…
FDA Device · Class II · 2014-10-01 · Justright Surgical - Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms
FDA Device · Class II · 2014-10-01 · Spacelabs Healthcare - 83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Controller, Clave, Rotating Luer, Item No. B9897
FDA Device · Class I · 2014-10-01 · Icu Medical - Pedi-Pak Pedi-Syringe Filter 60 mL Becton Dickinson/Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver sm…
FDA Device · Class II · 2014-09-24 · Genesis Bps - The Brilliance CT Big Bore is a whole-body Computed Tomography X-ray system intended to produce cross-sectional images of the body by compu…
FDA Device · Class II · 2014-09-24 · Philips Medical Systems Cleveland - Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter, Sterile
FDA Device · Class II · 2014-09-24 · Teleflex Medical - The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer…
FDA Device · Class II · 2014-09-24 · Philips Medical Systems Cleveland - AXIOM Luminos dRF system with SW VD10 or on Luminos dRF Max The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging…
FDA Device · Class II · 2014-09-24 · Siemens Medical Solutions Usa - Amerigel Wound Dressing Maximum Strength CAT# A2001
FDA Device · Class II · 2014-09-24 · Amerx Health Care - TRx Vertical Positioner, Classification Name: Wheelchair Component - Power Positioning System
FDA Device · Class II · 2014-09-24 · Motion Concepts - ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems, REF/Catalog Number/Siemens Material Number (SMN) 10491408, I…
FDA Device · Class II · 2014-09-24 · Siemens Healthcare Diagnostics - BD BBL Vancomycin Screen Agar Catalog number 222204 Vancomycin Screen Agar is used to test enterococci for resistance to vancomycin and to…
FDA Device · Class II · 2014-09-24 · Becton Dickinson And - Tenor is a mobile passive lift, intended to be used on horizontal surfaces for lifting and transfer in hospitals, nursing homes or other he…
FDA Device · Class II · 2014-09-24 · Arjohuntleigh Polska Sp Zo O - VERO Linear Accelerator System, Model Number MHI-TM2000
FDA Device · Class II · 2014-09-24 · Mitsubishi Heavy Industries Hiroshima Machinery Work - BD Vacutainer Trace Element Tubes (ROYAL BLUE TOP TUBE 6.0ML) Part Number: 363083 Part Number: FMC 87-8380-1 Single use tube used to collec…
FDA Device · Class II · 2014-09-24 · Fresenius Medical Care Holdings - JBAIDS Instrument System Software version 3.5.0.72
FDA Device · Class III · 2014-09-24 · Biofire Defense - Amerigel Hydrogel Saturated Gauze Dressing
FDA Device · Class II · 2014-09-24 · Amerx Health Care - Volcano TrakBack II Disposable Pullback Device
FDA Device · Class II · 2014-09-24 · Volcano - Bard DuaLok Breast Lesion Localization Wire, Product Code (Gauge x Length) LW0037 (20gx37mm)
FDA Device · Class II · 2014-09-24 · Bard Peripheral Vascular - BD Vacutainer Citrate Tubes (LIGHT BLUE TOP TUBE 2.7ML)Part number: BD 363083 Part Number: FMC 87-3083-8 Single use tube used to collect, s…
FDA Device · Class II · 2014-09-24 · Fresenius Medical Care Holdings - ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JResultNet is a stand-alone software package that provides connecti…
FDA Device · Class II · 2014-09-24 · Data Innovations - Luxurian
FDA Device · Class II · 2014-09-24 · Advanced Photonic Systems - B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Device
FDA Device · Class II · 2014-09-24 · B Braun Medical - ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 These MFE Electrodes are used in co…
FDA Device · Class II · 2014-09-24 · Bio Detek - BD Vacutainer Serum Tubes (RED TOP PLAIN TUBE 6.0 ML)Part Number: BD 367815 FMC Part Number: 87-7815-4 Single use tube used to collect, sep…
FDA Device · Class II · 2014-09-24 · Fresenius Medical Care Holdings - Siemens CentraLink Data Management System, software version 14
FDA Device · Class II · 2014-09-24 · Siemens Healthcare Diagnostics - Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amerigel Wound Wash, 22x2 Gauze Pads, and 1x3 Fabric Bandages CAT #…
FDA Device · Class II · 2014-09-24 · Amerx Health Care - Amerigel Daily Dressing Advanced 3-in-1 Hydrogel
FDA Device · Class II · 2014-09-24 · Amerx Health Care - ADVIA Centaur XP Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10285219, 10316507, 10317207, 10317284, 10319668, 10320…
FDA Device · Class II · 2014-09-24 · Siemens Healthcare Diagnostics - SUN DASH RADIUS 252 PN 8000809705
FDA Device · Class II · 2014-09-24 · Jk Products And Services - 4D Integrated Treatment Console (4DITC), versions 10 and 11. 4DITC provided assistance for accurate treatment delivery by monitoring linear…
FDA Device · Class II · 2014-09-24 · Varian Medical Systems
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