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.
- Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use
FDA Device · Class II · 2014-06-18 · Cordis - Alere Triage¿ D-Dimer Test PN 98100, Lot W53884B. The Alere Triage¿ D-Dimer Test is a fluorescence immunoassay to be used with the Alere Tr…
FDA Device · Class II · 2014-06-18 · Alere San Diego - Taut Operative Cholangiogram Catheter, 4.5FR (1.5mm) x 76cm To facilitate the introduction of contrast media into the biliary ducts to obta…
FDA Device · Class II · 2014-06-18 · Teleflex Medical - Stryker 6.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue d…
FDA Device · Class II · 2014-06-18 · Stryker Instruments Div - Siemens Healthcare Diagnostics Vista Air Compressor
FDA Device · Class II · 2014-06-18 · Siemens Healthcare Diagnostics - VITROS 5600 Integrated System, Product Code/Catalog Number 6802413 for in vitro diagnostic use
FDA Device · Class II · 2014-06-18 · Ortho Clinical Diagnostics - Stryker 4.5mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue du…
FDA Device · Class II · 2014-06-18 · Stryker Instruments Div - Stryker 6.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue du…
FDA Device · Class II · 2014-06-18 · Stryker Instruments Div - Stryker 6.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neuros…
FDA Device · Class II · 2014-06-18 · Stryker Instruments Div - Bard¿ Ventralight" ST Mesh with Echo PS" 8" Circle Number: 5955800 Indicated for use in the reconstruction of soft tissue deficiencies, suc…
FDA Device · Class II · 2014-06-11 · Davol Subs C R Bard - Spacelabs Medical Ultraview SL Command Module, Model 91496
FDA Device · Class II · 2014-06-11 · Spacelabs Healthcare - The Stryker NAV3i Platform is a mobile cart platform consisting of the sub-components Stryker Nav3 Graphite Camera, SPC-3 Computer and IO-T…
FDA Device · Class II · 2014-06-11 · Stryker Instruments Div - ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery
FDA Device · Class II · 2014-06-11 · Brainlab Ag - Bard¿ Ventralight" ST Mesh with Echo PS" 12"x14" Reorder Number: 5955124 Indicated for use in the reconstruction of soft tissue deficiencie…
FDA Device · Class II · 2014-06-11 · Davol Subs C R Bard - 115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or to raise a patients temperature and /or maintain a desired pati…
FDA Device · Class II · 2014-06-11 · Cincinnati Sub Zero Products - Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medic…
FDA Device · Class II · 2014-06-11 · Bayer - Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke Shunt System is intended to shut cerebrospi…
FDA Device · Class II · 2014-06-11 · Aesculap - BG3515-5 US 5mL BioGlue Surgical Adhesive
FDA Device · Class II · 2014-06-11 · Cryolife - Bard¿ Ventralight" ST Mesh with Echo PS TM 7"x9" Reorder Number: 5955790 Indicated for use in the reconstruction of soft tissue deficiencie…
FDA Device · Class II · 2014-06-11 · Davol Subs C R Bard - Bard¿ Ventralight" ST Mesh with Echo PS" 8"x10" Reorder Number: 5955810 Indicated for use in the reconstruction of soft tissue deficiencies…
FDA Device · Class II · 2014-06-11 · Davol Subs C R Bard - Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039
FDA Device · Class II · 2014-06-11 · Hologic - Bard¿ Ventralight" ST Mesh with Echo PS" 6" CircleReorder Number: 5955600 Indicated for use in the reconstruction of soft tissue deficienci…
FDA Device · Class II · 2014-06-11 · Davol Subs C R Bard - Bard¿ Ventralight" ST Mesh with Echo PS" 6"x10" Reorder Number: 5955610 Indicated for use in the reconstruction of soft tissue deficiencies…
FDA Device · Class II · 2014-06-11 · Davol Subs C R Bard - Bard¿ Ventralight" ST Mesh with Echo PS" 6"x8" Reorder Number: 5955680 Indicated for use in the reconstruction of soft tissue deficiencies,…
FDA Device · Class II · 2014-06-11 · Davol Subs C R Bard - Siemens Ysio Systems Product Usage: The Ysio (New RAD-FAMILY) systems are radiographic systems used in hospitals, clinics, and medical prac…
FDA Device · Class II · 2014-06-11 · Siemens Medical Solutions Usa - Siemens SOMATOM Emotion 16, Emotion 6, and SOMATOM Spirit Computed Tomography Systems Product Usage: To produce cross-sectional images of t…
FDA Device · Class II · 2014-06-11 · Siemens Medical Solutions Usa - Composix" LP with Echo PS" 6x10 Reorder Number: 0144610 Indicated for use in the reconstruction of soft tissue deficiencies, such as the re…
FDA Device · Class II · 2014-06-11 · Davol Subs C R Bard - Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device
FDA Device · Class II · 2014-06-11 · Synthes - Hologic M-IV Mammography System
FDA Device · Class II · 2014-06-11 · Hologic - Plum XL3 Multi line Infusion System, Micro Macro Plum XL3 Multi line Infusion System, and Micro Macro Plum XL Infusion System
FDA Device · Class II · 2014-06-11 · Hospira - Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture supernatant containing 15 mM sodium azide as a preservative
FDA Device · Class II · 2014-06-11 · Leica Microsystems - Composix" LP with Echo PS" 10x13 HUXH0294 HUXL0314 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair…
FDA Device · Class II · 2014-06-11 · Davol Subs C R Bard - Medtronic Model 8780 Ascenda Intrathecal Catheter
FDA Device · Class II · 2014-06-11 · Medtronic Neuromodulation - Plum XL, Micro Macro Plum XL3 with data port, and Micro Macro Plum XL with data port infusion pumps, indicated for intravenous, arterial, s…
FDA Device · Class II · 2014-06-11 · Hospira - Bard¿ Ventralight" ST Mesh with Echo PS" 4"x6" Reorder Number: 5955460 Indicated for use in the reconstruction of soft tissue deficiencies,…
FDA Device · Class II · 2014-06-11 · Davol Subs C R Bard - Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wound Drain***" Two different sizes, 10 units per box: 19 Fr…
FDA Device · Class II · 2014-06-11 · Bacterin International - Cochlear Baha Soft tissue gauge 6mm
FDA Device · Class II · 2014-06-11 · Cochlear Americas - Bard¿ Ventralight" ST Mesh with Echo PS" 4.5" Circle Reorder Number: 5955450 Indicated for use in the reconstruction of soft tissue deficie…
FDA Device · Class II · 2014-06-11 · Davol Subs C R Bard - enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM) (IM) v8.06 --- For in vitro quantitat…
FDA Device · Class II · 2014-06-11 · Ortho Clinical Diagnostics - Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL-L-GSTpi-438), a liquid tissue culture supernatant
FDA Device · Class II · 2014-06-11 · Leica Microsystems - Bard¿ Composix" LIP Mesh with Echo PS" 8"x10" Reorder Number: 0144810 Indicated for use in the reconstruction of soft tissue deficiencies,…
FDA Device · Class II · 2014-06-11 · Davol Subs C R Bard - LifeCare 5000 Pump (Plum 1.6) infusion pump, indicated for volumetric infusion of critical drugs and fluids by intravenous (I.V.) administr…
FDA Device · Class II · 2014-06-11 · Hospira - Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and 3.5mm x 30mm (catalog number 285330S). Screws ar…
FDA Device · Class II · 2014-06-11 · Integra Lifesciences - Kenex Radiation Shield and surgical lamps installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems
FDA Device · Class II · 2014-06-11 · Ge Healthcare - Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da Vinci Surgical System IS 4000
FDA Device · Class II · 2014-06-11 · Intuitive Surgical - Bard¿ Composix" LIP Mesh with Echo PS" 7"x9" Reorder Number: 0144790 Indicated for use in the reconstruction of soft tissue deficiencies, s…
FDA Device · Class II · 2014-06-11 · Davol Subs C R Bard - Integra Licox Test Kit REF BC10R Rx Only An accessory provided for use with the LCXO2 and AC31 PtO2 Monitors
FDA Device · Class II · 2014-06-11 · Integra Lifesciences - Arrow¿ Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or arterial access and device introduc…
FDA Device · Class II · 2014-06-11 · Arrow International - CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software
FDA Device · Class II · 2014-06-11 · Lap - MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is applied to the patient during electrosurgical proced…
FDA Device · Class II · 2014-06-11 · Conmed - Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT series, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core1…
FDA Device · Class II · 2014-06-11 · Philips Medical Systems Cleveland - IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001
FDA Device · Class II · 2014-06-11 · Philips Medical Systems Cleveland - SBi RingFix Olive Wires Product Usage: These are temporary devices indicated for: osteosynthesis of fractures with small osteoarticular fra…
FDA Device · Class II · 2014-06-11 · Small Bone Innovations - Bard¿Ventralight" ST Mesh with Echo PS" 10"x13" Reorder Number: 5955113 Indicated for use in the reconstruction of soft tissue deficiencies…
FDA Device · Class II · 2014-06-11 · Davol Subs C R Bard - Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system that is capable of radiographic and fluoroscopic studies used in…
FDA Device · Class II · 2014-06-11 · Toshiba American Medical Systems - AXIOM Luminos dRFsystem The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluorosc…
FDA Device · Class II · 2014-06-11 · Siemens Medical Solutions Usa - Composix" LP with Echo PS" 6 x8 Reorder Number: 0144680 Indicated for use in the reconstruction of soft tissue deficiencies, such as the r…
FDA Device · Class II · 2014-06-11 · Davol Subs C R Bard - The NAV3i Platform Power Box supplies the electrical components with power (e.g. Stryker Nav3 Graphite Camera, SPC-3 Computer, IO-Tablet (t…
FDA Device · Class II · 2014-06-11 · Stryker Instruments Div - Monoswift¿ PGCL [poly (glycolide-co-caprolactone)] Absorbable Surgical Suture
FDA Device · Class II · 2014-06-11 · C P Medical - PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc
FDA Device · Class II · 2014-06-11 · Microport Orthopedics - The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare p…
FDA Device · Class II · 2014-06-04 · Ge Healthcare - ADVIA Centaur Systems BRAHMS PCT 100 test Sold only OUS
FDA Device · Class II · 2014-06-04 · Siemens Healthcare Diagnostics - ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each)
FDA Device · Class II · 2014-06-04 · Abbott Laboratories - Synthes ProDisc-C 2.0mm Milling Bit, Synthes 2.0mm Milling Bit HXC, Synthes 2.0mm Milling Bit with 2.35mm x 33.5mm Shaft, and Synthes 2.0mm…
FDA Device · Class II · 2014-06-04 · Synthes - ADVIA Centaur Systems TSH3 Ultra Ready Pack, 100 test Catalog Number: 06491072
FDA Device · Class II · 2014-06-04 · Siemens Healthcare Diagnostics - Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer Spinal injection of anesthetics to provide regional anesthesia
FDA Device · Class II · 2014-06-04 · B Braun Medical - ADVIA Centaur Systems TSH3 Ultra , Ready Pack, 500 test Catalog Number: 06491080
FDA Device · Class II · 2014-06-04 · Siemens Healthcare Diagnostics - ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35)
FDA Device · Class II · 2014-06-04 · Siemens Medical Solutions Usa - ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) and using Stress Echo Feature
FDA Device · Class II · 2014-06-04 · Siemens Medical Solutions Usa - ARCHITECT Intact PTH Controls consists of 3 x 1 Bottle (8.0 mL each) of PTH (synthetic peptide) in Bis Tris Propane buffer with protein (bo…
FDA Device · Class II · 2014-06-04 · Abbott Laboratories - MAGNETOM Aera magnetic resonance system
FDA Device · Class II · 2014-06-04 · Siemens Medical Solutions Usa - IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation…
FDA Device · Class II · 2014-06-04 · Agfa - LIFEPAK 1000 defibrillator
FDA Device · Class II · 2014-06-04 · Physio Control - ADVIA Centaur Systems VitD 100 test, Ready Pack, Catalog Number: 10491994
FDA Device · Class II · 2014-06-04 · Siemens Healthcare Diagnostics - ADVIA Centaur Systems VitD Total 100 test, Ready Pack, For OUS
FDA Device · Class II · 2014-06-04 · Siemens Healthcare Diagnostics - ADVIA Centaur Systems VitD 500 test, Ready Pack, Catalog Number: 10631021
FDA Device · Class II · 2014-06-04 · Siemens Healthcare Diagnostics - Medtronic Temporary Pacemaker, Model 5348
FDA Device · Class II · 2014-06-04 · Medtronic Cardiac Rhythm Disease Management - Siemens Linear Accelerator (LINAC) models
FDA Device · Class II · 2014-06-04 · Siemens Medical Solutions Usa - ADVIA Centaur Systems TSH3 Ultra 2500 tests Catalog Number: 04862625
FDA Device · Class II · 2014-06-04 · Siemens Healthcare Diagnostics - Visitec Anterior Chamber Cannula, .40x22mm (27Gx7/8in) REF 585006 Cannulae are intended to irrigate and or aspirate ophthalmic solutions an…
FDA Device · Class II · 2014-06-04 · Beaver Visitec International - LATEX-FREE
FDA Device · Class II · 2014-05-28 · Hospira - Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634
FDA Device · Class II · 2014-05-28 · Gambro Renal Products - LATEX-FREE
FDA Device · Class II · 2014-05-28 · Hospira - ECATS E 850 Bariatric Bed, True Air Technologies, Inc
FDA Device · Class II · 2014-05-28 · Scm True Air Technologies - Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal
FDA Device · Class I · 2014-05-28 · Fisher And Paykel Healthcare - Polyflux Revaclear, Capillary Dialyzer, Model Number 110633
FDA Device · Class II · 2014-05-28 · Gambro Renal Products - MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator
FDA Device · Class II · 2014-05-28 · Fujifilm Medical System Usa - Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 XIRIS is a radiology information system (RIS) is a computer s…
FDA Device · Class II · 2014-05-28 · Philips Healthcare Informatics - GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicated for monitoring t…
FDA Device · Class II · 2014-05-28 · Ge Healthcare - LATEX-FREE
FDA Device · Class II · 2014-05-28 · Hospira - LATEX-FREE
FDA Device · Class II · 2014-05-28 · Hospira - Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle Part Number: 08-4000-LB The concentrate is formulated to be used with a three s…
FDA Device · Class I · 2014-05-28 · Fresenius Medical Care Holdings - TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 71675202, 11.5 MM X 18 CM, 125 degree, (3) REF 71675203, 13 MM X…
FDA Device · Class II · 2014-05-28 · Smith And Nephew - VITROS TT4 Calibrator For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the VITROS…
FDA Device · Class II · 2014-05-28 · Ortho Clinical Diagnostics - Esmark Elastic Bandage (Sterile), 4" x 9'. Item DYNJ05116A, Individually wrapped, 20 bandages per case
FDA Device · Class II · 2014-05-28 · Medline Industries - Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors
FDA Device · Class II · 2014-05-28 · Philips Medical Systems - Dimension Vista¿ CSA and CSAE The Cyclosporine method is an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CS…
FDA Device · Class II · 2014-05-28 · Siemens Healthcare Diagnostics - TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF 71676556, 11.5 MM X 36 CM, 125 degree, RIGHT, (3) REF…
FDA Device · Class II · 2014-05-28 · Smith And Nephew - 550 TxT Treatment Table of the Digital Linear Accelerator (LINAC) To deliver X-ray radiation for therapeutic treatment of cancer
FDA Device · Class II · 2014-05-28 · Siemens Medical Solutions Usa - MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc
FDA Device · Class II · 2014-05-28 · Scm True Air Technologies
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