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.
- Optiflux F18Nre Flux Dialyzers
FDA Device · Class II · 2014-03-05 · Fresenius Medical Care Holdings - NxStage PureFlow-B Solution
FDA Device · Class II · 2014-03-05 · Nxstage Medical - ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 8.5, Rx only, Product Usage: A tracheal tube is…
FDA Device · Class I · 2014-03-05 · Teleflex Medical - Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System
FDA Device · Class II · 2014-03-05 · Smith And Nephew - GE Healthcare - Giraffe¿ and Panda¿ iRes Infant Warmer Product Usage: The infant radiant warmers provide infrared heat in a controlled mann…
FDA Device · Class I · 2014-03-05 · Ge Healthcare - CATH ANGIOGRAPHY DRAPE PACK
FDA Device · Class I · 2014-03-05 · Medline Industries - Optiflux F200NR High Flux Dialyzers
FDA Device · Class II · 2014-03-05 · Fresenius Medical Care Holdings - ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 9.0, Rx only, Product Usage: A tracheal tube is…
FDA Device · Class I · 2014-03-05 · Teleflex Medical - Optiflux F200A High Flux Dialyzers
FDA Device · Class II · 2014-03-05 · Fresenius Medical Care Holdings - Optiflux F160NR High Flux Dialyzers
FDA Device · Class II · 2014-03-05 · Fresenius Medical Care Holdings - Optiflux F180NRe High Flux Dialyzers
FDA Device · Class II · 2014-03-05 · Fresenius Medical Care Holdings - CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125 Product Usage: The system is indicate…
FDA Device · Class III · 2014-03-05 · Cardiovascular Systems - Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109, lot 20000910 Product Usage: For in vitro diagnostic use
FDA Device · Class II · 2014-03-05 · Dako North America - The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching Frequency (LMF) DC generator, which produces dental ima…
FDA Device · Class II · 2014-03-05 · Instrumentarium Dental Palodex Group Oy - ANGIOGRAPHY PACK
FDA Device · Class I · 2014-03-05 · Medline Industries - Siemens Artis zee Ceiling Systems
FDA Device · Class II · 2014-03-05 · Siemens Medical Solutions Usa - Trabecular Metal" Reverse Shoulder System
FDA Device · Class II · 2014-03-05 · Zimmer - Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc
FDA Device · Class II · 2014-03-05 · Smith And Nephew - CATH LAB CUSTOM PACK
FDA Device · Class I · 2014-03-05 · Medline Industries - ANGIO PACK #2
FDA Device · Class I · 2014-03-05 · Medline Industries - Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packaged 10 vials/box, lyophilized
FDA Device · Class II · 2014-03-05 · Remel - ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.5, Rx only, Product Usage: A tracheal tube is a device inserted int…
FDA Device · Class I · 2014-03-05 · Teleflex Medical - PFC SIGMA Cruciate Retaining (CR)
FDA Device · Class II · 2014-03-05 · Depuy Orthopaedics - CONVALESCENT RECLINER 5251/5261, 525S/526S with Side Storage Pocket, Upholstered side-panels, Recessed hand-grips, Webbed suspension seatin…
FDA Device · Class II · 2014-03-05 · Winco Mfg - NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller, Model Number: 71978-001 Catalog Number: RFC2009 Produc…
FDA Device · Class II · 2014-03-05 · Hologic - Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012
FDA Device · Class II · 2014-03-05 · Siemens Healthcare Diagnostics - CATH PACK
FDA Device · Class I · 2014-03-05 · Medline Industries - VITROS Chemistry Products Na+ Slides, manufactured by Ortho Clinical Diagnostics 513 Technology Blvd Rochester, NY 14652 VITROS Na+ Slides…
FDA Device · Class II · 2014-03-05 · Ortho Clinical Diagnostics - Invivo Corporation Expression IP5 Information Portal Product Usage: The Expression Information Portal (Model IP5) a display and device cont…
FDA Device · Class II · 2014-03-05 · Invivo - Philips HeartStart MRx Monitor/Defibrillator used Model numbers: M3535A, M3536A, M3536J, M3536M, M3536MC
FDA Device · Class II · 2014-03-05 · Philips Medical Systems - GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe Stand-alone Infant Resuscitation System
FDA Device · Class I · 2014-03-05 · Ge Healthcare - ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.5, Rx only, Product Usage: A tracheal tube is a device inserted int…
FDA Device · Class I · 2014-03-05 · Teleflex Medical - HeartStart MRx Monitor/Defibrillator
FDA Device · Class II · 2014-03-05 · Philips Medical Systems - Optiflux B200 Flux Dialyzers
FDA Device · Class II · 2014-03-05 · Fresenius Medical Care Holdings - GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option (WDR1)
FDA Device · Class II · 2014-03-05 · Ge Healthcare - STERILE SAMPLE CATH LAB PACK
FDA Device · Class I · 2014-03-05 · Medline Industries - ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 6.5, Rx only, Product Usage: A tracheal tube is…
FDA Device · Class I · 2014-03-05 · Teleflex Medical - The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee disarticulation amputees
FDA Device · Class II · 2014-03-05 · Ossur Americas - ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 9.0, Rx only, Product Usage: A tracheal tube is a device inserted int…
FDA Device · Class I · 2014-03-05 · Teleflex Medical - CATH PACK
FDA Device · Class I · 2014-03-05 · Medline Industries - PREMIER CARE RECLINER 5570 with Urethane armrests, Multiple side-table options, 3 position lock-bar, Fully upholstered, OPTIONAL Heat or He…
FDA Device · Class II · 2014-03-05 · Winco Mfg - Philips HeartStart MRx Monitor/Defibrillator
FDA Device · Class II · 2014-03-05 · Philips Medical Systems - HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries Revision J The HeartStart MRx is for use for the termination of ventricul…
FDA Device · Class II · 2014-03-05 · Philips Medical Systems - DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear accelerators to conform radiation dose delivery to geometrical vol…
FDA Device · Class II · 2014-03-05 · Elekta - VITROS Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Diagnostics 1000 Lee Road Rochester, NY 14606 VITROS Chemistry P…
FDA Device · Class II · 2014-03-05 · Ortho Clinical Diagnostics - Optiflux F160NRe High Flux Dialyzers
FDA Device · Class II · 2014-03-05 · Fresenius Medical Care Holdings - Philips HeartStart XL, Defibrillator/Monitor Model number M4735A Product Usage: The M4735A HeartStart XL Defibrillator/Monitor is for use i…
FDA Device · Class II · 2014-03-05 · Philips Medical Systems - ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.0, Rx only, Product Usage: A tracheal tube is a device inserted int…
FDA Device · Class I · 2014-03-05 · Teleflex Medical - ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.0, Rx only, Product Usage: A tracheal tube is a device inserted int…
FDA Device · Class I · 2014-03-05 · Teleflex Medical - ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 7.0, Rx only, Product Usage: A tracheal tube is…
FDA Device · Class I · 2014-03-05 · Teleflex Medical - Specialty Straight Static Inserter Assembly Product Usage: This instrument is a part of the Navigator product brand . It is used for implan…
FDA Device · Class II · 2014-03-05 · Stryker Spine - ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.0, Rx only, Product Usage: A tracheal tube is a device inserted int…
FDA Device · Class I · 2014-03-05 · Teleflex Medical - VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx Only*** Product Usage: The VirtuoSaph Plus Endosc…
FDA Device · Class II · 2014-03-05 · Terumo Cardiovascular Systems - cobas¿ PCR Urine Kit 100 PKT IVD cobas¿ PCR Female Swab Kit 100 PKT IVD cobas¿ PCR media 100T IVD cobas¿ PCR Female Swab Kit 100 PKT JPN-IV…
FDA Device · Class II · 2014-03-05 · Roche Molecular Systems - STERILE SAMPLE BUILD
FDA Device · Class I · 2014-03-05 · Medline Industries - STERILE SAMPLE BUILD
FDA Device · Class I · 2014-03-05 · Medline Industries - ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.5, Rx only, Product Usage: A tracheal tube is a device inserted int…
FDA Device · Class I · 2014-03-05 · Teleflex Medical - Optiflux F200NRe High Flux Dialyzers
FDA Device · Class II · 2014-03-05 · Fresenius Medical Care Holdings - HEART CATH CUSTOM PACK
FDA Device · Class I · 2014-03-05 · Medline Industries - XL CONVALESCENT RECLINER 5291/529S with Padded armrests with guard, Dual fold down side-tables, Removable side panels, Built-in head-rest
FDA Device · Class II · 2014-03-05 · Winco Mfg - Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT, BrightView X & BrightView SPECT) Philips Healthcare Systems…
FDA Device · Class II · 2014-03-05 · Philips Medical Systems Cleveland - Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Titanium and Nitinol, Orthofix Inc., RX Only The Azure Anterior C…
FDA Device · Class II · 2014-03-05 · Orthofix - pCO2 D788 Membranes
FDA Device · Class II · 2014-03-05 · Radiometer America - GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant Resuscitation System
FDA Device · Class I · 2014-03-05 · Ge Healthcare - Medtronic Everest 20cc Inflation Device
FDA Device · Class III · 2014-03-05 · Medtronic Vascular - ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 7.5, Rx only, Product Usage: A tracheal tube is…
FDA Device · Class I · 2014-03-05 · Teleflex Medical - DROP-ARM CONVALESCENT RECLINER 5271/5281 with One-touch release for drop-arms, Built-in headrest, Padded push-handle, Three-position lock,…
FDA Device · Class II · 2014-03-05 · Winco Mfg - Philips HeartStart XL+ Defibrillator/Monitor Model: 861290 The HeartStart XL+ is intended for use in a hospital setting by qualified medica…
FDA Device · Class II · 2014-03-05 · Philips Medical Systems - ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 8.0, Rx only, Product Usage: A tracheal tube is…
FDA Device · Class I · 2014-03-05 · Teleflex Medical - ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 6.0, Rx only, Product Usage: A tracheal tube is…
FDA Device · Class I · 2014-03-05 · Teleflex Medical - M3536A HeartStart MRx with Wireless Link Upgrade (861289) The HeartStart MRx is for use for the termination of ventricular tachycardia and…
FDA Device · Class II · 2014-03-05 · Philips Medical Systems - 12/14 UNIPOLAR FEMORAL HE VERSYS CEM LD/FX SZ 11X12 VERSYS CEM LD/FX SZ 12X12 VERSYS CEM LD/FX SZ 14X13 VERSYS CEM LD/FX SZ 16X14 VERSYS CE…
FDA Device · Class II · 2014-02-26 · Zimmer - HERBERT MINI BONE SCREW 2 and HERBERT/WHIPPLE C ANN BONE. Items starting with 0011500 and 0011520
FDA Device · Class II · 2014-02-26 · Zimmer - Item codes starting with 001930 LAG SCR 12.7D X 55MM SHOR up to 155 MM, LAG SCR 12.7D X 55 MM SHO up to 100MM, LAG SCR 12.7D X 55MM STAN up…
FDA Device · Class II · 2014-02-26 · Zimmer - VERSYS HERITAGE FEM STEM
FDA Device · Class II · 2014-02-26 · Zimmer - INTERLOCKING IM SCREW SML, MED and LRG
FDA Device · Class II · 2014-02-26 · Zimmer - Synergy XVI The Elekta Synergy S is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by…
FDA Device · Class II · 2014-02-26 · Elekta - Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos IOL intended for primary implantation in the capsular bag of the eye for the visual…
FDA Device · Class II · 2014-02-26 · Bausch And Lomb Surgical - MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST, THOMPSON HIP PROSTHESIS 3, 4, 5 and 6
FDA Device · Class II · 2014-02-26 · Zimmer - Synthes 3.2 mm Guide Wire 400mm
FDA Device · Class II · 2014-02-26 · Synthes - Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766
FDA Device · Class II · 2014-02-26 · Implantech Associates - Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical…
FDA Device · Class II · 2014-02-26 · Integra Lifesciences - 2.7 X 6 CORT SCREW/SELFTA 2.7 X 7 CORT SCREW/SELFTA 2.7 X 8 CORT SCREW/SELFTA 2.7 X 9 CORT SCREW/SELFTA 2.7 X 10 CORT SCREW/SELFT 2.7 X 12…
FDA Device · Class II · 2014-02-26 · Zimmer - I/B II KNEE DOMED PATELLA, I/B II KNEE FLUTED ROD (1 and 2), MGII KNEE 10MM PATELLA (2,3 and 4), MGII KNEE SLF-TAP BONE ST
FDA Device · Class II · 2014-02-26 · Zimmer - PRESSFIT FEM ST FX 16 X 1
FDA Device · Class II · 2014-02-26 · Zimmer - Medtronic Select 3D Arterial Cannulae
FDA Device · Class II · 2014-02-26 · Medtronic Cardiac Rhythm Disease Management - 6 DEGREE COCR FEM HEAD 36
FDA Device · Class II · 2014-02-26 · Zimmer - GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690
FDA Device · Class II · 2014-02-26 · Ge Healthcare - RECON SCREW LG 5.5MM DIA and M/DN FEM IM NAIL 8MM DIA to 16 MM DIA. Item codes starting with 0022520, 0022521, 002522, 0022523, 0022524 and…
FDA Device · Class II · 2014-02-26 · Zimmer - Orbit soft Infusion sets, 9 mm soft cannula, P10 (42") tubing
FDA Device · Class II · 2014-02-26 · Perrigo Diabetes Care - ITST ANTI-ROTATION SCREW and FEM IM NAIL (10MM, 11 MM, 12 MM, 13 MM, 14 MM and 15 MM) DIA X (18, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48 and…
FDA Device · Class II · 2014-02-26 · Zimmer - DISTAL MEDIAL FEMORAL CON, DISTAL POSTERIOR/LATERAL, DISTAL SMALL VOLAR RADIUS, PROXIMAL DORSAL ULNA PLT, and PROXIMAL MEDIAL TIBIAL 4
FDA Device · Class II · 2014-02-26 · Zimmer - Medtronic Select 3D Arterial Cannulae
FDA Device · Class II · 2014-02-26 · Medtronic Cardiac Rhythm Disease Management - Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN and RAFN systems
FDA Device · Class II · 2014-02-26 · Synthes - CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3
FDA Device · Class II · 2014-02-26 · Biosense Webster - Magna-Fx Cannulated Screw Fixation System 7.0 mm
FDA Device · Class II · 2014-02-26 · Zimmer - HERBERT BONE SCREW, 3.0MM and HERBERT CANNULATED BONE S
FDA Device · Class II · 2014-02-26 · Zimmer - Medtronic Select 3D Arterial Cannulae
FDA Device · Class II · 2014-02-26 · Medtronic Cardiac Rhythm Disease Management - HGP II ACETABULAR CUP MOD
FDA Device · Class II · 2014-02-26 · Zimmer - FREE-LOCK LAG SCREW, 12.7, FREE-LOCK LAG SCREW, 15.8, FREE-LOCK SUPRACOND TUBE and FREE-LOCK TUBE & SCP PLAT. Items starting with codes 001…
FDA Device · Class II · 2014-02-26 · Zimmer
Other years
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