FDA Device · 2017
FDA Device recalls in 2017
RecallRadar indexes 2,615 FDA Device recall notices published in 2017. By classification: 51 Class I, 2,510 Class II, 54 Class III.
- Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotactic Assistant Surgical Device, Model 2.5.8. The firm name on t…
FDA Device · Class II · 2017-09-20 · Zimmer Biomet - Cell Marque, SOX-10 (Polyclonal), 7 mL, REF PA0813, IVD, This antibody is intended for in vitro diagnostic (IVD) use
FDA Device · Class II · 2017-09-20 · Leica Biosystems Richmond - Cell Marque, Napsin A (MRQ-60 Mab.), 7 mL, REF PA0805, IVD, The antibody is intended for in vitro diagnostic (IVD) use
FDA Device · Class II · 2017-09-20 · Leica Biosystems Richmond - Cell Marque, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.), 7 mL, REF PA0803, IVD, The antibody is intended for in vitro diagnost…
FDA Device · Class II · 2017-09-20 · Leica Biosystems Richmond - Coulter HmX CP and Coulter HmX AL Analyzers The purpose of the HmX Hematology Analyzer is to separate the normal patient, with all normal s…
FDA Device · Class II · 2017-09-13 · Beckman Coulter - MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX
FDA Device · Class II · 2017-09-13 · Microvention - Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit
FDA Device · Class II · 2017-09-13 · Qualigen - JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the di…
FDA Device · Class II · 2017-09-13 · Stanmore Implants Worldwide - CS 300 Intra-Aortic Balloon Pump
FDA Device · Class I · 2017-09-13 · Maquet Datascope Cardiac Assist Division - Coulter LH 750, Coulter LH 780, and Coulter LH 500 Analyzers Hematology Analyzers are quantitative, automated hematology analyzers and leuk…
FDA Device · Class II · 2017-09-13 · Beckman Coulter - Merge Unity software, formerly known as DR Systems Unity PACS software
FDA Device · Class II · 2017-09-13 · Merge Healthcare - CS 100 Intra-Aortic Balloon Pump
FDA Device · Class I · 2017-09-13 · Maquet Datascope Cardiac Assist Division - On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use
FDA Device · Class II · 2017-09-13 · Cryolife - Presource(R) Kits (custom surgical/procedural kits): The standard and custom kits are packed with all of the specific disposable class I, I…
FDA Device · Class II · 2017-09-13 · Cardinal Health 200 - CS 100i Intra-Aortic Balloon Pump
FDA Device · Class I · 2017-09-13 · Maquet Datascope Cardiac Assist Division - MOSAIQ Medical Charged-Particle Radiation Therapy System
FDA Device · Class II · 2017-09-13 · Elekta - VITEK¿ 2 Compact 30, REF numbers: 27530 and 27530R (clinical), and 27630 and 17630R (industry) software and reagent cards designed for the…
FDA Device · Class II · 2017-09-06 · Biomerieux - iFusion, Device Listing Number D203271
FDA Device · Class II · 2017-09-06 · Optovue - AirLife(TM) Reduced Heparin ARTERIAL BLOOD SAMPLER, REF 9025RHTR, 1ML SYRINE 25G 5/8", LUER SLIP PROTECTIVE SHEATH, 3.2 IU, STERILE R, Rx O…
FDA Device · Class II · 2017-09-06 · Vyaire Medical - CADD(R) Medication Cassette Reservoir with clamp and female Luer
FDA Device · Class II · 2017-09-06 · Smiths Medical Asd - CIVCO Arm Support, REF 106047, distributed as: (a) Rigid Arm Support, Large, Set, Red (PN: 106047) (b) PB2-BDLRL (PN: 109040) (c) Rigid Adj
FDA Device · Class II · 2017-09-06 · Med Tec - Burn Sheet, sterile - 60" x 96". Included in First Aid Kits: 36M - Delmarva Power/ACE - w/Logo, Certified Safety Manufacturing logo, and so…
FDA Device · Class II · 2017-09-06 · Certified Safety Mfg - Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems deve…
FDA Device · Class II · 2017-09-06 · Siemens Medical Solutions Usa - Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems deve…
FDA Device · Class II · 2017-09-06 · Siemens Medical Solutions Usa - mcompass 2-channel Balloon Catheters The mcompass Biofeedback Anorectal Manometry System is for use on patients requiring anorectal pressur…
FDA Device · Class II · 2017-09-06 · Medspira - POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, REF Numbers: a) ENF-50P-40 b) ENF-50P-50 c) ENF-50P-80 d) ENF-60P-40 e) ENF-60P-50 f) ENF-6…
FDA Device · Class II · 2017-09-06 · Kentec Medical - Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems deve…
FDA Device · Class II · 2017-09-06 · Siemens Medical Solutions Usa - Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previou…
FDA Device · Class II · 2017-09-06 · Neusoft Medical Systems - Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product Usage: The Fogarty adherent clot catheters are designed to effectiv…
FDA Device · Class II · 2017-09-06 · Edwards Lifesciences - Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems deve…
FDA Device · Class II · 2017-09-06 · Siemens Medical Solutions Usa - Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomo…
FDA Device · Class II · 2017-09-06 · Neusoft Medical Systems - UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Version 3.2. The DxH Slidemaker Stainer allows for adaptation of t…
FDA Device · Class II · 2017-09-06 · Beckman Coulter - Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched devices and 1 IFU insert
FDA Device · Class III · 2017-09-06 · Ameditech - LX3 Floor Stand for LuxOR Ophthalmic Microscope
FDA Device · Class II · 2017-09-06 · Alcon Research - MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numbers: REF S-200956 - 5mm PIN, SIZE 46 REF S-200957 - 5mm PIN, S…
FDA Device · Class II · 2017-09-06 · Encore Medical - CIVCO Arm Support, REF 106015, distributed as: (a) Rigid Arm Support, Standard, Set Red (PN: 106015) (b) Rigid Adj
FDA Device · Class II · 2017-09-06 · Med Tec - iVue 500 with iScan, D216606
FDA Device · Class II · 2017-09-06 · Optovue - Samsung GU60A system- Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/…
FDA Device · Class II · 2017-09-06 · Neurologica - POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, WITH SIDE PORT, REF Numbers: a) ENF-Y50P-40 b) ENF-Y50P-50 c) ENF-Y60P-40 d) ENF-Y60P-50 e)…
FDA Device · Class II · 2017-09-06 · Kentec Medical - Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems deve…
FDA Device · Class II · 2017-09-06 · Siemens Medical Solutions Usa - MEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve, XXL-XLONG Sterile Single-Use Gown
FDA Device · Class II · 2017-09-06 · Master And Frank Pinghu - Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems deve…
FDA Device · Class II · 2017-09-06 · Siemens Medical Solutions Usa - VITEK¿ 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification (ID) and antimicrobial suscep…
FDA Device · Class II · 2017-09-06 · Biomerieux - Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems deve…
FDA Device · Class II · 2017-09-06 · Siemens Medical Solutions Usa - Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems deve…
FDA Device · Class II · 2017-09-06 · Siemens Medical Solutions Usa - Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems deve…
FDA Device · Class II · 2017-09-06 · Siemens Medical Solutions Usa - Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems deve…
FDA Device · Class II · 2017-09-06 · Siemens Medical Solutions Usa - smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 76102260, NON STERILE, QTY: (1), Rx only Th…
FDA Device · Class II · 2017-09-06 · Smith And Nephew - Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems deve…
FDA Device · Class II · 2017-09-06 · Siemens Medical Solutions Usa - iVue with Normative Database, Device Listing Number D185549
FDA Device · Class II · 2017-09-06 · Optovue - Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems deve…
FDA Device · Class II · 2017-09-06 · Siemens Medical Solutions Usa - Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System Model: DREX-UI80 Ultimax is intended for gastrointestinal studies…
FDA Device · Class II · 2017-09-06 · Toshiba American Medical Systems - Tissu-Trans Filtron 500, 3-TT-FILTRON 500
FDA Device · Class II · 2017-08-30 · Shippert Medical Technologies - Tissu-Trans MEGA 1500, 3-TT-MEGA 1500
FDA Device · Class II · 2017-08-30 · Shippert Medical Technologies - Medtronic ENT Prgm 9734636 Add Fusion Nav AxiEM, reusable, Rx. This kit includes 9733908 (which includes 9733452 containing 9733449, Straig…
FDA Device · Class II · 2017-08-30 · Medtronic Navigation - Medtronic Instrument Set EM ENT, Ref. #9733452 and #9733452-G02, reusable, RX. This kit contains 9733449, Straight Suction, 9733450, 70 deg…
FDA Device · Class II · 2017-08-30 · Medtronic Navigation - Medtronic Suction 9734308 Small AxiEM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suct…
FDA Device · Class II · 2017-08-30 · Medtronic Navigation - Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by…
FDA Device · Class II · 2017-08-30 · Pentax - Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the ultrasound scanning unit made by…
FDA Device · Class II · 2017-08-30 · Pentax - Tissu-Trans Filtron 250, 3-TT-FILTRON 250
FDA Device · Class II · 2017-08-30 · Shippert Medical Technologies - Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES, INC.: (a) CMS-4153-R2 MPM Biopsy TRAY (b) CMS-5832-R1 Custom…
FDA Device · Class II · 2017-08-30 · Custom Assemblies - ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery
FDA Device · Class II · 2017-08-30 · Alcon Research - Medtronic Instrument Kit 9733908 Fusion ENT, reusable, RX. This kit includes Kit 9733452 (containing 9733449, Straight Suction, 9733450, 70…
FDA Device · Class II · 2017-08-30 · Medtronic Navigation - Medtronic Curved Suction 70 9733450 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suc…
FDA Device · Class II · 2017-08-30 · Medtronic Navigation - Tissu-Trans Filtron 1000, 3-TT-FILTRON 1000
FDA Device · Class II · 2017-08-30 · Shippert Medical Technologies - VASER PRO Amplifier, VASER 2.2 VASERlipo System stem, Rx Only, 115/230V - 60/50Hz 300VA The Vaser amplifier is intended for the fragmentati…
FDA Device · Class II · 2017-08-30 · Solta Medical - Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX. This kit contains 9734308, Small Straight suction
FDA Device · Class II · 2017-08-30 · Medtronic Navigation - Tissu-Trans Filtron 100, 3-TT-FILTRON 100
FDA Device · Class II · 2017-08-30 · Shippert Medical Technologies - Tissu-Trans Filtron 2000, 3-TT-FILTRON 2000
FDA Device · Class II · 2017-08-30 · Shippert Medical Technologies - Convertors Robotic Drape with Attached Leggings
FDA Device · Class II · 2017-08-30 · Cardinal Health 200 - Medtronic Curved Suction 90 9733451 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suc…
FDA Device · Class II · 2017-08-30 · Medtronic Navigation - VASER Amplifier, VASER 2.2 VASERlipo System, Rx Only, 115/230V - 60/50Hz 300VA The Vaser amplifier is intended for the fragmentation and em…
FDA Device · Class II · 2017-08-30 · Solta Medical - Tissu-Trans SFILL 360, 3-TT-SFILL 360
FDA Device · Class II · 2017-08-30 · Shippert Medical Technologies - Medtronic Straight Suction 9733449 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suct…
FDA Device · Class II · 2017-08-30 · Medtronic Navigation - DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and 3391/3391S, The lead…
FDA Device · Class II · 2017-08-30 · Medtronic Neuromodulation - ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery
FDA Device · Class II · 2017-08-30 · Alcon Research - Plum 360 Infusion System
FDA Device · Class II · 2017-08-23 · Icu Medical - 1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The GE Signa¿ HDx MR system is a…
FDA Device · Class II · 2017-08-23 · Ge Medical Systems - ThermaSure(TM), a CENORIN(TM) product, SERIES 300 MEDICAL DEVICE DRYER: (a) Model 330
FDA Device · Class II · 2017-08-23 · Cenorin - Discovery MR750 3.0T Product Usage: Intended use: The Discovery MR750 3.0Tsystem is a whole body magnetic resonance scanner designed to sup…
FDA Device · Class II · 2017-08-23 · Ge Medical Systems - Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001151050, (c) M00566670, (d) M0067101140
FDA Device · Class II · 2017-08-23 · Boston Scientific - VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200 Product Usage: Used with secondary IV sets or syringes with a female luer lock adapte…
FDA Device · Class II · 2017-08-23 · Carefusion 303 - Arctic Sun 5000 Temperature Management System, 100-120 V North America and 100-120 V US
FDA Device · Class II · 2017-08-23 · C R Bard - Optima MR750 3.0T Product Usage: The Optima MR450 1.5T system is a whole body magnetic resonance scanner designed to support high resolutio…
FDA Device · Class II · 2017-08-23 · Ge Medical Systems - HomeChoice Pro Automated PD system Model numbers: 5C8310, 5C8310R Product Usage: The HomeChoice Automated Personal Cycler is intended for a…
FDA Device · Class II · 2017-08-23 · Baxter Healthcare - Truliant Tibial Trial Handle
FDA Device · Class II · 2017-08-23 · Exactech - SQ-RX 1010 Pulse Generator, Rx. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-thr…
FDA Device · Class II · 2017-08-23 · Boston Scientific - VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator
FDA Device · Class II · 2017-08-23 · Cyberonics - EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator, RX. Product Usage: The S-ICD system is intended to provide d…
FDA Device · Class II · 2017-08-23 · Boston Scientific - LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product Usage: IVD test kit for the detection of lead in blood
FDA Device · Class II · 2017-08-23 · Magellan Diagnostics - Optima MR450w 1.5T Product Usage: The Optima MR450w 1.5T system is a whole body magnetic resonance scanner designed to support high resolut…
FDA Device · Class II · 2017-08-23 · Ge Medical Systems - ThermaSure(TM), a CENORIN(TM) product, SERIES 1000 MEDICAL DEVICE DRYER: (a) Model 1009
FDA Device · Class II · 2017-08-23 · Cenorin - Optima MR450 1.5T Product Usage: 1 .5T Brivo MR355 and 1.5T Optima MR360 are whole body magnetic resonance scanners designed to support hig…
FDA Device · Class II · 2017-08-23 · Ge Medical Systems - EMBLEM MRI S-ICD Model 219, Subcutaneous-Implantable Cardioverter Defibrillator, Rx. Product Usage: The S-ICD system is intended to provide…
FDA Device · Class II · 2017-08-23 · Boston Scientific - 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole b…
FDA Device · Class II · 2017-08-23 · Ge Medical Systems - HomeChoice Automated PD system Model numbers: 5C4471, 5C4471R Product Usage: The HomeChoice Automated Personal Cycler is intended for autom…
FDA Device · Class II · 2017-08-23 · Baxter Healthcare - Brivo MR355, Optima MR360 Product Usage: The Brivo MR355/Optima MR360 is a whole body magnetic resonance scanner designed to support high r…
FDA Device · Class II · 2017-08-23 · Ge Medical Systems - VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator
FDA Device · Class II · 2017-08-23 · Cyberonics - ThermaSure(TM), a CENORIN(TM) product, SERIES 130 MEDICAL DEVICE DRYER: (a) Model 135
FDA Device · Class II · 2017-08-23 · Cenorin - Signa PET/MR (K163619, K142098) Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron E…
FDA Device · Class II · 2017-08-23 · Ge Medical Systems
Other years
2026 (2,024) · 2025 (2,908) · 2024 (3,393) · 2023 (2,477) · 2022 (2,191) · 2021 (2,303) · 2020 (3,055) · 2019 (2,801) · 2018 (3,757) · 2017 (2,615) · 2016 (3,246) · 2015 (2,495) · 2014 (3,059) · 2013 (2,249) · 2012 (1,310)