FDA Device · 2015
FDA Device recalls in 2015
RecallRadar indexes 2,495 FDA Device recall notices published in 2015. By classification: 77 Class I, 2,300 Class II, 118 Class III.
- SOMATOM Emotion 6
FDA Device · Class II · 2015-06-03 · Siemens Medical Solutions Usa - HLS/HIT Set Advanced with Bioline and/or Softline Coating Console Product Usage: HLS/HIT Set Advanced: The CARDIO HELP System in configurat…
FDA Device · Class II · 2015-06-03 · Maquet Cardiovascular Us Sales - Base for Terumo Advanced Perfusion System 1, 220/240V The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the…
FDA Device · Class II · 2015-06-03 · Terumo Cardiovascular Systems - Water bottles, Catalog#10380062, #10291586
FDA Device · Class II · 2015-06-03 · Siemens Medical Solutions Diagnostics - Ingenuity TF Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI), 882380, Philips Medical Systems
FDA Device · Class II · 2015-06-03 · Philips Medical Systems Cleveland - Catalys Precision Laser System-Catalys - U - US product
FDA Device · Class II · 2015-06-03 · Optimedica - Keo Brace, elastic wrist brace for carpal tunnel
FDA Device · Class II · 2015-06-03 · United Surgical Associates - MEDRAD¿ Stellant CT Injector System with Certegra Workstation
FDA Device · Class II · 2015-06-03 · Medrad - Water Feed Kit, Catalog#10288216,#10389714
FDA Device · Class II · 2015-06-03 · Siemens Medical Solutions Diagnostics - Brilliance CT 64
FDA Device · Class II · 2015-06-03 · Philips Medical Systems Cleveland - Brilliance CT 16 Power
FDA Device · Class II · 2015-06-03 · Philips Medical Systems Cleveland - Accessory Kit, Catalog#10282965, #10373217,#10286080
FDA Device · Class II · 2015-06-03 · Siemens Medical Solutions Diagnostics - MX8000 Dualv
FDA Device · Class II · 2015-06-03 · Philips Medical Systems Cleveland - EXPEDIUM Spine System/Synapse System
FDA Device · Class II · 2015-06-03 · Depuy Spine - Brilliance CT 16 Water
FDA Device · Class II · 2015-06-03 · Philips Medical Systems Cleveland - Brilliance CT 16 Air
FDA Device · Class II · 2015-06-03 · Philips Medical Systems Cleveland - D2-40 (Lymphatic Marker)
FDA Device · Class III · 2015-06-03 · Biocare Medical - LCS COMPLETE RPS inserts, various sizes
FDA Device · Class II · 2015-06-03 · Depuy Orthopaedics - CareFusion AVEA ventilator, all models
FDA Device · Class I · 2015-06-03 · Carefusion 211 - Brilliance CT Big Bore Oncology
FDA Device · Class II · 2015-06-03 · Philips Medical Systems Cleveland - Brilliance CT 40
FDA Device · Class II · 2015-06-03 · Philips Medical Systems Cleveland - KimVent Turbo-Cleaning Closed Suction System for Adults, 10 F T-Piece (Product Code 227105)
FDA Device · Class II · 2015-06-03 · Halyard Health - SIEMENS Ysio Max
FDA Device · Class II · 2015-06-03 · Siemens Medical Solutions Usa - SOMATOM Emotion 16, the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of…
FDA Device · Class II · 2015-06-03 · Siemens Medical Solutions Usa - Elastic Ankle Support
FDA Device · Class II · 2015-06-03 · United Surgical Associates - LCS COMPLETE RPS Femoral Implants, various sizes and orientation
FDA Device · Class II · 2015-06-03 · Depuy Orthopaedics - Brilliance CT 10 Air
FDA Device · Class II · 2015-06-03 · Philips Medical Systems Cleveland - Ingenuity CT. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray…
FDA Device · Class II · 2015-06-03 · Philips Medical Systems Cleveland - Brilliance CT 6 Air
FDA Device · Class II · 2015-06-03 · Philips Medical Systems Cleveland - MYLA server HP Proliant: DL380-G8 and ML350-G6 version 3.xx computer application software
FDA Device · Class II · 2015-05-27 · Biomerieux - Lerner Laboratories Mucolexx, 1 pint / 473 ml & 1 gallon/3.8 L
FDA Device · Class II · 2015-05-27 · Richard Allan Scientific - EPIQ 5 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C, EPIQ 5W.Catalog Number:…
FDA Device · Class II · 2015-05-27 · Philips Ultrasound - Stryker Orthopaedics Triathlon femoral component
FDA Device · Class II · 2015-05-27 · Stryker Howmedica Osteonics - Philips Healthcare DuraDiagnost X- Ray
FDA Device · Class II · 2015-05-27 · Philips Medical Systems - PHALINX (TM) HAMMERTOE HANDLE, SIZE: LARGE, STYLE: ANGLED, REF 45304014, CONTENTS 1 EACH, RX ONLY
FDA Device · Class II · 2015-05-27 · Wright Medical Technology - ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition) Product Usage: The ABACUS Software is a Windows-based orde…
FDA Device · Class II · 2015-05-27 · Baxter Englewood - Stryker Howmedica Osteonics RESTORATION Acetabular Augment System
FDA Device · Class II · 2015-05-27 · Stryker Howmedica Osteonics - CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985
FDA Device · Class II · 2015-05-27 · Ge Healthcare - The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transd…
FDA Device · Class II · 2015-05-27 · Integra Lifesciences - Pinnacle3 Software Version 10.0, Model 459800200841
FDA Device · Class II · 2015-05-27 · Philips Medical Systems - Stryker Orthopaedics Scorpio femoral component
FDA Device · Class II · 2015-05-27 · Stryker Howmedica Osteonics - IMMULITE/IMMULITE 1000 Systems TBG, catalog LKTB1 Quantitative measurement of Thyroxine-Binding Globulin (TBG) in serum, as an aid in the d…
FDA Device · Class II · 2015-05-27 · Siemens Healthcare Diagnostics - DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only Product Usage: The device is a single-use specimen retrieval bag indica…
FDA Device · Class II · 2015-05-27 · Deroyal Industries - Carter-Thomason II Port Closure System
FDA Device · Class II · 2015-05-27 · Coopersurgical - The Integra Camino ICP Monitor is a compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transd…
FDA Device · Class II · 2015-05-27 · Integra Lifesciences - ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Product Usage: The instruments have application in multiple open or min…
FDA Device · Class II · 2015-05-27 · Ethicon Endo Surgery - Philips Healthcare DigitalDiagnost System X-Ray
FDA Device · Class II · 2015-05-27 · Philips Medical Systems - PHALINX (TM) HAMMERTOE HANDLE, SIZE: SMALL, STYLE: ANGLED, REF 45304012, CONTENTS 1 EACH, RX ONLY
FDA Device · Class II · 2015-05-27 · Wright Medical Technology - MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection
FDA Device · Class II · 2015-05-27 · Mela Sciences - PHALINX (TM) HAMMERTOE HANDLE, SIZE: MEDIUM, STYLE: ANGLED, REF 45304013, CONTENTS 1 EACH, RX ONLY
FDA Device · Class II · 2015-05-27 · Wright Medical Technology - Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086
FDA Device · Class II · 2015-05-27 · Medtronic Neuromodulation - Homocysteine test system - Homocysteine Reagent. 05385415190
FDA Device · Class II · 2015-05-27 · Roche Diagnostics Operations - PHALINX (TM) HAMMERTOE HANDLE, SIZE: X-SMALL, STYLE: ANGLED, REF 45304011, CONTENTS 1 EACH, RX ONLY
FDA Device · Class II · 2015-05-27 · Wright Medical Technology - The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transd…
FDA Device · Class II · 2015-05-27 · Integra Lifesciences - EPIQ 7 Ultrasound System versions 1.3.2 or lower, WITHOUT the Pediatric Cardiology option, Model: EPIQ 7G, EPIC 7C, EPIQ 7W. Catalog Number…
FDA Device · Class II · 2015-05-27 · Philips Ultrasound - Mucolytic Agent 1 pint/473 ml
FDA Device · Class II · 2015-05-27 · Richard Allan Scientific - Vitek 2 AST-YS06 REF 412 610, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical l…
FDA Device · Class II · 2015-05-20 · Biomerieux - GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50)
FDA Device · Class II · 2015-05-20 · Ge Healthcare - HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an elect…
FDA Device · Class I · 2015-05-20 · Heartware - TFN-ADVANCED Proximal Femoral Nailing System (TFNA)
FDA Device · Class II · 2015-05-20 · Synthes - Kinemax Stem Extenders, 80 mm, Product Usage: Kinemax Cemented Stem Extenders are modular components designed to be mated with tibial basep…
FDA Device · Class II · 2015-05-20 · Stryker Howmedica Osteonics - Vitek 2 AST-YS07 REF 414 967, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical l…
FDA Device · Class II · 2015-05-20 · Biomerieux - Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC CARDIO C60) Nuclear gamma cameras intended to produce images d…
FDA Device · Class II · 2015-05-20 · Philips Medical Systems Cleveland - ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item per pouch
FDA Device · Class II · 2015-05-20 · Handicare Usa - Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10
FDA Device · Class III · 2015-05-20 · Zimmer Surgical - Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant…
FDA Device · Class II · 2015-05-20 · Biohorizons Implant Systems - Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Dimension RxL Max, Dimension RxL Max HM, Dimension Xpand, Dimens…
FDA Device · Class II · 2015-05-20 · Siemens Healthcare Diagnostics - Vitek 2 AST-YS01 REF 22 108, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical la…
FDA Device · Class II · 2015-05-20 · Biomerieux - ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17
FDA Device · Class III · 2015-05-20 · Arc Medical - COULTER DxH Diluent, Catalog No. 628017, Part No. A59956
FDA Device · Class II · 2015-05-20 · Beckman Coulter - Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems, Cleveland, OH
FDA Device · Class II · 2015-05-20 · Philips Medical Systems Cleveland - Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1 Intended Use: Pict…
FDA Device · Class II · 2015-05-20 · Fujifilm Medical Systems U - VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402
FDA Device · Class II · 2015-05-20 · Covidien - FujiMedical Synapse Cardiovascular I ProSolv CardioVascular
FDA Device · Class II · 2015-05-20 · Fujifilm Medical Systems U - Spinal Elements 5.5 x 45MM Mercury lordosed rod
FDA Device · Class III · 2015-05-20 · Spinal Elements - Spacelabs qube Compact Monitor, Model 91390
FDA Device · Class II · 2015-05-20 · Spacelabs Healthcare - 104" (264 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Smallbore Trifuse Ext w/2 MicroClave, Anti-Siphon Valve, 3 Clamps (White,…
FDA Device · Class II · 2015-05-13 · Icu Medical - Aspire HD, Full Field Digital, System, x-Ray, Mammographic
FDA Device · Class II · 2015-05-13 · Fujifilm Medical Systems U - 1/4 in
FDA Device · Class II · 2015-05-13 · Stryker Instruments Div - 1/8 in
FDA Device · Class II · 2015-05-13 · Stryker Instruments Div - AXIOM ARISTOS FX
FDA Device · Class II · 2015-05-13 · Siemens Medical Solutions Usa - 3/16 in
FDA Device · Class II · 2015-05-13 · Stryker Instruments Div - 3/16 in
FDA Device · Class II · 2015-05-13 · Stryker Instruments Div - GE Discovery MR950 MRI system
FDA Device · Class II · 2015-05-13 · Ge Healthcare - NexGen Augment
FDA Device · Class II · 2015-05-13 · Zimmer - 1/4 in
FDA Device · Class II · 2015-05-13 · Stryker Instruments Div - 3/16 in
FDA Device · Class II · 2015-05-13 · Stryker Instruments Div - ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model number 10433816
FDA Device · Class II · 2015-05-13 · Siemens Medical Solutions Usa - 113" (287cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Smallbore Quadfuse Ext Set w/MicroClave, 4 Clamps (Blue…
FDA Device · Class II · 2015-05-13 · Icu Medical - 108" (274 cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp, Luer Lock, Non-DEHP Tubing, Item No. B33326
FDA Device · Class II · 2015-05-13 · Icu Medical - 1/4 in
FDA Device · Class II · 2015-05-13 · Stryker Instruments Div - ViewRay System, Radiation Therapy System
FDA Device · Class II · 2015-05-13 · Viewray - EPIQ 7 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 7G, EPIC 7C, EPIQ 7W. Catalog Number: 795200 / 795201
FDA Device · Class II · 2015-05-13 · Philips Ultrasound - EPIQ 5 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 5G, EPIC 5C, EPIQ 5W. Catalog Number: 795204 / 795205
FDA Device · Class II · 2015-05-13 · Philips Ultrasound - 3/16 in
FDA Device · Class II · 2015-05-13 · Stryker Instruments Div - Universal Charger Product Usage: The Stryker Universal Battery Charger is designed to be used in conjunction with and provide power to non-…
FDA Device · Class III · 2015-05-13 · Stryker Instruments Div - Ambulating Bulb Ambulating Bulb: The Ambulating Bulb comprises four main components: the suction reservoir, the PVC tubing, the slide clamp…
FDA Device · Class II · 2015-05-13 · Stryker Instruments Div - 127" (323cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp, Luer Lock, Non-DEHP Tubing, Item No. B33351 Prod…
FDA Device · Class II · 2015-05-13 · Icu Medical - 119" (302 cm) Transfer Set w/MicroClave T-Connector, Smallbore Quadfuse Ext Set w/3 MicroClave (Red, Glow Rings), 5 Check Valves, 0.2 Micro…
FDA Device · Class II · 2015-05-13 · Icu Medical - MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)
FDA Device · Class II · 2015-05-13 · Mitsubishi Heavy Industries Hiroshima Machinery Work
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)