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.
- CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, I…
FDA Device · Class II · 2017-03-01 · Custom Medical Specialties - Oxford Partial Knee System Left Medial Tibial Trial Tray Size A Product Usage: Instruments for use with the Oxford Uni Partial Knee System
FDA Device · Class II · 2017-03-01 · Biomet U K - Oxford Partial Knee System Right Medial Tibial Trial Tray Size C Product Usage: Instruments for use with the Oxford Uni Partial Knee System
FDA Device · Class II · 2017-03-01 · Biomet U K - Smith & Nephew Dyonics Saw Blade, Long, Special, Product Number 3706
FDA Device · Class II · 2017-03-01 · Smith And Nephew - Vascular catheter introduction kit The PICC is indicated for short or long term peripheral access to the central Venous system for intraven…
FDA Device · Class II · 2017-03-01 · Arrow International - Oxford Partial Knee System Left Medial Tibial Trial Tray Size B Product Usage: Instruments for use with the Oxford Uni Partial Knee System
FDA Device · Class II · 2017-03-01 · Biomet U K - GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide
FDA Device · Class II · 2017-03-01 · Vascular Solutions - Oxford Partial Knee System Right Medial Tibial Trial Tray Size B Product Usage: Instruments for use with the Oxford Uni Partial Knee System
FDA Device · Class II · 2017-03-01 · Biomet U K - DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy System (OAS) is a minimally invasive, cathete…
FDA Device · Class II · 2017-03-01 · Cardiovascular Systems - Oxford Partial Knee System Femoral Slap Hammer Product Usage: Instruments for use with the Oxford Uni Partial Knee System
FDA Device · Class II · 2017-03-01 · Biomet U K - Smith & Nephew Dyonics Saw Blade, Narrow, Product Number 3705
FDA Device · Class II · 2017-03-01 · Smith And Nephew - Oxford Unicompartmental Knee Phase 3 Shim Size 2 Product Usage: Instruments for use with the Oxford Uni Partial Knee System
FDA Device · Class II · 2017-03-01 · Biomet U K - Oxford Partial Knee System Phase 3 Tibial Template Left Medial Size C Product Usage: Instruments for use with the Oxford Uni Partial Knee S…
FDA Device · Class II · 2017-03-01 · Biomet U K - SRHS DeRoyal Heart Tracecart REF 53-1913, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN
FDA Device · Class III · 2017-03-01 · Deroyal Industries - Hidrex USA DVP1000
FDA Device · Class III · 2017-03-01 · Hidrex - Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing
FDA Device · Class II · 2017-03-01 · Tosoh Bioscience - Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size A Product Usage: Instruments for use with the Oxford Uni Partial Knee…
FDA Device · Class II · 2017-03-01 · Biomet U K - Smith & Nephew Dyonics Saw Blade, Standard, Product Number 3701
FDA Device · Class II · 2017-03-01 · Smith And Nephew - The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine Aminotransferase (ALTI) on the Dimension¿ clinical chemistry sys…
FDA Device · Class III · 2017-02-22 · Siemens Healthcare Diagnostics - Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE W/S Reference: 2002-300 Intended Use: To evacuate air and/or fluid from the chest cavit…
FDA Device · Class II · 2017-02-22 · Atrium Medical - Atrium PVC 10 Fr Straight Thoracic Catheter Code Number: 8010
FDA Device · Class II · 2017-02-22 · Atrium Medical - 1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw
FDA Device · Class II · 2017-02-22 · Zimmer Biomet - T-LOK BONE MARROW BIOPSY NEEDLE 8G x 4 EXT CAN
FDA Device · Class II · 2017-02-22 · Argon Medical Devices - ARTISTE MV System, medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family…
FDA Device · Class II · 2017-02-22 · Siemens Medical Solutions Usa - Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel
FDA Device · Class II · 2017-02-22 · Terumo Cardiovascular Systems - Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE Reference: 2002-400 Intended Use: To evacuate air and/or fluid from the chest cavity or…
FDA Device · Class II · 2017-02-22 · Atrium Medical - GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories
FDA Device · Class II · 2017-02-22 · Aesculap Implant Systems - CentraLink¿ Data Management System Software Versions: v13x,v14x,v15x The CentraLink system software is a network solution provider and mult…
FDA Device · Class II · 2017-02-22 · Siemens Healthcare Diagnostics - Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008
FDA Device · Class II · 2017-02-22 · Atrium Medical - ONCOR Impression, ONCOR Impression plus, and ONCOR Expression Medical charged-particle radiation therapy system Product Usage: The intended…
FDA Device · Class II · 2017-02-22 · Siemens Medical Solutions Usa - The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI and ALTI) and Aspartate Ami…
FDA Device · Class III · 2017-02-22 · Siemens Healthcare Diagnostics - ONCOR Avant-garde, medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family…
FDA Device · Class II · 2017-02-22 · Siemens Medical Solutions Usa - BrightView XCT
FDA Device · Class II · 2017-02-22 · Philips Medical Systems Cleveland - Maquet Express Dry Seal Suction OASIS DRAIN, DRY PEDI W/AC Reference: 3612-100 Intended Use: To evacuate air and/or fluid from the chest ca…
FDA Device · Class II · 2017-02-22 · Atrium Medical - BONE MARROW ASPIRATION NEEDLE 15G x 2.688 MAX and 15G x 4 MAX Intended for the purpose of harvesting bone and/or bone marrow specimens
FDA Device · Class II · 2017-02-22 · Argon Medical Devices - VIDAS 3 software v. 1.1.4
FDA Device · Class II · 2017-02-22 · Biomerieux - StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02
FDA Device · Class II · 2017-02-22 · Abbott Vascular - LIFEPAK 15 Monitor, Automated External Defibrillator (AED), Manual mode monitoring and therapy functions are intended for use on adult and…
FDA Device · Class I · 2017-02-22 · Physio Control - Vanguard Total Knee, PUNCH THRU TRL PLATES, 63 MM Item No: 32-487261, 67 MM Item No: 32-487262, 71 MM Item No: 32-487263, 75 MM Item No: 32…
FDA Device · Class II · 2017-02-22 · Zimmer Biomet - Integra Cadence Total Ankle System
FDA Device · Class II · 2017-02-22 · Integra Lifesciences - Discovery MR450 The systems are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and…
FDA Device · Class II · 2017-02-22 · Ge Healthcare - BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (4.5 ml x 13 x 75 mm) Catalog Number: 369714 Product Usage: The BD Vacut…
FDA Device · Class II · 2017-02-22 · Becton Dickinson And - Comprehensive Reverse Shoulder System Humeral Tray Model 115340
FDA Device · Class I · 2017-02-22 · Zimmer Biomet - Maquet Ocean Water Seal Chest Drain, Single Collection w/AC Reference: 2002-100 Intended Use: To evacuate air and/or fluid from the chest c…
FDA Device · Class II · 2017-02-22 · Atrium Medical - Maquet Ocean Water Seal Chest Drain, Single Collection WAC Reference: 2002-000 Intended Use: To evacuate air and/or fluid from the chest ca…
FDA Device · Class II · 2017-02-22 · Atrium Medical - HARVEST NEEDLE 15GA X 2 Intended for the purpose of harvesting bone and/or bone marrow specimens
FDA Device · Class II · 2017-02-22 · Argon Medical Devices - Maquet Express Dry Seal Suction Chest Drain, Single Collection w/AC Reference: 4000-100N Intended Use: To evacuate air and/or fluid from th…
FDA Device · Class II · 2017-02-22 · Atrium Medical - LIMA Modular Revision Hip Stem Model 428-01-050_110 Product Usage: The Modular Revision Femoral hip stem is made up of a modular stem coupl…
FDA Device · Class II · 2017-02-22 · Encore Medical - 6-hole Pubic Symphysis plate (PN 70-0451)
FDA Device · Class II · 2017-02-22 · Acumed - Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is used to hold surgical components during acetabular re…
FDA Device · Class II · 2017-02-22 · Mako Surgical - Offset Reamer Handle, T5766 Product Usage: The reamer handles are re-usable surgical instruments used in arthroplasty surgery of the hip jo…
FDA Device · Class II · 2017-02-22 · Greatbatch Medical - PRIMUS Medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear ac…
FDA Device · Class II · 2017-02-22 · Siemens Medical Solutions Usa - The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software
FDA Device · Class II · 2017-02-22 · Merge Healthcare - BrightView X upgraded to XCT 882454
FDA Device · Class II · 2017-02-22 · Philips Medical Systems Cleveland - Maquet Oasis Dry Suction Water Seal Chest Drain, Single Collection w/AC Reference: 3600-100 Intended Use: To evacuate air and/or fluid from…
FDA Device · Class II · 2017-02-22 · Atrium Medical - Arthrex Shoulder Suspension Tower
FDA Device · Class II · 2017-02-22 · Allen Medical Systems - STERRAD NX Sterilization System, Product Code: 10033, 10033-002
FDA Device · Class II · 2017-02-22 · Advanced Sterilization Products - Sheridan/CF, Cuffed Tracheal Tube, Catalog # 5-10114 and Sheridan/HVT Cuffed Tracheal Tube, Catalog # 5-10315 A tracheal tube is inserted i…
FDA Device · Class II · 2017-02-15 · Teleflex Medical - InterFuse Tail Traction Tool, Part Number 9116
FDA Device · Class II · 2017-02-15 · Vertebral Technologies - 9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set (Silicone, Non-Sterile) 9952 Extended Contoured, Malar…
FDA Device · Class II · 2017-02-15 · Stryker Leibinger And Kg - VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative measurement of total protein concentration in urine
FDA Device · Class II · 2017-02-15 · Ortho Clinical Diagnostics - Bariatric Bed - BAR600IVC
FDA Device · Class II · 2017-02-15 · Invacare - Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer
FDA Device · Class II · 2017-02-15 · Boston Scientific - Merge RadSuite software
FDA Device · Class II · 2017-02-15 · Merge Healthcare - VITROS Chemistry Products FS Calibrator 1, REF 680 1873 12 x 3 mL, Rx ONLY, IVD
FDA Device · Class III · 2017-02-15 · Ortho Clinical Diagnostics - LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option
FDA Device · Class II · 2017-02-15 · Physio Control - HOTLINE Blood and Fluid Warmer, Mole l HL-90
FDA Device · Class III · 2017-02-15 · Smiths Medical Asd - Dimension Vista¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The AMM method is an in vitro diagnostic test for the quantitative measur…
FDA Device · Class II · 2017-02-15 · Siemens Healthcare Diagnostics - AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A single PRO2 device is packaged in a conventional thermoformed pol…
FDA Device · Class II · 2017-02-15 · Atricure - Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all other countries), Catalog No. 1060177 (China only) --…
FDA Device · Class II · 2017-02-15 · Carestream Health - Dimension¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The AMM method is an in vitro diagnostic test for the quantitative measurement…
FDA Device · Class II · 2017-02-15 · Siemens Healthcare Diagnostics - Bariatric Bed - BARPKG-IVC 1633
FDA Device · Class II · 2017-02-15 · Invacare - Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distributed under the following labels: (a) angiodynamics UPN/Product No. H787471431,…
FDA Device · Class II · 2017-02-15 · Angiodynamics Navilyst Medical - Empowr PS Knee Tibial Insert
FDA Device · Class II · 2017-02-15 · Encore Medical - Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Im…
FDA Device · Class II · 2017-02-15 · Merge Healthcare - Junction Box - 1104343 and 1193560
FDA Device · Class II · 2017-02-15 · Invacare - Foot Section - BAR5490IVC
FDA Device · Class II · 2017-02-15 · Invacare - Thayer MiniSpacer Dual Spray MDI Adapter Counter Incrementing Actuator with 15mm O.D./I.D. Connections, Reference no. 1543A. The 15 mm Dual…
FDA Device · Class II · 2017-02-15 · Thayer Medical - QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain System, 4mm Flat w/Center Holes (Sterile) Accessories to TLS Su…
FDA Device · Class II · 2017-02-15 · Stryker Leibinger And Kg - MEDRAD Intego PET Infusion System - Pump Intended to deliver accurate doses of Fluoredeoxyglucose or F-Sodium Fluoride and commonly used fl…
FDA Device · Class II · 2017-02-15 · Bayer Healthcare - LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option
FDA Device · Class II · 2017-02-15 · Physio Control - Merge PACS software
FDA Device · Class II · 2017-02-15 · Merge Healthcare - VITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only
FDA Device · Class II · 2017-02-08 · Ortho Clinical Diagnostics - Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal
FDA Device · Class II · 2017-02-08 · Medtronic Neurosurgery - Genetic Screening Processor (GSP)
FDA Device · Class II · 2017-02-08 · Perkinelmer Life And Analytical Sciences Wallac Oy - Intact Disposable Wands (part of the Intact System) 777-115BT: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable wands ar…
FDA Device · Class II · 2017-02-08 · Medtronic Advanced Energy - IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LK3PS1, SMN 10706293 (US Kit Catalog) Product Usage: For in vitro…
FDA Device · Class II · 2017-02-08 · Siemens Healthcare Diagnostics - Intact Disposable Wands (part of the Intact System) 777-115: 5 Pack 15mm Disposable Product Usage: The Intact Medical disposable wands are…
FDA Device · Class II · 2017-02-08 · Medtronic Advanced Energy - Intact Disposable Wands (part of the Intact System) 777-110: 5 Pack 10mm Disposable Product Usage: The Intact Medical disposable wands are…
FDA Device · Class II · 2017-02-08 · Medtronic Advanced Energy - Vanguard Total Knee System Vanguard Open Box Femoral Components Item Number: 183100 Description: VNGD PS OPEN INTL FEM RT 55 Item Number: 1…
FDA Device · Class II · 2017-02-08 · Zimmer Biomet - Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10
FDA Device · Class II · 2017-02-08 · Covidien - Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
FDA Device · Class II · 2017-02-08 · Immuno Mycologics - Syngo.plaza, picture archiving and communications system
FDA Device · Class II · 2017-02-08 · Siemens Medical Solutions Usa - Mammomat Inspiration full, field digital,system,x-ray,mammographic Product Usage: The Mammomat Inspiration system is intended for mammograp…
FDA Device · Class II · 2017-02-08 · Siemens Medical Solutions Usa - Intact Disposable Wands (part of the Intact System) 900-130: 5 Pack 30mm Disposable Product Usage: The Intact Medical disposable wands are…
FDA Device · Class II · 2017-02-08 · Medtronic Advanced Energy - Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories Product Usage: Intended for primary and revision joint re…
FDA Device · Class II · 2017-02-08 · Synthes Usa Products - SwishTapered Implant
FDA Device · Class II · 2017-02-08 · Implant Direct Sybron Manufacturing - Intact Disposable Wands (part of the Intact System) 900-120: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands are…
FDA Device · Class II · 2017-02-08 · Medtronic Advanced Energy - Intact Disposable Wands (part of the Intact System) 777-112BT: 5 Pack 12mm Disposable Product Usage: The Intact Medical disposable wands ar…
FDA Device · Class II · 2017-02-08 · Medtronic Advanced Energy - Olympus Scientific Solutions Americas Corporation ( OSSA ) VANTA¿ XRF Analyzer
FDA Device · Class II · 2017-02-08 · Olympus Scientific Solutions Americas
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)