FDA Device · 2019
FDA Device recalls in 2019
RecallRadar indexes 2,801 FDA Device recall notices published in 2019. By classification: 369 Class I, 2,343 Class II, 89 Class III.
- Elekta Unity systems Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereot…
FDA Device · Class II · 2019-05-15 · Elekta - VITROS¿ ECi/ECiQ Immunodiagnostic System Product Code: 1922814 For use in the in vitro quantitative, semi-quantitative, and qualitative mea…
FDA Device · Class II · 2019-05-15 · Ortho Clinical Diagnostics - NM/CT 860 Product Usage: The GE NM/CT 860 system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope…
FDA Device · Class II · 2019-05-08 · Ge Healthcare - G-6-PDH Deficient Control (G-6-PDH CONTROL D), Catalogue Number PD2617 Product Usage: This product is intended for in vitro diagnostic use,…
FDA Device · Class II · 2019-05-08 · Randox Laboratories - Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 10492398
FDA Device · Class II · 2019-05-08 · Siemens Healthcare Diagnostics - SOMATOM Edge Plus, Model Number 10267000 Product Usage: Computed tomography systems intended to generate and process cross-sectional images…
FDA Device · Class II · 2019-05-08 · Siemens Medical Solutions Usa - AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-101 - Product Usage: Quantita…
FDA Device · Class II · 2019-05-08 · Perkinelmer Life And Analytical Sciences Wallac Oy - SiemensADVIA Centaur aTG (500 test kit) Siemens Material Number (SMN): 10492399
FDA Device · Class II · 2019-05-08 · Siemens Healthcare Diagnostics - NM/CT 850 Product Usage: The GE NM/CT 850 system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope…
FDA Device · Class II · 2019-05-08 · Ge Healthcare - Discovery NM/CT 670 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health…
FDA Device · Class II · 2019-05-08 · Ge Healthcare - SOMATOM Definition AS with Option syngo DE Scan for Single Source (Dual Spiral Dual Energy scan mode), Model Number 8098027 Product Usage:…
FDA Device · Class II · 2019-05-08 · Siemens Medical Solutions Usa - Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of…
FDA Device · Class II · 2019-05-08 · Ge Healthcare - Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description, Catalog Number a) Intrepid ArcticGel Small Pad Kit, 31705I b) Intrepid ArcticGe…
FDA Device · Class II · 2019-05-08 · Bard Medical Division - NM/CT 870 DR Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health profession…
FDA Device · Class II · 2019-05-08 · Ge Healthcare - CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321
FDA Device · Class III · 2019-05-08 · Carolina Liquid Chemistries - Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x23 (197809023L), 9x27 (197809027L), 11 x 23 (197811023L), 11x2…
FDA Device · Class II · 2019-05-08 · Depuy Spine - AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-112 - Product Usage: Quantita…
FDA Device · Class II · 2019-05-08 · Perkinelmer Life And Analytical Sciences Wallac Oy - Discovery NM 630 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear me…
FDA Device · Class II · 2019-05-08 · Ge Healthcare - Discovery NM/CT 670 CZT, Model/Catalogue/Code H3906CT Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear…
FDA Device · Class II · 2019-05-08 · Ge Healthcare - EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number: 131703-03
FDA Device · Class II · 2019-05-08 · Molnlycke Health Care - OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are in…
FDA Device · Class II · 2019-05-08 · Matrix Surgical Holdings - Fetal Spiral Electrode, Model No. 9898 031 37631
FDA Device · Class II · 2019-05-08 · Philips North America - Ethyl Alcohol Enzymatic Assay, (a) REF 0220 (small test kit), (b) REF 0221 (large test kit) Product Usage: Detergent causes faster degradat…
FDA Device · Class III · 2019-05-08 · Lin Zhi International - Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code 35700BAX - Product Usage: The Baxter SIGMA Spectrum…
FDA Device · Class II · 2019-05-08 · Baxter Healthcare - Ingenia Ambition S (781359), Ingenia Ambition X (781356) with Magnet Energization Device (MED), Philips MR systems are indicated for use as…
FDA Device · Class II · 2019-05-08 · Philips Medical Systems Nederlands - Discovery NM/CT 670 ES Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health…
FDA Device · Class II · 2019-05-08 · Ge Healthcare - SOMATOM Confidence, Model Number 10590100 Product Usage: Computed tomography systems intended to generate and process cross-sectional image…
FDA Device · Class II · 2019-05-08 · Siemens Medical Solutions Usa - Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (1…
FDA Device · Class II · 2019-05-08 · Depuy Spine - NM 830 Product Usage: The Discovery NM 630 is an all-purpose dual detector nuclear imaging system intended for general nuclear medicine ima…
FDA Device · Class II · 2019-05-08 · Ge Healthcare - FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116), Product Usage: The Fi…
FDA Device · Class II · 2019-05-08 · Biofire Diagnostics - G-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618 Product Usage: This product is intended for in vitro diagnostic use, in…
FDA Device · Class II · 2019-05-08 · Randox Laboratories - OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are i…
FDA Device · Class II · 2019-05-08 · Matrix Surgical Holdings - Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461
FDA Device · Class II · 2019-05-08 · Siemens Healthcare Diagnostics - NM/CT 870 CZT, Model/Catalogue/Code # H3906CW Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Medicine…
FDA Device · Class II · 2019-05-08 · Ge Healthcare - DELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: A007-101 - Product Usage: Quantitative…
FDA Device · Class II · 2019-05-08 · Perkinelmer Life And Analytical Sciences Wallac Oy - SOMATOM Definition Edge, Model Number 10590000 Product Usage: Computed tomography systems intended to generate and process cross-sectional…
FDA Device · Class II · 2019-05-08 · Siemens Medical Solutions Usa - CAROLINA(R) LIQUID CHEMISTRIES CORP. ETHA RGT. KIT, IVD, REF ST321
FDA Device · Class III · 2019-05-08 · Carolina Liquid Chemistries - Atellica IM aTG (500 test kit) Siemens Material Number (SMN): 10995462
FDA Device · Class II · 2019-05-08 · Siemens Healthcare Diagnostics - MRIdian Linac Radiation Therapy System, Model 20000
FDA Device · Class II · 2019-05-08 · Viewray - cobas e 801 immunoassay analyzer
FDA Device · Class II · 2019-05-08 · Roche Diagnostics - Fresenius Kabi CATSmart device (Continuous autotransfusion System)
FDA Device · Class II · 2019-05-01 · Fenwal - cone-beam CT system
FDA Device · Class II · 2019-05-01 · Kavo Dental Technologies - Siemens Digital Linear Accelerators of type: ARTISTE MV System MEVATRON M2/Primus Mid-Energy PRIMUS PRIMUS HI ONCOR Impression ONCOR Impres…
FDA Device · Class II · 2019-05-01 · Siemens Medical Solutions Usa - RT Elements Software revisions of the RT Elements applications have a specific software version number
FDA Device · Class II · 2019-05-01 · Brainlab Ag - TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the TriMed Ankle Fixation System
FDA Device · Class II · 2019-05-01 · Trimed - Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830705F Product Usage: The Fogarty dilation atri…
FDA Device · Class I · 2019-05-01 · Edwards Lifesciences - OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers: 1743566 (w/ Attached Console) 1743574 (w/ Remote Console) T…
FDA Device · Class II · 2019-05-01 · Carestream Health - Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices are indicated for resection of soft and osseous tissues in both lar…
FDA Device · Class II · 2019-05-01 · Arthrex - Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo Grasp" Auto Suture" grasper 5 mm instrument has applications in a…
FDA Device · Class II · 2019-05-01 · Covidien - Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien Endo Clinch" II Auto Suture" grasper 5mm has a 5 mm diameter, rot…
FDA Device · Class II · 2019-05-01 · Covidien - Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Product Code/REF Number: 6685775 Product Usage: The Edi Catheter is…
FDA Device · Class III · 2019-05-01 · Getinge Us Sales - Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left Ventricular Assist…
FDA Device · Class II · 2019-05-01 · Thoratec - Aquarius CSF1R/RPS14 (5q32-q33) Probe Red, Model LPH540-A Analyte specific reagent
FDA Device · Class III · 2019-05-01 · Cytocell - CryoPatch SG Pulmonary Hemi-Artery Patch
FDA Device · Class II · 2019-05-01 · Cryolife - Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030 Product Usage: Knee joint patellofemorotibial polymer/metal/pol…
FDA Device · Class II · 2019-05-01 · Exactech - Edwards Lifesciences, Miller Balloon Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830515F Product Usage: The Miller balloon atriosep…
FDA Device · Class I · 2019-05-01 · Edwards Lifesciences - Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usage: The Stryker Heavy Duty Sagittal Blades are used in the cuttin…
FDA Device · Class II · 2019-05-01 · Stryker Instruments Div - Jelco(R) ViaValve(TM) safety intravenous (I.V.) catheters, 18G x 1 1/4", Model Number REF 3265, MOD 10 The Jelco(R) ViaValve(TM) safety I.V…
FDA Device · Class II · 2019-05-01 · Smiths Medical Asd - St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile
FDA Device · Class II · 2019-05-01 · Abbott - Prevent G Safety Winged Blood Collection Set Glide - Rx Only -Sterile/EO - Product Usage: The IMPROSAFE Blood Collection Set is single-use,…
FDA Device · Class II · 2019-05-01 · Guangzhou Improve Medical Instruments - Procedure kits include devices from the affected lots distributed OUS only: (1)BOX KIT00529H KIT COLECISTECTOMIA ACCESO (2)BOX KIT00680 KIT…
FDA Device · Class II · 2019-05-01 · Covidien - VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 Product Usage: The VITROS XT 7600 Integrated System is intended f…
FDA Device · Class II · 2019-05-01 · Ortho Clinical Diagnostics - Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4040SS
FDA Device · Class II · 2019-04-24 · Gyrus Acmi - ProSun V3 42 Xlc(160w)(10 minutes) tanning bed, Model 500
FDA Device · Class II · 2019-04-24 · Prosun International - icumedical Oncology Kit w/12" (30cm) Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter
FDA Device · Class I · 2019-04-24 · Icu Medical - Abbott Alinity c Processing Module LN 03R67-01 - Product Usage: The Alinity c processing module is a fully automated chemistry analyzer all…
FDA Device · Class II · 2019-04-24 · Abbott And Kg - Olympus Diego Elite Console MDCONS 100
FDA Device · Class II · 2019-04-24 · Gyrus Acmi - Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Right, Part No. LJU202T
FDA Device · Class II · 2019-04-24 · Integra Lifesciences - Biomerieux Vitek 2 Test kit VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identific…
FDA Device · Class II · 2019-04-24 · Biomerieux - Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right, Product No. LJU813T
FDA Device · Class II · 2019-04-24 · Integra Lifesciences - ProSun Onyx 32 Sli Intensive (12 minutes) tanning bed, Model 32/1. Labeled as the following: PROSUN ONYX 32 SLI INTENSIVE RED, PROSUN ONYX…
FDA Device · Class II · 2019-04-24 · Prosun International - BIOVENTUS Bioactive Bone Graft Putty 15g Rx only/sterile
FDA Device · Class II · 2019-04-24 · Bioventus - Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC
FDA Device · Class II · 2019-04-24 · Gyrus Acmi - Cordis Vista Brite Tip & Androit Guiding Catheters Product Usage: The guiding catheter is intended for use for intravascular introduction o…
FDA Device · Class III · 2019-04-24 · Cordis - Innova IGS 630, Angiographic X-Ray, s5i system option used in generating fluoroscopic and rotational images of human anatomy for cardiovasc…
FDA Device · Class II · 2019-04-24 · Ge Healthcare - Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Right, Part No. LJU203T
FDA Device · Class II · 2019-04-24 · Integra Lifesciences - Albumin BCP Product Usage: ALBP is an in vitro test used for the quantitative determination of albumin in human serum and plasma on Roche/H…
FDA Device · Class II · 2019-04-24 · Roche Diagnostics - Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB2000SA
FDA Device · Class II · 2019-04-24 · Gyrus Acmi - Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Right, Product No. LJV180T
FDA Device · Class II · 2019-04-24 · Integra Lifesciences - BIOPHEN LMWH Control C4, REF 224201
FDA Device · Class III · 2019-04-24 · Aniara Diagnostica - Salto Talaris Tibial Ankle Prosthesis Tray, Talar Dome, Size 1, Right, Part No. LJU201T
FDA Device · Class II · 2019-04-24 · Integra Lifesciences - icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-80S. Used in IV administration sets
FDA Device · Class I · 2019-04-24 · Icu Medical - Diego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS
FDA Device · Class II · 2019-04-24 · Gyrus Acmi - Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Left, Part No. LJU212T
FDA Device · Class II · 2019-04-24 · Integra Lifesciences - Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Right, Product No. LJU812T
FDA Device · Class II · 2019-04-24 · Integra Lifesciences - VICRYL Sutures VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 4-0 UND VICRYL SUTURE 18"(45CM) 2-0 VIO VICRYL SUTURE 18"(45CM) 0 VIO…
FDA Device · Class II · 2019-04-24 · Ethicon - Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Left, Product No. LJV192T
FDA Device · Class II · 2019-04-24 · Integra Lifesciences - Talar Dome Total Ankle Prosthesis , Flat Cut, Size 3, Left, Product No. LJU823T
FDA Device · Class II · 2019-04-24 · Integra Lifesciences - 14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422
FDA Device · Class II · 2019-04-24 · Medical Components - icumedical Oncology Kit w/12" Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter
FDA Device · Class I · 2019-04-24 · Icu Medical - Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Left, Product No. LJU822T
FDA Device · Class II · 2019-04-24 · Integra Lifesciences - Tibial Total Ankle Prosthesis Tray, Size 2, Product No. LJU222T
FDA Device · Class II · 2019-04-24 · Integra Lifesciences - Salto Talaris, Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Right, Part No. LJU200T
FDA Device · Class II · 2019-04-24 · Integra Lifesciences - VICRYL PLUS Sutures: VICRYL PLUS SUTURE 18"(45CM) 3-0 VIO VICRYL PLUS SUTURE 18"(45CM) 0 UND VICRYL PLUS SUTURE 18"(45CM) 0 VIO VICRYL PLUS…
FDA Device · Class II · 2019-04-24 · Ethicon - Innova IGS 630, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiov…
FDA Device · Class II · 2019-04-24 · Ge Healthcare - Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector
FDA Device · Class II · 2019-04-24 · Philips Medical Systems Nederlands - Tibial Total Ankle Prosthesis Tray, Size 3, Product No. LJU223T
FDA Device · Class II · 2019-04-24 · Integra Lifesciences - SetSource ChemoClave Vented Vial Spike, 20mm, REF Z7148
FDA Device · Class I · 2019-04-24 · Icu Medical - FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the following blood culture…
FDA Device · Class II · 2019-04-24 · Biofire Diagnostics - PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intended for use in soft tissue approximation, including use in pediat…
FDA Device · Class II · 2019-04-24 · Ethicon
Other years
2026 (2,088) · 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)