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.
- Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571
FDA Device · Class II · 2019-02-27 · Cook - PageWriter TC50 Government Bundle, Product 860429, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of a…
FDA Device · Class II · 2019-02-27 · Philips North America - PageWriter TC70, Product 860315, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pedi…
FDA Device · Class II · 2019-02-27 · Philips North America - Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer
FDA Device · Class II · 2019-02-27 · Medtronic Cardiac Rhythm And Heart Failure Crhf - VITROS Chemistry Products VALP Reagent Pack
FDA Device · Class II · 2019-02-27 · Ortho Clinical Diagnostics - Aplicare Povidone Iodine Prep Pads packaged within Portex Pulsator Arterial Blood Sampling Kit with Liquid Sodium Heparin, models 4037NP-1,…
FDA Device · Class II · 2019-02-27 · Smiths Medical Asd - Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Elect…
FDA Device · Class II · 2019-02-27 · Smiths Medical Asd - PageWriter TC30, Product 860306, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric…
FDA Device · Class II · 2019-02-27 · Philips North America - PageWriter TC30 w/o trolley Government Bundle, Product 860355, Software revisions up to and including A.07.05.22 to evaluate the electrocar…
FDA Device · Class II · 2019-02-27 · Philips North America - AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatm…
FDA Device · Class II · 2019-02-27 · Baxter Healthcare - PageWriter TC50, Product 860310, Software revisions up to and including A.07.05.22 used to evaluate the electrocardiogram of adult and pedi…
FDA Device · Class II · 2019-02-27 · Philips North America - PageWriter TC70 w/trolley Government Bundle, Product 860352, Software revisions up to and including A.07.05. 22 to evaluate the electrocard…
FDA Device · Class II · 2019-02-27 · Philips North America - PageWriter TC30 w/ trolley Government Bundle, Product 860354, Software revisions up to and including A.07.05.22 to evaluate the electrocard…
FDA Device · Class II · 2019-02-27 · Philips North America - TRINIAS for diagnostic imaging and interventional procedures in cardiac angiography, neurovascular angiography, abdominal angiography, peri…
FDA Device · Class II · 2019-02-27 · Shimadzu Medical Systems Usa Com - Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3…
FDA Device · Class II · 2019-02-27 · Ortho Clinical Diagnostics - Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of balloon dilatation catheters or other intravascular devices duri…
FDA Device · Class II · 2019-02-27 · Boston Scientific - Randox CALCIUM (Ca) Colorimetric Method RX Series Cat
FDA Device · Class II · 2019-02-27 · Randox Laboratories - PageWriter TC70 w/o trolley Government Bundle, Product 860353, Software revisions up to and including A.07.05.22 to evaluate the electrocar…
FDA Device · Class II · 2019-02-27 · Philips North America - Pilling COOLEY SUMP-SUCTION TUBE, REF 351547
FDA Device · Class II · 2019-02-27 · Teleflex Medical - Randox CALCIUM (Ca) COLORIMETRIC METHOD RX DAYTONA PLUS Cat
FDA Device · Class II · 2019-02-27 · Randox Laboratories - Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the trea…
FDA Device · Class II · 2019-02-27 · Baxter Healthcare - VITEK 2 AST-N351 Test Kit
FDA Device · Class II · 2019-02-27 · Biomerieux - PageWriter TC20, Product 860332, Software revisions up to and including A.07.05.22 to evaluate the electrocardiogram of adult and pediatric…
FDA Device · Class II · 2019-02-27 · Philips North America - Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number SPDR01 (b) M…
FDA Device · Class I · 2019-02-20 · Medtronic Cardiac Rhythm And Heart Failure Crhf - MOSAIQ¿ Oncology Information System and Sequencer MOSAIQ is an oncology information system used to manage workflows for treatment planning…
FDA Device · Class II · 2019-02-20 · Elekta - Medtronic implantable pulse generator: ADAPTA, Dual chamber pacemaker (DDD): (a) Model Number ADD01 (b) Model Number ADDR01 (c) Model Numbe…
FDA Device · Class I · 2019-02-20 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed us…
FDA Device · Class III · 2019-02-20 · Luminex - COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001
FDA Device · Class II · 2019-02-20 · Atricure - Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01 (b) Model Number REDR01 (c) Model Number…
FDA Device · Class I · 2019-02-20 · Medtronic Cardiac Rhythm And Heart Failure Crhf - 21Y14 PushValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees
FDA Device · Class II · 2019-02-20 · Ottobock Orthopedic Industrie - Genius Knee Cemented CR Femoral Component Product Usage: Knee replacement component
FDA Device · Class II · 2019-02-20 · Signature Orthopedics - Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System
FDA Device · Class II · 2019-02-20 · Philips Medical Systems Dmc - vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1, A60A1 (b) E-series, Model Numbers: E50A1, E60A1 (c) G-series, M…
FDA Device · Class I · 2019-02-20 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: The HEMOTHERM¿ Model 400CE Dual Reservoir Cooler/Heater is used t…
FDA Device · Class II · 2019-02-20 · Cincinnati Sub Zero Products A Gentherm - 21Y14=S PushValve upper part Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb ampu…
FDA Device · Class II · 2019-02-20 · Ottobock Orthopedic Industrie - 21Y15 MagValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees
FDA Device · Class II · 2019-02-20 · Ottobock Orthopedic Industrie - ATLAS Loading Car
FDA Device · Class II · 2019-02-20 · Steris - COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002
FDA Device · Class II · 2019-02-20 · Atricure - OMNI K1 Broach Handle, Product Code HS-10054
FDA Device · Class II · 2019-02-20 · Omnilife Science - Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD): (a) Model Number SED01 (b) Model Number SEDR01 (c) Model Numbe…
FDA Device · Class I · 2019-02-20 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01
FDA Device · Class I · 2019-02-20 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Edward Lifesciences, Edwards Commander Delivery System: Model Number UDI Number 9600LDS20A (US) 00690103193930 9600LDS20J 00690103194852 96…
FDA Device · Class II · 2019-02-20 · Edwards Lifesciences - COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S
FDA Device · Class II · 2019-02-20 · Atricure - Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number ATDR01 (b…
FDA Device · Class I · 2019-02-20 · Medtronic Cardiac Rhythm And Heart Failure Crhf - COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI
FDA Device · Class II · 2019-02-20 · Atricure - HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.)
FDA Device · Class II · 2019-02-20 · The Magstim - Ingenuity TF PET/CT (non-RoHS), Model Number 882456 This device is a diagnostic imaging system that combines Positron Emission Tomography (…
FDA Device · Class II · 2019-02-20 · Philips Medical Systems Cleveland - Genius Knee Cemented Tibial Component Product Usage: Knee replacement component
FDA Device · Class II · 2019-02-20 · Signature Orthopedics - Aguja para Biopsia Tipo Medula Osea Ergonomica 11ga x 10cm
FDA Device · Class II · 2019-02-13 · Angiotech Manan Medical Products - Product: ABL800 FLEX with Crea
FDA Device · Class II · 2019-02-13 · Radiometer America - Aguja de Aspiration con Profundidad Ajustable Tipo I 15ga x 5 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and As…
FDA Device · Class II · 2019-02-13 · Angiotech Manan Medical Products - Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿¿ ¿¿¿ ¿¿¿
FDA Device · Class I · 2019-02-13 · Medex Cardio Pulmonary D B A Smiths Medical - Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ ¿¿¿
FDA Device · Class I · 2019-02-13 · Medex Cardio Pulmonary D B A Smiths Medical - MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices
FDA Device · Class II · 2019-02-13 · Medtronic Cardiac Rhythm And Heart Failure Crhf - ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800
FDA Device · Class II · 2019-02-13 · Arjohuntleigh Magog - CoaguChek XS PT Test
FDA Device · Class I · 2019-02-13 · Terrific Care - ARCHITECT Free T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminescent Microparticle Im…
FDA Device · Class II · 2019-02-13 · Abbott Ireland Diagnostics Division - Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW
FDA Device · Class III · 2019-02-13 · Ascension Orthopedics - Richard Wolf Bronchoscope Tubes, Model Texas
FDA Device · Class II · 2019-02-13 · Richard Wolf - Portex 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿
FDA Device · Class I · 2019-02-13 · Medex Cardio Pulmonary D B A Smiths Medical - BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing Infection Control Foley Catheter with Bard Hydrogel and Bacte…
FDA Device · Class II · 2019-02-13 · Bard Medical Division - J Type Bone Marrow Needle 13ga x 10 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration
FDA Device · Class II · 2019-02-13 · Angiotech Manan Medical Products - Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography…
FDA Device · Class II · 2019-02-13 · Ge Healthcare - Double Diamond J Type Bone Marrow Needle & Marrow Extraction Cannula 11ga x 10cm 14MTWX x 12.5 cm
FDA Device · Class II · 2019-02-13 · Angiotech Manan Medical Products - SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Product Codes: A119214M, A119216M, A119218M, A119416M, A153200, A300…
FDA Device · Class II · 2019-02-13 · Bard Medical Division - Portex 5ml Normal Saline (0.9%) Unit Dose¿¿¿¿ ¿
FDA Device · Class I · 2019-02-13 · Medex Cardio Pulmonary D B A Smiths Medical - Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿
FDA Device · Class I · 2019-02-13 · Medex Cardio Pulmonary D B A Smiths Medical - Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿
FDA Device · Class I · 2019-02-13 · Medex Cardio Pulmonary D B A Smiths Medical - Portex 500 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿
FDA Device · Class I · 2019-02-13 · Medex Cardio Pulmonary D B A Smiths Medical - BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878 BD FACSLyric is a high-performance flow cytometer designe…
FDA Device · Class III · 2019-02-13 · Becton Dickinson And Bd Biosciences - Portex 1000 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿
FDA Device · Class I · 2019-02-13 · Medex Cardio Pulmonary D B A Smiths Medical - Portex Unit Dose 15 ml Normal Saline ¿
FDA Device · Class I · 2019-02-13 · Medex Cardio Pulmonary D B A Smiths Medical - Naera Hospital Bassinet, Model No. 4402
FDA Device · Class II · 2019-02-13 · Stryker Medical Division - "J" Type Bone Marrow Needle 11ga x 10 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration
FDA Device · Class II · 2019-02-13 · Angiotech Manan Medical Products - Medline Prefilled 550 ml Sterile¿¿ ¿
FDA Device · Class I · 2019-02-13 · Medex Cardio Pulmonary D B A Smiths Medical - Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage: Curing light for use in dentistry
FDA Device · Class II · 2019-02-13 · Handpiece Headquarters - J Type Bone Marrow Needle 13ga x 6cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration
FDA Device · Class II · 2019-02-13 · Angiotech Manan Medical Products - GE Healthcare Centricity Universal Viewer Breast Imaging Centricity Universal Viewer is a device that displays medical images and data from…
FDA Device · Class II · 2019-02-13 · Ge Healthcare - NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 Multi-Slice CT Scanner System can be used…
FDA Device · Class II · 2019-02-13 · Neusoft Medical Systems Imp And Ex - Portex Unit Dose 5 ml Normal Saline (0.9%)¿¿¿¿ ¿
FDA Device · Class I · 2019-02-13 · Medex Cardio Pulmonary D B A Smiths Medical - Intermed 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿
FDA Device · Class I · 2019-02-13 · Medex Cardio Pulmonary D B A Smiths Medical - MEDTRONIC CARELINK 2090 programmer
FDA Device · Class II · 2019-02-13 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Aguja de Aspiracion con Profundidad Ajustable Tipo I 16ga x 5 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Asp…
FDA Device · Class II · 2019-02-13 · Angiotech Manan Medical Products - Medline Prefilled 350 ml Sterile¿¿¿¿ ¿¿¿¿ ¿
FDA Device · Class I · 2019-02-13 · Medex Cardio Pulmonary D B A Smiths Medical - ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminescent Microparticle I…
FDA Device · Class II · 2019-02-13 · Abbott Ireland Diagnostics Division - Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnosti…
FDA Device · Class I · 2019-02-06 · Edwards Lifesciences - Calix Lumbar Spinal Implant System: 22mm x 10mm x 7mm PLIF ASSY PC, REF X034-0172PC 22mm x 10mm x 8mm PLIF ASSY PC, REF X034-0173PC 26mm x…
FDA Device · Class II · 2019-02-06 · Xtant Medical - Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only
FDA Device · Class I · 2019-02-06 · West Pharma Services Il - Atellica IM 1300 Analyzer
FDA Device · Class II · 2019-02-06 · Siemens Healthcare Diagnostics - COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with Spike, DBF-2.4SN-230SP-20-S
FDA Device · Class II · 2019-02-06 · Wilson Cook Medical - Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131VF7P Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnos…
FDA Device · Class I · 2019-02-06 · Edwards Lifesciences - RESERVOIR "Y" ADAPTER, (a) BT920 (b) BT926 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system betw…
FDA Device · Class II · 2019-02-06 · Medtronic Perfusion Systems - Cell Saver 5/5+ Bowl Set, 70ml, Product ID: 0291E-00, 0291A-00 Indications for Use: The Haemonetics Cell Saver 5/5+ System and its related…
FDA Device · Class II · 2019-02-06 · Haemonetics - Anti-HAV IgM test System, Material No. 11820591160 Product Usage: The Roche Elecsys Anti-HAV IgM immunoassay is used for the in vitro quali…
FDA Device · Class II · 2019-02-06 · Roche Diagnostics - Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnost…
FDA Device · Class I · 2019-02-06 · Edwards Lifesciences - RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18 Product Usage: The Riverpoint Brachytherapy Grid is used during Brachythera…
FDA Device · Class III · 2019-02-06 · Riverpoint Medical - Atellica Sample Handler Prime
FDA Device · Class II · 2019-02-06 · Siemens Healthcare Diagnostics - Vial2BAG Transfer Device, REF 6070104, Single use only, Rx Only
FDA Device · Class I · 2019-02-06 · West Pharma Services Il - GE HEALTHCARE LOGIQ P6 Premium TruScan(TM) Imagining Technology: (a) Model BT09 (b) Model BT07 Product Usage: The device is intended for us…
FDA Device · Class II · 2019-02-06 · Ge Healthcare - COOK MEDICAL Captura SERRATED LARGE FORCEP-NO SPIKE, 2.4 mm, 230 cm, DBF-2.4SL- 230-20-S
FDA Device · Class II · 2019-02-06 · Wilson Cook Medical
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)