FDA Device · 2018
FDA Device recalls in 2018
RecallRadar indexes 3,757 FDA Device recall notices published in 2018. By classification: 136 Class I, 3,529 Class II, 92 Class III.
- HipLOC Hip Fracture Fixation System-Hiploc System 135¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-135-004 Product Usage: The HipLOC…
FDA Device · Class II · 2018-10-03 · Biomet Uk - G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement of % hemoglobin A1c in whole bl…
FDA Device · Class II · 2018-10-03 · Tosoh Bioscience - Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packaged in sterile pouches, 6/shipper
FDA Device · Class II · 2018-10-03 · Bausch And Lomb - AIIuraXperFDlO/10, System Code 722011 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications includi…
FDA Device · Class II · 2018-10-03 · Philips Electronics North America - Vanguard 360 Revision Knee System 75x 5mm Universal Tibial Block Augment, Model Number 185224 Intended for use in Total Knee Arthroplasty
FDA Device · Class II · 2018-10-03 · Zimmer Biomet - Cesar-DMCP-Visub(HM2000/3000), System Code 72239 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applicati…
FDA Device · Class II · 2018-10-03 · Philips Electronics North America - Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542
FDA Device · Class II · 2018-10-03 · Medtronic Navigation - Bausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm, packaged in sterile pouches, 6/shipper
FDA Device · Class II · 2018-10-03 · Bausch And Lomb - Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga
FDA Device · Class II · 2018-10-03 · Bausch And Lomb - PROPONENT Pacemaker
FDA Device · Class II · 2018-10-03 · Boston Scientific - Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with Sleeve Nitinol intended to be used for soft tissue to bone fixation with indic…
FDA Device · Class II · 2018-10-03 · Zimmer Biomet - INTEGRIS Allura 9 F FDXD, System Code 722497 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications…
FDA Device · Class II · 2018-10-03 · Philips Electronics North America - Cesar Powerpack-Visub(V3000), System Code 72243 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applicatio…
FDA Device · Class II · 2018-10-03 · Philips Electronics North America - Allura Xper F010 DR Table, System Code 722014 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications…
FDA Device · Class II · 2018-10-03 · Philips Electronics North America - Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Model Number 185221 Intended for use in Total Knee Arthroplasty
FDA Device · Class II · 2018-10-03 · Zimmer Biomet - VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
FDA Device · Class II · 2018-10-03 · Boston Scientific - Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35
FDA Device · Class III · 2018-10-03 · Medtronic Vascular - Allura Xper FD2O Biplane, System Code 722013 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications…
FDA Device · Class II · 2018-10-03 · Philips Electronics North America - Allura Xper F020 DR Table, System Code 722015 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications…
FDA Device · Class II · 2018-10-03 · Philips Electronics North America - Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-89456-14 and 02340-89457-00 Product Usage: The Durex Synthet…
FDA Device · Class II · 2018-10-03 · Reckitt Benckiser - Bausch + Lomb Stellaris Elite 23 GA Vit Cutter, Model BL5627, 7500 cpm, packaged in sterile pouches, 6/shipper
FDA Device · Class II · 2018-10-03 · Bausch And Lomb - da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS) Units The da Vinci System consists of a Surgeon Console, a Pa…
FDA Device · Class II · 2018-10-03 · Intuitive Surgical - Allura Xper FD2O, System Code 722012 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications includin…
FDA Device · Class II · 2018-10-03 · Philips Electronics North America - Poly C- DMCP-Visub(H3000), System Code 72238 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications…
FDA Device · Class II · 2018-10-03 · Philips Electronics North America - Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the following product name sold under: Product Name (Model Number): A…
FDA Device · Class II · 2018-10-03 · Ge Medical Systems - ESSENTIO Pacemaker
FDA Device · Class II · 2018-10-03 · Boston Scientific - AIIuraXperFDlO, System Code 722010 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including…
FDA Device · Class II · 2018-10-03 · Philips Electronics North America - Allura Xper FD2O, System Code 722006 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications includin…
FDA Device · Class II · 2018-10-03 · Philips Electronics North America - Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga
FDA Device · Class II · 2018-10-03 · Bausch And Lomb - AlIura Xper F010 F, System Code 722002 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications includ…
FDA Device · Class II · 2018-10-03 · Philips Electronics North America - HipLOC Hip Fracture Fixation System-Hiploc System 135¿ Plate 38 mm Barrel 3 Hole Plate Item Number: 2110-135-003 Product Usage: The HipLOC…
FDA Device · Class II · 2018-10-03 · Biomet Uk - Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospita…
FDA Device · Class II · 2018-10-03 · Boston Scientific - Retractor System Elastic Stays (Part 3314-lG
FDA Device · Class II · 2018-10-03 · Coopersurgical - Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002
FDA Device · Class II · 2018-10-03 · Stryker - INTEGRIS CV, System Code 722030 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including dia…
FDA Device · Class II · 2018-10-03 · Philips Electronics North America - Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures
FDA Device · Class II · 2018-10-03 · Terumo Cardiovascular Systems - Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga
FDA Device · Class II · 2018-10-03 · Bausch And Lomb - NTEGRIS Allura 9 0 FDXD, System Code 722498 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications i…
FDA Device · Class II · 2018-10-03 · Philips Electronics North America - Medtronic Clip Gun Magazines are packaged in individually sealed pouches and distributed in boxes containing 5 individually pouched Clip Gu…
FDA Device · Class II · 2018-10-03 · Medtronic Neurosurgery - HipLOC Hip Fracture Fixation System-Hiploc System 140¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-140-004 Product Usage: The HipLOC…
FDA Device · Class II · 2018-10-03 · Biomet Uk - Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga
FDA Device · Class II · 2018-10-03 · Bausch And Lomb - ACCOLADE Pacemaker
FDA Device · Class II · 2018-10-03 · Boston Scientific - INTEGRIS Allura 15-12 (biplane), System Code 722044 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applic…
FDA Device · Class II · 2018-10-03 · Philips Electronics North America - VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
FDA Device · Class II · 2018-10-03 · Boston Scientific - Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga
FDA Device · Class II · 2018-10-03 · Bausch And Lomb - Allura Xper F020 DR Table, System Code 722023 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications…
FDA Device · Class II · 2018-10-03 · Philips Electronics North America - INTEGRIS Allura 9 (biplane), System Code 722021 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applicatio…
FDA Device · Class II · 2018-10-03 · Philips Electronics North America - Allura Xper F010/10 DRTable, System Code 722019 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applicatio…
FDA Device · Class II · 2018-10-03 · Philips Electronics North America - Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga
FDA Device · Class II · 2018-10-03 · Bausch And Lomb - Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga
FDA Device · Class II · 2018-10-03 · Bausch And Lomb - Allura Xper F020 Biplane DR Table, System Code 722020 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging appl…
FDA Device · Class II · 2018-10-03 · Philips Electronics North America - 2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product U…
FDA Device · Class II · 2018-09-26 · Fresenius Medical Care Renal Therapies Group - Thermistor Foley catheter, nonsterile, Catalogue Number 102201101463MD Product Usage: This is sterile, single use, two-way silicone Foley C…
FDA Device · Class II · 2018-09-26 · Degania Silicone - Foley Catheter with temperature sensor 400TM 16FR, Catalogue Number 102201101680TY Product Usage: This is sterile, single use, two-way sili…
FDA Device · Class II · 2018-09-26 · Degania Silicone - Artis Q Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 10848281, 10848282, 10848283, 10848354 & 10848355
FDA Device · Class II · 2018-09-26 · Siemens Medical Solutions Usa - PR1000 Pivot Rehab Bed AC powered adjustable bed
FDA Device · Class II · 2018-09-26 · Med Mizer - P400 PREM U/M 16FR TMPSNS, Item Code P4P16TS
FDA Device · Class II · 2018-09-26 · Covidien - ultraView SISH DNP Detection Kit, Catalog Number 05907136001, model 800-098 Immunohistochemistry (IHC) for in vitro diagnostic use
FDA Device · Class I · 2018-09-26 · Ventana Medical Systems - Temperature Sensor Catheter 14FR, Catalogue Number 102201101463BI Product Usage: This is sterile, single use, two-way silicone Foley Cathet…
FDA Device · Class II · 2018-09-26 · Degania Silicone - Foley Temperature Sensor Catheter 10FR, Catalogue Number 102201101080JP Product Usage: This is sterile, single use, two-way silicone Foley…
FDA Device · Class II · 2018-09-26 · Degania Silicone - Temperature sensing catheter 14FR, Catalogue Number 102201101463NU Product Usage: This is sterile, single use, two-way silicone Foley Cathe…
FDA Device · Class II · 2018-09-26 · Degania Silicone - Temperature sensor Foley catheter 10FR, Catalogue Number 102205101080AB Product Usage: This is sterile, single use, two-way silicone Foley…
FDA Device · Class II · 2018-09-26 · Degania Silicone - Foley Catheter with temperature sensor 400TM 8FR, Catalogue Number 102201100880TY Product Usage: This is sterile, single use, two-way silic…
FDA Device · Class II · 2018-09-26 · Degania Silicone - DORO LUCENT Transitional Member, REF 1101.026 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries
FDA Device · Class I · 2018-09-26 · Pro Med Instruments - ISH Protease 3, Catalog Number 05273331001, model 780-4149 Immunohistochemistry (IHC) for in vitro diagnostic use
FDA Device · Class I · 2018-09-26 · Ventana Medical Systems - Thermistor Foley catheter, nonsterile, Catalogue Number 102201101663MD Product Usage: This is sterile, single use, two-way silicone Foley C…
FDA Device · Class II · 2018-09-26 · Degania Silicone - P400 PREM U/M 18FR TMPSNS, Item Code P4P18TS
FDA Device · Class II · 2018-09-26 · Covidien - URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type: Bag, which contains components: a) CD44 + p53, Catalog #: PM…
FDA Device · Class II · 2018-09-26 · Biocare Medical - CINtec p16 Histology (250) CE, Catalog Number 06695256001, model 825-4713 Immunohistochemistry (IHC) for in vitro diagnostic use
FDA Device · Class I · 2018-09-26 · Ventana Medical Systems - VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092 Immunohistochemistry (IHC) for in vitro diagnostic use
FDA Device · Class I · 2018-09-26 · Ventana Medical Systems - 400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16XTSD
FDA Device · Class II · 2018-09-26 · Covidien - Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101680MD Product Usage: This is sterile, single use, two-…
FDA Device · Class II · 2018-09-26 · Degania Silicone - Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101880MD Product Usage: This is sterile, single use, two-…
FDA Device · Class II · 2018-09-26 · Degania Silicone - Temperature sensing catheter 16FR, Catalogue Number 102203101663DO Product Usage: This is sterile, single use, two-way silicone Foley Cathe…
FDA Device · Class II · 2018-09-26 · Degania Silicone - Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101080MD Product Usage: This is sterile, single use, two-…
FDA Device · Class II · 2018-09-26 · Degania Silicone - Temperature Sensor Catheter 16FR, Catalogue Number 102201101663BI Product Usage: This is sterile, single use, two-way silicone Foley Cathet…
FDA Device · Class II · 2018-09-26 · Degania Silicone - Temperature Sensor Catheter 10FR, Catalogue Number 102201101063BI Product Usage: This is sterile, single use, two-way silicone Foley Cathet…
FDA Device · Class II · 2018-09-26 · Degania Silicone - Temperature Sensor Catheter 12FR, Catalogue Number 102201101263BI Product Usage: This is sterile, single use, two-way silicone Foley Cathet…
FDA Device · Class II · 2018-09-26 · Degania Silicone - TEMP SENSE SILICONE 14FR5CC2W, Item Code 50514T
FDA Device · Class II · 2018-09-26 · Covidien - CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody, Catalog Number 05278414001, Model 790-4325 Immunohistochemist…
FDA Device · Class I · 2018-09-26 · Ventana Medical Systems - Makoplasty RIO Standard System
FDA Device · Class II · 2018-09-26 · Mako Surgical - Endoscopic Cleaning Brush, single use, sold in kits and labeled as the following: a. Item Number DYK1002DCB, BRUSH, CLEANING, DOUBLE ENDED,…
FDA Device · Class II · 2018-09-26 · Medline Industries - Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201100880MD Product Usage: This is sterile, single use, two-…
FDA Device · Class II · 2018-09-26 · Degania Silicone - Foley Temperature Sensor Catheter 8FR, Catalogue Number 102201100880JP Product Usage: This is sterile, single use, two-way silicone Foley C…
FDA Device · Class II · 2018-09-26 · Degania Silicone - CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody, Catalog Number 05278392001, model 790-4296 Immunohistoche…
FDA Device · Class I · 2018-09-26 · Ventana Medical Systems - VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 790-1010 Immunohistochemistry (IHC) for in vitro diagnostic use
FDA Device · Class I · 2018-09-26 · Ventana Medical Systems - 400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16TSD
FDA Device · Class II · 2018-09-26 · Covidien - Foley Catheter with temperature sensor 400TM 14FR, Catalogue Number 102201101480TY Product Usage: This is sterile, single use, two-way sili…
FDA Device · Class II · 2018-09-26 · Degania Silicone - IsoFlex LAL Support Surface, Model Number 2860 Product Usage: : The IsoFlex LAL support surface assists in the prevention and treatment of…
FDA Device · Class II · 2018-09-26 · Stryker Medical Division - Permobil powered wheelchairs, Model Numbers: (a) M300 PS, (b) C300 PS, (c) C350 PS, (d) C500 PS, (e) C400 PS Product Usage: The devices ide…
FDA Device · Class II · 2018-09-26 · Permobil Ab - 400mL, Premium, Urine Meter, 14 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P14TSD
FDA Device · Class II · 2018-09-26 · Covidien - Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems
FDA Device · Class II · 2018-09-26 · Accuray - Temperature sensor Foley catheter 8FR, Catalogue Number 102205100880AB Product Usage: This is sterile, single use, two-way silicone Foley C…
FDA Device · Class II · 2018-09-26 · Degania Silicone - iView DAB Detection Kit, Catalog Number 05266157001, model 760-091 Immunohistochemistry (IHC) for in vitro diagnostic use
FDA Device · Class I · 2018-09-26 · Ventana Medical Systems - VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp
FDA Device · Class II · 2018-09-26 · Biomerieux - Gentle Thread PLGA Full Thread Interference Screw, 10x30mm, Item Number 905629
FDA Device · Class II · 2018-09-26 · Zimmer Biomet - Foley Temperature Sensor Catheter 12FR, Catalogue Number 102201101280JP Product Usage: This is sterile, single use, two-way silicone Foley…
FDA Device · Class II · 2018-09-26 · Degania Silicone - Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388
FDA Device · Class II · 2018-09-26 · Invivo - Foley Catheter with temperature sensor 400TM 12FR, Catalogue Number 102201101280TY Product Usage: This is sterile, single use, two-way sili…
FDA Device · Class II · 2018-09-26 · Degania Silicone - Temperature sensor Foley catheter 18FR, Catalogue Number 102205101880AB Product Usage: This is sterile, single use, two-way silicone Foley…
FDA Device · Class II · 2018-09-26 · Degania Silicone
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)