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.
- Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC
FDA Device · Class II · 2018-09-19 · Ohio Medical - AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the outer layers of tissue during the forming of an anast…
FDA Device · Class II · 2018-09-19 · Lemaitre Vascular - Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Transhepatic Biliary Self-Expanding Stent, 8MM X 80MM
FDA Device · Class II · 2018-09-19 · Sps Sterilization - ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascul…
FDA Device · Class II · 2018-09-19 · Micro Therapeutics - Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 420 mm, Item Number: 814413420
FDA Device · Class II · 2018-09-19 · Zimmer Biomet - Edwards Lifesciences Femoral Venous Cannula, 18FR, resterilized
FDA Device · Class II · 2018-09-19 · Sps Sterilization - VidiStar(TM) PACS & DICOM Viewer Software system
FDA Device · Class II · 2018-09-12 · Hitachi Healthcare Americas Informatics Division - GE LOGIQ 9 ultrasound system Product Usage: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal
FDA Device · Class II · 2018-09-12 · Ge Medical Systems Ultrasound And Primary Care Diagnostics Ll - GE Vivid 7 ultrasound system Product Usage: Vivid E7 is a general-purpose ultrasound system, specialized for use in cardiac imaging
FDA Device · Class II · 2018-09-12 · Ge Medical Systems Ultrasound And Primary Care Diagnostics Ll - GE Vivid E80 ultrasound system Vivid E80 / E90 / E95 ultrasound system is general-purpose ultrasound systems, specialized for use in cardia…
FDA Device · Class II · 2018-09-12 · Ge Medical Systems Ultrasound And Primary Care Diagnostics Ll - Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only
FDA Device · Class II · 2018-09-12 · Zimmer Dental - GE Vivid E7 ultrasound system Product Usage: Vivid E7 is a general-purpose ultrasound system, specialized for use in cardiac imaging
FDA Device · Class II · 2018-09-12 · Ge Medical Systems Ultrasound And Primary Care Diagnostics Ll - Laparoscopy CDS
FDA Device · Class II · 2018-09-12 · Medline Industries - Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020, Product Usage: The device i…
FDA Device · Class II · 2018-09-12 · Inspire Medical Systems - Art-Line Surgery Pack-LF, STERILE, 40 packs each per case
FDA Device · Class II · 2018-09-12 · Medline Industries - GE LOGIQ E9 ultrasound system Product Usage: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal
FDA Device · Class II · 2018-09-12 · Ge Medical Systems Ultrasound And Primary Care Diagnostics Ll - Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Catalog # OCS CEIL 58, Material Number 84433765
FDA Device · Class II · 2018-09-12 · Bayer Medical Care - AMSCO V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems The V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature S…
FDA Device · Class II · 2018-09-12 · Steris - GE Vivid E90 ultrasound system Product Usage: Vivid E80 / E90 / E95 ultrasound system is general-purpose ultrasound systems, specialized fo…
FDA Device · Class II · 2018-09-12 · Ge Medical Systems Ultrasound And Primary Care Diagnostics Ll - Foundation Modular Femoral Stem, Part Number, 220-10-110
FDA Device · Class II · 2018-09-12 · Encore Medical - Zen RC Toric-Gas permeable contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx)as follows: Zen RC TPC (Toric Peripheral Curve)…
FDA Device · Class III · 2018-09-12 · Alden Optical - GE Vivid E9 ultrasound system Product Usage: GE Vivid E9 ultrasound system is a general purpose ultrasound system for use in cardiac imaging
FDA Device · Class II · 2018-09-12 · Ge Medical Systems Ultrasound And Primary Care Diagnostics Ll - Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements
FDA Device · Class II · 2018-09-12 · Exactech - GE Vivid E95 ultrasound system Product The device is intended for use by a qualified physician for ultrasound evaluation of Fetal
FDA Device · Class II · 2018-09-12 · Ge Medical Systems Ultrasound And Primary Care Diagnostics Ll - Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic device used for stabilization and fixation of small bone fragme…
FDA Device · Class II · 2018-09-12 · Zimmer Biomet - Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with Bayer injector systems as a support for an injector head. , S…
FDA Device · Class II · 2018-09-12 · Bayer Medical Care - Cardiac Insulation Pad, OPEN HEART CDS
FDA Device · Class II · 2018-09-12 · Medline Industries - Pure Rayz, Light Therapy System, packaging, box, sleeve and user manual
FDA Device · Class II · 2018-09-12 · Quasar Bio Tech - McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing
FDA Device · Class II · 2018-09-12 · Mckesson Israel - AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(oge…
FDA Device · Class III · 2018-09-12 · Perkinelmer Life And Analytical Sciences Wallac Oy - Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx) as follows: Zenlens FT(Front Toric)
FDA Device · Class III · 2018-09-12 · Alden Optical - Quasar MD Plus, Light Therapy System, packaging, box, sleeve and user manual
FDA Device · Class II · 2018-09-12 · Quasar Bio Tech - LASER CDS
FDA Device · Class II · 2018-09-12 · Medline Industries - PICC Tray, STERILE, 12 packs each per case
FDA Device · Class II · 2018-09-12 · Medline Industries - Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Catalog # OCS 115A, Material Number 59880253
FDA Device · Class II · 2018-09-12 · Bayer Medical Care - DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)
FDA Device · Class II · 2018-09-12 · Canon Medical System Usa - Baby Quasar Plus, Light Therapy System, packaging, box, sleeve and user manual
FDA Device · Class II · 2018-09-12 · Quasar Bio Tech - AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01540S, for use on the cranium
FDA Device · Class II · 2018-09-05 · Stryker Leibinger And Kg - QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01534S, for use on the cranium
FDA Device · Class II · 2018-09-05 · Stryker Leibinger And Kg - Double Lumen CRRT/ABP Catheter Set
FDA Device · Class II · 2018-09-05 · Medical Components - GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems
FDA Device · Class II · 2018-09-05 · Ge Medical Systems China - Duo-Flow Catheter Full Tray
FDA Device · Class II · 2018-09-05 · Medical Components - FLOSEAL Special Applicator Tips in cartons labeled in part, "Floseal SPECIAL APPLICATOR TIPS***6 x Malleable Tip Trimmable Tip***Baxter***.…
FDA Device · Class II · 2018-09-05 · Baxter Healthcare - GE Carestation 30 anesthesia systems
FDA Device · Class II · 2018-09-05 · Ge Medical Systems China - QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01526S, for use on the cranium
FDA Device · Class II · 2018-09-05 · Stryker Leibinger And Kg - Duo-Flow Double Lumen Catheter Only/Catheter Set
FDA Device · Class II · 2018-09-05 · Medical Components - QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01536S, for use on the cranium
FDA Device · Class II · 2018-09-05 · Stryker Leibinger And Kg - Duo-Flow XTP Straight Full Set, RMS02105 RMS02108
FDA Device · Class II · 2018-09-05 · Medical Components - Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of pathogenic enteric bacteria, viruses, and genetic vir…
FDA Device · Class II · 2018-09-05 · Luminex - Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cobas p 612 pre-analytical system is a computer controlled fully autom…
FDA Device · Class II · 2018-09-05 · Roche Diagnostics - QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01521S The Stryker QuickFlap Sterile Procedure Pack i…
FDA Device · Class II · 2018-09-05 · Stryker Leibinger And Kg - RAPIDPoint 500 Blood Gas Analyzer
FDA Device · Class II · 2018-09-05 · Siemens Healthcare Diagnostics - SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER/CATHETER SET
FDA Device · Class II · 2018-09-05 · Medical Components - DUO FLOW CUSTOM TRAYS
FDA Device · Class II · 2018-09-05 · Medical Components - QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01538S, for use on the cranium
FDA Device · Class II · 2018-09-05 · Stryker Leibinger And Kg - Duo-Flow XTP Straight Full Set
FDA Device · Class II · 2018-09-05 · Medical Components - QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01532S, for use on the cranium
FDA Device · Class II · 2018-09-05 · Stryker Leibinger And Kg - RAPIDPoint 405 Blood Gas Analyzer
FDA Device · Class II · 2018-09-05 · Siemens Healthcare Diagnostics - Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems
FDA Device · Class II · 2018-09-05 · Covidien - SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER TRAY
FDA Device · Class II · 2018-09-05 · Medical Components - Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series
FDA Device · Class II · 2018-09-05 · Stanbio Laboratory - Ceterix Disposable Knot Pusher / Suture Cutter
FDA Device · Class II · 2018-09-05 · Ceterix Orthopedics - QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01522S, for use on the cranium
FDA Device · Class II · 2018-09-05 · Stryker Leibinger And Kg - CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO
FDA Device · Class II · 2018-09-05 · Civco Medical Instruments - QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01528S, for use on the cranium
FDA Device · Class II · 2018-09-05 · Stryker Leibinger And Kg - WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523
FDA Device · Class I · 2018-09-05 · Biosense Webster - QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01520S The Stryker QuickFlap Sterile Procedure Pack…
FDA Device · Class II · 2018-09-05 · Stryker Leibinger And Kg - Stryker Mako Vizadisc Knee Procedure Tracking Kit
FDA Device · Class II · 2018-09-05 · Mako Surgical - QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01530S, for use on the cranium
FDA Device · Class II · 2018-09-05 · Stryker Leibinger And Kg - AXS PP, 1X20MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01546S, for use on the cranium
FDA Device · Class II · 2018-09-05 · Stryker Leibinger And Kg - Haemonetics OrthoPAT System-Integrated Set
FDA Device · Class II · 2018-09-05 · Haemonetics - Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR Intended for flushing IV catheters and IV tubing only
FDA Device · Class II · 2018-09-05 · Medline Industries - Stryker Mako Vizadisc Hip Procedure Tracking Kit
FDA Device · Class II · 2018-09-05 · Mako Surgical - Haemonetics¿ OrthoPAT¿ System-OPAT QuickConnect Reservoirs
FDA Device · Class II · 2018-09-05 · Haemonetics - N Latex CDT Kit
FDA Device · Class II · 2018-09-05 · Csl Behring - RAPIDLab 1245 Blood Gas Analyzer
FDA Device · Class II · 2018-09-05 · Siemens Healthcare Diagnostics - Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva Luminescence immunoassay is intended for the in-vitro diagno…
FDA Device · Class II · 2018-09-05 · Tecan Us - AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01541S, for use on the cranium
FDA Device · Class II · 2018-09-05 · Stryker Leibinger And Kg - QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01524S, for use on the cranium
FDA Device · Class II · 2018-09-05 · Stryker Leibinger And Kg - RAPIDLab 1265 Blood Gas Analyzer
FDA Device · Class II · 2018-09-05 · Siemens Healthcare Diagnostics - AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S, for use on the cranium
FDA Device · Class II · 2018-09-05 · Stryker Leibinger And Kg - Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads
FDA Device · Class II · 2018-09-05 · Bard Medical Division - CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO
FDA Device · Class II · 2018-09-05 · Civco Medical Instruments - Duo-Flow Double Lumen Soft Tip CRRT/ABP Catheter Set
FDA Device · Class II · 2018-09-05 · Medical Components - AXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01548S, for use on the cranium
FDA Device · Class II · 2018-09-05 · Stryker Leibinger And Kg - Sysmex XN-Series Fluorocell PLT, Catalog #CD994563
FDA Device · Class II · 2018-09-05 · Sysmex America - GE 9100c NXT anesthesia systems
FDA Device · Class II · 2018-09-05 · Ge Medical Systems China - QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01531S, for use on the cranium
FDA Device · Class II · 2018-09-05 · Stryker Leibinger And Kg - AXS PP, 1X14MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01544S, for use on the cranium
FDA Device · Class II · 2018-09-05 · Stryker Leibinger And Kg - Duo-Flow IJ Full Tray
FDA Device · Class II · 2018-09-05 · Medical Components - P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
FDA Device · Class II · 2018-09-05 · Depuy Orthopaedics - DUO FLOW DOUBLE LUMEN CATHETER, XTP114CT, XTP114MT
FDA Device · Class II · 2018-09-05 · Medical Components - DigitalDiagnost Upgrades (Stitching Patient Support) 712083
FDA Device · Class II · 2018-08-29 · Philips Medical Systems Dmc - Vertebral Motion Analyzer (VMA) Version 2.3.252
FDA Device · Class II · 2018-08-29 · Ortho Kinematics - BD BBL GC-Lect Agar
FDA Device · Class II · 2018-08-29 · Becton Dickinson And - EasyDiagnost Eleva DRF (Stitching Patient Support) 706032
FDA Device · Class II · 2018-08-29 · Philips Medical Systems Dmc - is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) ant…
FDA Device · Class III · 2018-08-29 · Euro Diagnostica Ab - Philips SureSigns VS3 Vital Signs Monitor, 863069 863070 863071 863072 863073 863074 The SureSigns VS3 monitor is for monitoring, recording…
FDA Device · Class II · 2018-08-29 · Philips Electronics North America - Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232
FDA Device · Class II · 2018-08-29 · Ortho Kinematics - DigitalDiagnost Rel.4 Upgrades (Stitching Patient Support) 712084
FDA Device · Class II · 2018-08-29 · Philips Medical Systems Dmc
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