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.
- cobas b 221 AutoQC Module Complete
FDA Device · Class II · 2018-05-09 · Roche Diagnostics - StoneBreaker Pneumatic Lithotripter, Catalog number: SBL-KIT1
FDA Device · Class II · 2018-05-09 · Cook - SOMATOM Emotion Duo (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data
FDA Device · Class II · 2018-05-09 · Siemens Medical Solutions Usa - BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829
FDA Device · Class III · 2018-05-09 · Becton Dickinson And - StoneBreaker Probe Cap, Catalog number:SBA-PC
FDA Device · Class II · 2018-05-09 · Cook - cobas b 221<6>Roche OMNI S6 system
FDA Device · Class II · 2018-05-09 · Roche Diagnostics - PTS Panels¿ CHOL+GLU Test Strips (REF 1765)
FDA Device · Class II · 2018-05-09 · Polymer Technology Systems - MultiDiagnostic-Eleva with Flat Detector 708035 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiog…
FDA Device · Class II · 2018-05-09 · Philips Medical Systems Nederlands - MultiDiagnost Eleva 708036 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography…
FDA Device · Class II · 2018-05-09 · Philips Medical Systems Nederlands - SOMATOM Sensation Open Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data
FDA Device · Class II · 2018-05-09 · Siemens Medical Solutions Usa - Nanosil Spray Gel, "***IMMUNE SYSTEM SUPPORT***ENGINEERED NANO-SILVER SOLUTION***", Net
FDA Device · Class II · 2018-05-09 · Conseal International - Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: a) REF 6561-910C b) REF 6561-916K c) REF 6561-920C To remove bloo…
FDA Device · Class II · 2018-05-09 · Cardinal Health 200 - Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner
FDA Device · Class II · 2018-05-09 · Siemens Medical Solutions Usa - WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED
FDA Device · Class II · 2018-05-09 · Beaver Visitec International - StoneBreaker Exhaust Line, Catalog number: SBA-EL
FDA Device · Class II · 2018-05-09 · Cook - DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switch, with 15 ft (4.6 m) Cord and Holster, REF 88-001502 Product Usage: general s…
FDA Device · Class II · 2018-05-09 · Deroyal Industries - Beijing Syntech Laser Diode Laser surgical lasers
FDA Device · Class II · 2018-05-09 · Beijing Syntech Laser - Modular Head Component, Biomet Hip System
FDA Device · Class II · 2018-05-09 · Zimmer Biomet - HYPOTHERMIA SLIPPERS Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), SL3000 (b) Elasto-Gel(TM), SL3000LV (c)…
FDA Device · Class II · 2018-05-09 · Southwest Technologies - SOMATOM Sensation 64 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data
FDA Device · Class II · 2018-05-09 · Siemens Medical Solutions Usa - SOMATOM Scope Power Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data
FDA Device · Class II · 2018-05-09 · Siemens Medical Solutions Usa - StoneBreaker Sterilization Cap, Catalog number: SBA-SC
FDA Device · Class II · 2018-05-09 · Cook - 5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended length (5 count)
FDA Device · Class II · 2018-05-09 · Coopersurgical - BD MAX DNA MMK Lab Use, catalog no. 442828
FDA Device · Class III · 2018-05-09 · Becton Dickinson And - Beijing Syntech Laser Trixel C02 Laser surgical lasers
FDA Device · Class II · 2018-05-09 · Beijing Syntech Laser - Alere iScreen Dx Urine Drug Screen Card
FDA Device · Class III · 2018-05-09 · Ameditech - Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens
FDA Device · Class II · 2018-05-09 · Siemens Healthcare Diagnostics - SOMATOM Sensation 40 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data
FDA Device · Class II · 2018-05-09 · Siemens Medical Solutions Usa - Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) Specimen Gate Scree…
FDA Device · Class II · 2018-05-09 · Perkinelmer Life And Analytical Sciences Wallac Oy - Beijing Syntech Laser Trixel 11 C02 Laser surgical lasers
FDA Device · Class II · 2018-05-09 · Beijing Syntech Laser - SOMATOM Sensation Cardiac Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data
FDA Device · Class II · 2018-05-09 · Siemens Medical Solutions Usa - Mutlidiagnost-Eleva with Flat Detector 708034 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiogra…
FDA Device · Class II · 2018-05-09 · Philips Medical Systems Nederlands - Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, MAD700, QTY: 1 Intended for the application of topical ane…
FDA Device · Class II · 2018-05-09 · Teleflex Medical Europe - Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens
FDA Device · Class II · 2018-05-09 · Siemens Healthcare Diagnostics - Beijing Syntech Laser UL C02 Laser surgical lasers
FDA Device · Class II · 2018-05-09 · Beijing Syntech Laser - Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional fluoroscopic x-ray system Product Usag…
FDA Device · Class II · 2018-05-09 · Philips Electronics North America - Beijing Syntech Laser APOLLO JV+ Medical Platform surgical lasers
FDA Device · Class II · 2018-05-09 · Beijing Syntech Laser - StoneBreaker C02 Cartridge, Catalog number: SBC-10
FDA Device · Class II · 2018-05-09 · Cook - 708033 URODiagnost As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be…
FDA Device · Class II · 2018-05-09 · Philips Medical Systems Nederlands - StoneBreaker Exhaust Cap, Catalog number: SBA-EC
FDA Device · Class II · 2018-05-09 · Cook - SOMATOM Spirit Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data
FDA Device · Class II · 2018-05-09 · Siemens Medical Solutions Usa - Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441)
FDA Device · Class II · 2018-05-02 · Life Technologies - Advance¿ 35LP Low-Profile PTA Balloon Dilatation Catheter
FDA Device · Class II · 2018-05-02 · Cook - clariti 1 day (-1.25) 90 pack, UV Blocking, 90 silicone hydrogel, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hy…
FDA Device · Class III · 2018-05-02 · Coopervision - T4 Zipper Toga, Regular
FDA Device · Class II · 2018-05-02 · Stryker Instruments Div - T4 Pullover Toga, (S/M)
FDA Device · Class II · 2018-05-02 · Stryker Instruments Div - clariti 1 day/Fresh Day 90 pack (-1.00), UV Blocking, 90 silicon hydrogel, daily disposable contact lenses The Clariti 1 Day (somofilcon A)…
FDA Device · Class III · 2018-05-02 · Coopervision - Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M The device is made out of a macroporous three-dimensional monofilament polyester…
FDA Device · Class II · 2018-05-02 · Sofradim Production - CELLSEARCH¿ CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLSEARCH¿ CIRCULATING Tumor Cell Kit is intended for the enumeration…
FDA Device · Class II · 2018-05-02 · Menarini Silicon Biosystems - Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar, Model Number CP260600 Product Usage: The replacement of segmen…
FDA Device · Class II · 2018-05-02 · Zimmer Biomet - T4 Zipper Toga (S/M)
FDA Device · Class II · 2018-05-02 · Stryker Instruments Div - T4 Pullover Toga, X-Large
FDA Device · Class II · 2018-05-02 · Stryker Instruments Div - T4 Pullover Toga, L/XL
FDA Device · Class II · 2018-05-02 · Stryker Instruments Div - T5 Zipper Toga with Peel-Away Face Shield, (XL/T)
FDA Device · Class II · 2018-05-02 · Stryker Instruments Div - Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45
FDA Device · Class II · 2018-05-02 · Ethicon - Pressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip 2.4 mm Diameter
FDA Device · Class II · 2018-05-02 · Zimmer Biomet - Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures
FDA Device · Class II · 2018-05-02 · Smith And Nephew - ZMS Intramedullary Fixation Smooth Guide Wire 3.0 mm Diameter, 100 cm Length
FDA Device · Class II · 2018-05-02 · Zimmer Biomet - FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127 (6 test kit), when…
FDA Device · Class II · 2018-05-02 · Biofire Diagnostics - MicroVue SC5b-9 Plus EIA (RUO), Model A020
FDA Device · Class III · 2018-05-02 · Diagnostic Hybrids - Stem Extractor f/Guide Bar, Part number 03.401.072
FDA Device · Class II · 2018-05-02 · Synthes - T4 Zipper Toga, X-Large
FDA Device · Class II · 2018-05-02 · Stryker Instruments Div - M/DN Intramedullary Fixation Humeral Guide Wire Bullet Tip 2.4 mm Diameter, 70 cm Length
FDA Device · Class II · 2018-05-02 · Zimmer Biomet - MicroVue CIC-C1q EIA, Model A001
FDA Device · Class II · 2018-05-02 · Diagnostic Hybrids - BD Vacutainer¿ Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12 (Catalog no 367342)
FDA Device · Class II · 2018-05-02 · Becton Dickinson And - Widefield OCT software feature for the Spectralis HRA+OCT and variants
FDA Device · Class II · 2018-05-02 · Heidelberg Engineering - Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformi…
FDA Device · Class II · 2018-05-02 · Stryker - T5 Zipper Toga with Peel-Away Face Shield, (L/XL)
FDA Device · Class II · 2018-05-02 · Stryker Instruments Div - 56% 1 Day Silicone Hydrogel (-4.50), 10 pack, UV Blocking, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophil…
FDA Device · Class III · 2018-05-02 · Coopervision - Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The knee system devices are sterile, single-use devices intended for us…
FDA Device · Class II · 2018-05-02 · Howmedica Osteonics - M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only
FDA Device · Class II · 2018-05-02 · Zimmer Biomet - ZMS Intramedullary Fixation Smooth Guide Wire 2.4 mm Diameter, 100 cm Length
FDA Device · Class II · 2018-05-02 · Zimmer Biomet - Crimson Trace Corporation laser sights
FDA Device · Class II · 2018-05-02 · Crimson Trace - EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 4.8MM, Product Number HEM3348, GTIN Number 1 - 10884521047563, GTIN Nu…
FDA Device · Class II · 2018-05-02 · Covidien - ZMS Intramedullary Fixation Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length
FDA Device · Class II · 2018-05-02 · Zimmer Biomet - Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an extra…
FDA Device · Class II · 2018-05-02 · Keystone Dental - Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision total knee arthroplast…
FDA Device · Class II · 2018-05-02 · Howmedica Osteonics - Flowmeter Module (accessory to Terumo Advanced Perfusion System 1)
FDA Device · Class II · 2018-05-02 · Terumo Cardiovascular Systems - Avenir Muller Stem
FDA Device · Class II · 2018-05-02 · Zimmer - Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity
FDA Device · Class II · 2018-05-02 · Ace Surgical Supply - Quidel MicroVue Intact PTH EIA, Model 8044
FDA Device · Class III · 2018-05-02 · Diagnostic Hybrids - EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 3.5MM, Product Number HEM3335, GTIN Number 1 - 10884521047518, GTIN Nu…
FDA Device · Class II · 2018-05-02 · Covidien - Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 100 cm Length
FDA Device · Class II · 2018-05-02 · Zimmer Biomet - The humeral stems trials are packaged in a kit for Titan Modular Shoulder System under the following labeling: Catalog Number Product Descr…
FDA Device · Class II · 2018-05-02 · Integra Lifesciences - MicroVue CIC-C1q EIA, Model A001
FDA Device · Class III · 2018-05-02 · Diagnostic Hybrids - T4 Pullover Toga, Regular
FDA Device · Class II · 2018-05-02 · Stryker Instruments Div - Avenir Muller Stem
FDA Device · Class II · 2018-05-02 · Zimmer - Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm length
FDA Device · Class II · 2018-05-02 · Zimmer Biomet - MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029
FDA Device · Class III · 2018-05-02 · Diagnostic Hybrids - Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm length
FDA Device · Class II · 2018-05-02 · Zimmer Biomet - BD Vacutainer¿ Ultra TouchTM Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12
FDA Device · Class II · 2018-05-02 · Becton Dickinson And - Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length
FDA Device · Class II · 2018-05-02 · Zimmer Biomet - Accelerate PhenoTest BC kit, Ref #10101018
FDA Device · Class II · 2018-05-02 · Accelerate Diagnostics - T4 Pullover Toga, Large
FDA Device · Class II · 2018-05-02 · Stryker Instruments Div - 56% 1 Day Silicone Hydrogel (-2.50), 10 pack, UV Blocking, daily disposable contact lenses The Clariti 1 Day (somofilcon A) Soft (Hydrophil…
FDA Device · Class III · 2018-05-02 · Coopervision - Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of patients with localized tumors and other c…
FDA Device · Class II · 2018-05-02 · Ion Beam Applications - Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminophen150 test
FDA Device · Class II · 2018-05-02 · Roche Diagnostics - Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 100 cm Length
FDA Device · Class II · 2018-05-02 · Zimmer Biomet - Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length
FDA Device · Class II · 2018-05-02 · Zimmer Biomet - Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box
FDA Device · Class II · 2018-05-02 · Medtronic Vascular
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)