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.
- IMRIS ORT 300, Removable Operating Room Table, Part Numbers: (a) 114093-000, (b) 114093-006 - Product Usage: The ORT200 and ORT300 are inte…
FDA Device · Class II · 2018-12-26 · Deerfield Imaging - IMRIS ORT 100 table, Part Numbers: (a) 110470-000, (b) 110470-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagno…
FDA Device · Class II · 2018-12-26 · Deerfield Imaging - Genesys Analytical Column, REF 01-05-0017 intended to be used with automated high performance liquid chromatography (HPLC) systems employin…
FDA Device · Class II · 2018-12-26 · Clark Laboratories Dba Trinity Biotech Usa - ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with automated high performance liquid chromatography (HPLC) systems e…
FDA Device · Class II · 2018-12-26 · Clark Laboratories Dba Trinity Biotech Usa - Dimension Vista 1500, Model No. 10444801 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting…
FDA Device · Class II · 2018-12-26 · Siemens Healthcare Diagnostics - Centricity Universal Viewer Zero Footprint Client, Model Number 2090258-001, Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8…
FDA Device · Class II · 2018-12-26 · Ge Healthcare - 8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826
FDA Device · Class II · 2018-12-26 · Covidien - AIA-360 Analyzer is capable of performing two methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive bin…
FDA Device · Class II · 2018-12-26 · Tosoh Bioscience - Theragenics Applicator Needle (18g x 20cm) The device is comprised four basic elements
FDA Device · Class II · 2018-12-26 · Theragenics - NexGen¿ Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size E with Screw Item Number: 00599003523 NexGen Distal Femoral Au…
FDA Device · Class II · 2018-12-26 · Zimmer Biomet - Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of potassium in arterial, venous, or capillary whole blood
FDA Device · Class II · 2018-12-26 · Abbott Point - Protexis Neoprene Surgical Glove, Size 6.5 This powder-free Surgeon s glovessterile light brown colored surgeons gloves are a disposable de…
FDA Device · Class II · 2018-12-26 · Cardinal Health 200 - Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatric Adult Ventilator Puritan Bennett" 980 Neonatal Ventilator Pur…
FDA Device · Class I · 2018-12-26 · Covidien - IMRIS ORT 200, Removable Operating Room Table, Part Numbers: (a) 113821-000, (b) 113821-600, (c) 114148-000, (d) 114148-600 - Product Usage…
FDA Device · Class II · 2018-12-26 · Deerfield Imaging - VITROS 4600 Chemistry System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical i…
FDA Device · Class II · 2018-12-26 · Ortho Clinical Diagnostics - VITEK¿ 2 Systems Software Version 9.01 Update Kit
FDA Device · Class II · 2018-12-26 · Biomerieux - Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion ex…
FDA Device · Class II · 2018-12-26 · Clark Laboratories Dba Trinity Biotech Usa - Empower FastLoad CT Syringe Pack -sterile disposable syringe kit for use with the EmpowerCT¿, EmpowerCTA¿ and EmpowerCTA¿+ Injector Systems…
FDA Device · Class II · 2018-12-26 · Bracco Injeneering - Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
FDA Device · Class II · 2018-12-26 · Fresenius Medical Care Renal Therapies Group - Staclot LA 20 (REF 00594) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative detection of lupus…
FDA Device · Class II · 2018-12-26 · Diagnostica Stago - Protexis Neoprene Surgical Glove, Size 6.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of syn…
FDA Device · Class II · 2018-12-26 · Cardinal Health 200 - Bucky Stand SU-4000 Input 2017.11.17
FDA Device · Class II · 2018-12-26 · Konica Minolta Healthcare Americas - VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of cl…
FDA Device · Class II · 2018-12-26 · Ortho Clinical Diagnostics - Zimmer Compress Devices and Instruments: Item Number/Item Description 178350 Compress Device Anti-Rotation Spindle 178353 Compress Device A…
FDA Device · Class II · 2018-12-26 · Zimmer Biomet - Protexis Neoprene Surgical Glove, Size 5.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of syn…
FDA Device · Class II · 2018-12-26 · Cardinal Health 200 - Staclot¿ LA (REF 00600) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative detection of lupus an…
FDA Device · Class II · 2018-12-26 · Diagnostica Stago - VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vitro quantitative, semi-quantitative, and qualitative measurement o…
FDA Device · Class II · 2018-12-26 · Ortho Clinical Diagnostics - Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 453564483…
FDA Device · Class II · 2018-12-26 · Philips Electronics North America - Genesys Diluent Reagent, REF 01-03-0019 intended to be used with automated high performance liquid chromatography (HPLC) systems employing…
FDA Device · Class II · 2018-12-26 · Clark Laboratories Dba Trinity Biotech Usa - Genesys 2 Reagent, REF 01-03-0022 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion ex…
FDA Device · Class II · 2018-12-26 · Clark Laboratories Dba Trinity Biotech Usa - Avenir¿ Muller Stem Standard, uncemented HA, 1, Taper 12/14 Item Number: 01.06010.001 - Product Usage: Avenir@ Muller Stems are intended to…
FDA Device · Class II · 2018-12-26 · Zimmer - Protexis Neoprene Surgical Glove, Size 9.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of syn…
FDA Device · Class II · 2018-12-26 · Cardinal Health 200 - Jarvik 2000 Ventricular Assist System external components: JHI-212 Y Cable, JHI-202 Lithium-ion Battery Cable, JHI-204 Extensions Cable, JH…
FDA Device · Class II · 2018-12-26 · Jarvik Heart - SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02 Sapphire Epidural Sets are indicated…
FDA Device · Class II · 2018-12-26 · Icu Medical - IMRIS T2X table, Part Numbers: (a)108000-000, (b)108000-600, (c)109682-000, (d) 109682-600, (e) 110470-600 - Product Usage: The ORT200 and…
FDA Device · Class II · 2018-12-26 · Deerfield Imaging - Protexis Neoprene Surgical Glove, Size 8.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of syn…
FDA Device · Class II · 2018-12-26 · Cardinal Health 200 - GloCyte RBC Reagent - Product Usage: The GloCyte Automated Cell Counter System is intended for use by trained healthcare professionals in c…
FDA Device · Class II · 2018-12-26 · Advanced Instruments - Reliance LITe Nerve Hook Bayoneted, 90, Blunt Tip, REF # 48066103 The blunt probe can be used as a conventional means of achieving nerve re…
FDA Device · Class II · 2018-12-26 · Howmedica Osteonics - Protexis Neoprene Surgical Glove, Size 7.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of syn…
FDA Device · Class II · 2018-12-26 · Cardinal Health 200 - enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for primary implantation for the visual correction of aphakia in adul…
FDA Device · Class II · 2018-12-26 · Bausch And Lomb Surgical - Dimension Vista 500, model no. 10284473 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting,…
FDA Device · Class II · 2018-12-26 · Siemens Healthcare Diagnostics - VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical i…
FDA Device · Class II · 2018-12-26 · Ortho Clinical Diagnostics - Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Renaissance System (TPL0…
FDA Device · Class II · 2018-12-26 · Mazor Robotics - Covidien Emprint Standard Percutaneous Antenna with Thermosphere Technology, CA20L2 intended for use in percutaneous, laparoscopic, and int…
FDA Device · Class II · 2018-12-26 · Covidien - Covidien Emprint Long Percutaneous Antenna with Thermosphere Technology, Material CA30L2 intended for use in percutaneous, laparoscopic, an…
FDA Device · Class II · 2018-12-26 · Covidien - Protexis Neoprene Surgical Glove, Size 8.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of syn…
FDA Device · Class II · 2018-12-26 · Cardinal Health 200 - FoundationOne CDx Test Results
FDA Device · Class II · 2018-12-26 · Foundation Medicine - Covidien Emprint Short Percutaneous Antenna with Thermosphere Technology, Material CA15L2 intended for use in percutaneous, laparoscopic, a…
FDA Device · Class II · 2018-12-26 · Covidien - Protexis Neoprene Surgical Glove, Size 7.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of syn…
FDA Device · Class II · 2018-12-26 · Cardinal Health 200 - RT-5100 Refractor, a component of the Epic-5100 System
FDA Device · Class III · 2018-12-26 · Nidek - VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these susceptibility products: Catalog # 410028, VITEK 2 AST-ST01 C…
FDA Device · Class II · 2018-12-26 · Biomerieux - CIVCO Needle Guide Starter Kit, REF numbers P12920-01 and P12920-02, Reusable non-sterile bracket with sterile (1.5cm, 2.5cm, 3.5cm, 4.5cm…
FDA Device · Class II · 2018-12-19 · Civco Medical Instruments - CIVCO Needle Guide Starter Kit, REF 674-039, Reusable non-sterile bracket with sterile needle guides (1cm, 1.5cm, 2cm depths) with (10.2 x…
FDA Device · Class II · 2018-12-19 · Civco Medical Instruments - Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for H…
FDA Device · Class III · 2018-12-19 · Tosoh Bioscience - Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing of diseases and organ function for the ev…
FDA Device · Class II · 2018-12-19 · Ge Healthcare - B40i Patient Monitor and B40i Patient Monitor V3 The device is a portable multiparameter unit to be used for monitoring and recording of, a…
FDA Device · Class II · 2018-12-19 · Ge Healthcare - CIVCO Needle Guide Bracket, REF P03122-06, Reusable non-sterile bracket for use with SonoSite L25/L25e transducers, Mfg by: CIVCO, Kalona,…
FDA Device · Class II · 2018-12-19 · Civco Medical Instruments - AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competi…
FDA Device · Class II · 2018-12-19 · Tosoh Bioscience - B20i Patient Monitor and B20i V2 Patient Monitor
FDA Device · Class II · 2018-12-19 · Ge Healthcare - PROCARE B40 Patient Monitor, V1
FDA Device · Class II · 2018-12-19 · Ge Healthcare - Laser Fiber Assy-Single Use-LFS-365-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO- Private label: SU-365-RT SmartScope Packaging
FDA Device · Class II · 2018-12-19 · Leoni Fiber Optics - CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08, reusable non-sterile single-angle bracket for use with SonoSi…
FDA Device · Class II · 2018-12-19 · Civco Medical Instruments - SonoSite Needle Guide Bracket, REF numbers P06013-06 and P06013-07, Reusable non-sterile bracket for use with SonoSite L25 series transduce…
FDA Device · Class II · 2018-12-19 · Civco Medical Instruments - CIVCO Needle Guide Bracket, REF 674-057, Reusable non-sterile bracket for use with SonoSite L25 series tranducers, Rx
FDA Device · Class II · 2018-12-19 · Civco Medical Instruments - SonoSite L25 Bracket Kit containing 1 Reusable non-sterile bracket, REF numbers P03122-01, P03122-02, P03122-03, P03122-04, and P03122-05,…
FDA Device · Class II · 2018-12-19 · Civco Medical Instruments - CIVCO Needle Guide Starter Kit, REF numbers P12922-01 and P12922-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) nee…
FDA Device · Class II · 2018-12-19 · Civco Medical Instruments - Laser Fiber Assy-Single Use-LFS-272-RT-0.22NA-SMA905- Slim Extension Sleeve Silver-Sterile ETO- Private label: SU-200-RT SmartScope Packagi…
FDA Device · Class II · 2018-12-19 · Leoni Fiber Optics - Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY The…
FDA Device · Class II · 2018-12-19 · Helena Laboratories - Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394
FDA Device · Class II · 2018-12-19 · Zimmer Biomet - UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle Release Tool STERILE R CE 0050 Manufactured By: neotra…
FDA Device · Class II · 2018-12-19 · Neotract - Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant
FDA Device · Class II · 2018-12-19 · Howmedica Osteonics - CIVCO Sales Demo Kit, REF DEMOGPGUIDE, for use by CIVCO and customer sales representatives
FDA Device · Class II · 2018-12-19 · Civco Medical Instruments - Laser Fiber Assy-Single Use-LFS-200-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-ForTec Fiber SU-200-TRUE-RT Label Smartscope packaging
FDA Device · Class II · 2018-12-19 · Leoni Fiber Optics - Comprehensive Mini Stem, Item No. 113631
FDA Device · Class II · 2018-12-19 · Zimmer Biomet - CIVCO Needle Guide Starter Kit, REF 674-037, Reusable non-sterile bracket with sterile needle guides (1.5cm, 2.5cm, 3.5cm, 4.5 depths) with…
FDA Device · Class II · 2018-12-19 · Civco Medical Instruments - Discovery NM/CT 670 Pro, model 5376204-70-54
FDA Device · Class II · 2018-12-19 · Ge Healthcare - CIVCO Needle Guide Bracket, REF 674-057-10, Reusable non-sterile bracket for use with FUJIFILM SonoSite, Inc
FDA Device · Class II · 2018-12-19 · Civco Medical Instruments - CIVCO Biopsy Bracket, REF P03122-07, Reusable non-sterile single-angle bracket for use with SonoSite L25 series transducers
FDA Device · Class II · 2018-12-19 · Civco Medical Instruments - IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Product Usage: Indicated for use by health care professionals…
FDA Device · Class II · 2018-12-19 · Philips Electronics North America - Laser Fiber Assy-Single Use-LFS-550-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-550-RT SmartScope Packaging
FDA Device · Class II · 2018-12-19 · Leoni Fiber Optics - ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling - Product Usage: The Arjo Passive Clip Sling is a product intended for assisted trans…
FDA Device · Class II · 2018-12-19 · Arjohuntleigh Polska Sp Z O O - Discovery NM/CT 670 ES, model 5376204-70-57
FDA Device · Class II · 2018-12-19 · Ge Healthcare - SonoSite FUJIFILM Needle Guide Bracket, REF number P06013-08, Reusable non-sterile bracket for use with SonoSite L25 series transducers
FDA Device · Class II · 2018-12-19 · Civco Medical Instruments - St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6170 - STERILE EO Rx ONLY CE 0086 0123 St. Jude Medical Plano,…
FDA Device · Class II · 2018-12-19 · St Jude Medical - AIA-2000 Analyzer, Product code 022100, 022100R, 022101, 022101R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three…
FDA Device · Class II · 2018-12-19 · Tosoh Bioscience - Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE PG), Cat no. 55-711
FDA Device · Class II · 2018-12-19 · Angiodynamics Navilyst Medical - Laser Fiber Assy-Single Use-LFS-940-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-1000-RT SmartScope Packaging
FDA Device · Class II · 2018-12-19 · Leoni Fiber Optics - Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The HeartWare Ventricular Assist System (H…
FDA Device · Class II · 2018-12-19 · Heartware - Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch (3.3 mm) x 36" (91 cm), Product Code 8888264911 Product Usage: The Salem Sump Tubes are intende…
FDA Device · Class II · 2018-12-19 · Covidien - Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators an…
FDA Device · Class II · 2018-12-19 · The Binding Site Group - HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of HeartStart MRx Monitor/Defibrillators
FDA Device · Class II · 2018-12-19 · Philips North America - PROCARE B20 Patient Monitor, V1
FDA Device · Class II · 2018-12-19 · Ge Healthcare - AIA-900Analyzer, Product code 022930, 022930R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three methods of immunoa…
FDA Device · Class II · 2018-12-19 · Tosoh Bioscience - GE LOGIQ E10 Ultrasound System, Model #530000E10
FDA Device · Class II · 2018-12-19 · Ge Healthcare - CIVCO Needle Guide Starter Kit, REF 674-038, Reusable non-sterile bracket with sterile needle guide (1cm, 1.5cm, 2cm depths) with (10.2 x 1…
FDA Device · Class II · 2018-12-19 · Civco Medical Instruments - B105/125 Patient Monitor
FDA Device · Class II · 2018-12-19 · Ge Healthcare - CIVCO Needle Guide Starter Kit, REF numbers P12924-01 and P12924-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) nee…
FDA Device · Class II · 2018-12-19 · Civco Medical Instruments - BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL SYSTEM (LTP) PG) Cat. no. 60M183481
FDA Device · Class II · 2018-12-19 · Angiodynamics Navilyst Medical - BD BBL Trypticase Soy Agar with 5% Sheep Blood, Catalog No. 221261, (non-selective, non-differential)
FDA Device · Class II · 2018-12-12 · Becton Dickinson And - Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, bleached, non-woven, rayon/polyester sterile Gauze Pad 3 inch x 3 in…
FDA Device · Class II · 2018-12-12 · Aso
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)