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.
- Fellows "Mighty 8" Power strip (Part Number 04175-0008) and TrippLite Power strip (PS-415-HGULTRA - Part Number 13-00106-00) are two compon…
FDA Device · Class II · 2018-01-24 · Merge Healthcare - HIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm Needles, REF/Part Numbers RMS22606, RMS22609, RMS22612, RMS12606, RMS2…
FDA Device · Class II · 2018-01-17 · Repro Med Systems - Freedom60 Precision Flow Rate Tubing Sets, REF/Part Numbers F900, F2400, F60, F10, F275, F600, F45, F1200 F180
FDA Device · Class II · 2018-01-17 · Repro Med Systems - CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system CombiDiagnost R90 is a multi-functional general R/F system
FDA Device · Class II · 2018-01-17 · Philips Electronics North America - Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated for use in the palliation of malignant strictures in the biliary tr…
FDA Device · Class II · 2018-01-17 · Cordis - Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left
FDA Device · Class II · 2018-01-17 · Brainlab Ag - Mobile Mini C-arm system Part # 1000-0001
FDA Device · Class II · 2018-01-17 · Orthoscan - Philips Healthcare Brilliance iCT computed tomography x-ray system
FDA Device · Class II · 2018-01-17 · Philips Medical Systems Cleveland - LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage: The LIFEPAK 20e defibrillator/monitor is intended for use in the hospital, physic…
FDA Device · Class I · 2018-01-17 · Physio Control - Alaris PCA Pump, Model 8120
FDA Device · Class II · 2018-01-17 · Carefusion 303 - Mobile Mini C-arm system Part # 1000-0004-FD. Intended to provide the physician with general fluoroscopic visualization of the patient, inc…
FDA Device · Class II · 2018-01-17 · Orthoscan - Mobile Mini C-arm system Part # 1000-0005
FDA Device · Class II · 2018-01-17 · Orthoscan - Mac Pin Non-Cannulated Screw, 6.5 x 60mm
FDA Device · Class II · 2018-01-17 · Amendia - EMPOWR Porous Knee System TIBIAL PUNCH, SMALL, REF 801-05-202, NON STERILE, Qty 1 For use in orthopedic surgery
FDA Device · Class II · 2018-01-17 · Encore Medical - UNIVERSAL FLEX2 BREATHING CIRCUIT, Item Numbers: D460-6133Z, D390-6121Z, D390-6121Z, D495-61Z, DF4116-6121Z, D466-61Z, DFP170-6121, DF3115-…
FDA Device · Class II · 2018-01-17 · King Systems - DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE, REF 801-05-042, NON STERILE, Qty 1 For use in orthopedic surgery
FDA Device · Class II · 2018-01-17 · Encore Medical - EMPOWR Porous Knee System TIBIAL PUNCH, MEDIUM, REF 801-05-203, NON STERILE, Qty 1 For use in orthopedic surgery
FDA Device · Class II · 2018-01-17 · Encore Medical - Mobile Mini C-arm system Part # 1000-0004
FDA Device · Class II · 2018-01-17 · Orthoscan - Alaris Syringe Pump, Model 8110
FDA Device · Class II · 2018-01-17 · Carefusion 303 - EMPOWR Porous Knee System TIBIAL PUNCH, LARGE, REF 801-05-204, NON STERILE, Qty 1 For use in orthopedic surgery
FDA Device · Class II · 2018-01-17 · Encore Medical - Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A Product Usage: The Edwards Cert…
FDA Device · Class I · 2018-01-17 · Edwards Lifesciences - Philips Healthcare IQon Spectral CT computed tomography x-ray system
FDA Device · Class II · 2018-01-17 · Philips Medical Systems Cleveland - Sundream 12 V tanning bed
FDA Device · Class II · 2018-01-17 · Prosun International - Philips Healthcare Brilliance iCT SP computed tomography x-ray system
FDA Device · Class II · 2018-01-17 · Philips Medical Systems Cleveland - CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064
FDA Device · Class II · 2018-01-10 · Zimmer Biomet - Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pembert…
FDA Device · Class II · 2018-01-10 · Smiths Medical Asd - Lateral Troch Plate Full Crimp - 254mm, model # 350837
FDA Device · Class II · 2018-01-10 · Zimmer Biomet - Access 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative…
FDA Device · Class III · 2018-01-10 · Beckman Coulter - RED SEXP DSTL FEM 19CM RT ASSY, model # CP111817
FDA Device · Class II · 2018-01-10 · Zimmer Biomet - PPS RingLoc+ Acetabular Shell, RNGLC+ LTD HOLE SHELL SZ62 The Porous Plasma Spray (PPS) Ringloc¿+ Acetabular System is intended to replace…
FDA Device · Class II · 2018-01-10 · Zimmer Biomet - Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-drilling variable screws that are intended to be used with the Cere…
FDA Device · Class II · 2018-01-10 · Amendia - Mobile Detector Holder - Stationary X-ray System (RF System). suitable for positioning the wireless portable detector free in the room for…
FDA Device · Class II · 2018-01-10 · Philips Electronics North America - COMP PRIMARY STEM 8MM MINI, model # 113628
FDA Device · Class II · 2018-01-10 · Zimmer Biomet - ECHO POR FMRL NC 9X125, model # 192009
FDA Device · Class II · 2018-01-10 · Zimmer Biomet - OSS CEMENTED IM STEM 12X150, model # 150366
FDA Device · Class II · 2018-01-10 · Zimmer Biomet - Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pembe…
FDA Device · Class II · 2018-01-10 · Smiths Medical Asd - RED SEXP DSTL FEM 19CM LT ASSY, model # CP111828
FDA Device · Class II · 2018-01-10 · Zimmer Biomet - Lateral Troch Plate Full Crimp - 254mm, model # 350838
FDA Device · Class II · 2018-01-10 · Zimmer Biomet - COMP 12MM HUM FRAC STEM MACRO, model # 11-113562
FDA Device · Class II · 2018-01-10 · Zimmer Biomet - Access 2 Immunoassay System, Remanufactured, Catalog Number 386220
FDA Device · Class III · 2018-01-10 · Beckman Coulter - SafetyGlide Needle, 22GA 1-1/2in, Catalog n. 301701, manufactured by BD, sold in Centurion Convenience Kits
FDA Device · Class II · 2018-01-10 · Centurion Medical Products - Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA test result provides presumpt…
FDA Device · Class II · 2018-01-10 · Euro Diagnostica Ab - CER BIOLOXD OPTION HD 32MM, model # 650-1056
FDA Device · Class II · 2018-01-10 · Zimmer Biomet - CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc
FDA Device · Class II · 2018-01-10 · Smiths Medical Asd - UniCel DxC 600i SYNCHRON Access Clinical Systems
FDA Device · Class III · 2018-01-10 · Beckman Coulter - St. Jude Medical
FDA Device · Class I · 2018-01-03 · Sterilmed - Hi-Art(R) System, Model Number H-000-0003 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system fo…
FDA Device · Class II · 2018-01-03 · Accuray - Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01
FDA Device · Class II · 2018-01-03 · Remel - Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use
FDA Device · Class II · 2018-01-03 · Orthofix Srl - TomoH(R) System, Model Number 1018284 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t…
FDA Device · Class II · 2018-01-03 · Accuray - Sterile Elastic Esmark Bandage, 3" x 9", individually packaged in a Tyvek plastic form fill seal pouch and placed into a corrugate case, 20…
FDA Device · Class II · 2018-01-03 · Medline Industries - VITROS Chemistry Products PHYT Slides, REF/CATALOG 829 8671, Rx ONLY, IVD
FDA Device · Class II · 2018-01-03 · Ortho Clinical Diagnostics - L3 Security & Detection System Cabinet X-ray system used for security screening of checked airline baggage
FDA Device · Class II · 2018-01-03 · L3 Security And Detection - TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for…
FDA Device · Class II · 2018-01-03 · Accuray - Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD
FDA Device · Class II · 2018-01-03 · Randox Laboratories - IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP, IntelliVue Multi Measurement Server X2, IntelliVue Patient M…
FDA Device · Class II · 2018-01-03 · Philips Electronics North America - TomoHD(R) System, Model Number 1018283 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t…
FDA Device · Class II · 2018-01-03 · Accuray
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)