FDA Device · 2020
FDA Device recalls in 2020
RecallRadar indexes 3,055 FDA Device recall notices published in 2020. By classification: 182 Class I, 2,804 Class II, 69 Class III.
- HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175826P0 - Product Usage: for use in the replacement o…
FDA Device · Class II · 2020-05-13 · Maquet Cardiovascular - Fukushima suction tubes
FDA Device · Class II · 2020-05-13 · Tedan Surgical Innovations - Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830
FDA Device · Class II · 2020-05-13 · R82 A S - Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic, REF: A4GW6, 5F X 60cm, 9mm, Sterile EO, CE, UDI: (01)0060791…
FDA Device · Class I · 2020-05-13 · Applied Medical Resources - Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M002020955880 - Product Usage: for use in the…
FDA Device · Class II · 2020-05-13 · Maquet Cardiovascular - Inpeco FlexLab Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and…
FDA Device · Class II · 2020-05-13 · Inpeco - HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175820P0 - Product Usage: for use in the replacement…
FDA Device · Class II · 2020-05-13 · Maquet Cardiovascular - REF: Z3806, 131" (333 cm) 10 Drop Primary Set w/2 MicroClave, Remv 4 Gang 4-way Stopcocks (1 Remv), Check Valve, Rotating Luer, 1 Ext, Ster…
FDA Device · Class II · 2020-05-13 · Icu Medical - Transducer S8-3t UDI (01)00884838073524 REF 989605431171 Can be used as accessory with: EPIQ 7, Affiniti 70, EPIQ 5, EPIQ CVxi Ultrasound s…
FDA Device · Class II · 2020-05-13 · Philips Ultrasound - Temporary Abutment Non-Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 3666…
FDA Device · Class II · 2020-05-13 · Nobel Biocare Usa - Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M002020955010 - Product Usage: For use in the…
FDA Device · Class II · 2020-05-13 · Maquet Cardiovascular - Abbott Accelerator a3600 Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5…
FDA Device · Class II · 2020-05-13 · Inpeco - Transducer S7-3t UDI (01)00884838067530 REF 989605439232 Used as accessory with: iE33, HD11 Ultrasound Systems - Product Usage: Diagnostic…
FDA Device · Class II · 2020-05-13 · Philips Ultrasound - HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175828P0 - Product Usage: for use in the replacement…
FDA Device · Class II · 2020-05-13 · Maquet Cardiovascular - WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Product Usage: is intended to give a patient limited mobility by r…
FDA Device · Class II · 2020-05-13 · Wright Medical Technology - REF: Z2850, 112" (284 cm) 10 Drop Primary set w/2 Clave, Remv 3 Gang 1o2 Manifold w/3 Clave, Baseplate, Rotating Luer w/Filter Cap, 1 Ext,…
FDA Device · Class II · 2020-05-13 · Icu Medical - HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175930P0 - Product Usage: for use in the replacement o…
FDA Device · Class II · 2020-05-13 · Maquet Cardiovascular - HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175926P0 - Product Usage: for use in the replacement o…
FDA Device · Class II · 2020-05-13 · Maquet Cardiovascular - R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496
FDA Device · Class II · 2020-05-13 · Epimed International - HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175732P0 - Product Usage: for use in the replacement o…
FDA Device · Class II · 2020-05-13 · Maquet Cardiovascular - Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System
FDA Device · Class II · 2020-05-13 · Philips North America - DELFI SINGLE USE VARIFIT TOURNIQUET CUFF SINGLE PORT SINGLE BLADDER CONTOUR THIGH CUFF WITH MATHCING LIMP PROTECTION SLEEVE Rx Only, Sterile
FDA Device · Class II · 2020-05-13 · Delfi Medical Innovations - AUTOLITH URO-TCH 9FR PROBE 54CM
FDA Device · Class II · 2020-05-13 · Northgate Technologies - ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion i…
FDA Device · Class III · 2020-05-13 · Abbott Laboratories - HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175922P0 - Product Usage: for use in the replacement o…
FDA Device · Class II · 2020-05-13 · Maquet Cardiovascular - Philips Brilliance iCT Computed Tomography X-Ray System
FDA Device · Class II · 2020-05-13 · Philips North America - REF: B30211, 37" (94 cm) Appx 4.2 ml, 10 Drop Admin Set W/Luer Lock, Bag Hanger, Sterile R, UDI: (01)00887709063211
FDA Device · Class II · 2020-05-13 · Icu Medical - da Vinci X Surgical System, IS4200 - Product Usage: The da Vinci Xi surgical system (IS4000) is made of three main components: the Surgeon…
FDA Device · Class II · 2020-05-13 · Intuitive Surgical - HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Code: M00202175734P0 - Product Usage: for use in the replacement…
FDA Device · Class II · 2020-05-13 · Maquet Cardiovascular - Varian Multileaf Collimator [MLC]
FDA Device · Class II · 2020-05-13 · Varian Medical Systems - System AXIOM Aristos FX - Product Usage: A dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposure…
FDA Device · Class II · 2020-05-13 · Siemens Medical Solutions Usa - Tibial Tray Nonporous A Size 4
FDA Device · Class II · 2020-05-13 · Ortho Development - Temporary Abutment Engaging CC RP pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36664 -…
FDA Device · Class II · 2020-05-13 · Nobel Biocare Usa - Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36669 - Pro…
FDA Device · Class II · 2020-05-13 · Nobel Biocare Usa - Universal Base CC RP 1.5 mm
FDA Device · Class II · 2020-05-13 · Nobel Biocare Usa - 3.5mm Aresenal Screw Drill Bit , Ref: 330-35-001, Qty. 70, Rx Only, Non-Sterile, UDI: (01)00812926029696 - Product Usage: A drill bit facil…
FDA Device · Class II · 2020-05-13 · Trilliant Surgical - Snappy Abutment 5.5 CC RP 3 mm
FDA Device · Class II · 2020-05-13 · Nobel Biocare Usa - HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Product Code: M00202175728AP0 - Product Usage: for use in the repla…
FDA Device · Class II · 2020-05-13 · Maquet Cardiovascular - Tibial Tray Nonporous A Size 2
FDA Device · Class II · 2020-05-13 · Ortho Development - REF: B90240-50, 96" (244 cm) Appx 11.2 ml, 10 Drop Admin Set w/Coiled Tubing, Pre-Slit Port, Clave, Rotating Luer, Sterile R, UDI: (01)0088…
FDA Device · Class II · 2020-05-13 · Icu Medical - Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006)
FDA Device · Class II · 2020-05-13 · Stryker - Zimmer Tourniquet Cuff 30" (Blue), PLC Dual Port, Single Bladder, Item Number: 60-7070-105, UDI: 00885825013868, Reprocessed Tourniquet Cuf…
FDA Device · Class II · 2020-05-06 · Stryker Sustainability Solutions - VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468
FDA Device · Class III · 2020-05-06 · Ortho Clinical Diagnostics - Lunar iDXA Advance (iDXA with enCORE v16) bone densitometer
FDA Device · Class II · 2020-05-06 · Ge Healthcare - Prismaflex System, Prismaflex Control Unit
FDA Device · Class II · 2020-05-06 · Baxter Healthcare - Portex Lumbar Puncture Tray
FDA Device · Class II · 2020-05-06 · Smiths Medical Asd - Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079 Image guidance in diagnostic, interventional and minimally invasive surgery p…
FDA Device · Class II · 2020-05-06 · Philips North America - H12+ and patient cable for the H12+ Holter Recorders with the following device name: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL 10WIRE LEADF…
FDA Device · Class II · 2020-05-06 · Welch Allyn Mortara - ViewRay System: Model No. 10000 and 20000 for radiation treatment
FDA Device · Class II · 2020-05-06 · Viewray - Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350, ELI 150c, ELI 250c, ELI 230, ELI 280, ELI 380, R-Scri…
FDA Device · Class II · 2020-05-06 · Welch Allyn Mortara - Q-Stress/XScribe
FDA Device · Class II · 2020-05-06 · Welch Allyn Mortara - Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v18) bone densitometer
FDA Device · Class II · 2020-05-06 · Ge Healthcare - Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409, TSA161410 - Product Usage:The d…
FDA Device · Class II · 2020-05-06 · U And I - S4 and patient cable for the S4 Wireless Telemeter with the following device names: CABLE 10 WIRE LF ECG SNAP ENDS AHA GRAY, CABLE 10 WIRE…
FDA Device · Class II · 2020-05-06 · Welch Allyn Mortara - Langston Dual Lumen Catheter 6F Model 5540
FDA Device · Class I · 2020-05-06 · Vascular Solutions - ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a U-Channel Sheath through whic…
FDA Device · Class II · 2020-05-06 · Uromedica - Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen
FDA Device · Class II · 2020-05-06 · Obalon Therapeutics - CapsoCAM Plus, UDI: 00867770000209
FDA Device · Class II · 2020-05-06 · Capso Vision - Prismaflex System, Prismaflex Control Unit
FDA Device · Class II · 2020-05-06 · Baxter Healthcare - Prismaflex System, Prismaflex Control Unit
FDA Device · Class II · 2020-05-06 · Baxter Healthcare - Lunar iDXA Pro/Lunar iDXA Advance (iDXA with enCORE v17) bone densitometer
FDA Device · Class II · 2020-05-06 · Ge Healthcare - iLab Polaris Multi-Modality Guidance System
FDA Device · Class II · 2020-05-06 · Boston Scientific - Replaceable lead set for the Wireless Acquisition Module (WAM), which is the ECG front-end for various Electrocardiographs
FDA Device · Class II · 2020-05-06 · Welch Allyn Mortara - MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be used for the surgical incision/excision, vaporization, ablati…
FDA Device · Class II · 2020-05-06 · Boston Scientific - Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography
FDA Device · Class II · 2020-05-06 · Philips North America - CareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use Only, Rx only, Catalog Number PIG1280T, UDI Number 01)1088540310…
FDA Device · Class II · 2020-05-06 · Becton Dickinson And - Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test
FDA Device · Class II · 2020-05-06 · Bio Rad Labs - Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot 1.5 when used with the Azurion R2.0 system Interventional fluor…
FDA Device · Class II · 2020-05-06 · Philips North America - CORFLO Percutaneous Endoscopic Gastrostomy (PEG)Kit
FDA Device · Class II · 2020-05-06 · Avanos Medical - Prismaflex System, Prismaflex Control Unit
FDA Device · Class II · 2020-05-06 · Baxter Healthcare - Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Usage: The Neptune E-SEP is an Integrated Smoke Evacuation Penci…
FDA Device · Class II · 2020-05-06 · Stryker Instruments Div - Lunar iDXA bone densitometer
FDA Device · Class II · 2020-05-06 · Ge Healthcare - Prismaflex System, Prismaflex Control Unit
FDA Device · Class II · 2020-05-06 · Baxter Healthcare - X12+ and patient cable for the X12+ Telemeter with the following device name: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL 10WIRE LEADFORM IEC…
FDA Device · Class II · 2020-05-06 · Welch Allyn Mortara - ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499
FDA Device · Class II · 2020-05-06 · Icu Medical - Q-Tel
FDA Device · Class II · 2020-05-06 · Welch Allyn Mortara - Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 BC 8.6 DIA 13.8, Rx, Sterile
FDA Device · Class II · 2020-05-06 · Allied Vision Group - Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lower
FDA Device · Class II · 2020-05-06 · Siemens Healthcare Diagnostics - Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans fo…
FDA Device · Class II · 2020-05-06 · Elekta - T12
FDA Device · Class II · 2020-05-06 · Welch Allyn Mortara - Surveyor S12/S19 and patient cable for the S12/S19 Bedside Monitor under the following device names: PAT CBL 10WIRE AHA SNAP JSCREW, PAT CB…
FDA Device · Class II · 2020-05-06 · Welch Allyn Mortara - ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004
FDA Device · Class II · 2020-05-06 · Radiometer Medical Aps - Leksell Vantage Stereotactic System
FDA Device · Class II · 2020-05-06 · Elekta - Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Trial Kit, Ref # 36990 - Product Usage: The intended use of this…
FDA Device · Class II · 2020-05-06 · Kerr Pentron - ELI PC. The ELI PC Service automatically converts resting ECG recordings collected with WAM PC patient cables and WebUpload into DICOM 12-l…
FDA Device · Class II · 2020-05-06 · Welch Allyn Mortara - Prismaflex System, Prismaflex Control Unit
FDA Device · Class II · 2020-05-06 · Baxter Healthcare - SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250)
FDA Device · Class II · 2020-05-06 · Beckman Coulter - PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT
FDA Device · Class II · 2020-05-06 · Merit Medical Systems - Percuflex Plus Ureteral Stent Set 6FX24CM with .038 Sensor UPN: M006175262110
FDA Device · Class II · 2020-04-29 · Boston Scientific - KT RECOVERY+ ICE/HEAT MASSAGE BALL Rolling ball with hot and cold packs that can be interchanged depending on the therapy type desired
FDA Device · Class II · 2020-04-29 · Kt Health - Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110
FDA Device · Class II · 2020-04-29 · Boston Scientific - Medivators EndoGator REF 100650
FDA Device · Class II · 2020-04-29 · Medivators - Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent
FDA Device · Class II · 2020-04-29 · Carolina Liquid Chemistries - Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101080MD - Product Usage: is a 3 lumen silicone catheter with a sensor…
FDA Device · Class II · 2020-04-29 · Degania Medical Devices Pvt - Medivators Endo carry-on Procedure Kit REF CPK-100222-0002 - Product Usage: is intended to be used with an air or CO2 source and/or a pump…
FDA Device · Class II · 2020-04-29 · Medivators - Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, RxOnly
FDA Device · Class II · 2020-04-29 · Acutus Medical - Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX BLUEST AR
FDA Device · Class II · 2020-04-29 · Fresenius Medical Care Holdings - Medivators Endo Smartcap Endoscope Tubing
FDA Device · Class II · 2020-04-29 · Medivators - Acutus Medical AcQGuide Mini Fixed-Curve Introducer with AcQCros QX Integrated Dilator/Transseptal Needle, Ref: 112852 Sterile EO, RxOnly
FDA Device · Class II · 2020-04-29 · Acutus Medical - Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M0066703101 box 5 UPN: M0066703100 single unit
FDA Device · Class II · 2020-04-29 · Boston Scientific
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)