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.
- MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planni…
FDA Device · Class II · 2020-04-01 · Elekta Impac Software - Dexcom G4 PLATINUM Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring…
FDA Device · Class II · 2020-04-01 · Dexcom - Wave Prep Tubes (1710-03) and single use cups (17--00-24)
FDA Device · Class II · 2020-04-01 · Carroll Baccari - NaviCare Patient Safety Software Versions 3.5.400-3.9.300
FDA Device · Class II · 2020-04-01 · Hill Rom - Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
FDA Device · Class II · 2020-04-01 · Medtronic Minimed - Karl Storz, Model # 11161C2, Flexible Neuroscope
FDA Device · Class II · 2020-04-01 · Karl Storz Endoscopy - Medline Sterile 3mL Syringes with 21GA x 1 Inch Needle 80 each REF DYND3ML21G1A lot 18JBH655 (01) 1088438982153
FDA Device · Class II · 2020-04-01 · Medline Industries - Dexcom G6 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device i…
FDA Device · Class II · 2020-04-01 · Dexcom - ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114 (70 mL) - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic…
FDA Device · Class II · 2020-04-01 · Siemens Healthcare Diagnostics - Pericardiocentesis Set, Irrigation Catheter, Reference Part Number C-PCS-700-TORONT0-042997, Order Number G10643
FDA Device · Class II · 2020-04-01 · Cook - iChemVELOCITY Strips, Catalog 800-7212
FDA Device · Class II · 2020-04-01 · Beckman Coulter - 1.PowerPort Implantable Port With Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter REF: 1709600, Air Guard, With suture Plugs, (01)…
FDA Device · Class II · 2020-04-01 · Bard Peripheral Vascular - ev3 Pipeline Flex Embolization Device with Shield Technology
FDA Device · Class I · 2020-04-01 · Micro Therapeutics - Precision Xtra Blood Glucose & Ketone Monitoring System, UDI: 00093815715023, 00093815988144
FDA Device · Class II · 2020-04-01 · Abbott Diabetes Care - Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intellijoint Navigation System is a computer…
FDA Device · Class II · 2020-04-01 · Intellijoint Surgical - Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vials with 5 x 0.25 mL vials per box
FDA Device · Class II · 2020-04-01 · Quidel Cardiovascular - MiniMed Insulin Pump, model # MMT-508
FDA Device · Class II · 2020-04-01 · Medtronic Minimed - PowerFlow Implatable Apheresis IV Port with attachable 9.6 F ChronoFl x Open-Ended Single-Lumen Venous Catheter, Ref A710962, UDI:(01)00801…
FDA Device · Class II · 2020-04-01 · Bard Peripheral Vascular - 1. Groshong 9.5 Dual-Lumen CV Catheter, Ref: 7726950, UDI: (01)00801741041570
FDA Device · Class II · 2020-04-01 · Bard Peripheral Vascular - FlipCutter III Drill
FDA Device · Class II · 2020-04-01 · T A G Medical Products - 1. X-Port isp M.R.I Implantable Port, with Pre-Attached 9.6 F Open-Ended Single-Lumen Venous Catheter, REF:0607550, UDI:(01)00801741026195…
FDA Device · Class II · 2020-04-01 · Bard Peripheral Vascular - BardPort Titanium Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter , REF: 0602230, UDI: (01)00801741025563 Pr…
FDA Device · Class II · 2020-04-01 · Bard Peripheral Vascular - Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct bilirubin SMN: 11097532 - Product Usage: ADVIA DBI…
FDA Device · Class II · 2020-04-01 · Siemens Healthcare Diagnostics - Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin
FDA Device · Class II · 2020-04-01 · Siemens Healthcare Diagnostics - Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
FDA Device · Class II · 2020-04-01 · Medtronic Minimed - Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112
FDA Device · Class II · 2020-04-01 · Siemens Healthcare Diagnostics - FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810
FDA Device · Class II · 2020-04-01 · Abbott Diabetes Care - Chemistry QC Premium Plus, Cat
FDA Device · Class II · 2020-04-01 · Randox Laboratories - ev3 Pipeline Flex Embolization Device
FDA Device · Class I · 2020-04-01 · Micro Therapeutics - Medtronic MiniMed Paradigm Veo Insulin pump, model numbers MMT-554CM and MMT-754CM
FDA Device · Class II · 2020-04-01 · Medtronic Minimed - Medline Stick Sponge Presaturated W/PVP REF DYND70288 DYND70288H 2/PK Expiration 06/30/2022
FDA Device · Class II · 2020-04-01 · Medline Industries - Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage: The intended use of the comprehensive humeral stem…
FDA Device · Class II · 2020-04-01 · Biomet - Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
FDA Device · Class II · 2020-04-01 · Medtronic Minimed - Medtronic MiniMed Paradigm Insulin pump, model number MMT-712E
FDA Device · Class II · 2020-04-01 · Medtronic Minimed - VITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed f…
FDA Device · Class II · 2020-04-01 · Biomerieux - LemonPrep Tubes (MD0019-T) and Single use cups (MD0019-SUP)
FDA Device · Class II · 2020-04-01 · Carroll Baccari - Karl Storz RHINO-LARYNGO-BRONCHO FIBERSCOPE, Model # 11005BC1
FDA Device · Class II · 2020-04-01 · Karl Storz Endoscopy - BardPort M.R.I. Implantable Port with Attachale 9.6 F Open-Ended Single-Lumen Venous Catheter, REF: 0602680, UDI:(01)00801741025679 Product…
FDA Device · Class II · 2020-04-01 · Bard Peripheral Vascular - Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
FDA Device · Class II · 2020-04-01 · Medtronic Minimed - Encina HA Femoral Stem, Size 11 Coxa Vara Collared, REF 100-30-011, Ti6AI4V Allow with HA Coating, For use with Stinson Orthopedics Inc
FDA Device · Class II · 2020-04-01 · Signature Orthopaedics Europe - BardPort M.R.I. Hard Base Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter, Ref: 0604550, UDI: (01)0080174102…
FDA Device · Class II · 2020-04-01 · Bard Peripheral Vascular - Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin SMN: 11097531 - Product Usage: Atellica TB…
FDA Device · Class II · 2020-04-01 · Siemens Healthcare Diagnostics - ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 (40 mL) & 10341113 (70 mL). Product Usage: ADVIA TBIL_2 is for in vitro diagnostic u…
FDA Device · Class II · 2020-04-01 · Siemens Healthcare Diagnostics - Dexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device i…
FDA Device · Class II · 2020-04-01 · Dexcom - Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319
FDA Device · Class II · 2020-03-25 · The Binding Site Group - Artis Q Biplane, Model No. 10848282
FDA Device · Class II · 2020-03-25 · Siemens Medical Solutions Usa - TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013
FDA Device · Class II · 2020-03-25 · Materialise N V - COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes, model nos
FDA Device · Class II · 2020-03-25 · Aesculap Implant Systems - Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeri…
FDA Device · Class II · 2020-03-25 · Avid Medical - Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeri…
FDA Device · Class II · 2020-03-25 · Avid Medical - Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeri…
FDA Device · Class II · 2020-03-25 · Avid Medical - Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeri…
FDA Device · Class II · 2020-03-25 · Avid Medical - Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeri…
FDA Device · Class II · 2020-03-25 · Avid Medical - DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and ar…
FDA Device · Class II · 2020-03-25 · Tedan Surgical Innovations - IMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21(D) and OUS: LKE21 - Product Usage: For in vitro diagnostic use with the IMMULITE sy…
FDA Device · Class II · 2020-03-25 · Siemens Healthcare Diagnostics - AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synt…
FDA Device · Class II · 2020-03-25 · Agfa N V - Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components, model nos
FDA Device · Class II · 2020-03-25 · Aesculap Implant Systems - UroDiagnost Eleva, system code 708033
FDA Device · Class II · 2020-03-25 · Philips North America - COLUMBUS CR/PS TIB.PLAT.PLASMAPORE, Knee implant components, various sizes, model nos
FDA Device · Class II · 2020-03-25 · Aesculap Implant Systems - Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 - Product Usage: Implantable cardioverter defibril…
FDA Device · Class II · 2020-03-25 · Boston Scientific - Stryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051926 This pr…
FDA Device · Class II · 2020-03-25 · Stryker - LEGION PS High Flex XLPE size 5-6 9mm Articular Insert
FDA Device · Class II · 2020-03-25 · Smith And Nephew - Medtronic CareLink 2090 Programmer
FDA Device · Class II · 2020-03-25 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Artis zee Biplane, Model No. 10094141
FDA Device · Class II · 2020-03-25 · Siemens Medical Solutions Usa - D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws…
FDA Device · Class II · 2020-03-25 · Tedan Surgical Innovations - CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress
FDA Device · Class I · 2020-03-25 · Cme America - MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038
FDA Device · Class II · 2020-03-25 · Philips North America - Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044)
FDA Device · Class II · 2020-03-25 · Philips North America - Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeri…
FDA Device · Class II · 2020-03-25 · Avid Medical - HeartStart MRx Monitor/Defibrillators with model numbers M3535A M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536…
FDA Device · Class II · 2020-03-25 · Philips North America - Cardio Vascular-Allura Centron, system code 722400
FDA Device · Class II · 2020-03-25 · Philips North America - DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and ar…
FDA Device · Class II · 2020-03-25 · Tedan Surgical Innovations - Stryker, REF: 0250070460, 5.0 mm x 32 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051971 These p…
FDA Device · Class II · 2020-03-25 · Stryker - Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeri…
FDA Device · Class II · 2020-03-25 · Avid Medical - Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeri…
FDA Device · Class II · 2020-03-25 · Avid Medical - AS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components, various sizes, model nos
FDA Device · Class II · 2020-03-25 · Aesculap Implant Systems - Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray system
FDA Device · Class II · 2020-03-25 · Siemens Medical Solutions Usa - Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeri…
FDA Device · Class II · 2020-03-25 · Avid Medical - LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm or…
FDA Device · Class II · 2020-03-25 · Livanova Usa - Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354 Artis Q.zen Floor, Model No. 10848353 Product Usage: Artis…
FDA Device · Class II · 2020-03-25 · Siemens Medical Solutions Usa - Integris Allura 9, system codes 722018 722021
FDA Device · Class II · 2020-03-25 · Philips North America - Boston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:The Boston Scientific LATITUDE Programming System is intended fo…
FDA Device · Class II · 2020-03-25 · Boston Scientific - IMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(D) (200 tests) and L2KE26(D) (600 tests) and OUS: L2KE22 (200 tests), L2KE26 (600…
FDA Device · Class II · 2020-03-25 · Siemens Healthcare Diagnostics - TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001
FDA Device · Class II · 2020-03-25 · Materialise N V - OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe
FDA Device · Class II · 2020-03-25 · Xtant Medical - Medtronic CareLink Encore 29901 Programmer
FDA Device · Class II · 2020-03-25 · Medtronic Cardiac Rhythm And Heart Failure Crhf - COLUMBUS CRA/PSA TIB.PLAT.CEMENTED, Knee implant components, various sizes, model nos
FDA Device · Class II · 2020-03-25 · Aesculap Implant Systems - Allura Exper FD Series
FDA Device · Class II · 2020-03-25 · Philips North America - OmniDiagnost Eleva System codes 708028 708027
FDA Device · Class II · 2020-03-25 · Philips North America - Poly G Integris H5000, System code 72246
FDA Device · Class II · 2020-03-25 · Philips North America - Teleflex Pilling Aortic Punch, 4.0mm
FDA Device · Class II · 2020-03-25 · Deroyal Industries Lafollette - Allura CV20, system code 722031
FDA Device · Class II · 2020-03-25 · Philips North America - D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws…
FDA Device · Class II · 2020-03-25 · Tedan Surgical Innovations - Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used with the Ankle Fusion Line of plates and is intend…
FDA Device · Class II · 2020-03-25 · Arthrex - RayStation/RayPlan 8B, Build Number 8.1.0.47, stand-alone software treatment planning system
FDA Device · Class II · 2020-03-18 · Raysearch Laboratories Ab - Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S
FDA Device · Class II · 2020-03-18 · Cordis - FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only
FDA Device · Class II · 2020-03-18 · Biofire Diagnostics - Monoject Hypodermic Safety Needle 30G X 1/2" Item Code 1183005 - Product Usage: used for general purpose injection and aspiration of fluids…
FDA Device · Class II · 2020-03-18 · Cardinal Health 200 - Braemar Manufacturing LLC DL950 Holter Monitor 1285 Corporate Center Dr. Suite 150 Eagan, MN 55121 USA Rx Only
FDA Device · Class II · 2020-03-18 · Braemar Manufacturing - Randox Laboratories Ltd
FDA Device · Class II · 2020-03-18 · Response Biomedical
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)