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.
- Giraffe Incubator with installed Servo Oxygen module
FDA Device · Class II · 2020-06-24 · Ge Healthcare - Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x37,5 mm Catalog Number: 18965037S - Product Usage: Stryker implants are single use device…
FDA Device · Class II · 2020-06-24 · Stryker - DDU-2400EN Lifeline PRO, UDI 00815098020270 - Product Usage: Automated External Defibrillators (AED) are indicated for use on victims of su…
FDA Device · Class II · 2020-06-24 · Defibtech - VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Product Code 1202670, UDI # 10758750008513 - Product Usage: For in v…
FDA Device · Class II · 2020-06-24 · Ortho Clinical Diagnostics - BioFlo Midline Convenience Kits - Product Usage: These introducers are used for the percutaneous introduction of diagnostic or therapeutic…
FDA Device · Class II · 2020-06-24 · Angiodynamics - Giraffe OmniBed with installed Servo Oxygen module
FDA Device · Class II · 2020-06-24 · Ge Healthcare - BioFlo PICC and Xcela PICC Convenience Kits - Product Usage: are indicated for short or long-term peripheral access to the central venous s…
FDA Device · Class II · 2020-06-24 · Angiodynamics - Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x50 mm Catalog Number: 18965050S - Product Usage: Stryker implants are single use devices…
FDA Device · Class II · 2020-06-24 · Stryker - PENTARAY NAV eco HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO - Product Usage: The Biosense Webster PENTARAY NAV High-D…
FDA Device · Class II · 2020-06-24 · Biosense Webster - DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS
FDA Device · Class II · 2020-06-24 · Diasol - Stryker Locking Screw, Partially Threaded T2 Tibia ¿5x55 mm Catalog Number: 18915055S - Product Usage: Stryker implants are single use devi…
FDA Device · Class II · 2020-06-24 · Stryker - Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument Product Code: 14235
FDA Device · Class II · 2020-06-24 · Biomet - Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler
FDA Device · Class II · 2020-06-24 · Medtronic Sofamor Danek Usa - DDU-2450 Lifeline ECG Model Numbers DDU-A2450EN DDU-E2450DE DDU-E2450EN DDU-E2450FR DDU-E2450TH Cat
FDA Device · Class II · 2020-06-24 · Defibtech - Xience Sierra TM Everolimus Eluting Coronary Stent System, RX 3.5mm x 33mmStrength: 100 ¿g/cm¿, Nominal Everolimus Content: 209 ¿g
FDA Device · Class II · 2020-06-24 · Abbott Vascular - Infant Child Starter Kits, Part Number: 3202784-009, containing Infant/Child Reduced Energy Defibrillation Electrodes, for use with LIFEPAK…
FDA Device · Class II · 2020-06-17 · Physio Control - A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 14 HOLE 234MM, Item Number: 110030409 - Product Usage: Intended for temporary int…
FDA Device · Class II · 2020-06-17 · Biomet - Mazor X Surgical System Positioner Type II, REF: ASM0214-02
FDA Device · Class II · 2020-06-17 · Medtronic Navigation - Infinix-8000F with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used…
FDA Device · Class II · 2020-06-17 · Canon Medical System Usa - Biomet 8.0 Cannulated Screw Tap-Bone fixation screw Item Number: 110008467 - Product Usage: Intended for temporary internal fixation and st…
FDA Device · Class II · 2020-06-17 · Biomet - RayStation 6 Service Pack 1, UDI #s 07350002010037, 07350002010082 - Product Usage: For radiation therapy and medical oncology which can al…
FDA Device · Class II · 2020-06-17 · Raysearch Laboratories Ab - A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM LOCKING PEG 60MM , Item Number: 110025460 - Product Usage: Intended for temporary internal f…
FDA Device · Class II · 2020-06-17 · Biomet - A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 14 HOLE 227MM, Item Number: 110030209 - Product Usage: Intended for temporary inte…
FDA Device · Class II · 2020-06-17 · Biomet - A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 140MM Item Number: 110025472 - Product Usage: Intended for tempor…
FDA Device · Class II · 2020-06-17 · Biomet - A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 11 HOLE 197MM, Item Number: 110030308 - Product Usage: Intended for temporary inte…
FDA Device · Class II · 2020-06-17 · Biomet - Dimension Vista Enzymatic Creatinine, Siemens Material Number 10700444, UDI Number 00842768036262 - Product Usage: use in the quantitative…
FDA Device · Class II · 2020-06-17 · Siemens Healthcare Diagnostics - A.L.P.S. T15 LOW PROFILE CORTICAL SCREW 3.5mm x 28mm, Item Number: 110017628 - Product Usage: Intended for temporary internal fixation and…
FDA Device · Class II · 2020-06-17 · Biomet - Genicon Natura Model 210-005-251, 5mm diameter, 150mm length (one cannula, threaded) - Product Usage: The universal handle can be used as a…
FDA Device · Class II · 2020-06-17 · Genicon - RayStation 7, UDI # 07350002010068 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatme…
FDA Device · Class II · 2020-06-17 · Raysearch Laboratories Ab - Dimension Enzymatic Creatinine, Siemens Material Number 10471520, UDI Number 00842768030512 - Product Usage: use in the quantitative determ…
FDA Device · Class II · 2020-06-17 · Siemens Healthcare Diagnostics - Genicon GENILook Model 200-005-152, 5mm diameter, 100mm legnth (2 cannula, threaded) - Product Usage: The universal handle can be used as a…
FDA Device · Class II · 2020-06-17 · Genicon - STAINLESS STEEL REPROCESSING TRAY, 2D CAMERA HEAD, IS4000, Model No. 400499-03 - Product Usage: is designed to enable complex surgery using…
FDA Device · Class II · 2020-06-17 · Intuitive Surgical - A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 11 HOLE 190MM, Item Number: 110030108 - Product Usage: Intended for temporary inte…
FDA Device · Class II · 2020-06-17 · Biomet - Genicon Natura Model 210-105-251, 5mm diameter, 150mm length (1 cannula) - Product Usage: The universal handle can be used as a pistol grip…
FDA Device · Class II · 2020-06-17 · Genicon - Infinix-8000C with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used…
FDA Device · Class II · 2020-06-17 · Canon Medical System Usa - FilmArray BCID Panel, RFIT-ASY-0126, 30, Rx Only, CE, IVD, UDI: 00815381020086 used with the following BACT/ALERT Blood Culture Bottle Cata…
FDA Device · Class II · 2020-06-17 · Biofire Diagnostics - A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 234MM Item Number: 110025473 - Product Usage: Intended for tempora…
FDA Device · Class II · 2020-06-17 · Biomet - RayStation 8A Service Pack 1, UDI # 07350002010136 - Product Usage: For radiation therapy and medical oncology which can also be used to ad…
FDA Device · Class II · 2020-06-17 · Raysearch Laboratories Ab - Genicon GENILook Model 200-005-151, 5mm diameter, 100mm length (one cannula, threaded) - Product Usage: The universal handle can be used as…
FDA Device · Class II · 2020-06-17 · Genicon - A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM CALIBRATED DRILL BIT, Item Number: 110017737 - Product Usage: Intended for temporary interna…
FDA Device · Class II · 2020-06-17 · Biomet - Genicon Natura Model 210-005-051
FDA Device · Class II · 2020-06-17 · Genicon - Infinix-8000V with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used…
FDA Device · Class II · 2020-06-17 · Canon Medical System Usa - smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331842 48M…
FDA Device · Class II · 2020-06-17 · Smith And Nephew - smith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 40MM 71335540…
FDA Device · Class II · 2020-06-17 · Smith And Nephew - RayStation 9A, UDI # 07350002010174 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatm…
FDA Device · Class II · 2020-06-17 · Raysearch Laboratories Ab - RayStation 9B Service Pack 1, UDI # 07350002010297 - Product Usage: For radiation therapy and medical oncology which can also be used to ad…
FDA Device · Class II · 2020-06-17 · Raysearch Laboratories Ab - A.L.P.S PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 3.2MM, Item Number: 110017553 - Product Usage: Intended for temporary inte…
FDA Device · Class II · 2020-06-17 · Biomet - Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - Product Usage: The SureSigns VM1 is a patient monitor that measures oxygen saturati…
FDA Device · Class II · 2020-06-17 · Philips North America - Genicon GENILook Model 200-005-251, 5mm diameter, 150mm length (one cannula, threaded) - Product Usage: The universal handle can be used as…
FDA Device · Class II · 2020-06-17 · Genicon - Genicon GENILook Model 200-005-153
FDA Device · Class II · 2020-06-17 · Genicon - BD FACS Sample Prep Assistant (SPA) III - Product Usage: Prep Assistant III is intended to prepare human whole blood for flow cytometric an…
FDA Device · Class II · 2020-06-17 · Becton Dickinson And Bd Biosciences - Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-Ray System) as follows: Artis Q floor Model: 10848280
FDA Device · Class II · 2020-06-17 · Siemens Medical Solutions Usa - smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM…
FDA Device · Class II · 2020-06-17 · Smith And Nephew - A.L.P.S. T15 Multi-Directional Locking Screw 3.5mm x 60mm, Item Number: 110017960 - Product Usage: Intended for temporary internal fixation…
FDA Device · Class II · 2020-06-17 · Biomet - Histoplasma Immunodiffusion (ID) Antigen
FDA Device · Class II · 2020-06-17 · Immuno Mycologics - Elekta Unity, UDI 05060191071321, Image-guided radiation therapy system - Product Usage: is indicated for radiation therapy treatments and…
FDA Device · Class II · 2020-06-17 · Elekta - Biomet 6.5 Cannulated Screw Tap - Bone fixation screw, Item Number: 110008466 - Product Usage: Intended for temporary internal fixation and…
FDA Device · Class II · 2020-06-17 · Biomet - smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM…
FDA Device · Class II · 2020-06-17 · Smith And Nephew - A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Open Interbody 32x24x12 7 A Link Z Ti Unitary Open Inte…
FDA Device · Class II · 2020-06-17 · Acuity Surgical Devices - RayStation 9B, UDI # 07350002010266 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatm…
FDA Device · Class II · 2020-06-17 · Raysearch Laboratories Ab - A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 14 HOLE 227MM, Item Number: 110030109 - Product Usage: Intended for temporary inte…
FDA Device · Class II · 2020-06-17 · Biomet - RadiForce GX560 monochrome LCD monitor, models 0FTD2347 and 0FTD2379 - Product Usage: is indicated for use in displaying radiological image…
FDA Device · Class II · 2020-06-17 · Eizo - RayStation 6, UDI # 07350002010013 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatme…
FDA Device · Class II · 2020-06-17 · Raysearch Laboratories Ab - smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Sizes REF/product number 48MM 71338663…
FDA Device · Class II · 2020-06-17 · Smith And Nephew - RayStation 8B Service Pack 2, UDI # 07350002010235 - Product Usage: For radiation therapy and medical oncology which can also be used to ad…
FDA Device · Class II · 2020-06-17 · Raysearch Laboratories Ab - A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 7 HOLE 140MM, Item Number: 110030407 - Product Usage: Intended for temporary inte…
FDA Device · Class II · 2020-06-17 · Biomet - RayStation 8B, UDI # 07350002010129 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatm…
FDA Device · Class II · 2020-06-17 · Raysearch Laboratories Ab - RayStation 6 Service Pack 3, UDI # 07350002010242 - Product Usage: For radiation therapy and medical oncology which can also be used to adm…
FDA Device · Class II · 2020-06-17 · Raysearch Laboratories Ab - ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941, UDI Number 00630414558073 - Product Usage: use in the quanti…
FDA Device · Class II · 2020-06-17 · Siemens Healthcare Diagnostics - Genicon GENILook Model 200-105-152, 5mm diameter, 100mm length (2 cannula) - Product Usage: The universal handle can be used as a pistol gr…
FDA Device · Class II · 2020-06-17 · Genicon - BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when u…
FDA Device · Class II · 2020-06-17 · Becton Dickinson And Bd Biosciences - Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/UltraSert DELIVERY SYSTEM, UV w/BLUE LIGHT…
FDA Device · Class II · 2020-06-17 · Alcon Research - RayStation 4.0 to RayStation 5 Service Pack 2 - Product Usage: For radiation therapy and medical oncology which can also be used to adminis…
FDA Device · Class II · 2020-06-17 · Raysearch Laboratories Ab - Atellica CH Fructosamine Reagent (FRUC), Siemens Material Number 11097637, UDI Number 00630414595580 use in the quantitative measurement of…
FDA Device · Class II · 2020-06-17 · Siemens Healthcare Diagnostics - BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with…
FDA Device · Class II · 2020-06-17 · Becton Dickinson And Bd Biosciences - A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 14 HOLE 234MM, Item Number: 110030309 - Product Usage: Intended for temporary inte…
FDA Device · Class II · 2020-06-17 · Biomet - Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq +13 degrees, Rx. Manufactured by Ormco Corporation, This de…
FDA Device · Class II · 2020-06-17 · Ormco Sybronendo - ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen
FDA Device · Class II · 2020-06-17 · Olympus - RayStation 5 Service Pack 3, UDI # 07350002010020 - Product Usage: For radiation therapy and medical oncology which can also be used to adm…
FDA Device · Class II · 2020-06-17 · Raysearch Laboratories Ab - Regard
FDA Device · Class II · 2020-06-17 · Roi Cps - 4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H
FDA Device · Class II · 2020-06-17 · Biocare Medical - Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number 00630414595795 - Product Usage: use in the quantitative de…
FDA Device · Class II · 2020-06-17 · Siemens Healthcare Diagnostics - Infant/Child Reduced Energy Defibrillation Electrodes, Part Number: 3202380-006, for use with LIFEPAK 1000 defibrillator, LIFEPAK 500 defib…
FDA Device · Class II · 2020-06-17 · Physio Control - Genicon GENILook Model 200-105-252, 5mm diameter, 150mm length (2 cannula) - Product Usage: The universal handle can be used as a pistol gr…
FDA Device · Class II · 2020-06-17 · Genicon - Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J, TV-AB2380-I, TV-AB2380-J, TV-AB2680-I, TV-AB2680-J, TV-AB2980-I, T…
FDA Device · Class I · 2020-06-17 · Endologix - Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Aspiration System, UDI: 00850291007079
FDA Device · Class II · 2020-06-17 · Inari Medical - Arrow FlexTip Plus Epidural Kit with NRFit Connector, catheter system, Product Codes (US) OT19TAGSK OT19TAGSKA OT19TAPSK OT19TCGLK Product…
FDA Device · Class II · 2020-06-17 · Arrow International - A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 11 HOLE 190MM, Item Number: 110030208 - Product Usage: Intended for temporary inte…
FDA Device · Class II · 2020-06-17 · Biomet - therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121
FDA Device · Class II · 2020-06-17 · Qiagen Sciences - RayStation 6 Service Pack 2, UDI # 07350002010075 - Product Usage: For radiation therapy and medical oncology which can also be used to adm…
FDA Device · Class II · 2020-06-17 · Raysearch Laboratories Ab - smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 48MM…
FDA Device · Class II · 2020-06-17 · Smith And Nephew - A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 2.7MM, Item Number: 110017563 - Product Usage: Intended for temporary int…
FDA Device · Class II · 2020-06-17 · Biomet - FilmArray BCID Panel, RFIT-ASY-0127, 6, Rx Only, CE, IVD, UDI: 00815381020093 used with the following BACT/ALERT Blood Culture Bottle Catal…
FDA Device · Class II · 2020-06-17 · Biofire Diagnostics - Genicon GENILook Model 200-105-251, 5mm diameter, 150mm length (1 cannula) - Product Usage: The universal handle can be used as a pistol gr…
FDA Device · Class II · 2020-06-17 · Genicon - ADVIA Chemistry Enzymatic Creatinine_2, Siemens Material Number 10335869, UDI Number 00630414526690 - Product Usage: use in the quantitativ…
FDA Device · Class II · 2020-06-17 · Siemens Healthcare Diagnostics - A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK SET SCREW, Item Number: 110017551 - Product Usage: Intended for temporary internal fix…
FDA Device · Class II · 2020-06-17 · Biomet - A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 11 HOLE 197MM, Item Number: 110030408 - Product Usage: Intended for temporary int…
FDA Device · Class II · 2020-06-17 · Biomet - HardyCHROM MRSA,REF
FDA Device · Class II · 2020-06-17 · Hardy Diagnostics - Comprehensive VRS Inserter, shoulder prosthesis, Item No. 110019068
FDA Device · Class II · 2020-06-17 · Biomet - Genicon Natura Model 210-005-052, 5mm diameter, 70mm length (two cannula, threaded) - Product Usage: The universal handle can be used as a…
FDA Device · Class II · 2020-06-17 · Genicon
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)