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.
- Pressure Monitoring Set, C-PMS, G02838
FDA Device · Class II · 2020-06-10 · Cook - System, Tomography Computed Emmission
FDA Device · Class II · 2020-06-10 · Ge Healthcare - Gambro Cartridge Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment…
FDA Device · Class II · 2020-06-10 · Baxter Healthcare - Custom Packs to be used in surgical procedures
FDA Device · Class II · 2020-06-10 · American Contract Systems - Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Syste…
FDA Device · Class II · 2020-06-10 · Baxter Healthcare - OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer
FDA Device · Class II · 2020-06-10 · Olympus - Centrella Smart+ Bed, Catalog Number P7900
FDA Device · Class II · 2020-06-10 · Hill Rom - Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X55MM, Item Number 810M7555 - Product Usage: are non-cervical spinal fixatio…
FDA Device · Class II · 2020-06-10 · Zimmer Biomet - safeCLINITUBES Blood Sampler;REF 942-969;D957P-70-45x1
FDA Device · Class II · 2020-06-10 · Radiometer Medical Aps - Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X35MM, Item Number 810M5535 - Product Usage: are non-cervical spinal fixatio…
FDA Device · Class II · 2020-06-10 · Zimmer Biomet - JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surg…
FDA Device · Class II · 2020-06-03 · Smith And Nephew - LinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500
FDA Device · Class II · 2020-06-03 · Boston Scientific Neuromodulation - VACUETTE Blood Transfer Unit
FDA Device · Class II · 2020-06-03 · C A Greiner And Sohne Gesellschaftmbh - Knee Products: 189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM 189422 Vanguard Knee System, PS Mono Lock Tibial Bea…
FDA Device · Class II · 2020-06-03 · Biomet - Knee Products: 189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM 189720 Vanguard Knee System, CR Mono Lock Tibial B…
FDA Device · Class II · 2020-06-03 · Biomet - Knee Products: 183622 Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 MM 183620 Vanguard Knee System PS Tibial Bearing, 10 MM X 63/67…
FDA Device · Class II · 2020-06-03 · Biomet - Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP
FDA Device · Class I · 2020-06-03 · Heartware - Kangaroo Joey Safety Screw Spike with Flush Bag, Anti-free Flow,1000 mL, Product Code 765100
FDA Device · Class II · 2020-06-03 · Cardinal Health - Skater Introducer Set 6F x 18cm
FDA Device · Class II · 2020-06-03 · Argon Medical Devices - Clearview Total Uterine Manipulator (model UM750), The device is labeled in part, "ClearView(R) TOTAL, 7 cm* * *CLINICAL INNOVATIONS Manufa…
FDA Device · Class II · 2020-06-03 · Clinical Innovations - CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21
FDA Device · Class II · 2020-06-03 · Coopersurgical - Kangaroo Epump Safety Screw Spike with Flush Bag, Anti-free Flow, 1000 mL, Product Code 775100
FDA Device · Class II · 2020-06-03 · Cardinal Health - Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110147
FDA Device · Class II · 2020-06-03 · Applied Medical Resources - Heartware HVAD Pump Implant accessories, Product (REF) Number 1153
FDA Device · Class I · 2020-06-03 · Heartware - Heartware HVAD Pump Implant Kit, Product (REF) Number 1104
FDA Device · Class I · 2020-06-03 · Heartware - The LinearTM 3-4 70 cm 8 Contact Lead Kit, part number M365SC2352700 is part of a spinal cord stimulation system for prescription use only…
FDA Device · Class II · 2020-06-03 · Boston Scientific Neuromodulation - Aptio Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, F…
FDA Device · Class II · 2020-06-03 · Inpeco - Panther Fusion Extraction Reagent-S, Ref PRD-04331, IVD, CE, Rx Only consisting of FCR-S Fusion Capture Reagent - S, Nucleic Acid in a buff…
FDA Device · Class II · 2020-06-03 · Hologic - Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350
FDA Device · Class II · 2020-06-03 · Boston Scientific Neuromodulation - ABL90 FLEX, model no. 393-090
FDA Device · Class II · 2020-06-03 · Radiometer Medical Aps - ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 - Product Usage: are intended for the quantitative determinatio…
FDA Device · Class II · 2020-06-03 · Beckman Coulter - Kangaroo 924 Safety Screw Spike Set, Product Code 775759
FDA Device · Class II · 2020-06-03 · Cardinal Health - Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guidewire Compatibility 0.035 in, Working Length 90 cm, Balloon Out…
FDA Device · Class II · 2020-06-03 · Spectranetics - Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used on the iPhone, iPad and iPod Touch devices
FDA Device · Class II · 2020-06-03 · Medtronic - Sprotte Needle, REF 33115131B w/ Intro 20 G x 3.5", distributed by Teleflex Medical The SPROTTE lumbar puncture needles are intended to gai…
FDA Device · Class II · 2020-06-03 · Teleflex Medical - Knee Products: 150414 Orthopedic Salvage System (OSS) Tibial Bearing, 20 MM Standard - Product Usage: Knee prosthesis
FDA Device · Class II · 2020-06-03 · Biomet - Knee Products: 183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infus…
FDA Device · Class II · 2020-06-03 · Biomet - Giraffe Shuttle
FDA Device · Class II · 2020-06-03 · Ge Healthcare - FlexLab Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interf…
FDA Device · Class II · 2020-06-03 · Inpeco - Hip Products Item Number: 1) 110010462 RingLoc Hip System, Acetabular Bi-Polar Cup, 28 MM X 51 MM 2) 11-165218 RingLoc Bi-Polar Hip System,…
FDA Device · Class II · 2020-06-03 · Biomet - Knee Products: 184762 Knees Vanguard Knee System, Series-A Standard Patella, 28 MM
FDA Device · Class II · 2020-06-03 · Biomet - Nikon Metrology XTH cabinet x-ray Systems which includes variations STH225, XTH225ST, and MCT225
FDA Device · Class II · 2020-06-03 · Nikon Metrology - Accelerator a3600 Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283),…
FDA Device · Class II · 2020-06-03 · Inpeco - Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-10308194
FDA Device · Class II · 2020-06-03 · Siemens Medical Solutions Usa - Philips Sterilizable Defibrillator Internal Paddles - Internal paddles are an accessory to the compatible monitor/defibrillator Switchless:…
FDA Device · Class II · 2020-06-03 · Philips North America - Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Catalog Number: 07 0006 The specimen containers are used for tempo…
FDA Device · Class II · 2020-06-03 · Thermo Fisher Scientific Monterrey - Philips HeartStart XL Monitor/Defibrillators Model number: M4735A - Product Usage: is for use in the hospital by qualified medical personne…
FDA Device · Class II · 2020-06-03 · Philips North America - Knee Products: US154709 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B8 US154722 Knees Vanguard M…
FDA Device · Class II · 2020-06-03 · Biomet - ARTIS Pheno - Interventional Fluoroscopic X-Ray System Model: 10849000 - Product Usage: is a family of dedicated angiography systems develo…
FDA Device · Class II · 2020-06-03 · Siemens Medical Solutions Usa - Sprotte Needle, REF 32115130C w/ Intro 22 G x 3.5", distributed by Teleflex Medical The SPROTTE lumbar puncture needles are intended to gai…
FDA Device · Class II · 2020-06-03 · Teleflex Medical - Accelerator a3600 Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N F…
FDA Device · Class II · 2020-06-03 · Inpeco - Kangaroo Connect ENPlus Spike Set Anti-free Flow, Product Code 77000FD
FDA Device · Class II · 2020-06-03 · Cardinal Health - Kangaroo Joey Safety Screw Spike Set, Anti-free Flow, Product Code 765559
FDA Device · Class II · 2020-06-03 · Cardinal Health - ABL90 FLEX PLUS, model no. 393-02
FDA Device · Class II · 2020-06-03 · Radiometer Medical Aps - FlexLab Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01,…
FDA Device · Class II · 2020-06-03 · Inpeco - ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700. 2 x 8 Surgical Paddle Lead Kit: (1) One Paddle Lead (4)
FDA Device · Class II · 2020-06-03 · Boston Scientific Neuromodulation - Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY, UDI: (01)00607915110154
FDA Device · Class II · 2020-06-03 · Applied Medical Resources - Precision TM M8 Adapter, 15 cm, part number M365SC9218150 - Product Usage: The adapter is part of a spinal cord stimulation system for pres…
FDA Device · Class II · 2020-06-03 · Boston Scientific Neuromodulation - Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 4…
FDA Device · Class II · 2020-06-03 · Biomet - ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and treatment of gentamicin overdose…
FDA Device · Class II · 2020-06-03 · Abbott And Kg - Knee Products: 154335 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D3 154336 Oxford Partial Knee System, Fix…
FDA Device · Class II · 2020-06-03 · Biomet - GENTLEWAVE REF: FG-002-0001
FDA Device · Class II · 2020-06-03 · Sonendo - Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components)
FDA Device · Class II · 2020-06-03 · The Binding Site Group - Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM 155326 Knees AGC Knee System PS Molded Tibial Compone…
FDA Device · Class II · 2020-06-03 · Biomet - Body Weight Support (BWS) Light
FDA Device · Class II · 2020-06-03 · Motek Medical B V - Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination of v…
FDA Device · Class II · 2020-06-03 · Philips North America - Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7 (11)190916 (17)290913 (10)059135 (The device is a component…
FDA Device · Class II · 2020-06-03 · Quest Medical - Cios Alpha Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA20-10308191 and VA30-10308194 The Cios Alpha and Cios Spin are a mo…
FDA Device · Class II · 2020-06-03 · Siemens Medical Solutions Usa - Heartware HVAD Pump Implant Kit, Product (REF) Number 1103
FDA Device · Class I · 2020-06-03 · Heartware - da Vinci SP Camera
FDA Device · Class II · 2020-06-03 · Intuitive Surgical - Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125
FDA Device · Class I · 2020-06-03 · Heartware - Medtronic Confida Expandable Sheath, REF CES122230
FDA Device · Class I · 2020-06-03 · Medtronic Vascular Galway - Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Product Usage: The Deep Brain Stimulation (DBS) System is indicated…
FDA Device · Class II · 2020-06-03 · Boston Scientific Neuromodulation - JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surg…
FDA Device · Class II · 2020-06-03 · Smith And Nephew - Knee Products: TMJPM-1510 Microfixation Custom Made Device, Left PM-TMJ Model (01)00841036226534(17)220111(10)735550 Product Usage: Knee pr…
FDA Device · Class II · 2020-06-03 · Biomet - DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)30607915139620
FDA Device · Class II · 2020-06-03 · Applied Medical Resources - Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage: Lead Extensions are designed to connect the percutan…
FDA Device · Class II · 2020-06-03 · Boston Scientific Neuromodulation - Kangaroo Epump Safety Screw Spike Set, Anti-free Flow, Product Code 775659
FDA Device · Class II · 2020-06-03 · Cardinal Health - Clip Applier Kit, REF: K2887, UDI: (01)30607915139132(17)220822(30)1(10)
FDA Device · Class II · 2020-06-03 · Applied Medical Resources - Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex Series-A Patella 3 Peg, 37 MM Product Usage: Knee prosthesis
FDA Device · Class II · 2020-06-03 · Biomet - Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Left, Sterile, Catalog # 504-02-54C-L, UDI (01)07613327012354(17)
FDA Device · Class II · 2020-05-27 · Howmedica Osteonics - STEALTH SPRING CLIP 6mm latis (1/4 Force)
FDA Device · Class II · 2020-05-27 · Applied Medical Resources - Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 right, Sterile, Catalog # 504-02-66F-R, UDI (01)07613327012477(17)
FDA Device · Class II · 2020-05-27 · Howmedica Osteonics - K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90181, UDI # 108888571…
FDA Device · Class II · 2020-05-27 · K2m - Dako Autostainer instruments: Autostainer Link 48, Model AS480
FDA Device · Class II · 2020-05-27 · Dako Denmark A S - K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90149, UDI # 108888571…
FDA Device · Class II · 2020-05-27 · K2m - B-Hydroxybutyrate LiquiColor, Item code CH2440058 - Product Usage: Product is used for the quantitative determination of B-Hydroxybutyrate…
FDA Device · Class II · 2020-05-27 · Cardinal Health - Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 right, Sterile, Catalog # 504-02-64E-R, UDI (01)07613327012460(17)
FDA Device · Class II · 2020-05-27 · Howmedica Osteonics - DFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 1402 - Product U…
FDA Device · Class II · 2020-05-27 · Merit Medical Systems - BARD MYPICC KIT 5F Triple-Lumen, Catalog Number CK000278
FDA Device · Class II · 2020-05-27 · Becton Dickinson And - Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical Plate System - Product Usage: The Cervical Plate System is in…
FDA Device · Class II · 2020-05-27 · Innovasis - Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 left, Sterile, Catalog # 504-02-62E-L, UDI (01)07613327012453(17)
FDA Device · Class II · 2020-05-27 · Howmedica Osteonics - Cranio/Sculpt C, 10cc, Bone Void Filler, UDI: 00813845021129 - Product Usage: CRANIO/SCULPT C is a calcium phosphate bone void filler indic…
FDA Device · Class II · 2020-05-27 · Skeletal Kinetics - Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Right, Sterile, Catalog # 504-02-56D-R, UDI (01)07613327012347(17)
FDA Device · Class II · 2020-05-27 · Howmedica Osteonics - K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90125, UDI # 108888571…
FDA Device · Class II · 2020-05-27 · K2m - AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode - Product Usage: The device is intended to restore a level of auditory sens…
FDA Device · Class II · 2020-05-27 · Advanced Bionics - Prismaflex Control Unit
FDA Device · Class II · 2020-05-27 · Baxter Healthcare - BARD MYPICC KIT 5F Triple-Lumen, Catalog Number CK000026A
FDA Device · Class II · 2020-05-27 · Becton Dickinson And - K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90153, UDI # 108888571…
FDA Device · Class II · 2020-05-27 · K2m - Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Right, Sterile, Catalog # 504-02-58D-R, UDI (01)07613327012446(17)
FDA Device · Class II · 2020-05-27 · Howmedica Osteonics
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)