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.
- The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based on widely used nucleic acid amplificatio…
FDA Device · Class II · 2020-12-09 · Biomeme - CME America T-Syringe Pump - T34L PCA - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at p…
FDA Device · Class II · 2020-12-09 · Cme America - Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The Anti-Torque Alignment Tube (the Alignment Tube ) provides cou…
FDA Device · Class II · 2020-12-09 · K2m - CME America T-Syringe Pump - Neofeed - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at pr…
FDA Device · Class II · 2020-12-09 · Cme America - CME America T-Syringe Pump -T34L - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precis…
FDA Device · Class II · 2020-12-09 · Cme America - Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN01, PM35MN05, DLPM35MN02 - Product Usage: use during both no m…
FDA Device · Class II · 2020-12-09 · Covidien - MiniMed 630G with SmartGuard, insulin pump, Ref/Model # MMT-1754K, MMT-1714K, MMT-1755K - Product Usage: intended for continuous delivery o…
FDA Device · Class II · 2020-12-09 · Medtronic - PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm
FDA Device · Class II · 2020-12-09 · Ethicon - Olympus Ultrasound Endoscope, Model number: GF-UCT160-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of…
FDA Device · Class II · 2020-12-09 · Olympus - MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product Usage: The kit is used as a test for patients to monitor th…
FDA Device · Class II · 2020-12-09 · Chromsystems Instruments And Chemicals - 6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usage: The kit is used as a test for patien…
FDA Device · Class II · 2020-12-09 · Chromsystems Instruments And Chemicals - Olympus Ultrasound Endoscope, Model number: GF-UC160P-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of…
FDA Device · Class II · 2020-12-09 · Olympus - MiniMed 640G, insulin pump, Ref/Model # MMT-1711K, MMT-1752K, MMT-1752, Rx Only - Product Usage: indicated for the continuous delivery of i…
FDA Device · Class II · 2020-12-09 · Medtronic - Olympus Ultrasound Endoscope, Model number: GF-UE160-AL5 - Product Usage: used for endoscopic ultrasonic imaging of the gastrointestinal wa…
FDA Device · Class II · 2020-12-09 · Olympus - MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage: The kit is used as a test for patients to monitor the…
FDA Device · Class II · 2020-12-09 · Chromsystems Instruments And Chemicals - Regard - Product Usage: Obstetric Gynecologic specialized manual instrument
FDA Device · Class II · 2020-12-09 · Roi Cps - CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interventional Angiography System, Model numbers: Infinix-8000C and In…
FDA Device · Class II · 2020-12-09 · Canon Medical System Usa - Olympus Ultrasound Endoscope, Model number: GF-UMQ130 - Product Usage: used with an Olympus Endoscopic Ultrasound Center, EVIS Video System…
FDA Device · Class II · 2020-12-09 · Olympus - BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the bladder noninvasively
FDA Device · Class II · 2020-12-09 · Verathon - Olympus Ultrasound Endoscope, Model number: GF-UM130 - Product Usage: used with an Olympus Endoscopic Ultrasound Center, EVIS Video System…
FDA Device · Class II · 2020-12-09 · Olympus - Olympus Ultrasound Endoscope, Model Number: GF-UCT140-AL5 - Product Usage: used with other supporting equipment for endoscopic real-time ul…
FDA Device · Class II · 2020-12-09 · Olympus - Olympus Ultrasound Endoscope, Model number: GF-UCT180 - Product Usage: used with an Olympus universal endoscopic ultrasound center or a dia…
FDA Device · Class II · 2020-12-09 · Olympus - Olympus Ultrasound Endoscope, Model number: GF-UCT140P-AL5 - Product Usage: used with other supporting equipment for endoscopic real-time u…
FDA Device · Class II · 2020-12-09 · Olympus - Luminesse ML PMMA, 98x20mm, REF: 5336-B1 - Product Usage: used as a milling blank in the fabrication of provisional crowns and bridges
FDA Device · Class III · 2020-12-09 · Talladium - MX60ET (enhanced enVista Toric) enVista¿ One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is intended for placeme…
FDA Device · Class II · 2020-12-09 · Bausch And Lomb Surgical - ACCEL ELISA COVID-19 for the detection of total antibodies to SARS-CoV-2 Catalog AE301U Kit lots: PXCOV073020, PXCOV081220 Expiration dates…
FDA Device · Class II · 2020-12-09 · Veo Diagnostics - CME America T-Syringe Pump - NeoThrive - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at…
FDA Device · Class II · 2020-12-09 · Cme America - ViewRay MRIdian System: Model No. 10000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input in Amp…
FDA Device · Class II · 2020-12-02 · Viewray - Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF3, PROBE 60SF3 CRYOFLEX 10-S 26L - is a single use, disposable cryoprobe th…
FDA Device · Class II · 2020-12-02 · Medtronic Ats Medical - Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic Syringe Catalog/REF Number: FLEXD-150-SCS Description: 2 - 150 mL F…
FDA Device · Class II · 2020-12-02 · Bayer Medical Care - iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip replacement components as we…
FDA Device · Class II · 2020-12-02 · Conformis - AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used to power the following devices: Na¿da CI Q90 Sound Processo…
FDA Device · Class III · 2020-12-02 · Advanced Bionics - Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60CM1, CLAMP 60CM1 CRYOFLEX PROBE 26L - is a single use, disposable cryoprobe t…
FDA Device · Class II · 2020-12-02 · Medtronic Ats Medical - EMPOWR Partial Knee Peg Drill Guide
FDA Device · Class II · 2020-12-02 · Encore Medical - EMPOWR Partial Knee Peg Drill
FDA Device · Class II · 2020-12-02 · Encore Medical - Geistlich Bio-Oss Pen 0.25-1mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantolog…
FDA Device · Class II · 2020-12-02 · Geistlich Pharma North America - ViewRay MRIdian Linac System: Model No. 20000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input…
FDA Device · Class II · 2020-12-02 · Viewray - Life2000 Ventilation System, including Life2000 Ventilator and Life2000 Compressor, Model MS-01-0118 - Product Usage: use in home and insti…
FDA Device · Class II · 2020-12-02 · Hill Rom Manufacturing - Geistlich Bio-Oss Pen 0.25-1mm 0.25g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantolo…
FDA Device · Class II · 2020-12-02 · Geistlich Pharma North America - Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to navigate the Ion Fully Articulating Catheter within…
FDA Device · Class II · 2020-12-02 · Intuitive Surgical - Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF2 CRYOFLEX 10CM 26L - Product Usage: is a single use, disposab…
FDA Device · Class II · 2020-12-02 · Medtronic Ats Medical - Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF7, PROBE 60SF7 CRYOFLEX 7CM 26L - is a single use, disposable cryoprobe tha…
FDA Device · Class II · 2020-12-02 · Medtronic Ats Medical - Geistlich Bio-Oss Pen 1-2mm 0.5g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology,…
FDA Device · Class II · 2020-12-02 · Geistlich Pharma North America - Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Aci…
FDA Device · Class II · 2020-12-02 · Luminex - MEVION S250i, MEVION S250
FDA Device · Class II · 2020-12-02 · Mevion Medical Systems - Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid…
FDA Device · Class II · 2020-12-02 · Luminex - ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038-990-075U/ 7.5, 038-990-070U/ 7.0, 038-990-065U/ 6.5 *Note: pr…
FDA Device · Class I · 2020-12-02 · Flexicare Medical - AB PowerCel 170 (velvet black), REF: CI-5517-150, UDI: (01) 07630016833113 used to power the following devices: Na¿da CI Q90 Sound Processo…
FDA Device · Class III · 2020-12-02 · Advanced Bionics - Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates…
FDA Device · Class II · 2020-12-02 · Coloplast Manufacturing Us - RayStation standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1, 9…
FDA Device · Class II · 2020-12-02 · Raysearch Laboratories Ab - Kangaroo Connect 500ml Bag Set, Non-Sterile, Product Code 77500FD - Product Usage: single-use tubing sets used with pumps in the delivery o…
FDA Device · Class II · 2020-11-25 · Cardinal Health 200 - Elastic Traction Device, 11mm Lower
FDA Device · Class II · 2020-11-25 · Micro Tech Usa - Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning Aid Systems-intended to assist manual flexible endoscope cleaning…
FDA Device · Class III · 2020-11-25 · Steris - Merit Medical Cultura Collection and Transport System, Ref CFTS100, Single Use, IVD, for the following unit counts: 1 Unit - (01)0088445049…
FDA Device · Class II · 2020-11-25 · Merit Medical Systems - Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.…
FDA Device · Class II · 2020-11-25 · Mako Surgical - Alpen Clinic 100 Carbide Instruments (R100057C)
FDA Device · Class II · 2020-11-25 · Coltene Whaledent - cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be used for the configura…
FDA Device · Class II · 2020-11-25 · Roche Diagnostics Operations - VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals wit…
FDA Device · Class II · 2020-11-25 · Ortho Clinical Diagnostics - Strauss 25 Carbide Dental Burs (100057XXV)
FDA Device · Class II · 2020-11-25 · Coltene Whaledent - Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium
FDA Device · Class II · 2020-11-25 · Exactech - Osteosynthesis Compression Staple EasyClip
FDA Device · Class II · 2020-11-25 · Stryker - VNS Therapy¿ AspireSR¿ Generator
FDA Device · Class II · 2020-11-25 · Livanova Usa - COAPTITE Injectable Implant, injectable, sterile, non-pyrogenic implant composed of spherical particles (75-125 microns in diameter of calc…
FDA Device · Class II · 2020-11-25 · Merz North America - Clinic Pack 100 Pieces FG 57 100057C (100057C)
FDA Device · Class II · 2020-11-25 · Coltene Whaledent - Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
FDA Device · Class II · 2020-11-25 · Exactech - VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an ass…
FDA Device · Class III · 2020-11-25 · Ortho Clinical Diagnostics - Atellica IM 1300 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical speci…
FDA Device · Class II · 2020-11-25 · Siemens Healthcare Diagnostics - Class IV New Era medical laser device
FDA Device · Class II · 2020-11-25 · Inova Lasers - MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies…
FDA Device · Class II · 2020-11-25 · Medicrea International - Artis zee floor, Artis Q ceiling, Artis Q.zen ceiling
FDA Device · Class II · 2020-11-25 · Siemens Medical Solutions Usa - Atellica IM 1600 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical speci…
FDA Device · Class II · 2020-11-25 · Siemens Healthcare Diagnostics - Merit Medical Cultura Collection and Transport System, 3 mL Viral Transport Medium, Ref: VCTS100, Single Use, IVD, for the following unit c…
FDA Device · Class II · 2020-11-25 · Merit Medical Systems - Wuxi Nest, model numbers 202115, 202117, 202017, 202018 - Product Usage: Patient specimen collection
FDA Device · Class II · 2020-11-25 · Thomas Scientific - CEI Cutting Edge Instruments (PTC-57C)
FDA Device · Class II · 2020-11-25 · Coltene Whaledent - v|tome|x L Series non-destructive testing cabinet x-ray systems
FDA Device · Class II · 2020-11-25 · Ge Inspection Technologies - FG 57 100057X (100057X)
FDA Device · Class II · 2020-11-25 · Coltene Whaledent - MeritMedical Cultura Flex Swab, Sterile Flocked Collection Device, Ref C100F, Sterile, for the following unit count:1 unit - (01)0088445049…
FDA Device · Class II · 2020-11-25 · Merit Medical Systems - VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: For use in monitoring the performance of the VITROS Immunodi…
FDA Device · Class II · 2020-11-25 · Ortho Clinical Diagnostics - Kangaroo Connect 1000ml Bag Set, Non-Sterile, Product Code 77100FD - Product Usage: single-use tubing sets used with pumps in the delivery…
FDA Device · Class II · 2020-11-25 · Cardinal Health 200 - XTANT Medical, ## mm x ## mm x # mm x # ,Lordotic/Packaged InTice - C, Sterile R, Single Use Only, for the following Reference numbers/ Pri…
FDA Device · Class III · 2020-11-18 · Xtant Medical - EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: This kit is intended for qualitative detection of human anti-COVID-19…
FDA Device · Class II · 2020-11-18 · Epitope Diagnostics - Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on patient population sizes from Neonatal (NICU) through Adult who r…
FDA Device · Class II · 2020-11-18 · Covidien - FlexLab (FLX) Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is…
FDA Device · Class II · 2020-11-18 · Inpeco - Aptio Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modula…
FDA Device · Class II · 2020-11-18 · Inpeco - OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (tibia)
FDA Device · Class II · 2020-11-18 · Merete Medical - Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for cutting an 11 mm diame…
FDA Device · Class II · 2020-11-18 · Stryker Instruments Div - Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
FDA Device · Class II · 2020-11-18 · Fresenius Medical Care Holdings - Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usage: intended to be op…
FDA Device · Class II · 2020-11-18 · Shanghai United Imaging Healthcare - OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (femur)
FDA Device · Class II · 2020-11-18 · Merete Medical - Computed Tomography X-Ray System, Model uCT 530, Rx, CE, GTIN: 06971576831012 - Product Usage: ntended to produce cross-sectional images of…
FDA Device · Class II · 2020-11-18 · Shanghai United Imaging Healthcare - Strep B Carrot Broth One-Step, Ref
FDA Device · Class III · 2020-11-18 · Hardy Diagnostics - AMS 700 MS Pump with and without InhibiZone, sold as individual units and also pre-connected to AMS 700 cylinders
FDA Device · Class II · 2020-11-18 · Boston Scientific - SUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technologyt - Product Usage: intended for use in the dermatologic and surgical procedures f…
FDA Device · Class II · 2020-11-18 · Aesthetics Biomedical - Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to monitor blood parameters during cardiopulmonary bypass (CPB) or…
FDA Device · Class II · 2020-11-18 · Maquet Cardiovascular Us Sales - Computed Tomography X-Ray System, Model uCT 550, Rx, CE, GTIN: 06971576831036 - Product Usage: ntended to produce cross-sectional images of…
FDA Device · Class II · 2020-11-18 · Shanghai United Imaging Healthcare - QUIDEL Sofia SARS Antigen FIA IVD REF 20374
FDA Device · Class II · 2020-11-18 · Quidel - OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus)
FDA Device · Class II · 2020-11-18 · Merete Medical - Accelerator a3600 Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation)…
FDA Device · Class II · 2020-11-18 · Inpeco - Computed Tomography X-Ray System, Model uCT 760, Rx, CE, GTIN: 06971576831043 - Product Usage: ntended to produce cross-sectional images of…
FDA Device · Class II · 2020-11-18 · Shanghai United Imaging Healthcare - Niobe ES System, Models 001-006000-1 and 001-006100-1
FDA Device · Class II · 2020-11-18 · Stereotaxis
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)