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.
- LightPod ERA lasers
FDA Device · Class II · 2020-01-15 · Aerolase - Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST
FDA Device · Class II · 2020-01-15 · Nextremity Solutions - Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.)
FDA Device · Class II · 2020-01-15 · Cochlear Americas - Medical convenience trays and kits, labeled as: Medical Action Industries, Inc.: ***CVC*** Clear Sequence Change Kit, REF 77070B ***DIALYSI…
FDA Device · Class II · 2020-01-15 · Medical Action Industries 306 - Blood Glucose Monitoring System, Model Number 08453071001 ACCU-CHEK GUIDE RETAIL KIT FCN MG/DL US - Product Usage: The Accu-Chek Guide Bloo…
FDA Device · Class II · 2020-01-08 · Roche Diabetes Care - iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgical/interventional suite with integrated MRI and X-ray angiograp…
FDA Device · Class II · 2020-01-08 · Deerfield Imaging - Blood Glucose Monitoring System, Model Number 07400926001 ACCU-CHEK GUIDE RETAIL KIT MG/DL - Product Usage: The Accu-Chek Guide Blood Gluco…
FDA Device · Class II · 2020-01-08 · Roche Diabetes Care - Medicrea Pass LP, REF B02217545, Non Sterile, Material: Ti-6Al-4V ELI, VIS PEDICULAIRE POLYAXIALE 7.5MM x 45MM, POLYAXIAL PEDICLE SCREW 7.5…
FDA Device · Class II · 2020-01-08 · Medicrea International - Blood Glucose Monitoring System, Model Number 07400870001 ACCU-CHEK GUIDE SAMPLE KIT MG/DL - Product Usage: The Accu-Chek Guide Blood Gluco…
FDA Device · Class II · 2020-01-08 · Roche Diabetes Care - Invia Foam Dressing Kit with FitPad - X-Large (3 pcs) SKU # 0876224
FDA Device · Class II · 2020-01-08 · Medela - Apollo DRF, Model Number 9784220831 - Product Usage: The remote controlled table Apollo DRF is an X-ray equipment that allows to perform ge…
FDA Device · Class II · 2020-01-08 · Villa Sistemi Medicali S P A - The products involved are DeWALT laser distance measurers, model numbers DW0165, DW0165S, DW0330S and Stanley Fatmax FMHT77506
FDA Device · Class II · 2020-01-08 · Stanley Black And Decker - Blood Glucose Monitoring System, Model Number 08453063001 ACCU-CHEK GUIDE SAMPLE KIT FCN MG/DL US - Product Usage: The Accu-Chek Guide Bloo…
FDA Device · Class II · 2020-01-08 · Roche Diabetes Care - Blood Glucose Monitoring System, Model Number 08313202001 ACCU CHEK GUIDE HCP SAMPLE LAUNCH BOX - Product Usage: The Accu-Chek Guide Blood…
FDA Device · Class II · 2020-01-08 · Roche Diabetes Care - Apollo, Model Numbers 9784100231, 9784120131, 9784130131 - Product Usage: Apollo table is a remote controlled X-ray system suitable for rad…
FDA Device · Class II · 2020-01-08 · Villa Sistemi Medicali S P A - Blood Glucose Monitoring System, Model Number 07400942001 ACCU-CHEK GUIDE METER ONLY MG/DL US - Product Usage: The Accu-Chek Guide Blood Gl…
FDA Device · Class II · 2020-01-08 · Roche Diabetes Care - Juno DRF, Model Number 709020 - Product Usage: General. multi-function x-ray systems capable of routine radiographs and general fluoroscopy…
FDA Device · Class II · 2020-01-08 · Villa Sistemi Medicali S P A - Apollo EZ, Model Number 9784152036 - Product Usage: The Apollo EZ remote-controlled table is X-ray equipment that can be used to perform ge…
FDA Device · Class II · 2020-01-08 · Villa Sistemi Medicali S P A - There is a complaint regarding internal check cable guide mechanism failure for the Nucletron Flexitron brachytherapy afterloader system
FDA Device · Class II · 2020-01-08 · Nucletron Bv - HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI or GTIN: 00813024010890, when connected to the Hear…
FDA Device · Class II · 2020-01-08 · Thoratec - O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000
FDA Device · Class II · 2020-01-08 · Medtronic Navigation Littleton - The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX Elite 9000 Swept-Source OCT [SS-OCT] is a non- contact, high res…
FDA Device · Class II · 2020-01-08 · Carl Zeiss Meditec - i-STAT cTnI cartridge
FDA Device · Class II · 2020-01-08 · Abbott Point - NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image capture of endothelium e…
FDA Device · Class III · 2020-01-08 · Nidek - Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR1000 - Product Usage: The device can assist in the diagnosis a…
FDA Device · Class II · 2020-01-01 · Axis Shield Diagnostics - 7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to dilute samples when assay values exceed the reportable (dy…
FDA Device · Class II · 2020-01-01 · Ortho Clinical Diagnostics - CARESCAPE Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data within…
FDA Device · Class II · 2020-01-01 · Ge Healthcare - CIC Pro Clinical Information Center Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and ne…
FDA Device · Class II · 2020-01-01 · Ge Healthcare - Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802
FDA Device · Class I · 2020-01-01 · Galemed - STA SYSTEM CONROL N + P (ref. 00678)
FDA Device · Class II · 2020-01-01 · Diagnostica Stago - Lamicel 20PK 5MM INTL
FDA Device · Class II · 2020-01-01 · Medtronic Xomed - Lamicel 10PK 10MM INTL
FDA Device · Class II · 2020-01-01 · Medtronic Xomed - Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
FDA Device · Class I · 2020-01-01 · Galemed - Lamicel 20PK 3MM INTL Cervical dilator
FDA Device · Class II · 2020-01-01 · Medtronic Xomed - CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae…
FDA Device · Class II · 2020-01-01 · Abbott Medical - BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy device is intended for use in obtaining biopsies fr…
FDA Device · Class II · 2020-01-01 · Bard Peripheral Vascular - ElectroTek Temporal Sensor Cable Gold - Long Length, Graduated - Product Usage: The electroencephalographic system ElectroTek is intended t…
FDA Device · Class II · 2020-01-01 · Lifelines Neuro - Cordis S.M.A.R.T. CONTROL /S.M.A.R.T. Vascular Stent System
FDA Device · Class II · 2020-01-01 · Cardinal Health - Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868
FDA Device · Class II · 2020-01-01 · Mazor Robotics - INTEGRA, Drill CS 4.0, quick coupling single use, REF 430425
FDA Device · Class III · 2020-01-01 · Aap Implantate Ag - S.M.A.R.T. Nitinol Stent System and the S.M.A.R.T. Control Nitinol Stent System
FDA Device · Class II · 2020-01-01 · Cardinal Health - INTEGRA, Drill CS 4.5, quick coupling single use, REF 430453
FDA Device · Class III · 2020-01-01 · Aap Implantate Ag - ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healt…
FDA Device · Class II · 2020-01-01 · Ge Healthcare - Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100 - Product Usage: The device can assist in the diagnosis an…
FDA Device · Class II · 2020-01-01 · Axis Shield Diagnostics - Urine Electrolyte Diluent, Product Code: 1112352 - Product Usage: used to dilute urine specimens for analysis of sodium (Na+) and potassium…
FDA Device · Class II · 2020-01-01 · Ortho Clinical Diagnostics - AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls
FDA Device · Class III · 2020-01-01 · Tosoh Smd - RayStation stand-alone software treatment planning system, Model Numbers 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 -…
FDA Device · Class II · 2020-01-01 · Raysearch Laboratories Ab - STA UNICALIBRATOR (ref. 00675)
FDA Device · Class II · 2020-01-01 · Diagnostica Stago - ElectroTek Temporal Sensor Cable Gold - Long Length, Single Length - Product Usage: The electroencephalographic system ElectroTek is intend…
FDA Device · Class II · 2020-01-01 · Lifelines Neuro - 3M Durapore Advanced, Surgical Tape, Model Numbers: 1590-0, 1590-1, 1590-2, 1590-3, 1591-0, 1591-1, 1591-2, 1591-3, 1590S-1, 1590S-2, 1590B…
FDA Device · Class II · 2020-01-01 · 3m Health Care Business - Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
FDA Device · Class I · 2020-01-01 · Galemed - Cordis Precise Nitinol Stent System
FDA Device · Class II · 2020-01-01 · Cardinal Health - Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHBC100 - Product Usage: The device can assist in the diagnosis and…
FDA Device · Class II · 2020-01-01 · Axis Shield Diagnostics - PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers
FDA Device · Class II · 2020-01-01 · Polymer Technology Systems - VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy
FDA Device · Class I · 2020-01-01 · Livanova Usa
Other years
2026 (2,088) · 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)