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.

• STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Model No. 400498-02 - Product Usage: is designed to enable complex surgery using…
  FDA Device · Class II · 2020-06-17 · Intuitive Surgical
• RayStation 8A, UDI # 07350002010112 - 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
• IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including but not limited to ph…
  FDA Device · Class II · 2020-06-17 · Philips Healthcare Informatics
• Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes anatomic pathology (AP) labor…
  FDA Device · Class II · 2020-06-17 · Ventana Medical Systems
• A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 90MM, Item Number: 110025471 - Product Usage: Intended for tempora…
  FDA Device · Class II · 2020-06-17 · Biomet
• A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 7 HOLE 140MM, Item Number: 110030307 - Product Usage: Intended for temporary inter…
  FDA Device · Class II · 2020-06-17 · Biomet
• Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571
  FDA Device · Class II · 2020-06-17 · Elekta
• Genicon Natura Model 210-005-151
  FDA Device · Class II · 2020-06-17 · Genicon
• A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Plate-Cage 32x21x15 7 A Link Z Ti Unitary Plate-Cage 32…
  FDA Device · Class II · 2020-06-17 · Acuity Surgical Devices
• RayStation 8B Service Pack 1, UDI # 07350002010204 - 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 200-105-151, 5mm diameter, 100mm length (one cannula) - Product Usage: The universal handle can be used as a pistol…
  FDA Device · Class II · 2020-06-17 · Genicon
• Genicon Natura Model 210-005-152, 5mm diameter, 100mm length (two cannula, threaded) - Product Usage: The universal handle can be used as a…
  FDA Device · Class II · 2020-06-17 · Genicon
• RadiForce RX360, model 0FTD2346 - Product Usage: is a color LCD monitor indicated for use in displaying radiological images for review, ana…
  FDA Device · Class II · 2020-06-17 · Eizo
• OSTEOVATIONEX 5CC IMPACTFORMULA. REF/UDI: 390-0205/00813845020047 - Product Usage: The product provides a bone void filler that is replaced…
  FDA Device · Class II · 2020-06-10 · Osteomed
• Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X45MM, Item Number 810M4545 - Product Usage: are non-cervical spinal fixatio…
  FDA Device · Class II · 2020-06-10 · Zimmer Biomet
• Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X55MM, Item Number 810M5555 - Product Usage: are non-cervical spinal fixatio…
  FDA Device · Class II · 2020-06-10 · Zimmer Biomet
• Multifire VersaTrack Auto Suture Hernia Stapler, 4.8mm, Part No. 174023 - Product Usage: has application in endoscopic general surgery proc…
  FDA Device · Class II · 2020-06-10 · Covidien
• Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X35MM, Item Number 810M6535 - Product Usage: are non-cervical spinal fixatio…
  FDA Device · Class II · 2020-06-10 · Zimmer Biomet
• Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X40MM, Item Number 811M8540 - Product Usage: are non-cervical spinal fixation…
  FDA Device · Class II · 2020-06-10 · Zimmer Biomet
• Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X50MM, Item Number 810M5550 - Product Usage: are non-cervical spinal fixatio…
  FDA Device · Class II · 2020-06-10 · Zimmer Biomet
• safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1
  FDA Device · Class II · 2020-06-10 · Radiometer Medical Aps
• OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product Usage: The product provides a bone void filler that is replaced b…
  FDA Device · Class II · 2020-06-10 · Osteomed
• Accelerator APS Aliquoter Module, List number: 07L40 - Product Usage: The ACCELERATOR APS Workcell is a modular system designed to automate…
  FDA Device · Class II · 2020-06-10 · Abbott Laboratories
• Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - Product Usage: has application in endoscopic general surgery proc…
  FDA Device · Class II · 2020-06-10 · Covidien
• Aptio Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems consolidate multiple Analytical instru…
  FDA Device · Class II · 2020-06-10 · Inpeco
• OSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product Usage: The product provides a bone void filler that is replaced…
  FDA Device · Class II · 2020-06-10 · Osteomed
• Beckman Coulter ACCESS Immunoassay Systems, Access GI Monitor Cancer Antigen 19-9, REF 387687 ( UDI: 15099590231842) the Access Family of I…
  FDA Device · Class II · 2020-06-10 · Beckman Coulter
• AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type number: 6010/200 - Product Usage: DR 800: Agfa s DR 800 system is i…
  FDA Device · Class II · 2020-06-10 · Agfa N V
• ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System…
  FDA Device · Class II · 2020-06-10 · Siemens Medical Solutions Usa
• TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM - Product Usage: is intended for the quantitative measurement of glucose (sugar) in fresh…
  FDA Device · Class II · 2020-06-10 · Trividia Health
• Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X55MM, Item Number 811M8555 - Product Usage: are non-cervical spinal fixation…
  FDA Device · Class II · 2020-06-10 · Zimmer Biomet
• Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X50MM, Item Number 810M7550 - Product Usage: are non-cervical spinal fixatio…
  FDA Device · Class II · 2020-06-10 · Zimmer Biomet
• OSTEOVATION 3CC IMPACTFORMULA. REF/UDI: 390-2103/00813845020078 - Product Usage: The product provides a bone void filler that is replaced b…
  FDA Device · Class II · 2020-06-10 · Osteomed
• OSTEOVATION 10 CC IMPACT FORMULA. REF/UDI: 390-2110/ /00813845021092 - Product Usage: The product provides a bone void filler that is repla…
  FDA Device · Class II · 2020-06-10 · Osteomed
• Sterile Custom Packs to be used in surgical procedures
  FDA Device · Class II · 2020-06-10 · American Contract Systems
• OSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - Product Usage: The product provides a bone void filler that is replace…
  FDA Device · Class II · 2020-06-10 · Osteomed
• OSTEOVATION 5CC INJECT FORMULA. REF/UDI: 390-2005/00813845020054 - Product Usage: The product provides a bone void filler that is replaced…
  FDA Device · Class II · 2020-06-10 · Osteomed
• EQUISTREAM¿ XK Long-Term Hemodialysis Catheter
  FDA Device · Class II · 2020-06-10 · Bard Peripheral Vascular
• Magnetic Resonance Imaging Diagnostic Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows, r…
  FDA Device · Class II · 2020-06-10 · Philips North America
• OSTEOVATION RMX 10 CC Injectable
  FDA Device · Class II · 2020-06-10 · Osteomed
• Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X50MM, Item Number 810M6550 - Product Usage: are non-cervical spinal fixatio…
  FDA Device · Class II · 2020-06-10 · Zimmer Biomet
• Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X40MM, Item Number 810M6540 - Product Usage: are non-cervical spinal fixatio…
  FDA Device · Class II · 2020-06-10 · Zimmer Biomet
• AC Powered hospital adjustable bed
  FDA Device · Class II · 2020-06-10 · Umano Medical
• Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis…
  FDA Device · Class II · 2020-06-10 · Baxter Healthcare
• Type S Extension For use with Varian, CIVCO, Prescription Only - Product Usage: Device is intended for patient positioning
  FDA Device · Class II · 2020-06-10 · Med Tec
• Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X35MM, Item Number 810M7535 - Product Usage: are non-cervical spinal fixatio…
  FDA Device · Class II · 2020-06-10 · Zimmer Biomet
• Sterile Custom Packs to be used in surgical procedures
  FDA Device · Class II · 2020-06-10 · American Contract Systems
• OSTEOVATIONEX 2CC INJECT FORMULA. REF/UDI: 390-0002/00813845020009 - Product Usage: The product provides a bone void filler that is replace…
  FDA Device · Class II · 2020-06-10 · Osteomed
• EQUISTREAM¿ XK Long-Term Hemodialysis Catheter
  FDA Device · Class II · 2020-06-10 · Bard Peripheral Vascular
• Sterile Custom Packs to be used in surgical procedures
  FDA Device · Class II · 2020-06-10 · American Contract Systems
• PerkinElmer 226 Sample Collection Device
  FDA Device · Class III · 2020-06-10 · Perkinelmer Health Sciences
• Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X50MM, Item Number 811M8550 - Product Usage: are non-cervical spinal fixation…
  FDA Device · Class II · 2020-06-10 · Zimmer Biomet
• Accelerator a3600 Automation System using the Aliquoter Module (Inpeco P/N FLX-212) - Product Usage: The systems consolidate multiple Analy…
  FDA Device · Class II · 2020-06-10 · Inpeco
• System, Tomography Computed Emmission
  FDA Device · Class II · 2020-06-10 · Ge Healthcare
• OSTEOVATIONEX 3CC IMPACTFORMULA. REF/UDI: 390-0203/00813845020030 - Product Usage: The product provides a bone void filler that is replaced…
  FDA Device · Class II · 2020-06-10 · Osteomed
• Sterile Custom Packs to be used in surgical procedures
  FDA Device · Class II · 2020-06-10 · American Contract Systems
• Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X55MM, Item Number 810M6555 - Product Usage: are non-cervical spinal fixatio…
  FDA Device · Class II · 2020-06-10 · Zimmer Biomet
• Xhibit Central, Model No. 96102 - Product Usage: intended use is to provide clinicians with central monitoring of adult, pediatric and neon…
  FDA Device · Class II · 2020-06-10 · Spacelabs Healthcare
• Sterile Custom Packs to be used in surgical procedures
  FDA Device · Class II · 2020-06-10 · American Contract Systems
• Beckman Coulter ACCESS Immunoassay Systems, Access Total T3 Triiodothyronine , REF 33830 (UDI: 15099590227210) for use with the Access Fami…
  FDA Device · Class II · 2020-06-10 · Beckman Coulter
• Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant abutments are intended…
  FDA Device · Class II · 2020-06-10 · Nobel Biocare Usa
• safeCLINITUBES Blood Sampler;REF 942-892;D957P-70-100x1
  FDA Device · Class II · 2020-06-10 · Radiometer Medical Aps
• Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763000043001
  FDA Device · Class II · 2020-06-10 · Medtronic
• Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Part No. 174025 - Product Usage: has application in endoscopic ge…
  FDA Device · Class II · 2020-06-10 · Covidien
• Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X40MM, Item Number 810M5540 - Product Usage: are non-cervical spinal fixatio…
  FDA Device · Class II · 2020-06-10 · Zimmer Biomet
• Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X30MM, Item Number 810M4530 - Product Usage: are non-cervical spinal fixatio…
  FDA Device · Class II · 2020-06-10 · Zimmer Biomet
• Omnipod DASH Insulin Management System (mmol/L configuration), Catalog Number PT000011 M/D: INT1D001MM - Product Usage: is intended for sub…
  FDA Device · Class II · 2020-06-10 · Insulet
• Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin, REF 33860 (UDI: 15099590227173) for use with the Access Family of Immunoa…
  FDA Device · Class II · 2020-06-10 · Beckman Coulter
• Beckman Coulter Access Immunoassay Systems, Access Free T4 Thyroxine, REF 33880 (UDI:15099590225834) for use with Access Family of Immunoas…
  FDA Device · Class II · 2020-06-10 · Beckman Coulter
• NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619
  FDA Device · Class II · 2020-06-10 · Nobel Biocare Usa
• Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X60MM, Item Number 811M8560 - Product Usage: are non-cervical spinal fixation…
  FDA Device · Class II · 2020-06-10 · Zimmer Biomet
• Pressure Monitoring Tray, C-PMSY, G02854
  FDA Device · Class II · 2020-06-10 · Cook
• Sterile Custom Packs to be used in surgical procedures
  FDA Device · Class II · 2020-06-10 · American Contract Systems
• Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin Antibody II, REF A32898 (UDI: 15099590202910) for use with the Access Fami…
  FDA Device · Class II · 2020-06-10 · Beckman Coulter
• Power supply provided with Afinion 2, Catalog numbers 1116553, 1116554, 1116556, 1116557, 1116597, 1116598, 1116663, 1116679, 1116680, 1116…
  FDA Device · Class II · 2020-06-10 · Abbott Diagnostics Technologies As
• Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit , Part No. 174027 - Product Usage: has application in endoscopic ge…
  FDA Device · Class II · 2020-06-10 · Covidien
• Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X45MM, Item Number 810M6545 - Product Usage: are non-cervical spinal fixatio…
  FDA Device · Class II · 2020-06-10 · Zimmer Biomet
• Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X45MM, Item Number 810M5545 - Product Usage: are non-cervical spinal fixatio…
  FDA Device · Class II · 2020-06-10 · Zimmer Biomet
• OSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - Product Usage: The product provides a bone void filler that is replace…
  FDA Device · Class II · 2020-06-10 · Osteomed
• da Vinci SP surgical system
  FDA Device · Class II · 2020-06-10 · Intuitive Surgical
• Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT000010 M/D: INT1D001MG - Product Usage: is intended for subc…
  FDA Device · Class II · 2020-06-10 · Insulet
• OSTEOVATION RMX Injectable BVF 5CC . REF/UDI: 390-6001/ /00813845021082 - Product Usage: The product provides a bone void filler that is re…
  FDA Device · Class II · 2020-06-10 · Osteomed
• Sterile Custom Packs to be used in surgical procedures
  FDA Device · Class II · 2020-06-10 · American Contract Systems
• Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X45MM, Item Number 811M8545 - Product Usage: are non-cervical spinal fixation…
  FDA Device · Class II · 2020-06-10 · Zimmer Biomet
• FlexLab Augomation System using the Aliquoter Module (Inpeco P/N FLX-212) The systems consolidate multiple Analytical instruments into a un…
  FDA Device · Class II · 2020-06-10 · Inpeco
• Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X45MM, Item Number 810M7545 - Product Usage: are non-cervical spinal fixatio…
  FDA Device · Class II · 2020-06-10 · Zimmer Biomet
• Vital MIS Spinal Fixation system implants VITAL MIS TAB BREAKER, Item Number 850M0055 - Product Usage: are non-cervical spinal fixation dev…
  FDA Device · Class II · 2020-06-10 · Zimmer Biomet
• Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X40MM, Item Number 810M7540 - Product Usage: are non-cervical spinal fixatio…
  FDA Device · Class II · 2020-06-10 · Zimmer Biomet
• Sterile Custom Packs to be used in surgical procedures
  FDA Device · Class II · 2020-06-10 · American Contract Systems
• Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X40MM, Item Number 810M4540 - Product Usage: are non-cervical spinal fixatio…
  FDA Device · Class II · 2020-06-10 · Zimmer Biomet
• Sterile Custom Packs to be used in surgical procedures
  FDA Device · Class II · 2020-06-10 · American Contract Systems
• Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a h…
  FDA Device · Class II · 2020-06-10 · Baxter Healthcare
• Sterile Custom Packs to be used in surgical procedures
  FDA Device · Class II · 2020-06-10 · American Contract Systems
• Beckman Coulter Access Immunoassay Systems, Access Free T3 Triiodothyronine, REF A13422 (UDI: 15099590201661) for use with the Access Famil…
  FDA Device · Class II · 2020-06-10 · Beckman Coulter
• Sterile Custom Packs to be used in surgical procedures
  FDA Device · Class II · 2020-06-10 · American Contract Systems
• Cardiovascular Monitoring Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows, respiration b…
  FDA Device · Class II · 2020-06-10 · Philips North America
• Sterile Custom Packs to be used in surgical procedures
  FDA Device · Class II · 2020-06-10 · American Contract Systems
• Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X35MM, Item Number 810M4535 - Product Usage: are non-cervical spinal fixatio…
  FDA Device · Class II · 2020-06-10 · Zimmer Biomet
• Sterile Custom Packs to be used in surgical procedures
  FDA Device · Class II · 2020-06-10 · American Contract Systems
• ProxiDiagnost N90, UDI 706100
  FDA Device · Class II · 2020-06-10 · Philips North America

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)