FDA Device · 2019
FDA Device recalls in 2019
RecallRadar indexes 2,801 FDA Device recall notices published in 2019. By classification: 369 Class I, 2,343 Class II, 89 Class III.
- Go-EZ Screw 6.5x32, Item Number 19652 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System
FDA Device · Class II · 2019-08-21 · Biopro - Go-EZ Screw 6.5x36, Item Number 19654 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System
FDA Device · Class II · 2019-08-21 · Biopro - Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151811
FDA Device · Class II · 2019-08-21 · Zimmer Biomet - K-Wire Sterile Single Trochar .045, Item Number 19108 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS Syst…
FDA Device · Class II · 2019-08-21 · Biopro - ARIES GBS Assay , REF 50-10021, UDI # 00840487100165
FDA Device · Class II · 2019-08-21 · Luminex - Go-EZ Screw 6.5x110, Item Number 19670 - Product Usage:Accessories to the BioPro Go-Ez screw system and the BioPro HBS System
FDA Device · Class II · 2019-08-21 · Biopro - SOMATOM Definition AS, Model Number 8098027 - Product Usage: Computed tomography systems intended to generate and process cross-sectional i…
FDA Device · Class II · 2019-08-21 · Siemens Medical Solutions Usa - K-Wire HBS Sterile, Item Number 19688 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System
FDA Device · Class II · 2019-08-21 · Biopro - Go-EZ Screw 6.5x95, Item Number 19667 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System
FDA Device · Class II · 2019-08-21 · Biopro - SOMATOM Force, Model Number 10742326 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images o…
FDA Device · Class II · 2019-08-21 · Siemens Medical Solutions Usa - Go-EZ Screw 6.5x90, Item Number 19666 - Product Usage:Accessories to the BioPro Go-Ez screw system and the BioPro HBS System
FDA Device · Class II · 2019-08-21 · Biopro - Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151813
FDA Device · Class II · 2019-08-21 · Zimmer Biomet - Go-EZ Screw 6.5x30, Item Number 19651 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System
FDA Device · Class II · 2019-08-21 · Biopro - Vigilant Agilia, Vigilant Drug'Lib, REF Z073476, versions 1.0 and 1.1 Product Usage: Vigilant Drug Lib is Dose Error Reduction Software tha…
FDA Device · Class I · 2019-08-21 · Fenwal - Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151815
FDA Device · Class II · 2019-08-21 · Zimmer Biomet - Smith & Nephew Negative Pressure Wound Therapy 15FR Channel Wound Drain PN: 02872 An introduction/drainage catheter is a device that is a f…
FDA Device · Class II · 2019-08-21 · Degania Silicone - Cardinal Health Jackson-Pratt Channel Drain 19FR, 3/4 flutes, with trocar Cardinal Health: PN JP-2225 An introduction/drainage catheter is…
FDA Device · Class II · 2019-08-21 · Degania Silicone - Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes Cardinal Health PN: JP-2188 An introduction/drainage catheter is a device tha…
FDA Device · Class II · 2019-08-21 · Degania Silicone - SOMATOM Edge Plus, Model Number 10267000 - Product Usage: Computed tomography systems intended to generate and process cross-sectional imag…
FDA Device · Class II · 2019-08-21 · Siemens Medical Solutions Usa - Medline Silicone Drain 15Fr 3/16" Full Fluted PN: DYNJWE2188HB An introduction/drainage catheter is a device that is a flexible single or m…
FDA Device · Class II · 2019-08-21 · Degania Silicone - K-Wire Single Trocar 1.6x150mm, Item Number OL15016S - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System
FDA Device · Class II · 2019-08-21 · Biopro - Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes Cardinal Health: PN JP-2190 An introduction/drainage catheter is a device tha…
FDA Device · Class II · 2019-08-21 · Degania Silicone - Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151812
FDA Device · Class II · 2019-08-21 · Zimmer Biomet - BD Vacutainer Fluoride Tubes for Blood Alcohol determinations Part Number: 367001 Product Usage: Blood Alcohol determinations
FDA Device · Class II · 2019-08-21 · Becton Dickinson And - Go-EZ Screw 6.5x38, Item Number 19655 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System
FDA Device · Class II · 2019-08-21 · Biopro - HS70A Diagnostic Ultrasound System Version 2.01.00, 2.01.01, 2.01.02, 2.01.03, 2.01.04, 2.01.05, 2.01.06, 1.00.06, 1.00.07, 1.00.08, 1.00.0…
FDA Device · Class II · 2019-08-21 · Neurologica - MED-RX POLYURETHANE FEEDING TUBES: a) 5Fr X 16" (40cm), REF 54-1650R b) 6.5Fr X16" (40cm), REF 54-1665R c) 5Fr X 24" (60cm), REF 54-2450R d…
FDA Device · Class II · 2019-08-21 · Canadian Hospital Specialties - Cardinal Health Jackson-Pratt Channel Drain 15FR Cardinal PN:JP-2223 An introduction/drainage catheter is a device that is a flexible singl…
FDA Device · Class II · 2019-08-21 · Degania Silicone - VOLUMAT MC AGILIA US, Infusion Pump, REF Z021135, software versions 1.7 and 1.9a Product Usage: The Volumat MC Agilia is a piece of transpo…
FDA Device · Class I · 2019-08-21 · Fenwal - K-Wire Single Trocar 1.1x150mm, Item Number OL15011S - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System
FDA Device · Class II · 2019-08-21 · Biopro - ARIES Extraction Kit
FDA Device · Class II · 2019-08-21 · Luminex - Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes, with trocar Product Number: JP-2189 An introduction/drainage catheter is a d…
FDA Device · Class II · 2019-08-21 · Degania Silicone - Go-EZ Screw 6.5x85, Item Number 19665 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System
FDA Device · Class II · 2019-08-21 · Biopro - SOMATOM Drive, Model Number 10431700 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images o…
FDA Device · Class II · 2019-08-21 · Siemens Medical Solutions Usa - Go-EZ Screw 6.5x115, Item Number 19671 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System
FDA Device · Class II · 2019-08-21 · Biopro - ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295
FDA Device · Class II · 2019-08-21 · Luminex - ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059
FDA Device · Class II · 2019-08-21 · Luminex - K-Wire HBS Sterile Lot, Item Number 19688 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System
FDA Device · Class II · 2019-08-21 · Biopro - SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System
FDA Device · Class II · 2019-08-21 · Pega Medical - K-Wire Sterile Single Trochar, Item Number 19106 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System
FDA Device · Class II · 2019-08-21 · Biopro - Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes, with trocar Cardinal Health: PN: JP-2191 An introduction/drainage catheter i…
FDA Device · Class II · 2019-08-21 · Degania Silicone - ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158
FDA Device · Class II · 2019-08-21 · Luminex - SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box of 20
FDA Device · Class II · 2019-08-21 · Suntech Medical - Regard ¿ custom surgical pack labeled as "LAPAROSCOPIC - OSU" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II…
FDA Device · Class II · 2019-08-14 · Roi Consolidated Service Center Csc - Spectrum Laser Projection Series
FDA Device · Class II · 2019-08-14 · Gk Photonics - CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IEDAT3 - Product Usage: BIOMET3i Restorative products are intended for use as a…
FDA Device · Class II · 2019-08-14 · Biomet 3i - STERILE FLUORO SSP TRAY Kit Code: MNS11605 - Product Usage: This kit is used for arthrogram injection and aspiration
FDA Device · Class II · 2019-08-14 · Centurion Medical Products - VITROS 5600 Integrated System, clinical chemistry analyzer
FDA Device · Class II · 2019-08-14 · Ortho Clinical Diagnostics - EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 10G - REF ECP011…
FDA Device · Class II · 2019-08-14 · Bard Peripheral Vascular - Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.25g, For single use only, Part Number 20115 - Product Usag…
FDA Device · Class II · 2019-08-14 · Geistlich Pharma North America - Atom Laser Projection Series
FDA Device · Class II · 2019-08-14 · Gk Photonics - ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs)
FDA Device · Class I · 2019-08-14 · St Jude Medical - MED EL Cochlear Implant System, PULSARci100 Standard - Product Usage: The PULSARci100 Implant is an implantable part of the MED EL Cochlear…
FDA Device · Class II · 2019-08-14 · Med El Elektromedizinische Gereate - YXLON Cougar Cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control
FDA Device · Class II · 2019-08-14 · Comet Technologies Usa - Lantis 8.3 Commander, Model # 8148178 - Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver treatment to the…
FDA Device · Class II · 2019-08-14 · Siemens Medical Solutions Usa - Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction…
FDA Device · Class II · 2019-08-14 · Olympus - Dimension¿ Ferritin (FERR) Flex¿ reagent cartridge DM FERR Product Usage: The FERR Flex reagent cartridge is intended to be used on the Dim…
FDA Device · Class II · 2019-08-14 · Siemens Healthcare Diagnostics - VITROS Chemistry Products GLU Slides-Product Code:1707801
FDA Device · Class II · 2019-08-14 · Ortho Clinical Diagnostics - Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 1-2mm 0.5g, For single use only, Part Number 20126 - Product Usage: Au…
FDA Device · Class II · 2019-08-14 · Geistlich Pharma North America - Brilliance 64 Model # 728231, computed tomography x-ray system
FDA Device · Class II · 2019-08-14 · Philips Medical Systems Cleveland - Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a chemiluminescent microparticle immunoassay (CMIA) use…
FDA Device · Class II · 2019-08-14 · Abbott Ireland Diagnostics Division - VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
FDA Device · Class II · 2019-08-14 · Ortho Clinical Diagnostics - CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number ILDAT3 - Product Usage:BIOMET3i Restorative products are intended for use as an…
FDA Device · Class II · 2019-08-14 · Biomet 3i - MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types: a. SONATAti100 FLEXsoft
FDA Device · Class II · 2019-08-14 · Med El Elektromedizinische Gereate - EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 12G - REF ECP011…
FDA Device · Class II · 2019-08-14 · Bard Peripheral Vascular - 14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061423 Product Usage: An aid for introducing a hemod…
FDA Device · Class II · 2019-08-14 · Medical Components - Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray system as follows: Azurion 3 M12, Azurion 3 M15, Azur…
FDA Device · Class II · 2019-08-14 · Philips North America - Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 570-0414 Product Usage: PTS Panels Lipid Panel test str…
FDA Device · Class III · 2019-08-14 · Polymer Technology Systems - Ingenuity Core Model # 728321, computed tomography x-ray system
FDA Device · Class II · 2019-08-14 · Philips Medical Systems Cleveland - VITROS 5,1 FS Chemistry System, clinical chemistry analyzer
FDA Device · Class II · 2019-08-14 · Ortho Clinical Diagnostics - DAILY DRIVELINE KIT Kit Code: DM940 - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient popul…
FDA Device · Class II · 2019-08-14 · Centurion Medical Products - DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usage: The Salivary Testoste…
FDA Device · Class II · 2019-08-14 · Drg Instruments - Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform peritoneal dialysis (APD) in conjunction with the Li…
FDA Device · Class II · 2019-08-14 · Fresenius Medical Care Renal Therapies Group - The DABRA Laser (model RA-308) is designed to provide ultraviolet laser energy endovascularly through a catheter to occluded lesions in the…
FDA Device · Class II · 2019-08-14 · Ra Medical Systems - SenTec Membrane Changer Set (1 charger plus 1 insert) - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxi…
FDA Device · Class II · 2019-08-14 · Sentec Ag - ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs)
FDA Device · Class I · 2019-08-14 · St Jude Medical - IDEAL IMPLANT Structured Breast Implant, saline breast implant, in the following sizes: 210cc, 240cc, 270cc, 300cc, 335cc, 370cc, 405cc, 44…
FDA Device · Class II · 2019-08-14 · Ideal Implant - VITROS 4600 Chemistry System, clinical chemistry analyzer
FDA Device · Class II · 2019-08-14 · Ortho Clinical Diagnostics - ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: 05414734507738
FDA Device · Class I · 2019-08-14 · St Jude Medical - CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number IEDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an acc…
FDA Device · Class II · 2019-08-14 · Biomet 3i - YXLON Cheetah cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing and quality control
FDA Device · Class II · 2019-08-14 · Comet Technologies Usa - Lantis Commander, Model # 4503178 - Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver treatment to the pati…
FDA Device · Class II · 2019-08-14 · Siemens Medical Solutions Usa - SenTec Neonatal Starter Set with and without Service Gas (2 Chargers each) - Product Usage: is indicated for continuous, non-invasive monit…
FDA Device · Class II · 2019-08-14 · Sentec Ag - HIGH DRAINAGE LVAD TRAY Kit Code: DM950 - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient p…
FDA Device · Class II · 2019-08-14 · Centurion Medical Products - STERILE GRAVES VAGINAL SPECULUM MEDIUM Kit Code # GVS10MST - Product Usage:The speculum is used to spread the walls of the vagina to facili…
FDA Device · Class II · 2019-08-14 · Centurion Medical Products - VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer
FDA Device · Class II · 2019-08-14 · Ortho Clinical Diagnostics - The Visibly Online Refractive Vision Test which is part of the Visibly Vision Test Solution, This is a software application that partners a…
FDA Device · Class II · 2019-08-14 · Opternative - Burstberry Laser Projection Series
FDA Device · Class II · 2019-08-14 · Gk Photonics - IQon Spectral CT Model # 728332, computed tomography x-ray system
FDA Device · Class II · 2019-08-14 · Philips Medical Systems Cleveland - VITROS 4600 Chemistry System, clinical chemistry analyzer
FDA Device · Class II · 2019-08-14 · Ortho Clinical Diagnostics - Ingenuity TF PET/CT Model # 882456, computed tomography x-ray system
FDA Device · Class II · 2019-08-14 · Philips Medical Systems Cleveland - EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 7GV Upright (Ver…
FDA Device · Class II · 2019-08-14 · Bard Peripheral Vascular - Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100
FDA Device · Class II · 2019-08-14 · Howmedica Osteonics - EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF numbers 10GV Upright (V…
FDA Device · Class II · 2019-08-14 · Bard Peripheral Vascular - ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: 05414734507585
FDA Device · Class I · 2019-08-14 · St Jude Medical - SNAG FREE SUTURE TRAY Kit Code: SUT14355 - Product Usage: Kit is used for laceration repairs for general population
FDA Device · Class II · 2019-08-14 · Centurion Medical Products - SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and o…
FDA Device · Class II · 2019-08-14 · Sentec Ag - UNIVERSAL BLOCK TRAY Kit Code: MNS6645 - Product Usage: Kit is used for regional anesthesia nerve blocks for general population
FDA Device · Class II · 2019-08-14 · Centurion Medical Products - SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014
FDA Device · Class II · 2019-08-14 · Microaire Surgical Instruments - CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM, Item Number ILDAN3 - Product Usage: BIOMET3i Restorative products are intended for use as an acc…
FDA Device · Class II · 2019-08-14 · Biomet 3i
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)