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.
- Diego Elite Malleable, 4mm Standard Monopolar Blades Product Code:MM4000SS
FDA Device · Class II · 2019-04-24 · Gyrus Acmi - icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV administration sets
FDA Device · Class I · 2019-04-24 · Icu Medical - BIOPHEN UFH Control C2, REF 223901
FDA Device · Class III · 2019-04-24 · Aniara Diagnostica - Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 1, Left, Part No. LJU211T
FDA Device · Class II · 2019-04-24 · Integra Lifesciences - Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Left, Part No. LJU210T
FDA Device · Class II · 2019-04-24 · Integra Lifesciences - A warming pad, a component of the PINTLER PEAK & PINTLER SUMMIT Heated OR pad
FDA Device · Class II · 2019-04-24 · Pintler Medical - Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XC
FDA Device · Class II · 2019-04-24 · Gyrus Acmi - Innova IGS 6, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovas…
FDA Device · Class II · 2019-04-24 · Ge Healthcare - syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clinical system that assists medical laboratory professions with…
FDA Device · Class II · 2019-04-24 · Siemens Healthcare Diagnostics - BIOPHEN UFH Control C1, REF 224101
FDA Device · Class III · 2019-04-24 · Aniara Diagnostica - Foot Switches used with the following systems: 722001 Allura Xper FD 10 C 722002 Allura Xper FD10 F 722003 Allura Xper FD10 722005 Allura X…
FDA Device · Class II · 2019-04-24 · Philips Medical Systems Nederlands - Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Left, Part No. LJU213T
FDA Device · Class II · 2019-04-24 · Integra Lifesciences - Obturator (long cone), Part number 25162 Product Usage: The obturator is a component of the Flex Rectoscope which is an accessory to the Fl…
FDA Device · Class II · 2019-04-24 · Medrobotics - Bilirubin Total Gen.3, Cat
FDA Device · Class II · 2019-04-24 · Roche Diagnostics - Tibial Total Ankle Prosthesis Tray, Size 1, Product No. LJU221T
FDA Device · Class II · 2019-04-24 · Integra Lifesciences - Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB4000SS
FDA Device · Class II · 2019-04-24 · Gyrus Acmi - Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Left, Product No. LJV191T
FDA Device · Class II · 2019-04-24 · Integra Lifesciences - Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040SC
FDA Device · Class II · 2019-04-24 · Gyrus Acmi - Talar Dome Total Ankle Prosthesis, Flat Cut, Size 1, Left, Product No. LJU821T
FDA Device · Class II · 2019-04-24 · Integra Lifesciences - Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS
FDA Device · Class II · 2019-04-24 · Gyrus Acmi - Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Left, Product No. LJV193T
FDA Device · Class II · 2019-04-24 · Integra Lifesciences - Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Right, Product No. LJV182T
FDA Device · Class II · 2019-04-24 · Integra Lifesciences - Tina-quant IgM Gen.2, Catalog Nos. 03507190190, 05220726190, 03507041190, 03507149190 Product Usage: Immunoturbidimetric assay for the quan…
FDA Device · Class II · 2019-04-24 · Roche Diagnostics - Tibial Total Ankle Prosthesis Tray, Size 0, Product No. LJU220T
FDA Device · Class II · 2019-04-24 · Integra Lifesciences - Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***added as of 5/10/19*** 03183700190 Product Usage: An In vitro diagnos…
FDA Device · Class II · 2019-04-24 · Roche Diagnostics - Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 ) Intended Use The Spine & Traum…
FDA Device · Class I · 2019-04-24 · Brainlab Ag - icumedical ChemoLock Closed Vial Spike w/Skirt, (a) REF CL-80S-4 (4 units) (b) REF CL-80S-5 (5 units)
FDA Device · Class I · 2019-04-24 · Icu Medical - IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and managemen…
FDA Device · Class II · 2019-04-24 · Topcon Medical Systems - Brilliance 16 Air, 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by comput…
FDA Device · Class II · 2019-04-24 · Philips Medical Systems Cleveland - Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Left, Product No. LJV190T
FDA Device · Class II · 2019-04-24 · Integra Lifesciences - Obturator (shortcone), Part number 26114 Product Usage: The obturator is a component of the Flex Rectoscope which is an accessory to the Fl…
FDA Device · Class II · 2019-04-24 · Medrobotics - Abbott Alinity i Processing Module LN 03R65-01 - Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer a…
FDA Device · Class II · 2019-04-24 · Abbott And Kg - Brilliance 64, 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer r…
FDA Device · Class II · 2019-04-24 · Philips Medical Systems Cleveland - Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic polypectomy
FDA Device · Class II · 2019-04-24 · Wilson Cook Medical - Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Right, Product No. LJV183T
FDA Device · Class II · 2019-04-24 · Integra Lifesciences - Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Right, Product No. LJV181T
FDA Device · Class II · 2019-04-24 · Integra Lifesciences - icumedical ChemoLock, 20mm, (a) REF CL-80S (b) REF CL-80S-10 (10 units)
FDA Device · Class I · 2019-04-24 · Icu Medical - Brilliance iCT, 728306 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer…
FDA Device · Class II · 2019-04-24 · Philips Medical Systems Cleveland - Talar Dome Total Ankle Prosthesis , Flat Cut, Size 1, Right, Product No. LJU811T
FDA Device · Class II · 2019-04-24 · Integra Lifesciences - Abbott ARCHITECT c16000 Processing Module, List No. 03L77 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic…
FDA Device · Class II · 2019-04-17 · Abbott Laboratories - CORAIL AMT COXA VARA NECK SEGMENT (KLA) Pro
FDA Device · Class II · 2019-04-17 · Depuy Orthopaedics - syngo.via syngo.CT Cardiac Function, Model Number 10496180 Product Usage: Syngo.CT Cardiac Planning and syngo CT. Cardiac Function are imag…
FDA Device · Class II · 2019-04-17 · Siemens Medical Solutions Usa - Gravity IV Set with 3-port Closed Stopcock Manifold Model CS42522E-07
FDA Device · Class II · 2019-04-17 · Becton Dickinson And - Integra bioBLOCK Resorbable subtaler Implant, 10mm Catalog Number: 40010 - Product Usage: The bioBLOCK Implant is indicated for internal su…
FDA Device · Class II · 2019-04-17 · Integra - Abbott ARCHITECT c8000 Processing Module, List No. 01G06 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic u…
FDA Device · Class II · 2019-04-17 · Abbott Laboratories - Vyon DUALSTOP White Cap used for intravascular lines Product Code: 9888.002- Product Usage: Cap used for intravascular lines
FDA Device · Class II · 2019-04-17 · Vygon U - iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.) M5725INT0600010 (Model No.) Product U…
FDA Device · Class II · 2019-04-17 · Conformis - SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung…
FDA Device · Class II · 2019-04-17 · Livanova Usa - Exprt Precision System: Revision Hip, Proximal Body with Bolt, Lateral Offset, Sterile R, djo surgical, REF: 495-00-065, 495-00-075, 495-00…
FDA Device · Class II · 2019-04-17 · Encore Medical - AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a component of AquaBeam Robotic System. 320301 distributed outside the U.…
FDA Device · Class II · 2019-04-17 · Procept Biorobotics - Gravity IV Set with 3-port Closed Stopcock Manifold Model CM42500E-07
FDA Device · Class II · 2019-04-17 · Becton Dickinson And - Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in Cataract and Glaucoma procedures REF # 370824 Product Usage:…
FDA Device · Class II · 2019-04-17 · Beaver Visitec - Immunoassay Premium Controls, Model Numbers IA2633 and IA2638 Product Usage: This product is intended for in vitro diagnostic use, as assay…
FDA Device · Class III · 2019-04-17 · Randox Laboratories - COBAS INTEGRA 400 plus analyzer used in the following assays: a)Tina-quant Apolipoprotein A-1 ver.2 Catalog Number: 03032566122 b)Tina-quan…
FDA Device · Class II · 2019-04-17 · Roche Diagnostics - CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD), Pro
FDA Device · Class II · 2019-04-17 · Depuy Orthopaedics - CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro
FDA Device · Class II · 2019-04-17 · Depuy Orthopaedics - Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular lines
FDA Device · Class II · 2019-04-17 · Vygon U - Integra bioBLOCK Resorbable subtaler Implant, 12mm Catalog Number: 040012 - Product Usage: The bioBLOCK Implant is indicated for internal s…
FDA Device · Class II · 2019-04-17 · Integra - ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive Power -1.00D, -1.25D x 100, 6 pack
FDA Device · Class II · 2019-04-17 · Johnson And Johnson Vision Care - Integra bioBLOCK Resorbable subtaler Implant, 11mm Catalog Number: 040011 - Product Usage: The bioBLOCK Implant is indicated for internal s…
FDA Device · Class II · 2019-04-17 · Integra - BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010
FDA Device · Class II · 2019-04-17 · Becton Dickinson And - ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws in a spinal implant construct
FDA Device · Class II · 2019-04-17 · Ulrich Medical Usa - Liquid Immunoassay Premium Controls, Model Number LIA3105 Product Usage: This product is intended for in vitro diagnostic use, as assayed q…
FDA Device · Class III · 2019-04-17 · Randox Laboratories - Arrow¿ Two-Lumen Central Venous Catheterization Kit with Blue FlexTip¿ Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132
FDA Device · Class II · 2019-04-17 · Arrow International - Abbott ARCHITECT c4000 Processing Module, List No. 02P24 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic u…
FDA Device · Class II · 2019-04-17 · Abbott Laboratories - Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta Unity using Magnetic Resonance Imaging is indicated for radiation…
FDA Device · Class II · 2019-04-17 · Elekta - Azurion FlexArm, 722079
FDA Device · Class II · 2019-04-17 · Philips North America - Arrow¿ Two-Lumen Central Venous Catheterization Set with Blue FlexTip¿ Catheter Product Code: CD-10802 GTN: 00801902015396
FDA Device · Class II · 2019-04-17 · Arrow International - cobas c 111 with ISE analyzers analyzer used in the following assays: a)Creatinine plus ver.2 Catalog Number: 05401470190
FDA Device · Class II · 2019-04-17 · Roche Diagnostics - Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device is a 10.5 Fr (3.5mm), triple lumen, 100cm long catheter with an elasto…
FDA Device · Class II · 2019-04-17 · Edwards Lifesciences - Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product Usage: This product is intended for in vitro diagnostic use, as…
FDA Device · Class III · 2019-04-17 · Randox Laboratories - syngo.via syngo.CT Cardiac Planning, Model Number 10496180 Product Usage: Syngo.CT Cardiac Planning and syngo CT. Cardiac Function are imag…
FDA Device · Class II · 2019-04-17 · Siemens Medical Solutions Usa - Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx30mm-Low Profile Titanium, Accessory to total hip implant Item Number: 103533 Produ…
FDA Device · Class II · 2019-04-10 · Zimmer Biomet - Na¿da CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120
FDA Device · Class II · 2019-04-10 · Advanced Bionics - e500 Automatic Transport Ventilator, Model Number 01EVE500
FDA Device · Class I · 2019-04-10 · O Two Medical Technologies - iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102
FDA Device · Class II · 2019-04-10 · Conformis - Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile Titanium
FDA Device · Class II · 2019-04-10 · Zimmer Biomet - McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test, Part numbers 178-CK30T, 178-CT30, 178¿TBSO, 178-CM25, 178-CK50, 178-CM5…
FDA Device · Class III · 2019-04-10 · Cypress Medical Products - e600 Automatic Transport Ventilator, Model Number 01EVE600
FDA Device · Class I · 2019-04-10 · O Two Medical Technologies - e700 Automatic Transport Ventilator, Model Number 01EVE700
FDA Device · Class I · 2019-04-10 · O Two Medical Technologies - Na¿da CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120
FDA Device · Class II · 2019-04-10 · Advanced Bionics - UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that are re-configured so that the DxI system is separated from the…
FDA Device · Class II · 2019-04-10 · Beckman Coulter - Micro Knife 5.0mm 30¿, Part Number 0001522 The Beaver¿ Micro Knife 5.0mm 30¿ is a sharp pointed tip intended for ophthalmic, ENT and other…
FDA Device · Class III · 2019-04-10 · Beaver Visitec - The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line
FDA Device · Class II · 2019-04-10 · Beckman Coulter - Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341
FDA Device · Class II · 2019-04-10 · Abbott Laboratories - Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21
FDA Device · Class II · 2019-04-10 · Abbott Laboratories - Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation to be used during surgical procedures utilizing th…
FDA Device · Class II · 2019-04-10 · Zimmer Biomet - Na¿da CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140
FDA Device · Class II · 2019-04-10 · Advanced Bionics - CELL-DYN Emerald analyzer, REF 09H39-01
FDA Device · Class II · 2019-04-10 · Abbott Laboratories - Urodiagnost, Product No. 708033 Product Usage: The Philips UroDiagnost MRF can be used to perform all urological and gynecological routine…
FDA Device · Class II · 2019-04-03 · Philips North America - JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8 , REF 74013988 The JOURNEY II XR Tibial Posterior Keel Punch is a reusable surgical instru…
FDA Device · Class II · 2019-04-03 · Smith And Nephew - Randox Blood Gas Control Level 2 -Model BG5002
FDA Device · Class II · 2019-04-03 · Randox Laboratories - Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artifici…
FDA Device · Class II · 2019-04-03 · Keystone Dental - MultiDiagnost Eleva w/ Flat Detector, Product codes 708034, 708037, 708038 Product Usage: As a multifunctional I universal imaging applicat…
FDA Device · Class II · 2019-04-03 · Philips North America - URODiagnost Eleva, Product codes 708026, 708027, 708028 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray syst…
FDA Device · Class II · 2019-04-03 · Philips North America - BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm (25G x 1.3 in)
FDA Device · Class II · 2019-04-03 · Beaver Visitec - LW Scientific ZIP IQ Combo Centrifuge, ZIC-CMBO-2RT3 Rev B Product Usage: used as a general purpose centrifuge to spin down blood in hemato…
FDA Device · Class II · 2019-04-03 · Lw Scientific - Paltop 1.25 Hex Drivers, Short Part Number: 60-70102
FDA Device · Class II · 2019-04-03 · Keystone Dental - LW Scientific ZIP IQ PCV Centrifuge, ZIC-24HD-75T3 Rev C Product Usage: used as a general purpose centrifuge to spin down blood in hematocr…
FDA Device · Class II · 2019-04-03 · Lw Scientific - Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736
FDA Device · Class II · 2019-04-03 · Covidien
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)