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.
- Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229002A Model: VST66SF AIM
FDA Device · Class II · 2019-07-03 · Maquet Cardiovascular Us Sales - Replacement ECG leadwires with snap ends REF/Catalog Number Description 2106386-101 Replacement ECG Leadwire, snap, LL, AHA, 130 cm/ 51 in…
FDA Device · Class III · 2019-07-03 · Ge Healthcare - Freedom EVO 200 - Product Usage: It is intended for routine laboratory tasks, such as general purpose pipetting and general purpose liquid…
FDA Device · Class II · 2019-07-03 · Tecan Us - EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product Usage: The EPi-Sense Guided Coagulation System with VisiTra…
FDA Device · Class II · 2019-07-03 · Atricure - Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229036A Model:VST66SF
FDA Device · Class II · 2019-07-03 · Maquet Cardiovascular Us Sales - Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: VLT600SF AIM STP
FDA Device · Class II · 2019-07-03 · Maquet Cardiovascular Us Sales - Replacement leadwires with grabber ends: REF/Catalog Number Description 2106388-005 Replacement ECG Leadwire, grabber, BRN V, AHA, 74 cm/ 2…
FDA Device · Class III · 2019-07-03 · Ge Healthcare - Hancock II T510 Bioprosthesis, Mitral, REF T505U227 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitra…
FDA Device · Class II · 2019-07-03 · Medtronic - TASE 500 Imaging systems
FDA Device · Class II · 2019-07-03 · Collins Aerospace - SmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696
FDA Device · Class I · 2019-07-03 · Becton Dickinson And - Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product Usage: Centricity Universal Viewer is a device that…
FDA Device · Class II · 2019-07-03 · Ge Healthcare - Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811961 Model: VLT600DF AIM STP
FDA Device · Class II · 2019-07-03 · Maquet Cardiovascular Us Sales - Mosaic 310 Bioprosthesis, Mitral, REF 310C31 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves
FDA Device · Class II · 2019-07-03 · Medtronic - Thermo Scientific General Purpose Dynamic Bath Precision 5L GP Bath Model Number: TSGP05
FDA Device · Class II · 2019-07-03 · Thermo Fisher Scientific Asheville - RNeasy DSP FFPE Kit (48), REF 73604 - Product Usage: The RNeasy DSP FFPE Kit is a system intended for the purification of total RNA from fo…
FDA Device · Class II · 2019-07-03 · Qiagen Sciences - Thermo Scientific General Purpose Dynamic Bath Precision 2L-Shallow GP Bath Model Number: TSGP2S
FDA Device · Class II · 2019-07-03 · Thermo Fisher Scientific Asheville - Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229034A Model: VST60SF
FDA Device · Class II · 2019-07-03 · Maquet Cardiovascular Us Sales - Thermo Scientific General Purpose Dynamic Bath Precision 28L GP Bath Model Number: TSGP28
FDA Device · Class II · 2019-07-03 · Thermo Fisher Scientific Asheville - Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model: VST60DF AIM
FDA Device · Class II · 2019-07-03 · Maquet Cardiovascular Us Sales - Thermo Scientific General Purpose Dynamic Bath Precision 5 & 10L Dual GP Bath Model Number: TSGP15D
FDA Device · Class II · 2019-07-03 · Thermo Fisher Scientific Asheville - Thermo Scientific General Purpose Dynamic Bath Precision 20L GP Bath Model Number: TSGP20
FDA Device · Class II · 2019-07-03 · Thermo Fisher Scientific Asheville - TASE 400 Imaging systems
FDA Device · Class II · 2019-07-03 · Collins Aerospace - Discovery Ml DR Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) im…
FDA Device · Class II · 2019-06-26 · Ge Healthcare - Arrow JACC with Chlorag+ard Technology Jugular Axillo subclavian Central Catheter Product Code: CDC 42552 JX1A
FDA Device · Class II · 2019-06-26 · Arrow International - 2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0)
FDA Device · Class II · 2019-06-26 · Mako Surgical - Hudson RCI Sheridan: 1) HVT 6.0 mm, Product Code 5-10312 2) HVT 6.5 mm, Product Code 5-10313 3) HVT 7.0 mm, Product Code 5-10314 4) HVT 7.5…
FDA Device · Class I · 2019-06-26 · Teleflex Medical - Arrow¿ PICC with Chlorag+ard¿ Technology Product Code: PR 45541 HPHNL
FDA Device · Class II · 2019-06-26 · Arrow International - Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS" Precision Stylet Product Code: CDC 45063 HPK1A
FDA Device · Class II · 2019-06-26 · Arrow International - Arrow¿ JACC with Chlorag+ard¿ Technology Jugular Axillo subclavian Central Catheter Product Code: CDC 42563 JX1A
FDA Device · Class II · 2019-06-26 · Arrow International - CIVCO Solstice(TM) SRS Immobilization System, Part Numbers: a) CHS03, b) CHS04 - Product Usage: The Tilting Head Fixation (Solstice) device…
FDA Device · Class II · 2019-06-26 · Med Tec - Arrow PICC with Chlorag+ard Technology Product Code: CDA 44052 HPK1A
FDA Device · Class II · 2019-06-26 · Arrow International - Arrowg+ard Blue Advance JACC Product Code: CDC 41541 JX1A
FDA Device · Class II · 2019-06-26 · Arrow International - Optima PET/CT 560, 560FX Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography…
FDA Device · Class II · 2019-06-26 · Ge Healthcare - SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
FDA Device · Class II · 2019-06-26 · Covidien - Arrow PICC with Chlorag+ard Technology Product Code: CDA 45541 HPK1A
FDA Device · Class II · 2019-06-26 · Arrow International - SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
FDA Device · Class II · 2019-06-26 · Covidien - Sheridan/HVT: 1) Novaplus 7.0 mm, Product Code V5-10314 2) Novaplus 7.5 mm, Product Code V5-10315 3) Novaplus 8.0 mm, Product Code V5-10316…
FDA Device · Class I · 2019-06-26 · Teleflex Medical - Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/80cm, Catalog Number ASB5-35-80-6-4, REF Number G35252 Product Usage: T…
FDA Device · Class I · 2019-06-26 · Cook - EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
FDA Device · Class II · 2019-06-26 · Covidien - Arrow¿ PICC with Chlorag+ard Technology Product Code: CDC 44052 HPK1A
FDA Device · Class II · 2019-06-26 · Arrow International - Sheridan/CF Novaplus 7.0 mm, Product Code V5-10114 Product Usage: Tracheal tube/airway management
FDA Device · Class I · 2019-06-26 · Teleflex Medical - Arrow¿ JACC with Chlorag+ard¿ Technology Jugular Axillosubclavian Central Catheter Product Code: CDC 43063 JX1A
FDA Device · Class II · 2019-06-26 · Arrow International - Arrow¿ PICC Kit Product Code: ASK 45541 LVH1
FDA Device · Class II · 2019-06-26 · Arrow International - Hudson RCI Sheridan: 1) Preformed 6.0 mm, Product Codes: a) 5-22212, b) 5-22312, c) 5-22112, d) 5-22012, 2) Preformed 6.5 mm, Product Codes…
FDA Device · Class I · 2019-06-26 · Teleflex Medical - SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
FDA Device · Class II · 2019-06-26 · Covidien - Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108, ZIMB-22-118, ZIMB-22-128, ZIMB-22-70, ZIMB-22-84, ZIMB-22-9…
FDA Device · Class II · 2019-06-26 · Cook - SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
FDA Device · Class II · 2019-06-26 · Covidien - Arrowg+ard Blue Advance" PICC pre loaded with Arrow¿ VPS" Precision Stylet Product Code: CDC 45041 VPS2
FDA Device · Class II · 2019-06-26 · Arrow International - Arrow PICC powered by Arrow VPS Stylet Product Code: ASK45041JHVA
FDA Device · Class II · 2019-06-26 · Arrow International - Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/135cm, Catalog Number ASB5-35-135-6-4, REF Number G35257 Product Usage:…
FDA Device · Class I · 2019-06-26 · Cook - Arrow¿ PICC with Chlorag+ard Technology Product Code:PR 45541 HPHNM
FDA Device · Class II · 2019-06-26 · Arrow International - Arrow PICC Kit pre loaded with Arrow¿ VPS Precision Stylet Product Code: ASK 45552 CRM
FDA Device · Class II · 2019-06-26 · Arrow International - Arrow PICC with Chlorag+ard Technology Product Code: CDA 45041 HPK1A
FDA Device · Class II · 2019-06-26 · Arrow International - Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10
FDA Device · Class II · 2019-06-26 · Monarch Medical Technologies - EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
FDA Device · Class II · 2019-06-26 · Covidien - EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
FDA Device · Class II · 2019-06-26 · Covidien - Arrow¿ JACC with Chlorag+ard Technology Product Code: JR 42541 HPHNM
FDA Device · Class II · 2019-06-26 · Arrow International - Arrowg+ard Blue Advance PICC Product Code: CDC45541HPK1A
FDA Device · Class II · 2019-06-26 · Arrow International - Arrowg+ard Blue Advance JACC Product Code: JRT 43552 HPHNM
FDA Device · Class II · 2019-06-26 · Arrow International - ETHIBOND EXCEL¿ Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is int…
FDA Device · Class II · 2019-06-26 · Ethicon - Discovery PET/CT 710 Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PE…
FDA Device · Class II · 2019-06-26 · Ge Healthcare - Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/50cm, Catalog Number ASB5-35-50-6-4, REF Number G35248 Product Usage: T…
FDA Device · Class I · 2019-06-26 · Cook - Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS" Precision Stylet Product Code: CDC 44052 VPS2
FDA Device · Class II · 2019-06-26 · Arrow International - Discovery Ml Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imagi…
FDA Device · Class II · 2019-06-26 · Ge Healthcare - SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
FDA Device · Class II · 2019-06-26 · Covidien - Arrow PICC Kit Product Code: ASK 45552 RWJ4
FDA Device · Class II · 2019-06-26 · Arrow International - Discovery IQ Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imagi…
FDA Device · Class II · 2019-06-26 · Ge Healthcare - Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS" Precision Stylet Product Code: CDC 44063 VPS2
FDA Device · Class II · 2019-06-26 · Arrow International - Arrowg+ard Blue Advance Midline Product Code: PR 41541 BAS
FDA Device · Class II · 2019-06-26 · Arrow International - Hudson RCI Sheridan: 1) EZ-ENDO 6.0 mm, Product Code 5-22512 2) EZ-ENDO 6.5 mm, Product Code 5-22513 3) EZ-ENDO 7.0 mm, Product Code 5-2251…
FDA Device · Class I · 2019-06-26 · Teleflex Medical - Aquarius D13S319 Plus Deletion Probe, Model LPH068-A Product Usage: The D13S319 probe, labelled in red, covers a 156kb region including mos…
FDA Device · Class III · 2019-06-26 · Cytocell - Discovery PET/CT 610 Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PE…
FDA Device · Class II · 2019-06-26 · Ge Healthcare - Arrow¿ JACC with Chlorag+ard Technology Product Code:JR 42563 HPHNM
FDA Device · Class II · 2019-06-26 · Arrow International - Arrow PICC with Chlorag+ard Technology Product Code: CDA 45552 VPS2
FDA Device · Class II · 2019-06-26 · Arrow International - Arrowg+ard Blue Advance JACC Product Code: JRT 43541 HPHNM
FDA Device · Class II · 2019-06-26 · Arrow International - ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W Product Usage: ETHIBOND EXCEL Suture is inten…
FDA Device · Class II · 2019-06-26 · Ethicon - Hudson RCI Sheridan: 1) Uncuffed 6.0 mm, Product Code 5-10412 2) Uncuffed 6.5 mm, Product Code 5-10413 3) Uncuffed 7.0 mm, Product Code 5-1…
FDA Device · Class I · 2019-06-26 · Teleflex Medical - Arrow PICC Kit Product Code: ASK 45541 RWJ4
FDA Device · Class II · 2019-06-26 · Arrow International - Arrow¿ PICC with Chlorag+ard¿ Technology Product Code: PR 45552 HPHNL
FDA Device · Class II · 2019-06-26 · Arrow International - Arrowg+ard Blue Advance JACC Product Code: CDC 41552 JX1A
FDA Device · Class II · 2019-06-26 · Arrow International - Arrow PICC with Chlorag+ard Technology Product Code: CDA 45052 HPK1A
FDA Device · Class II · 2019-06-26 · Arrow International - 2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)
FDA Device · Class II · 2019-06-26 · Mako Surgical - EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
FDA Device · Class II · 2019-06-26 · Covidien - Arrow¿ JACC with Chlorag+ard Technology Product Code: JR 42063 HPHNM
FDA Device · Class II · 2019-06-26 · Arrow International - Arrowg+ard Blue Advance PICC pre loaded with Arrow¿ VPS" Precision Stylet Product Code: CDC 45063 VPS2
FDA Device · Class II · 2019-06-26 · Arrow International - Arrow¿ PICC with Chlorag+ard¿ Technology Product Code:PR 45552 HPHNM
FDA Device · Class II · 2019-06-26 · Arrow International - AUTION HYBRID AU-4050
FDA Device · Class II · 2019-06-26 · Arkray Factory Usa - Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway management
FDA Device · Class I · 2019-06-26 · Teleflex Medical - Liquid Cardiac Control, Model Nos
FDA Device · Class II · 2019-06-26 · Randox Laboratories - Endotrac ECTR Hook/Triangle Blade Kit, Catalogue Number 2056-1
FDA Device · Class II · 2019-06-26 · Stryker - Arrowg+ard Blue Advance JACC Product Code:CDC 42052 JX1A
FDA Device · Class II · 2019-06-26 · Arrow International - LVivo EF app on Vscan Extend
FDA Device · Class II · 2019-06-26 · Ge Healthcare - EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
FDA Device · Class II · 2019-06-26 · Covidien - EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
FDA Device · Class II · 2019-06-26 · Covidien - Arrow¿ JACC with Chlorag+ard Technology Product Code: JR 42041 HPHNM
FDA Device · Class II · 2019-06-26 · Arrow International - Arrowg+ard Blue Advance JACC Product Code: CDC 42063 JX1A
FDA Device · Class II · 2019-06-26 · Arrow International - Mobi-C 14mm Distraction Screw, Quick Start
FDA Device · Class II · 2019-06-26 · Zimmer Biomet - Cepheid Xpert C. difficile/Epi Control Panel
FDA Device · Class III · 2019-06-26 · Microbiologics - Hudson RCI Sheridan: 1) CF 6.0 mm, Product Codes: 5-10112, 5-10212 2) CF 6.5 mm, Product Codes: 5-10113, 5-10213 3) CF 7.0 mm, Product Code…
FDA Device · Class I · 2019-06-26 · Teleflex Medical - Arrowg+ard Blue Advance JACC Product Code: CDC 42041 JX1A
FDA Device · Class II · 2019-06-26 · Arrow International
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)