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.
- NeuViz 16 Essence Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomog…
FDA Device · Class II · 2019-05-29 · Neusoft Medical Systems - Drill, cannulated, 2.5x95mm, AO, Item Number ST502015621
FDA Device · Class II · 2019-05-29 · Zimmer - Thio Med w/Dex, Hem, Vit, K (7ml) 100/PK Product Usage
FDA Device · Class II · 2019-05-29 · Remel - Drill, contra-angle, 1.5x85mm, Item Number 502015706
FDA Device · Class II · 2019-05-29 · Zimmer - Cook Kwart Retro-Inject Ureteral Stent Set: PRODUCT/CATALOG NUMBER/GPN: 4.7 Fr 003500 G14916
FDA Device · Class II · 2019-05-29 · Cook - V-TEK", Micro-countersink, AO , Item Number ST28.66.113
FDA Device · Class II · 2019-05-29 · Zimmer - Thio Med w/Dex, Hem, Vit K (9ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cult…
FDA Device · Class II · 2019-05-29 · Remel - Drill, cannulated, 4x120mm, AO, Item Number 502015402
FDA Device · Class II · 2019-05-29 · Zimmer - ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when u…
FDA Device · Class III · 2019-05-22 · Abbott Laboratories - MediPress pneumatic compression system, Half Leg-Segmental Gradient, Model #6102-S
FDA Device · Class II · 2019-05-22 · Compass Health Brands Corporate Office - SureSigns VS3 NBP, SpO2, Product Number 863071
FDA Device · Class II · 2019-05-22 · Philips North America - Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is int…
FDA Device · Class II · 2019-05-22 · Pentax - Molift 2-Point sling bar, an accessory for Molift Mover 180/Air
FDA Device · Class II · 2019-05-22 · Moller Vital - Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra Flowable Wound Matrix is indicated for the treatment of tunneling a…
FDA Device · Class II · 2019-05-22 · Integra - MediPress pneumatic compression system Full Leg (Long)-Segmental Gradient, Model #6103L-S
FDA Device · Class II · 2019-05-22 · Compass Health Brands Corporate Office - Endoscopic Curved Intraluminal Stapler, 25 mm diameter, Model ECS25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic s…
FDA Device · Class I · 2019-05-22 · Ethicon Endo Surgery - Curved Intraluminal Staplers, 33 mm diameter, Model CDH33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers av…
FDA Device · Class I · 2019-05-22 · Ethicon Endo Surgery - SureSigns VS3 NBP, SpO2, Rec, Product Number 863072
FDA Device · Class II · 2019-05-22 · Philips North America - Tissu-Trans FILTRON 250, Catalog 3-TT-FILTRON 250, sterile, disposable, one-patient use
FDA Device · Class II · 2019-05-22 · Shippert Medical Technologies - MediPress pneumatic compression system Full Leg (Short)-Segmental Gradient, Model #6103S-S
FDA Device · Class II · 2019-05-22 · Compass Health Brands Corporate Office - Endoscopic Curved Intraluminal Stapler, 33 mm diameter, Model ECS33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic s…
FDA Device · Class I · 2019-05-22 · Ethicon Endo Surgery - MediPress pneumatic compression system Full Arm (Medium)-Segmental Gradient, Model #6104M-S
FDA Device · Class II · 2019-05-22 · Compass Health Brands Corporate Office - Endoscopic Curved Intraluminal Stapler, 29 mm diameter, Model ECS29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic s…
FDA Device · Class I · 2019-05-22 · Ethicon Endo Surgery - Tissu-Trans Syringe Fill 360, Catalog 3-TT-SFILL 360, sterile, disposable, one-patient use
FDA Device · Class II · 2019-05-22 · Shippert Medical Technologies - BD Veritor System Reader -In Vitro Diagnostic for use with BD Veritor System Test Kit Devices Catalog Number: 256055
FDA Device · Class II · 2019-05-22 · Becton Dickinson And - Straight Intraluminal Staplers, 21 mm diameter, Model SDH21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers…
FDA Device · Class I · 2019-05-22 · Ethicon Endo Surgery - Pentax Medical C2 CryoBalloon Standard 90 degree Catheter, Model FG 1030, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is…
FDA Device · Class II · 2019-05-22 · Pentax - MediPress pneumatic compression system Full Arm (Short)-Segmental Gradient, Model #6104S-S
FDA Device · Class II · 2019-05-22 · Compass Health Brands Corporate Office - Tissu-Trans FILTRON 1000, Catalog 3-TT-FILTRON 1000, sterile, disposable, one-patient use
FDA Device · Class II · 2019-05-22 · Shippert Medical Technologies - SureSigns VS3 NBP, SpO2, Temp, Rec, Product Number 863074
FDA Device · Class II · 2019-05-22 · Philips North America - Tissu-Trans FILTRON 100, Catalog 3-TT-FILTRON 100, sterile, disposable, one-patient use
FDA Device · Class II · 2019-05-22 · Shippert Medical Technologies - Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-44052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated…
FDA Device · Class II · 2019-05-22 · Arrow International - Straight Intraluminal Staplers, 25 mm diameter, Model SDH25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers…
FDA Device · Class I · 2019-05-22 · Ethicon Endo Surgery - Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradiol assay is a Chemiluminescent Microparticle Immunoassay (CMIA…
FDA Device · Class II · 2019-05-22 · Abbott Ireland Diagnostics Division - Curved Intraluminal Staplers, 21 mm diameter, Model CDH21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers av…
FDA Device · Class I · 2019-05-22 · Ethicon Endo Surgery - Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems…
FDA Device · Class II · 2019-05-22 · Siemens Medical Solutions Usa - Tissu-Trans FILTRON 500, Catalog 3-TT-FILTRON 500, sterile, disposable, one-patient use
FDA Device · Class II · 2019-05-22 · Shippert Medical Technologies - Straight Intraluminal Staplers, 29 mm diameter, Model SDH29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers…
FDA Device · Class I · 2019-05-22 · Ethicon Endo Surgery - Fungitell Kit, Catalog FT001 - Product Usage: The Fungitell assay is a potease zymogen-based colorimetric assay for the qualitative detecti…
FDA Device · Class II · 2019-05-22 · Associates - Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-45052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated…
FDA Device · Class II · 2019-05-22 · Arrow International - SureSigns VS4 Government Bundle, Product Number 863286
FDA Device · Class II · 2019-05-22 · Philips North America - Artis Zee (material # 10094135, 10094137, 10094141) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography syst…
FDA Device · Class II · 2019-05-22 · Siemens Medical Solutions Usa - Endoscopic Curved Intraluminal Stapler, 21 mm diameter, Model ECS21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic s…
FDA Device · Class I · 2019-05-22 · Ethicon Endo Surgery - Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588 The electronic gas blender provides…
FDA Device · Class II · 2019-05-22 · Terumo Cardiovascular Systems - Curved Intraluminal Staplers, 29 mm diameter, Model CDH29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers av…
FDA Device · Class I · 2019-05-22 · Ethicon Endo Surgery - ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are for the calibration of the ARCHITECT iSystem when…
FDA Device · Class III · 2019-05-22 · Abbott Laboratories - SureSigns VS3 NBP, Product Number 863069
FDA Device · Class II · 2019-05-22 · Philips North America - SureSigns VS3 NBP, SpO2, Temp, Product Number 863073
FDA Device · Class II · 2019-05-22 · Philips North America - Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to…
FDA Device · Class III · 2019-05-22 · Abbott Laboratories - Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to…
FDA Device · Class III · 2019-05-22 · Abbott Laboratories - M200 Fall Monitoring System
FDA Device · Class II · 2019-05-22 · Stanley Security Solutions - Molift 2-Point sling bar, an accessory for Molift Mover 205
FDA Device · Class II · 2019-05-22 · Moller Vital - SureSigns VS3 NBP Temp, Product Number 863070
FDA Device · Class II · 2019-05-22 · Philips North America - BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System Test Devices
FDA Device · Class II · 2019-05-22 · Becton Dickinson And - ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibrators are for the calibration of the Alinity i analyzer when u…
FDA Device · Class III · 2019-05-22 · Abbott Laboratories - Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Estradiol assay is a chemiluminescent microparticle immunoassay (CMIA) us…
FDA Device · Class II · 2019-05-22 · Abbott Ireland Diagnostics Division - ARCHITECT STAT High Sensitive Troponin-I Controls - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estima…
FDA Device · Class III · 2019-05-22 · Abbott Laboratories - MediPress pneumatic compression system Full Leg (Medium)-Segmental Gradient, Model #6103M-S
FDA Device · Class II · 2019-05-22 · Compass Health Brands Corporate Office - Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems…
FDA Device · Class II · 2019-05-22 · Siemens Medical Solutions Usa - Straight Intraluminal Staplers, 33 mm diameter, Model SDH33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers…
FDA Device · Class I · 2019-05-22 · Ethicon Endo Surgery - ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i System when used fo…
FDA Device · Class III · 2019-05-22 · Abbott Laboratories - Abbott Alinity ci-series System Control Module software version 2.5.1
FDA Device · Class II · 2019-05-22 · Abbott And Kg - Tissu-Trans MEGA 1500, Catalog 3-TT-MEGA 1500, sterile, disposable, one-patient use
FDA Device · Class II · 2019-05-22 · Shippert Medical Technologies - Curved Intraluminal Staplers, 25 mm diameter, Model CDH25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers av…
FDA Device · Class I · 2019-05-22 · Ethicon Endo Surgery - ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem whe…
FDA Device · Class III · 2019-05-22 · Abbott Laboratories - SureSigns VS4 NBP, SpO2, Product Number 863283
FDA Device · Class II · 2019-05-22 · Philips North America - CS011 GNR PNA FISH Control Slide, manufactured as a component of the CS011-10 GNR PNA FISH Control Slide kit . In-Vitro Diagnostic The CS01…
FDA Device · Class II · 2019-05-22 · Opgen - ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the est…
FDA Device · Class III · 2019-05-22 · Abbott Laboratories - Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000
FDA Device · Class II · 2019-05-22 · Stryker Medical Division - Tissu-Trans FILTRON 2000, Catalog 3-TT-FILTRON 2000, sterile, disposable, one-patient use
FDA Device · Class II · 2019-05-22 · Shippert Medical Technologies - Wombat Living, Size 3, Item Numbers: 953121-00, 953126-00, 953131-00, 953132-00, 935-135-00, 935136-00, 953211-00, 953221-00, 953222-00, 95…
FDA Device · Class II · 2019-05-22 · R82 A S - Artis Zeego (material 10280959) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems developed for si…
FDA Device · Class II · 2019-05-22 · Siemens Medical Solutions Usa - Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intende…
FDA Device · Class II · 2019-05-22 · Pentax - VITROS¿ 5600 Integrated System -Software V3.3.2 & below Product Code: 6802413 For use in the in vitro quantitative, semi-quantitative, and…
FDA Device · Class II · 2019-05-15 · Ortho Clinical Diagnostics - ChemoPlus Chemo Spill Kit, Home Health Kit Product Code:DP5108K Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and c…
FDA Device · Class II · 2019-05-15 · Cardinal Health 200 - ConMed Anchor Tissue Retrieval System 10 MM, 235 ML, (5/BX) Catalog Number: TRS100SB2 The Anchor Tissue Retrieval System" by CONMED is a st…
FDA Device · Class II · 2019-05-15 · Conmed - VITROS¿ 5600 Integrated System Refurbished-Software V3.3.2 & below Product Code: 6802915 For use in the in vitro quantitative, semi-quantit…
FDA Device · Class II · 2019-05-15 · Ortho Clinical Diagnostics - Medica Wash1-Wash solution used prior to Lipase assay on the EasyRA clinical chemistry analyzer REF 10680 - Product Usage: For use in washi…
FDA Device · Class II · 2019-05-15 · Medica - Abbott ARCHITECT cSystems ICT Module, REF 09D28-03
FDA Device · Class II · 2019-05-15 · Abbott Laboratories - Atellica IM 1300 Analyzer, Material Number 11066001
FDA Device · Class II · 2019-05-15 · Siemens Healthcare Diagnostics - ChemoPlus Chemo Spill Kit Product Code:DP5016K Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of che…
FDA Device · Class II · 2019-05-15 · Cardinal Health 200 - ChemoPlus Chemo Spill Kit Product Code:CT4004 Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chem…
FDA Device · Class II · 2019-05-15 · Cardinal Health 200 - Cios Alpha, Model Number 10308191 Mobile X-ray system - Product Usage: The Cios Alpha is a mobile X-Ray system designed to provide X-ray im…
FDA Device · Class II · 2019-05-15 · Siemens Medical Solutions Usa - T7 Driver Solid AO (Part Number 110018541) Product Usage: The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fix…
FDA Device · Class II · 2019-05-15 · Zimmer Biomet - Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices
FDA Device · Class II · 2019-05-15 · Medtronic - Neuro Omega System, incorporating HaGuide software
FDA Device · Class I · 2019-05-15 · Alpha Omega Engineering - ConMed Anchor Tissue Retrieval System, VATS, 15 MM, 1550 ML (3/BX) Catalog Number: TRS-VATS-15 The Anchor Tissue Retrieval System" by CONME…
FDA Device · Class II · 2019-05-15 · Conmed - Atellica IM 1600 Analyzer, Material Number 11066000
FDA Device · Class II · 2019-05-15 · Siemens Healthcare Diagnostics - ConMed Anchor Tissue Retrieval System", 12 MM, 300 ML (5/BX) Catalog Number: TRS-ROBO-12 The Anchor Tissue Retrieval System" by CONMED is a…
FDA Device · Class II · 2019-05-15 · Conmed - Cios Alpha with software version VA30-mobile C-arm x-ray Material # 11105200 Product Usage: The Cios Alpha is a mobile X-Ray system designe…
FDA Device · Class II · 2019-05-15 · Siemens Medical Solutions Usa - ChemoPlus Protective Wrap-around Goggles Product Code:DP5030G Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and con…
FDA Device · Class II · 2019-05-15 · Cardinal Health 200 - Atellica Sample Handler Prime, Material Number 11069001
FDA Device · Class II · 2019-05-15 · Siemens Healthcare Diagnostics - VITROS¿ 3600 Immunoassay System-Software V3.3.2 & below Product Code: 6802783 For use in the in vitro quantitative, semi-quantitative, and…
FDA Device · Class II · 2019-05-15 · Ortho Clinical Diagnostics - VITROS ECi Immunodiagnostic System Refurbished Product Code: 6801059 For use in the in vitro quantitative, semi-quantitative, and qualitati…
FDA Device · Class II · 2019-05-15 · Ortho Clinical Diagnostics - ConMed Anchor Tissue Retrieval System 15 MM, 1550 ML (3/BX) Catalog Number: TRS175SB2 The Anchor Tissue Retrieval System" by CONMED is a st…
FDA Device · Class II · 2019-05-15 · Conmed - ConMed Anchor Tissue Retrieval System, 15 MM, 1850 ML (3/BX) Catalog Number:TRS190SB2 The Anchor Tissue Retrieval System" by CONMED is a st…
FDA Device · Class II · 2019-05-15 · Conmed - VITROS¿ 3600 Immunoassay System Refurbished-Software V3.3.2 & below Product Code: 6802914 For use in the in vitro quantitative, semi-quanti…
FDA Device · Class II · 2019-05-15 · Ortho Clinical Diagnostics - T7 Driver Cannulated AO (Part Number 110018531) Product Usage: The Biomet Headless Compression Screws and Twist-Off Screws are indicated fo…
FDA Device · Class II · 2019-05-15 · Zimmer Biomet - VITROS¿ XT 7600 Integrated System-Software V3.4.1 & below Product Code: 6844461 For use in the in vitro quantitative, semi-quantitative, an…
FDA Device · Class II · 2019-05-15 · Ortho Clinical Diagnostics - ConMed Anchor Tissue Retrieval System, 8 MM, 125 ML (5/BX) Catalog Number:TRS-ROBO-8 The Anchor Tissue Retrieval System" by CONMED is a ste…
FDA Device · Class II · 2019-05-15 · Conmed
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)