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.
- Endotrac EPF/EGR Hook Blade, Angled, Catalog Number 3055A-1 The EPF system is designed for the treatment of plantar fasciosis
FDA Device · Class II · 2019-09-04 · Stryker - Endotrac EPF/EGR Triangle Blade, Angled, Catalog Number 3054A-1 The EPF system is designed for the treatment of plantar fasciosis
FDA Device · Class II · 2019-09-04 · Stryker - Endintrak 2 Hook Blade, Catalog Number 4058-1 The EPF system is designed for the treatment of plantar fasciosis
FDA Device · Class II · 2019-09-04 · Stryker - EXACTAMED Oral Dispensers, 5mL, AMBER: PHARMACY PACK, REF H9388505, x500 PHARMACY PACK, REF H9388105, x100 COST CONTAINMENT, REF H93884205,…
FDA Device · Class III · 2019-09-04 · Baxter Healthcare - EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5913190, 16F, Straight, 19cm length, BARD, UDI: 00801…
FDA Device · Class II · 2019-09-04 · Bard Peripheral Vascular - EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5904270, 14.5F, Straight ,27cm length, BARD, UDI: 0080174…
FDA Device · Class II · 2019-09-04 · Bard Peripheral Vascular - GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet, REF/Product code:5393420, 14.5F, Straight, 42cm length, BARD, UDI: 0080174…
FDA Device · Class II · 2019-09-04 · Bard Peripheral Vascular - AD-TECH Spencer Probe Depth Electrode Product Usage: The Ad-Tech Depth Electrodes (Depth Electrodes, Foramen Ovale Depth Electrodes, Macro…
FDA Device · Class II · 2019-09-04 · Ad Tech Medical Instrument - SOMATOM go.Up
FDA Device · Class II · 2019-09-04 · Siemens Medical Solutions Usa - Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodia…
FDA Device · Class II · 2019-09-04 · Phadia Ab - Endotrac ECTR Hook Blade, Angled, Catalog Number 2055A-1 The EPF system is designed for the treatment of plantar fasciosis
FDA Device · Class II · 2019-09-04 · Stryker - Endotrig ETF Hook Blade, Catalog Number 1052-1 The EPF system is designed for the treatment of plantar fasciosis
FDA Device · Class II · 2019-09-04 · Stryker - Medline SYRINGE, PISTON,IRR TRAY,W/.9, REF DYNC2303
FDA Device · Class II · 2019-09-04 · Medline Industries - Laseredge 1.1mm Arrow Knife Angled, REF E7592 Product Usage: Available to surgeons for use in ophthalmic surgical procedures
FDA Device · Class II · 2019-09-04 · Bausch And Lomb Irb - EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet, REF/Product code:5903230, 14.5F, Straight ,23cm length, BARD, UDI: 0080174…
FDA Device · Class II · 2019-09-04 · Bard Peripheral Vascular - SOMATOM go.All
FDA Device · Class II · 2019-09-04 · Siemens Medical Solutions Usa - DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding patient mobility
FDA Device · Class II · 2019-09-04 · Leventon S A U - Laseredge Knife 1.5mm X 1.7mm TRAPEZOID ANGLED, REF E7599 Product Usage: Available to surgeons for use in ophthalmic surgical procedures
FDA Device · Class II · 2019-09-04 · Bausch And Lomb Irb - BD Vacutainer Lithium HeparinN 75 USP Units Blood Collection Tubes, Catalog Number 367884
FDA Device · Class II · 2019-08-28 · Becton Dickinson And - Kit BD Max StaphSR
FDA Device · Class II · 2019-08-28 · Becton Dickinson And - BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 367960
FDA Device · Class II · 2019-08-28 · Becton Dickinson And - IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128
FDA Device · Class II · 2019-08-28 · Siemens Healthcare Diagnostics - Kit BD Max MRSA XT
FDA Device · Class II · 2019-08-28 · Becton Dickinson And - ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Siemens Medical Solutions, containing software version VA10A, VA1…
FDA Device · Class II · 2019-08-28 · Siemens Medical Solutions Usa - TiLite X-Short anti-tip tubes, models TRA, AERO T, ZRA, AERO Z, 2GX, AERO X, Twist, and AERO R, a component of the TiLite wheelchair (anti-…
FDA Device · Class II · 2019-08-28 · Tisport - Kit BD Max ExK DNA 2 EU LUO
FDA Device · Class II · 2019-08-28 · Becton Dickinson And - Luer Lock Set - Catalog # MPC-125, for IV administration sets
FDA Device · Class II · 2019-08-28 · Molded Products - PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-2 PRO-DEX Battery Pack, 40 Pouches - PDB…
FDA Device · Class II · 2019-08-28 · Pro Dex - Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (26mm) 9630TF26 UDI:00690103201253
FDA Device · Class I · 2019-08-28 · Edwards Lifesciences - Kit BD Max Enteric Bacterial Panel EU
FDA Device · Class II · 2019-08-28 · Becton Dickinson And - MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914
FDA Device · Class II · 2019-08-28 · Siemens Medical Solutions Usa - Kit BD Max ExK TNA 2
FDA Device · Class II · 2019-08-28 · Becton Dickinson And - Kit BD Max ExK DNA 1 EU LUO
FDA Device · Class II · 2019-08-28 · Becton Dickinson And - BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes, Catalog Number 368056
FDA Device · Class II · 2019-08-28 · Becton Dickinson And - Kit EXT Enteric Bacterial Panel
FDA Device · Class II · 2019-08-28 · Becton Dickinson And - ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use
FDA Device · Class II · 2019-08-28 · Aniara Diagnostica - BD Vacutainer Lithium HeparinN (LH) 37 USP Units Blood Collection Tubes, Catalog Number 366664
FDA Device · Class II · 2019-08-28 · Becton Dickinson And - BD Vacutainer LH (Lithium Heparin) 68 I.U. Plus Blood Collection Tubes, Catalog Number 368884
FDA Device · Class II · 2019-08-28 · Becton Dickinson And - ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use
FDA Device · Class II · 2019-08-28 · Aniara Diagnostica - Kit BD Max Enteric Viral Panel RUO
FDA Device · Class II · 2019-08-28 · Becton Dickinson And - BD Vacutainer LH (Lithium Heparin) 102 I.U. Plus Blood Collection Tubes, Catalog Number 368886
FDA Device · Class II · 2019-08-28 · Becton Dickinson And - Kit BD Max Check-Points CPO IVD EU
FDA Device · Class II · 2019-08-28 · Becton Dickinson And - IMMULITE 2000 Progesterone
FDA Device · Class II · 2019-08-28 · Siemens Healthcare Diagnostics - BD Vacutainer Lithium HeparinN (LH) 95 USP Units Blood Collection Tubes, Catalog Number 367886
FDA Device · Class II · 2019-08-28 · Becton Dickinson And - BD Vacutainer PST Gel and Lithium HeparinN (LH) Blood Collection Tubes, Catalog Number 367963
FDA Device · Class II · 2019-08-28 · Becton Dickinson And - MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer
FDA Device · Class III · 2019-08-28 · Cincinnati Sub Zero Products A Gentherm - Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories
FDA Device · Class II · 2019-08-28 · Luminex - BD Vacutainer LH (Lithium Heparin) 34 I.U. Plus Blood Collection Tubes, Catalog Number 368494
FDA Device · Class II · 2019-08-28 · Becton Dickinson And - ABL90 FLEX Analyzer REF 393090 UDI:05700693930909
FDA Device · Class II · 2019-08-28 · Radiometer America - Kit BD Max ExK DNA 1 USA
FDA Device · Class II · 2019-08-28 · Becton Dickinson And - N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in serum, plasma, urine and CSF. Sieme…
FDA Device · Class II · 2019-08-28 · Siemens Healthcare Diagnostics - Kit BD Max Enteric Viral Panel EU Catalog # 443985
FDA Device · Class II · 2019-08-28 · Becton Dickinson And - Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (20 mm) 9630TF20 UDI:00690103201239
FDA Device · Class I · 2019-08-28 · Edwards Lifesciences - Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (23mm) 9630TF23 UDI:00690103201246
FDA Device · Class I · 2019-08-28 · Edwards Lifesciences - Kit BD Max MRSA
FDA Device · Class II · 2019-08-28 · Becton Dickinson And - ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA…
FDA Device · Class II · 2019-08-28 · Siemens Medical Solutions Usa - Kit BD Max GC RT PCR Assay
FDA Device · Class II · 2019-08-28 · Becton Dickinson And - BD Vacutainer PST Gel and Lithium HeparinN (LH) 126 Units Blood Collection Tubes, Catalog Number 367964
FDA Device · Class II · 2019-08-28 · Becton Dickinson And - BD Vacutainer Lithium HeparinN (LH) 56 USP Units Blood Collection Tubes, Catalog Number 366667
FDA Device · Class II · 2019-08-28 · Becton Dickinson And - Kit BD Max ExK DNA 2 USA
FDA Device · Class II · 2019-08-28 · Becton Dickinson And - Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System
FDA Device · Class II · 2019-08-28 · Thoratec - DeRoyal Enteral Safe Feeding Tubes: a) REF 54-2450R, 5 FR x 24" Polyurethane b) REF 54-2465R, 6.5 FR x 24" Polyurethane c) REF 54-2480R, 8…
FDA Device · Class II · 2019-08-28 · Deroyal Industries - BD Vacutainer PST Gel and Lithium HeparinN (LH) 83 Units Blood Collection Tubes, Catalog Number 367962
FDA Device · Class II · 2019-08-28 · Becton Dickinson And - Kit BD Max Enteric Parasite Panel EU
FDA Device · Class II · 2019-08-28 · Becton Dickinson And - Kit BD Max CT/GC/TV
FDA Device · Class II · 2019-08-28 · Becton Dickinson And - Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Left Ventricular Assist Device (…
FDA Device · Class II · 2019-08-28 · Thoratec - ACUSON NX3 Elite Diagnostic Ultrasound System, Model # 11235411, RX Only, Siemens Medical Solutions, containing software versions: VA10A, V…
FDA Device · Class II · 2019-08-28 · Siemens Medical Solutions Usa - BD Vacutainer Lithium HeparinN (LH) 158 USP Units Blood Collection Tubes, Catalog Number 367880
FDA Device · Class II · 2019-08-28 · Becton Dickinson And - Kit BD Max Vaginal Panel
FDA Device · Class II · 2019-08-28 · Becton Dickinson And - QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsymphony SP instrument is designed to perform automated…
FDA Device · Class II · 2019-08-28 · Qiagen Sciences - MAGNETOM Prisma magnetic resonance diagnostic devices Model #10849582
FDA Device · Class II · 2019-08-28 · Siemens Medical Solutions Usa - Kit BD Max StaphSR
FDA Device · Class II · 2019-08-28 · Becton Dickinson And - Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29 UDI:00690103201260
FDA Device · Class I · 2019-08-28 · Edwards Lifesciences - Kit BD Max Cdiff EU
FDA Device · Class II · 2019-08-28 · Becton Dickinson And - MAGNETOM Skyra magnetic resonance diagnostic devices Model # 10432915
FDA Device · Class II · 2019-08-28 · Siemens Medical Solutions Usa - MAGNETOM Spectra magnetic resonance diagnostic devices Model # 10837643
FDA Device · Class II · 2019-08-28 · Siemens Medical Solutions Usa - BD Vacutainer PST Gel and Lithium HeparinN (LH) 65 Units Blood Collection Tubes, Catalog Number 367961
FDA Device · Class II · 2019-08-28 · Becton Dickinson And - ACUSON NX3 Diagnostic Ultrasound System, Model # 11235612, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA10B,…
FDA Device · Class II · 2019-08-28 · Siemens Medical Solutions Usa - Brand Name Burn Navigator¿ Model Numbers: Catalog 1120, Burn Navigator¿ H2 Catalog 1125, Burn Navigator¿ H2 Transport Package Burn Navigato…
FDA Device · Class II · 2019-08-28 · Arcos - Microdot Xtra blood glucose test strips
FDA Device · Class II · 2019-08-28 · Cambridge Sensors - BD Vacutainer PST Blood Collection Tubes, Catalog Number 368035, 368036
FDA Device · Class II · 2019-08-28 · Becton Dickinson And - Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452
FDA Device · Class II · 2019-08-21 · Luminex - SOMATOM Confidence, Model Number 10590100 - Product Usage: Computed tomography systems intended to generate and process cross-sectional ima…
FDA Device · Class II · 2019-08-21 · Siemens Medical Solutions Usa - K-Wire Single Trocar 2.5x170mm, Item Number OL17025S - 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 6.5x120, Item Number 19672 - 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 6.5x34, Item Number 19653 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System
FDA Device · Class II · 2019-08-21 · Biopro - ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469
FDA Device · Class II · 2019-08-21 · Luminex - iGUIDE System with software build iGuide 2.2.0, 2.2.1, and 2.2.2
FDA Device · Class II · 2019-08-21 · Elekta - K-Wire Single Trocar 2.5x150mm, Item Number OL15025S - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System
FDA Device · Class II · 2019-08-21 · Biopro - WS80A Diagnostic Ultrasound System Version 1.00.16, 3.00.17, 3.00.18, 3.00.19, 3.01.00, 3.01.01, 3.01.02, 3.01.03, 3.01.04, 3.01.05, 3.01.0…
FDA Device · Class II · 2019-08-21 · Neurologica - Go-EZ Screw 6.5x100, Item Number 19668 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System
FDA Device · Class II · 2019-08-21 · Biopro - Medline Primary Warmer Pack, Product No. DYNJ52510A. The Medline Primary Warmer Pack contains the recalled Vyaire enFlow Disposable Cartrid…
FDA Device · Class I · 2019-08-21 · Medline Industries - VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory instrument to ANY 5mm spot suction/irrigation catheter
FDA Device · Class II · 2019-08-21 · Santanello Surgical - Go-EZ Screw 6.5x105, Item Number 19669 - 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 # 151810
FDA Device · Class II · 2019-08-21 · Zimmer Biomet - Centurion Convenience Kits, containing BD Alaris Pump Infusion Sets
FDA Device · Class I · 2019-08-21 · Medline Industries - SOMATOM Definition Flash, Model Number 10430603 - Product Usage: Computed tomography systems intended to generate and process cross-section…
FDA Device · Class II · 2019-08-21 · Siemens Medical Solutions Usa - Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151814
FDA Device · Class II · 2019-08-21 · Zimmer Biomet - SOMATOM Definition Edge, Model Number 10590000 - Product Usage: Computed tomography systems intended to generate and process cross-sectiona…
FDA Device · Class II · 2019-08-21 · Siemens Medical Solutions Usa - GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm)
FDA Device · Class II · 2019-08-21 · Codman And Shurtleff
Other years
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