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.
- Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices: 1) NxStage One, Model NX1000-1
FDA Device · Class II · 2019-12-25 · Nxstage Medical - Natrelle Silicone Filled Breast Implants for the following Styles and Sizes: Style 10, Style 15, Style 20, Style 40, Style 45 Style 10/UDI:…
FDA Device · Class III · 2019-12-25 · Allergan - VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjunction with the VisuMax Femtosecond Laser…
FDA Device · Class II · 2019-12-25 · Carl Zeiss Meditec - Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J
FDA Device · Class II · 2019-12-25 · Arrow International - Walgreens At-Home A1C Test Kit, Software Version Revision D, REF Number 3056
FDA Device · Class II · 2019-12-25 · Polymer Technology Systems - Rhondium OVC3 One Visit Crown, Model FDI 24/25L USA 12/13L A2 HT, Nonsterile, Rx. The firm name on the label is Rhondium Ltd., Katikati, Ne…
FDA Device · Class II · 2019-12-25 · Rhondium - Alliance Tech Medical, Inc
FDA Device · Class II · 2019-12-25 · Alliance Tech Medical - smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX Mallet is a reusable surgical instrument used to tap instru…
FDA Device · Class II · 2019-12-25 · Smith And Nephew - HydroDot brand: Wave Prep Single use cups, 8.5 gm (0.3 oz) 24/box-Product 1700-24 - Product Usage: An electroconductive cream for use with…
FDA Device · Class II · 2019-12-25 · Bio Signal Group - A1CNow SELF CHECK (European), Software Version Revision D, REF Numbers 3054, 3062
FDA Device · Class II · 2019-12-25 · Polymer Technology Systems - QuickTox 5 Panel Drug Screen DipCard
FDA Device · Class III · 2019-12-25 · Ameditech - MICRO-PSD HDR, Catalog Number: PSD-HB5N - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measur…
FDA Device · Class II · 2019-12-25 · Angiodynamics - MICRO-PSD Electron, Catalog Number: PSD-EE5N - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to m…
FDA Device · Class II · 2019-12-25 · Angiodynamics - Aestiva 7900, Model Numbers: a) 1006-9300-000 b) 1006-9305-000 c) 1006-9118-000 d) 1006-9112-000 e) 1006-9113-000 f) 1006-9020-000 g) 1006-…
FDA Device · Class II · 2019-12-25 · Ge Healthcare - Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130
FDA Device · Class II · 2019-12-25 · Arrow International - OARTRAC PROSTATE IMMOBILIZATION ENDORECTAL BALLOON DEVICE KIT, Catalog Number: ORB-60F - Product Usage: pre-calibrated PSD sensors are inte…
FDA Device · Class II · 2019-12-25 · Angiodynamics - Aestiva 7100, Model Numbers: 1. 1006-9320-000 2. 1006-9321-000 3. 1006-9320-000-001101 4. 1006-9021-000 5. 1006-9012-000 6. 1006-9111-000 7…
FDA Device · Class II · 2019-12-25 · Ge Healthcare - A1CNow+ Systems (professional use product), Software Version Revision D, REF Numbers US: 3021, 3024
FDA Device · Class II · 2019-12-25 · Polymer Technology Systems - DeRoyal KNEE BRACE, WARRIOR RECOVERY: 1) REF KB9000-01 2) REF 11-450A-00 3) REF 1150UTPP
FDA Device · Class II · 2019-12-25 · Deroyal Industries - Arrow EZ-IO Intraosseous Vascular Access System 45mm Needle+Stabilizer Kit, Product Code 9079P-VC-005 - Product Usage: The Arrow EZ-IO Intr…
FDA Device · Class II · 2019-12-25 · Teleflex Medical - HydroDot brand: Wave Prep 4 oz. tubes-Product 1710-03
FDA Device · Class II · 2019-12-25 · Bio Signal Group - AngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D 105650-001H 105650-001R 105650-001Z 105650-002R 105650-004H 105650-004R 105650…
FDA Device · Class II · 2019-12-25 · Boston Scientific - Elasto-Gel Absorbent Wound Dressing, Item DR8000. 5 Dressings 4" x 4". Sterile
FDA Device · Class II · 2019-12-25 · Southwest Technologies - TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile
FDA Device · Class II · 2019-12-25 · Tekia - MICRO-PSD EXTERNAL BEAM PHOTON, Catalog Number: PSD-PE5N - Product Usage: pre-calibrated PSD sensors are intended for use during cancer tre…
FDA Device · Class II · 2019-12-25 · Angiodynamics - Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351
FDA Device · Class II · 2019-12-25 · Medtronic Perfusion Systems - Ascension¿ Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product Usage: The Ascension Silicone PIP implant is intended for cem…
FDA Device · Class II · 2019-12-25 · Integra Lifesciences Sales - NATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20, Inspira X (responsive gel), Inspira F (responsive gel), Inspir…
FDA Device · Class III · 2019-12-25 · Allergan - Aespire 7100, Model Numbers: 1. 1009-9000-000-009469 2. 1009-9000-000 3. 1009-9000-000-013913 4. 1009-9000-000-001366 5. 1009-9000-000-0098…
FDA Device · Class II · 2019-12-25 · Ge Healthcare - ReliOn FastA1C Test, Software Version Revision D, REF Number 3055
FDA Device · Class II · 2019-12-25 · Polymer Technology Systems - OARtrac PLUS CLINICAL DETECTOR UNIT Catalog Number: OTS-V2-Plus - Product Usage: pre-calibrated PSD sensors are intended for use during can…
FDA Device · Class II · 2019-12-25 · Angiodynamics - Arrow EZ-IO Intraosseous Vascular Access System 25mm Needle+Stabilizer Kit, Product Code 9001P-VC-005 - Product Usage: The Arrow EZ-IO Intr…
FDA Device · Class II · 2019-12-25 · Teleflex Medical - Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes: 7607 SSM, 7608 SSF, 7609 SSX, 7513 SRL, 7514 SRLP, 75…
FDA Device · Class III · 2019-12-25 · Allergan - Artis zee/ zeego Interventional Fluoroscopic X-Ray System, Model Number: 10094142, Software Version: VC21C
FDA Device · Class II · 2019-12-25 · Siemens Medical Solutions Usa - LIFESTREAM Balloon Expandable Vascular Covered Stent . BARD PERIPHERAL VASCULAR. 6mm X 26mm X 80 Recommended Introducer 6F (2.00mm) NP 8atm…
FDA Device · Class II · 2019-12-25 · Bard Peripheral Vascular - HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135 - Product Usage: The Sheridan Endobronchial Tubes are intended for use in T…
FDA Device · Class II · 2019-12-25 · Teleflex Medical - CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059
FDA Device · Class II · 2019-12-25 · Polymer Technology Systems - Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 00763000054915), contained in the following…
FDA Device · Class II · 2019-12-25 · Medtronic Navigation - Anesthesia Pediatric Circuit 72", Model DYNJAPF6057A
FDA Device · Class II · 2019-12-25 · Medline Industries - Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style LP, Style 68 HP, Style 68 MP, Style LP/UDI: NATRELLE Style…
FDA Device · Class III · 2019-12-25 · Allergan - Aestiva MRI, Model Numbers: a) 1006-9310-000 b) 1006-9110-000 c) 1006-9023-000 d) 1006-9028-000 e) 1006-9310-000-305077 f) 1006-9310-000-01…
FDA Device · Class II · 2019-12-25 · Ge Healthcare - Arrow EZ-IO Intraosseous Vascular Access System 15mm Needle+Stabilizer Kit, Product Code 9018P-VC-005 - Product Usage: The Arrow EZ-IO Intr…
FDA Device · Class II · 2019-12-25 · Teleflex Medical - Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi coba…
FDA Device · Class II · 2019-12-25 · Roche Diagnostics Operations - CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For diagnostic and interventional vascular procedures
FDA Device · Class I · 2019-12-18 · Cook - MRIdian Linac Radiation Therapy System Model 10000 and 20000
FDA Device · Class II · 2019-12-18 · Viewray - Radiofrequency Grounding Pad, REF RF-DGP-L
FDA Device · Class II · 2019-12-18 · Abbott Medical - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161
FDA Device · Class II · 2019-12-18 · Maquet Cardiovascular Us Sales - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For diagnostic and interventional vascular procedures
FDA Device · Class I · 2019-12-18 · Cook - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - Healix Knotless ADV BR 4.75 Suture Anchor
FDA Device · Class II · 2019-12-18 · Depuy Mitek A Johnson And Johnson - Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determin…
FDA Device · Class II · 2019-12-18 · The Binding Site Group - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - Monaco Radiation Treatment Planning System (RTP) System
FDA Device · Class II · 2019-12-18 · Elekta - Healix Knotless ADV BR 5.5 Suture Anchor
FDA Device · Class II · 2019-12-18 · Depuy Mitek A Johnson And Johnson - Cognision, Subject Kit (Clinical Grade), Model 3000- containing Hydro Dot brand Wave Prep cups-electroconductive cream for use with externa…
FDA Device · Class II · 2019-12-18 · Neuronetrix Solutions - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 For diagnostic and interventional vascular procedures
FDA Device · Class I · 2019-12-18 · Cook - Habib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 - Product Usage: The Habib EUS RFA is indicated for coagulation and abl…
FDA Device · Class II · 2019-12-18 · Boston Scientific - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - Philips Volcano FFR software used in the following systems connected to the McKesson, Schwarzer, and some Philips Xper Hemodynamic Systems…
FDA Device · Class II · 2019-12-18 · Volcano - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units (40mL/each) - Product Usage: For dentinal hypersensitivity and for the r…
FDA Device · Class II · 2019-12-18 · Young Dental Manufacturing - CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 For diagnostic and interventional vascular procedures
FDA Device · Class I · 2019-12-18 · Cook - Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and…
FDA Device · Class II · 2019-12-18 · Roche Diagnostics Operations - VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly
FDA Device · Class II · 2019-12-18 · Livanova Usa - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - Biopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108
FDA Device · Class II · 2019-12-18 · Medtronic Navigation - SKINFUSE Resuce Calming Complex Kit containing: SKINFUSE LIFT HG - Product Usage: The SKINFUSE Rescue Calming Complex is intend to be used…
FDA Device · Class II · 2019-12-18 · Bellus Medical - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - Habib EUS RFA, 20mm electrode active tip, Material Number/UPN: 6700 - Product Usage: The Habib EUS RFA is indicated for coagulation and abl…
FDA Device · Class II · 2019-12-18 · Boston Scientific - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size: 10mm, (01) 00889795018182, Sterile R, Single Us…
FDA Device · Class II · 2019-12-18 · Paragon 28 - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096
FDA Device · Class II · 2019-12-18 · Encore Medical - Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943
FDA Device · Class II · 2019-12-18 · Medtronic Navigation - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000
FDA Device · Class II · 2019-12-18 · Getinge Us Sales - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences - C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
FDA Device · Class II · 2019-12-18 · Integra Lifesciences
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