FDA Device · 2014

FDA Device recalls in 2014

RecallRadar indexes 3,059 FDA Device recall notices published in 2014. By classification: 558 Class I, 2,441 Class II, 60 Class III.

• API Listeria (REF 10300)
  FDA Device · Class II · 2014-04-30 · Biomerieux
• Sengstaken Tube and Sengstaken-Blakemore Tube
  FDA Device · Class II · 2014-04-30 · Teleflex Medical
• Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205
  FDA Device · Class I · 2014-04-30 · Heartware
• VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077, used in conjunction with: VITROS Chemis…
  FDA Device · Class II · 2014-04-30 · Ortho Clinical Diagnostics
• ToxCup Drug Screen Cup, Catalogue Numbers: HT15, HT15A, PT11, PT11A, PT15A, PT23A, a screening device for the detection of drugs and drug m…
  FDA Device · Class II · 2014-04-30 · Branan Medical
• SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usage: Sigma Spectrum Volumetric Infusion Pumps with Master Drug L…
  FDA Device · Class I · 2014-04-30 · Baxter Healthcare
• Nice-En-Smooth Berry Burst, 4 oz., Manufactured by Meta Labs LLC, UPC 80604-8 Product Usage: Flavored lubricant water based, condom friendl…
  FDA Device · Class II · 2014-04-30 · Altasource
• Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is used for receiving, managing, archiving, distribu…
  FDA Device · Class II · 2014-04-30 · Philips Medical Systems
• Mega-Gen His Personal Lubricant, 8 fl. oz., Meta Labs, UPC Code 80708-3
  FDA Device · Class II · 2014-04-30 · Altasource
• GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM products
  FDA Device · Class II · 2014-04-30 · Ge Healthcare
• LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inch with Prepierced Reseals, OPTION-LOK and Inline Dual Channel…
  FDA Device · Class II · 2014-04-30 · Hospira
• Siemens ACUSON X700 Ultrasound Systems with software version 1.0.00, 1.0.01, 1.0.02, 1.1.00 and 1.1.02. ultrasound imaging system
  FDA Device · Class II · 2014-04-30 · Siemens Medical Solutions Usa
• GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized for use in cardiac imaging
  FDA Device · Class II · 2014-04-30 · Ge Healthcare
• Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number CDC-35052-VPS, peripherally inserted central catheter
  FDA Device · Class II · 2014-04-30 · Arrow International
• Monofilament and Multifilament Non-absorbable Steel Suture
  FDA Device · Class II · 2014-04-30 · Teleflex Medical
• Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116
  FDA Device · Class II · 2014-04-30 · Ion Beam Applications
• Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box
  FDA Device · Class II · 2014-04-30 · Remel
• API NIH (REF 10400)
  FDA Device · Class II · 2014-04-30 · Biomerieux
• On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors
  FDA Device · Class II · 2014-04-30 · Varian Medical Systems
• ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW PTA Dilatation Cath…
  FDA Device · Class II · 2014-04-30 · Ev3
• iLab Ultrasound Imaging System
  FDA Device · Class II · 2014-04-30 · Boston Scientific
• Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, catalogue number AK-45854-CDC
  FDA Device · Class II · 2014-04-30 · Arrow International
• RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software
  FDA Device · Class II · 2014-04-30 · Raysearch Laboratories Ab
• Stryker PenAdapt"
  FDA Device · Class II · 2014-04-30 · Stryker Instruments Div
• Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff Shaft, 0.035" (0.89mm), 260 cm (102")
  FDA Device · Class II · 2014-04-30 · Merit Medical Systems
• Digital Diagnost, stationary radiographic system
  FDA Device · Class II · 2014-04-30 · Philips Medical Systems
• ZYM B Reagent (REF 70493)
  FDA Device · Class II · 2014-04-30 · Biomerieux
• FB Reagent (REF 70562)
  FDA Device · Class II · 2014-04-30 · Biomerieux
• MULTIX FUSION. The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices
  FDA Device · Class II · 2014-04-30 · Siemens Medical Solutions Usa
• Oxoid Legionella Pneumo Groups 2-14, DR0802M, containing 50 tests per box
  FDA Device · Class II · 2014-04-30 · Remel
• TRABECULAR METAL MODULAR ACETABULAR SYSTEM, Shell with Cluster Holes, Porous 60mm
  FDA Device · Class II · 2014-04-30 · Zimmer
• Fassier-Duval IM Telescopic System
  FDA Device · Class II · 2014-04-30 · Pega Medical
• The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20ul (list 06J37-018) is an Analyte Specific Reagent (ASR) containing a single vial of CEP 8 sp…
  FDA Device · Class III · 2014-04-30 · Abbott Molecular
• Merit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard Shaft, Catalog No. LWSTDA35260EX, 260 cm (102")
  FDA Device · Class II · 2014-04-30 · Merit Medical Systems
• Hot Ice, 1 fl. oz., Meta Labs LLC, UPC 80705-2 Product Usage: A topical gel that increases men and womens secual excitement and pleasure
  FDA Device · Class II · 2014-04-30 · Altasource
• The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm Product Usage: Used to expose bone for procedures
  FDA Device · Class II · 2014-04-23 · Synthes
• BIOMET 3i Endosseous Dental Implant
  FDA Device · Class II · 2014-04-23 · Biomet 3i
• Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology, Brilliance iCT, Ingenuity CT, Ingenu…
  FDA Device · Class II · 2014-04-23 · Philips Medical Systems Cleveland
• Synthes CMF Battery Powered Driver, Part no. 305.840
  FDA Device · Class II · 2014-04-23 · Synthes
• Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae with Duraflo Coating, arterial cannula sizes 16, 18 and 20 French, Models DF…
  FDA Device · Class II · 2014-04-23 · Edwards Lifesciences
• FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures
  FDA Device · Class II · 2014-04-23 · Solta Medical
• CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Line Valve Only 82-8801 In Line Valve with C…
  FDA Device · Class II · 2014-04-23 · Codman And Shurtleff
• The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic x-ray) is designed to provide fluoroscopic and spot-film image…
  FDA Device · Class II · 2014-04-23 · Ge Oec Medical Systems
• Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical Systems (Cleveland), Inc
  FDA Device · Class II · 2014-04-23 · Philips Medical Systems Cleveland
• Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, 18 and 20 French, models: FEMII016A, FEMII016AS,…
  FDA Device · Class II · 2014-04-23 · Edwards Lifesciences
• Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal
  FDA Device · Class I · 2014-04-23 · Micro Therapeutics
• Brainlab, Spine & Trauma 3D 2.0, Navigation Software
  FDA Device · Class II · 2014-04-23 · Brainlab Ag
• Terumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack with FX25RE Catalog Number: 73431
  FDA Device · Class II · 2014-04-23 · Terumo Cardiovascular Systems
• SmartSite Extension Set, Model No. 20029E, intravascular administration set
  FDA Device · Class II · 2014-04-23 · Carefusion 303
• Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge set, STND PRM LN and 1…
  FDA Device · Class II · 2014-04-23 · Gambro Renal Products
• SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed
  FDA Device · Class I · 2014-04-23 · Del Mar Reynolds Medical
• AXIOM Vertix MD Trauma systems radiographic X-ray
  FDA Device · Class II · 2014-04-23 · Siemens Medical Solutions Usa
• Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery
  FDA Device · Class I · 2014-04-23 · Micro Therapeutics
• VITROS Chemistry Products CRBM Slides, REF 889 2382, IVD -- Ortho-Clinical Diagnostics, Inc
  FDA Device · Class II · 2014-04-23 · Ortho Clinical Diagnostics
• Methamphetamine Test Card
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Buprenorphine Test Strip
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• CK-MB Test Card (Whole Blood)
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Cocaine Strip
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• 10mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
  FDA Device · Class II · 2014-04-16 · Aspen Surgical Products
• Alcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal cuts/incisions, anterior capsulotomy and laser phacof…
  FDA Device · Class II · 2014-04-16 · Alcon Lensx
• Sit/stand Rolling Walker, SKU/Item Number 66838
  FDA Device · Class II · 2014-04-16 · Central Purchasing
• Salmonella typhi IgG/IgM Duo Test
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• 400003 Medcare Lift with Scale 400013 Medcare Lift w/Scale 600 lb 400600 Scale Hanger Assembly Product Usage: The intended use is a patient…
  FDA Device · Class II · 2014-04-16 · Ergosafe Product
• Buprenorphine Test Card
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Barbiturate Strip
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analyzer intended for the in vitro quantitativ…
  FDA Device · Class II · 2014-04-16 · Roche Diagnostics Operations
• Morphine Strips (2000)
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Saber 100ml Infection Control PVC Bulb Evacuator, Sterile (10/case) Intended to provide manual suction and collection of fluids for closed…
  FDA Device · Class II · 2014-04-16 · Aspen Surgical Products
• 15FR Drain Kit Round End Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
  FDA Device · Class II · 2014-04-16 · Aspen Surgical Products
• EDDP Strip
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Amphetamine Strip
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Rotavirus Test Card LumiQuick, Santa Clara, CA 95054
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Alcohol Test, Saliva
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Methadone Test Strip
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Morphine Test Card (2000)
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Fentanyl Test Card
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• THC Test Card
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for in vitro diagnostic use as a control to monitor the performan…
  FDA Device · Class II · 2014-04-16 · Clinical Diagnostic Solutions
• 10mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case) Intended for closed wound suction drainage
  FDA Device · Class II · 2014-04-16 · Aspen Surgical Products
• Legionella Test Card
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• 7mm Drain Kit Fluted 4 Channel with 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage
  FDA Device · Class II · 2014-04-16 · Aspen Surgical Products
• Adenovirus Antigen Test Card
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Morphine Strip (300)
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• H. Pylori Antibody Test Card (Whole Blood) LumiQuick, Santa Clara, CA 95054
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Dengue NS1 Antigen Test Card
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Tuberculosis Antibody Test Card Serum
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Propoxyphene Test Strip
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• 5X250 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number IS3000
  FDA Device · Class II · 2014-04-16 · Intuitive Surgical
• CK-MB Test Card (serum)
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Fentanyl Test Strip
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• K-Lite Knee 2 Stays with Visco, Model No. 122015
  FDA Device · Class II · 2014-04-16 · Breg
• Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290, automatic external defibrillator
  FDA Device · Class II · 2014-04-16 · Philips Medical Systems
• PSA Test Card (Serum)
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• 7mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
  FDA Device · Class II · 2014-04-16 · Aspen Surgical Products
• Syphilis Test Card (Serum)
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Smiths Medical HOTLINE¿ Fluid Warming Set L-70
  FDA Device · Class II · 2014-04-16 · Smiths Medical Asd
• Cocaine Test Card
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• GLOBAL¿ Anchor Peg Glenoid Plus (APG+) 2.5MM Breakaway Guide Pin Part # 2230-00-019, Non-Sterile, DePuy, Johnson & Johnson Product Usage: U…
  FDA Device · Class II · 2014-04-16 · Depuy Orthopaedics
• Malaria pan Antigen Test
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• PCP Test (Strip)
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics

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)