FDA Device · 2015
FDA Device recalls in 2015
RecallRadar indexes 2,495 FDA Device recall notices published in 2015. By classification: 77 Class I, 2,300 Class II, 118 Class III.
- Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145049CP
FDA Device · Class II · 2015-07-08 · Covidien - Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000
FDA Device · Class II · 2015-07-08 · Atrium Medical - Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123408P
FDA Device · Class II · 2015-07-08 · Covidien - GE Healthcare Innova IGS 540
FDA Device · Class II · 2015-07-08 · Ge Healthcare - Infinite M1000 in vitro diagnostic
FDA Device · Class II · 2015-07-08 · Tecan Us - DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm)
FDA Device · Class II · 2015-07-08 · Synthes - Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273
FDA Device · Class II · 2015-07-08 · Pega Medical - Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064
FDA Device · Class II · 2015-07-08 · Covidien - Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064CP
FDA Device · Class II · 2015-07-08 · Covidien - Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter personal lubricant
FDA Device · Class II · 2015-07-08 · Sheffield Pharmaceuticals - Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062CP
FDA Device · Class II · 2015-07-08 · Covidien - Ocean Water Seal Chest Drain, SINGLE W/AC P/N: 2002-100
FDA Device · Class II · 2015-07-08 · Atrium Medical - GE Healthcare Innova IGS 630
FDA Device · Class II · 2015-07-08 · Ge Healthcare - Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133508P
FDA Device · Class II · 2015-07-08 · Covidien - Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066C
FDA Device · Class II · 2015-07-08 · Covidien - HDL-Cholesterol gen.3. For the quantitative determination of high-density lipoprotein Cholesterol (HDL-C) in serum and plasma
FDA Device · Class II · 2015-07-08 · Roche Diagnostics Operations - Creatinine Plus
FDA Device · Class II · 2015-07-08 · Roche Diagnostics Operations - Infinite M1000 PRO in vitro diagnostic
FDA Device · Class II · 2015-07-08 · Tecan Us - Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133509
FDA Device · Class II · 2015-07-08 · Covidien - GE Healthcare Innova 2121IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnost…
FDA Device · Class II · 2015-07-08 · Ge Healthcare - GE Healthcare Discovery IGS 730
FDA Device · Class II · 2015-07-08 · Ge Healthcare - Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066CP
FDA Device · Class II · 2015-07-08 · Covidien - Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145049P
FDA Device · Class II · 2015-07-08 · Covidien - ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option
FDA Device · Class II · 2015-07-08 · Siemens Medical Solutions Usa - Palindrome SI Chronic Catheter Kit 14.5 Fr x 19cm Item Code: 8888245062 The Palindrome SI Chronic Catheter is indicated for acute and chron…
FDA Device · Class II · 2015-07-08 · Covidien - Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064
FDA Device · Class II · 2015-07-08 · Covidien - EasyLink Data Management System
FDA Device · Class II · 2015-07-08 · Siemens Healthcare Diagnostics - GE Healthcare Discovery IGS 740 & GE Healthcare Innova IGS 740
FDA Device · Class II · 2015-07-08 · Ge Healthcare - Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128458
FDA Device · Class II · 2015-07-08 · Covidien - Treatment Planning and Delivery System Software version 3.6. ViewRay
FDA Device · Class II · 2015-07-08 · Viewray - Accurus 2500 Standalone Vitreous Probe REF 8065741018
FDA Device · Class II · 2015-07-08 · Alcon Research - Cholesterol Gen.2. The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in vitro diagnostic reagent system intended for use on…
FDA Device · Class II · 2015-07-08 · Roche Diagnostics Operations - Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123408
FDA Device · Class II · 2015-07-08 · Covidien - GE Healthcare Optima CL 323i
FDA Device · Class II · 2015-07-08 · Ge Healthcare - Velocity" Biopsy Valve, 25 units per box, Product Usage: The disposable Velocity biopsy valve is used to cover the opening of the biopsy in…
FDA Device · Class II · 2015-07-08 · Us Endoscopy Group - Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145048P
FDA Device · Class II · 2015-07-08 · Covidien - Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code:8888145049C
FDA Device · Class II · 2015-07-08 · Covidien - Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128459
FDA Device · Class II · 2015-07-08 · Covidien - LifeHealth, IRMA TRUPOINT model 443914, typically used in point-of-care settings
FDA Device · Class II · 2015-07-08 · Lifehealth - Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062P
FDA Device · Class II · 2015-07-08 · Covidien - StoneLight 30 Laser System (NS3000)
FDA Device · Class II · 2015-07-08 · New Star Lasers - Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 28 cm Item Code:8888228458
FDA Device · Class II · 2015-07-08 · Covidien - GE Healthcare Innova IGS 520
FDA Device · Class II · 2015-07-08 · Ge Healthcare - Cholesterol CHOD-PAP. In vitro diagnostic reagent system intended for use on the Hitachi systems for The quantitative determination of tota…
FDA Device · Class II · 2015-07-08 · Roche Diagnostics Operations - LDL-Cholesterol gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low-density li…
FDA Device · Class II · 2015-07-08 · Roche Diagnostics Operations - ICT Serum Calibrator REF 146-03
FDA Device · Class II · 2015-07-08 · Abbott Laboratories - Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050C
FDA Device · Class II · 2015-07-08 · Covidien - GE Healthcare Innova 3131IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnost…
FDA Device · Class II · 2015-07-08 · Ge Healthcare - Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050C
FDA Device · Class II · 2015-07-08 · Covidien - GE Healthcare Innova 3100IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnost…
FDA Device · Class II · 2015-07-08 · Ge Healthcare - HDL-Cholesterol plus gen.3
FDA Device · Class II · 2015-07-08 · Roche Diagnostics Operations - Hamilton Medical Infant Flow Sensor, single use, (1.6m), Part number 260177
FDA Device · Class II · 2015-07-08 · Hamilton Medical - GE Healthcare Innova IGS 530
FDA Device · Class II · 2015-07-08 · Ge Healthcare - The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placi…
FDA Device · Class II · 2015-07-08 · Varian Medical Systems - Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064C
FDA Device · Class II · 2015-07-08 · Covidien - INSTRUMENT ARM DRAPE, IS4000, 20 PACK
FDA Device · Class II · 2015-07-08 · Intuitive Surgical - Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon Catheter
FDA Device · Class II · 2015-07-08 · Boston Scientific - Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064
FDA Device · Class II · 2015-07-08 · Covidien - Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062C
FDA Device · Class II · 2015-07-08 · Covidien - Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119369
FDA Device · Class II · 2015-07-08 · Covidien - Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128458P
FDA Device · Class II · 2015-07-08 · Covidien - Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063P
FDA Device · Class II · 2015-07-08 · Covidien - SYNGO IMAGING (VERSION V30 and V31)
FDA Device · Class II · 2015-07-08 · Siemens Medical Solutions Usa - GE Healthcare Optima IGS 320
FDA Device · Class II · 2015-07-08 · Ge Healthcare - JustRight 5mm Stapler, JR-ST25-2.0 Stapler is packaged in cases of 6, placed in a tray and sealed with a Tyvek lid
FDA Device · Class II · 2015-07-08 · Justright Surgical - Gelseal Straight Diameter 8mm Length 30cm
FDA Device · Class II · 2015-07-08 · Vascutek - Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic
FDA Device · Class II · 2015-07-08 · Biomerieux - Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145057C
FDA Device · Class II · 2015-07-08 · Covidien - Triglycerides GPO. In vitro test for the quantitative determination of triglycerides in human serum and plasma on the COBAS Integra 800 and…
FDA Device · Class II · 2015-07-08 · Roche Diagnostics Operations - Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145048CP
FDA Device · Class II · 2015-07-08 · Covidien - Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123409P
FDA Device · Class II · 2015-07-08 · Covidien - Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in configuration 803/791
FDA Device · Class II · 2015-07-08 · Zimmer - Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133508P
FDA Device · Class II · 2015-07-08 · Covidien - JustRight 5mm Reload, JR-REL25-2.0 Reload is packaged in cases of 12., placed in a tray and sealed with a Tyvek lid
FDA Device · Class II · 2015-07-08 · Justright Surgical - SOMATOM Emotion 6
FDA Device · Class II · 2015-07-08 · Siemens Medical Solutions Usa - Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT
FDA Device · Class II · 2015-07-08 · Axis Shield Diagnostics - Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145065P
FDA Device · Class II · 2015-07-08 · Covidien - Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066CP
FDA Device · Class II · 2015-07-08 · Covidien - Lactate
FDA Device · Class II · 2015-07-08 · Roche Diagnostics Operations - Medtronic Navigated Cannulated Taps Individual cannulated taps are packaged in a clear plastic tube with protective plastic end caps
FDA Device · Class II · 2015-07-08 · Medtronic Navigation - Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066P
FDA Device · Class II · 2015-07-08 · Covidien - Uric Acid plus ver.2 In vitro test for the quantitative determination of uric acid in human serum, plasma and urine or Roche/Hitachi MODULA…
FDA Device · Class II · 2015-07-08 · Roche Diagnostics Operations - Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145048
FDA Device · Class II · 2015-07-08 · Covidien - CentraLink" Data Management System
FDA Device · Class II · 2015-07-08 · Siemens Healthcare Diagnostics - Gentle Threads Interference Screw 10x25mm Round Head
FDA Device · Class II · 2015-07-08 · Biomet - Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050CP
FDA Device · Class II · 2015-07-08 · Covidien - LDL-Cholesterol plus gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low-densi…
FDA Device · Class II · 2015-07-08 · Roche Diagnostics Operations - Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145065C
FDA Device · Class II · 2015-07-08 · Covidien - Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119368P
FDA Device · Class II · 2015-07-08 · Covidien - Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145049
FDA Device · Class II · 2015-07-08 · Covidien - Sechrist Low Profile Wheeled Stretcher, Model No. 21762-110-33H, 21762-110-36H, 21762-110-41H, 21762-135-33HJ, 21762-010-36H, 21762-010-41H…
FDA Device · Class II · 2015-07-08 · Sechrist Industries - Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133509P
FDA Device · Class II · 2015-07-08 · Covidien - Infinite F500, in vitro diagnostic
FDA Device · Class II · 2015-07-08 · Tecan Us - Gentle Threads Interference Screw 9x35mm Full Thread
FDA Device · Class II · 2015-07-08 · Biomet - Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063CP
FDA Device · Class II · 2015-07-08 · Covidien - Gelseal Straight Diameter 8mm Length 15cm
FDA Device · Class II · 2015-07-08 · Vascutek - Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and DLP Femoral Cannula Replacement Kit, Models 96017 and 96021
FDA Device · Class II · 2015-07-08 · Medtronic Perfusion Systems - Hamilton Medical Infant Flow Sensor, single use, (3.1m), Part number 260179
FDA Device · Class II · 2015-07-08 · Hamilton Medical - EXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N
FDA Device · Class II · 2015-07-08 · Atrium Medical - GE Healthcare Innova 2100IQ. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnost…
FDA Device · Class II · 2015-07-08 · Ge Healthcare
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