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 SI Chronic Catheter Sport Pack 14.5 Fr x 23 cm Item Code: 8888223408
FDA Device · Class II · 2015-07-08 · Covidien - Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 44cm Item Code: 8888146144CP
FDA Device · Class II · 2015-07-08 · Covidien - Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code:8888145064
FDA Device · Class II · 2015-07-08 · Covidien - Infinite 200 PRO in vitro diagnostic
FDA Device · Class II · 2015-07-08 · Tecan Us - The Rapidlab 1260 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in a…
FDA Device · Class II · 2015-07-08 · Siemens Healthcare Diagnostics - The Rapidlab 1265 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in a…
FDA Device · Class II · 2015-07-08 · Siemens Healthcare Diagnostics - Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145048C
FDA Device · Class II · 2015-07-08 · Covidien - Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123409
FDA Device · Class II · 2015-07-08 · Covidien - Spine Wave Access Kit, Catalog Number 10-1530 Package contents: RLSP494-Rhythmlink Monopolar Stimulating Probe and 10-1525 Disposable Dilat…
FDA Device · Class II · 2015-07-08 · Spine Wave - Cios Alpha
FDA Device · Class II · 2015-07-08 · Siemens Medical Solutions Usa - Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119369P
FDA Device · Class II · 2015-07-08 · Covidien - Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145065
FDA Device · Class II · 2015-07-08 · Covidien - Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cmItem Code: 8888145065CP
FDA Device · Class II · 2015-07-08 · Covidien - Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 33 cm Item Code: 8888233508
FDA Device · Class II · 2015-07-08 · Covidien - Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066
FDA Device · Class II · 2015-07-08 · Covidien - 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 - Triglycerides/Glycerol Blanked
FDA Device · Class II · 2015-07-08 · Roche Diagnostics Operations - HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refracto…
FDA Device · Class II · 2015-07-08 · Heartware - Creatinine Plus ver. 2. Intended for use on COBAS INTEGRA systems , cobas c111, and cobas c systems for the quantitative determination of t…
FDA Device · Class II · 2015-07-08 · Roche Diagnostics Operations - Palindrome SI Chronic Catheter Kit 14.5 Fr x 23cm Item Code: 8888245063
FDA Device · Class II · 2015-07-08 · Covidien - Milestone Wand STA Handpiece for the delivery of local anesthesia to dental tissue
FDA Device · Class III · 2015-07-08 · Milestone Scientific - Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063C
FDA Device · Class II · 2015-07-08 · Covidien - Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050P
FDA Device · Class II · 2015-07-08 · Covidien - Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100
FDA Device · Class II · 2015-07-08 · Atrium Medical - NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle Catalog Number: 08-4000-LB Thi…
FDA Device · Class II · 2015-07-01 · Fresenius Medical Care Holdings - Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit Prelude Sheath Introducer is intende…
FDA Device · Class II · 2015-07-01 · Merit Medical Systems - Artis zee/ zeego systems
FDA Device · Class II · 2015-07-01 · Siemens Medical Solutions Usa - VersaTREK Instrument Series 240 REF 6240, Manufactured for Remel Inc
FDA Device · Class II · 2015-07-01 · Remel - Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcu…
FDA Device · Class II · 2015-07-01 · Unomedical As - LapSac Surgical Tissue Pouch
FDA Device · Class II · 2015-07-01 · Cook - ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair
FDA Device · Class II · 2015-07-01 · Smith And Nephew - Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone:…
FDA Device · Class II · 2015-07-01 · X Spine Systems - IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test), Siemens Material Number (SMN) 10386079, IVD. For in…
FDA Device · Class II · 2015-07-01 · Siemens Healthcare Diagnostics - Custom Surgical Kits containing Medtronic Covidien Devon(TM) Light Gloves: ANGIO TRAY, REF 50-12127
FDA Device · Class II · 2015-07-01 · Deroyal Industries - Cannula and Seal
FDA Device · Class II · 2015-07-01 · Stryker Sustainability Solutions - Prestige Plus 185cm J-Tip: Part number: 9185J
FDA Device · Class II · 2015-07-01 · Volcano - EVAC 70 XTRA with Integrated Cable REF EICA5872-01 Product Usage: PLASMA WAND devices are indicated for ablation, resection, and coagulatio…
FDA Device · Class II · 2015-07-01 · Arthrocare Medical - ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012
FDA Device · Class II · 2015-07-01 · Orthofix - McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to facilitate visualization during gyn…
FDA Device · Class II · 2015-07-01 · Coopersurgical - SERFAS 90 degree Energy Probe, Part Number 279-350-101
FDA Device · Class II · 2015-07-01 · Stryker Endoscopy - Fios First Entry
FDA Device · Class II · 2015-07-01 · Stryker Sustainability Solutions - Lifesaver Single Patient Use Manual Resuscitator Product Usage: The Hudson RCI Lifesaver Single Patient Use manual resuscitator with pressu…
FDA Device · Class I · 2015-07-01 · Teleflex Medical - VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc
FDA Device · Class II · 2015-07-01 · Remel - Surface Applicator Set with Leipzig-style Cone
FDA Device · Class II · 2015-07-01 · Varian Medical Systems - Custom Cardiovascular Procedure Kits
FDA Device · Class II · 2015-07-01 · Terumo Cardiovascular Systems - Volcano PV .035 Catheter: Part number: 88901
FDA Device · Class II · 2015-07-01 · Volcano - Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 (1.5 metric), 18" (45 cm), Conventional Cutt…
FDA Device · Class II · 2015-07-01 · Ethicon - Steriseal-Cannula Ophthalmic
FDA Device · Class II · 2015-07-01 · Hill Rom - GE Healthcare, Treadmill T2100
FDA Device · Class II · 2015-07-01 · Ge Healthcare - The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154
FDA Device · Class III · 2015-07-01 · Bio Rad Laboratories - Optical Access System
FDA Device · Class II · 2015-07-01 · Stryker Sustainability Solutions - PROcise XP Wand with Integrated Cable REF EICA8872-01 Product Usage: PLASMA WAND devices are indicated for ablation, resection, and coagula…
FDA Device · Class II · 2015-07-01 · Arthrocare Medical - Vanguard M Unicondylar Tibial Trial For use during knee joint replacement
FDA Device · Class II · 2015-06-24 · Biomet - Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surgical Systems
FDA Device · Class II · 2015-06-24 · Intuitive Surgical - T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Rx only, Part no. 2S0706 Us…
FDA Device · Class II · 2015-06-24 · Mrp - Neusoft NeuViz 64 Multi-slice CT Scanner System
FDA Device · Class II · 2015-06-24 · Neusoft Medical System - ELI 380 Electrocardiograph
FDA Device · Class II · 2015-06-24 · Mortara Instrument - Amerigel Hydrogel Gauze Dressing 2 x 2, A5002
FDA Device · Class II · 2015-06-24 · Amerx Health Care - I-Portal¿ NOTC and VNG
FDA Device · Class II · 2015-06-24 · Neuro Kinetics - Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catalog number: 795088
FDA Device · Class II · 2015-06-24 · Philips Ultrasound - CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, using firmware version 2.08
FDA Device · Class II · 2015-06-24 · Boston Scientific - HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205
FDA Device · Class I · 2015-06-24 · Heartware - Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central programming, monitoring an…
FDA Device · Class II · 2015-06-24 · Carefusion 303 - BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584671 Ophthalmic surgical kits
FDA Device · Class II · 2015-06-24 · Beaver Visitec International - MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80
FDA Device · Class II · 2015-06-24 · Coopersurgical - BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584648 Ophthalmic surgical kits
FDA Device · Class II · 2015-06-24 · Beaver Visitec International - 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws
FDA Device · Class II · 2015-06-24 · Synthes - BD Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec Chlamydia trachomatis (CT) Qx Assay (cat. #442959)…
FDA Device · Class II · 2015-06-24 · Becton Dickinson And - Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in Part Number Kits: 9732540, 9732622, 9733174, 9733935
FDA Device · Class II · 2015-06-24 · Medtronic Navigation - BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584676 Ophthalmic surgical kits
FDA Device · Class II · 2015-06-24 · Beaver Visitec International - T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 15G x 38.5 mm 10 NEEDLE SET STERILE EO Single Use Rx only Vidacare Corporati…
FDA Device · Class II · 2015-06-24 · Vidacare - Viking M, L, and XL Mobile Lifts
FDA Device · Class II · 2015-06-24 · Hill Rom - Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting, Catalog No. 110-4L The Camino Intracranial Pressure M…
FDA Device · Class II · 2015-06-24 · Integra Lifesciences - CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measu…
FDA Device · Class II · 2015-06-24 · Smiths Medical Asd - BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584569 Ophthalmic surgical kits
FDA Device · Class II · 2015-06-24 · Beaver Visitec International - Pull Reduction Device For 4.3mm Percutaneous Drill Guide
FDA Device · Class II · 2015-06-24 · Synthes - Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and Articulated Arm Camera, 7700-103-001U Product Usage:…
FDA Device · Class II · 2015-06-24 · Stryker Instruments Div - BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584649 Ophthalmic surgical kits
FDA Device · Class II · 2015-06-24 · Beaver Visitec International - CardioMD III (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems
FDA Device · Class II · 2015-06-17 · Philips Medical Systems Cleveland - BrightView XCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems
FDA Device · Class II · 2015-06-17 · Philips Medical Systems Cleveland - EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004
FDA Device · Class II · 2015-06-17 · Advanced Sterilization Products - Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX FR…
FDA Device · Class II · 2015-06-17 · Smiths Medical Asd - Mallory/Head Primary Hip System
FDA Device · Class III · 2015-06-17 · Biomet - MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM
FDA Device · Class III · 2015-06-17 · Biomet - Gemini LXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems
FDA Device · Class II · 2015-06-17 · Philips Medical Systems Cleveland - GEMINI TF Big Bore (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems
FDA Device · Class II · 2015-06-17 · Philips Medical Systems Cleveland - RELIEVA FLEX Sinus Guide Catheter F-70
FDA Device · Class III · 2015-06-17 · Acclarent - The Optigun Ratchet is a hand-held cement gun for use with Optivac
FDA Device · Class II · 2015-06-17 · Biomet France R L - BBL Port A Cul tubes with Swabs Sterile Pack, catalog number 221607
FDA Device · Class II · 2015-06-17 · Becton Dickinson And - FORTE (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems
FDA Device · Class II · 2015-06-17 · Philips Medical Systems Cleveland - Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 Fr (3.5 mm) x 39.4" (100 cm) ThruPort System
FDA Device · Class II · 2015-06-17 · Edwards Lifesciences - ClearSight, Model No. EVHRS Heart Reference Sensor
FDA Device · Class II · 2015-06-17 · Edwards Lifesciences - Brilliance CT 40 - Slices (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging s…
FDA Device · Class II · 2015-06-17 · Philips Medical Systems Cleveland - Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator
FDA Device · Class II · 2015-06-17 · Resmed - Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V, Standard Length Porous Plasma
FDA Device · Class III · 2015-06-17 · Biomet - Diamond Select Brilliance CT 16 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Ima…
FDA Device · Class II · 2015-06-17 · Philips Medical Systems Cleveland - Biomet Cobalt-Chrome Femoral Components, 32MM MOD HEAD COCR -6MM NECK
FDA Device · Class III · 2015-06-17 · Biomet - Ingenuity Core (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems
FDA Device · Class II · 2015-06-17 · Philips Medical Systems Cleveland - VITROS 5600 Chemistry System, Software Version 3.2 & Below
FDA Device · Class II · 2015-06-17 · Ortho Clinical Diagnostics - Roscoe Mini Neb Compressor User Manual for the NEB-ROS Product Usage: Inhaler therapy that converts liquid medicine into a fine mist that i…
FDA Device · Class II · 2015-06-17 · Compass Health Brands
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