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.
- Ebola Accessories assembled, self-contained package, Catalog No. I-104 virus test kit
FDA Device · Class I · 2015-04-15 · Lusys Laboratories - Double Swivel Connector with Suction Port Connector, Airway (Extension) King Systems part 7169 Product Usage: An airway connector is a devi…
FDA Device · Class II · 2015-04-08 · King Systems - GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM. Catalog number GAP-N48-16
FDA Device · Class II · 2015-04-08 · Pega Medical - Medcomp Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split…
FDA Device · Class II · 2015-04-08 · Medical Components - ToggleLoc
FDA Device · Class II · 2015-04-08 · Biomet - Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EX-Lok Sampling
FDA Device · Class II · 2015-04-08 · C R Bard - LASER RESISTANT WAND - STERILE, 7/8" X 8" (2.22cm x 20.32cm), REF 24013, QTY 10 EA, STERILE EO, NO LATEX Intended use: The smoke evacuator…
FDA Device · Class II · 2015-04-08 · Microtek Medical - LIS27T - Lacrimal Intubation Set RX Only Sterile Used in various ophthalmology procedures
FDA Device · Class II · 2015-04-08 · Quest Medical - Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL Drainage Catheter and APDL Drainage Catheter Kit, Expel" Drainage Cath…
FDA Device · Class II · 2015-04-08 · Boston Scientific - VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), REF 24009, QTY 24\CS, NON-STERILE Intended use: The smoke evacuator and accessories are intend…
FDA Device · Class II · 2015-04-08 · Microtek Medical - Skintact ECG Electrode FS-50, Catalog no. 58028 , & Stable Base ECG Electrode SBT-60, Catalog no. 50547
FDA Device · Class II · 2015-04-08 · Leonhard Lang Medizintechnik - VACUUM TUBING 7/8" X 6' (2.22cm X 182.88cm), WITH TUBING EXTENDER, STERILE, REF 24010, QTY 24\CS, STERILE EO Intended use: The smoke evacua…
FDA Device · Class II · 2015-04-08 · Microtek Medical - ACCU-CHEK Connect Diabetes Management App
FDA Device · Class II · 2015-04-08 · Roche Diabetes Care - Smoke Evacuation Tubing Set for Coherent CPG Handpiece, 7/8" x 16' (2.22 cm x 487.88 cm), REF 24244, QTY 3/CS, NON STERILE NO LATEX Intende…
FDA Device · Class II · 2015-04-08 · Microtek Medical - LAPAROSCOPIC TUBING SET, 3/16" ¿ X 10' (48cm x 304.8cm) WITH MALE LUER LOCK - STERILE, REF 24311 QTY 10/CS, STERILE EO Intended use: The sm…
FDA Device · Class II · 2015-04-08 · Microtek Medical - Ziploop Button Product Usage: The Ziploop Button is a non-resorbable system intended to aid in ACL reconstructive procedure due to injury o…
FDA Device · Class II · 2015-04-08 · Biomet - Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm
FDA Device · Class II · 2015-04-08 · Synthes - Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technology, Brilliance iCT, Brilliance iCT SP, Ingenuity Core, Ingenu…
FDA Device · Class II · 2015-04-08 · Philips Medical Systems Cleveland - GE Healthcare, Aespire 7900, Aespire View Anesthesia Machines
FDA Device · Class II · 2015-04-08 · Ge Healthcare - TUBING 7/8' X 10', W/WAND & TIP, 24/CS, REF 24187, QTY 24\CS, STERILE EO Intended use: The smoke evacuator and accessories are intended to…
FDA Device · Class II · 2015-04-08 · Microtek Medical - FREEDOMAIRE(R) HELMET WITH MOTOR MODULE, REF 11113STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be worn by…
FDA Device · Class II · 2015-04-08 · Microtek Medical - FREEDOMAIRE(R) HELMET SYSTEM WITH BELT, REF 11114STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be worn by…
FDA Device · Class II · 2015-04-08 · Microtek Medical - Vitagel
FDA Device · Class II · 2015-04-08 · Orthovita - Bio-CORE Cannula (Needle) Set
FDA Device · Class II · 2015-04-08 · Biologic Therapies - Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits
FDA Device · Class II · 2015-04-08 · Boston Scientific - Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 The Autoject E1 is an injector used by patients to inject drugs…
FDA Device · Class II · 2015-04-08 · Owen Mumford Usa - FREEDOMAIRE(R) MOTOR MODULE, REF 11112STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be worn by surgical pe…
FDA Device · Class II · 2015-04-08 · Microtek Medical - FREEDOMAIRE(R) HELMET SYSTEM WITH SUPER POWER PAK BATTERY, LUMBAR BELT AND MOTOR MODULE, REF 11110STK, QTY 1/CS, NON STERILE, NO LATEX The…
FDA Device · Class II · 2015-04-08 · Microtek Medical - YC-1800 OPHTHALMIC YAG LASER SYSTEM
FDA Device · Class II · 2015-04-08 · Nidek - Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only
FDA Device · Class II · 2015-04-08 · Medtronic Cardiac Rhythm Disease Management - Syngo.plaza
FDA Device · Class II · 2015-04-08 · Siemens Medical Solutions Usa - CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent
FDA Device · Class II · 2015-04-08 · Bd Biosciences Systems And Reagents - TUBING SET 7/8" X 6' WITH 1/4" x 24" TUBING, REF 24136, QTY 3/CS, NON STERILE, NO LATEX Intended use: The smoke evacuator and accessories a…
FDA Device · Class II · 2015-04-08 · Microtek Medical - Bio-PLASTY Cannula (Needle)
FDA Device · Class II · 2015-04-08 · Biologic Therapies - RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip implantation
FDA Device · Class II · 2015-04-08 · Depuy Orthopaedics - (S) TUBE SET 1/4" X 10' (0.64 cm X 304.8 cm) with 7/8" (2.22 cm) Adaptor, Sterile, REF 24155, QTY 10/CS, STERILE EO, NO LATEX Intended use:…
FDA Device · Class II · 2015-04-08 · Microtek Medical - Brand Name: Persona¿ Anterior Referencing Sizer with Locking Boom The Persona Anterior Referencing Sizer is a sterilizable instrument inten…
FDA Device · Class II · 2015-04-08 · Zimmer - Medtronic Dual Chamber Temporary External Pacemaker, Model 5392
FDA Device · Class II · 2015-04-08 · Medtronic Cardiac Rhythm Disease Management - INTEGRAL WAND W/TUBING, STERILE, REF 24185, QTY 24/CS, STERILE EO Intended use: The smoke evacuator and accessories are intended to evacuat…
FDA Device · Class II · 2015-04-08 · Microtek Medical - Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8, 10, 12 French,Sterile EO, Rx Only, Manufacturer Edwards Lifesciences LLC, Irvi…
FDA Device · Class II · 2015-04-08 · Edwards Lifesciences - BD FACSCalibur
FDA Device · Class II · 2015-04-08 · Bd Biosciences Systems And Reagents - Bio-MAC Cannula (Needle) Set
FDA Device · Class II · 2015-04-08 · Biologic Therapies - GE Inspection Technologies x|argos 160D system
FDA Device · Class II · 2015-04-01 · Ge Inspection Technologies - Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) staining
FDA Device · Class II · 2015-04-01 · Leica Microsystems - The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations
FDA Device · Class II · 2015-04-01 · Ossur H F - GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T,…
FDA Device · Class II · 2015-04-01 · Ge Healthcare - DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only
FDA Device · Class II · 2015-04-01 · In2bones Sas - MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A
FDA Device · Class II · 2015-04-01 · Siemens Medical Solutions Usa - da Vinci Xi Surgical System, IS4000
FDA Device · Class II · 2015-04-01 · Intuitive Surgical - Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting…
FDA Device · Class II · 2015-04-01 · Synthes - Ameda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouches with Tyvek header (9.5 x 13.63 x 3.75") within a secondary c…
FDA Device · Class II · 2015-04-01 · Ameda - Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125
FDA Device · Class I · 2015-04-01 · Cardiovascular Systems - Variable Angle Locking Peg, D:1.8mm x L:14.0mm
FDA Device · Class II · 2015-04-01 · Flower Orthopedics - Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425
FDA Device · Class II · 2015-04-01 · Advanced Sterilization Products - Penner Patient Stretcher/Transfer Lift System Models 391000-1 and 392000-1 The Pacific Stretcher/Transfer Lift is used with Whirlpool or Aq…
FDA Device · Class II · 2015-04-01 · Penner Mfg - Alaris PC units, Model No. 8015
FDA Device · Class II · 2015-04-01 · Carefusion 303 - da Vinci Xi Surgical System, IS4000
FDA Device · Class II · 2015-04-01 · Intuitive Surgical - ADVIA Chemistry Systems Drug Calibrator I
FDA Device · Class II · 2015-04-01 · Siemens Healthcare Diagnostics - Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upgraded to CDAS, Part Number: 9065 and 9067
FDA Device · Class II · 2015-04-01 · Philips Medical Systems - GE Inspection Technologies x|tome|x L240 an Cabinet X-ray system
FDA Device · Class II · 2015-04-01 · Ge Inspection Technologies - cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
FDA Device · Class III · 2015-04-01 · Roche Molecular Systems - RayStation Radiation Therapy Treatment Planning System
FDA Device · Class II · 2015-04-01 · Raysearch Laboratories Ab - Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile, Manufactured by Titan Spine, LLC. Endo TCS driver is one of the instrument…
FDA Device · Class II · 2015-04-01 · Titan Spine - da Vinci Xi Surgical System, IS4000
FDA Device · Class II · 2015-04-01 · Intuitive Surgical - Intraocular Lens (IOL), Part No. EC-3 PAL, Diopter: 17.5, 18.0, 18.5, 19.0, 19.5, 21.5, 23.5, 9.0, 22.5, 23.0, 21.0, 24.0. The device is in…
FDA Device · Class II · 2015-04-01 · Aaren Scientific - NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only
FDA Device · Class II · 2015-04-01 · Zimmer Trabecular Metal Technology - BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton Dickinson Infusion Therapy Systems…
FDA Device · Class II · 2015-04-01 · Becton Dickinson And - Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primary packaging is 12 pouches with Tyvek header (10.75 x 16.375 x…
FDA Device · Class II · 2015-04-01 · Ameda - ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures
FDA Device · Class II · 2015-04-01 · Brainlab Ag - Coblator II System, 120V. Product Usage: The Coblator II (Model RF8000E) is a bipolar, radiofrequency electrosurgical system designed for u…
FDA Device · Class II · 2015-04-01 · Arthrocare Medical - DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only
FDA Device · Class II · 2015-04-01 · In2bones Sas - BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerGlide Midline Catheter Full Kit (20G) (8cm), PowerGlide…
FDA Device · Class II · 2015-03-25 · Bard Access Systems - GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, all configurations
FDA Device · Class II · 2015-03-25 · Ge Healthcare - Triathlon Distal Capture Assembly Catalog No: 6541-1-723 The Triathlon Distal Capture Assembly is used when a surgeon elects to use a captu…
FDA Device · Class II · 2015-03-25 · Stryker Howmedica Osteonics - CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only
FDA Device · Class II · 2015-03-25 · Smiths Medical Asd - NovaPlus Brand Warm Gel Infant Heel Gel Warmer, Item # V6391 NovaPlus Brand Liquid Heal Warmer
FDA Device · Class II · 2015-03-25 · Coopersurgical - BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerLoc Port Access Kit 19G x 1 in, PowerLoc Port Access Ki…
FDA Device · Class II · 2015-03-25 · Bard Access Systems - Fisher Brand Gel Infant Heel Gel Warmers, Cat
FDA Device · Class II · 2015-03-25 · Coopersurgical - TactiSys Quartz Pack, PN-004 400
FDA Device · Class II · 2015-03-25 · St Jude Medical - Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Guides are intended to be used as part of the Signa…
FDA Device · Class II · 2015-03-25 · Materialise N V - Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves
FDA Device · Class II · 2015-03-25 · Sybron Dental Specialties - Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number 03.010.048) and the Thumb Screw for th…
FDA Device · Class II · 2015-03-25 · Synthes - Siemens LANTIS Oncology Information System Servers
FDA Device · Class II · 2015-03-25 · Siemens Medical Solutions Usa - GE Healthcare, Treadmill T2100 and Treadmill T2000 with power cord part numbers 408930-001 Rev E, 408930-002 Rev C, or 2028038-008 Rev B. A…
FDA Device · Class II · 2015-03-25 · Ge Healthcare - MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis
FDA Device · Class II · 2015-03-25 · Baxter Healthcare - GE Healthcare Engstrom Carestation, Engstrom Pro, Cart Only S/5 EC. GE model numbers 1505-8538-000, 1505-9000-000, and 1505-9003-000
FDA Device · Class II · 2015-03-25 · Ge Healthcare - N Latex IgM
FDA Device · Class III · 2015-03-25 · Siemens Healthcare Diagnostics - MediChoice WarmGel Infant Heel Warmer, Item # 1643069911 MediChoice Liquid Infant Heel Warmer, Item # 1643069912 Single Use and Disposable
FDA Device · Class II · 2015-03-25 · Coopersurgical - CooperSurgical Infant Heel Gel Warmers, P/N 20418 CooperSurgical The Infant Heal Warmer, P/N 2440 To provide gentle heat to increase blood…
FDA Device · Class II · 2015-03-25 · Coopersurgical - Elekta Precise Treatment Table
FDA Device · Class II · 2015-03-25 · Elekta - BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Bard Poly Midline 3F Full Tray (Single-Lumen) (with Microint…
FDA Device · Class II · 2015-03-25 · Bard Access Systems - Crea A and B membranes, packaged 4 per box Used in conjunction with the ABL800 FLEX analyzers which are intended for: In Vitro Testing of s…
FDA Device · Class II · 2015-03-25 · Radiometer America - Symbia E is a multi-purpose SPECT system used to detect or image the distribution of radionuclides in the body or organ, using the followin…
FDA Device · Class II · 2015-03-25 · Siemens Medical Solutions Usa - Medstream 81" (206 cm) 20 drop Universal Administration Sets
FDA Device · Class II · 2015-03-25 · Us Infusion - Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection and Alarms) Intended for intra hospital use under the direct s…
FDA Device · Class II · 2015-03-25 · Mindray Ds Usa - ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software
FDA Device · Class II · 2015-03-25 · Siemens Medical Solutions Usa - Puritan absorbent foam tipped applicator
FDA Device · Class II · 2015-03-25 · Puritan Medical Products - BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: SafeStep Port Access Kit 22G x 0.75in , SafeStep Port Access…
FDA Device · Class II · 2015-03-25 · Bard Access Systems - Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065
FDA Device · Class I · 2015-03-25 · Medtronic Cardiac Rhythm Disease Management - ML 7090 Calibrated LASIK Blade (CLB)
FDA Device · Class II · 2015-03-25 · Med Logics
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