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.
- NovoCut Suture Manager
FDA Device · Class II · 2015-11-18 · Ceterix Orthopedics - Philips HeartStart MRx Monitor/Defibrillator Models:M3535A, M3536A, M3536M, M3536MC, M3536M4, M3536M5 The HeartStart MRx is for use for the…
FDA Device · Class II · 2015-11-18 · Philips Medical Systems - RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Extra Support
FDA Device · Class I · 2015-11-18 · Boston Scientific - TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811
FDA Device · Class II · 2015-11-18 · Tekia - Rusch Flexi-slip tracheal tube Stylet, Size Ch 6, Sterile, Teleflex Medical
FDA Device · Class II · 2015-11-18 · Teleflex Medical - Shimadzu C-arm Table, Catalog No. IVS-110, Medical Imaging Table
FDA Device · Class II · 2015-11-18 · Shimadzu Medical Systems - Villa Sistemi Rotograph EVO 3D X-ray
FDA Device · Class II · 2015-11-18 · Villa Radiology Systems - Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). Intended to provide defibrillation therapy
FDA Device · Class II · 2015-11-18 · Boston Scientific - Biomet 3i Narrow Right Angle Large Driver Tip (Hexed)
FDA Device · Class II · 2015-11-18 · Biomet 3i - Smooth Muscle Action (SMA) Immunohistochemistry reagent
FDA Device · Class II · 2015-11-18 · Biocare Medical - Biomet 3i Narrow Right Angle Square Driver Tip
FDA Device · Class II · 2015-11-18 · Biomet 3i - Triton Infusion Pump (model 300000) and Triton fp Infusion Pump (model 400000) (proprietary name: AFF (Mark I) Volumetric Infusion Pump)
FDA Device · Class II · 2015-11-18 · Walkmed Infusion - CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans
FDA Device · Class II · 2015-11-18 · Innokas Medical Oy - Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy
FDA Device · Class II · 2015-11-18 · Neurologica - GE Healthcare, SIGNA PET/MR 3.0T. Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron…
FDA Device · Class II · 2015-11-18 · Ge Healthcare - RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy
FDA Device · Class I · 2015-11-18 · Boston Scientific - DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE or…
FDA Device · Class II · 2015-11-18 · Deroyal Industries - Owandy Radiology I -MAX Touch 3D X-ray
FDA Device · Class II · 2015-11-18 · Villa Radiology Systems - Access CEA Assay, Part No. 33200
FDA Device · Class II · 2015-11-18 · Beckman Coulter - Ventilator Tubing
FDA Device · Class II · 2015-11-18 · Instrumentation Industries - GE Healthcare, SIGNA HDx 3.0T. Product Usage: The GE Signa HDx MR system is a whole body magnetic resonance scanner for use as a diagnostic…
FDA Device · Class II · 2015-11-18 · Ge Healthcare - Amphirion Deep OTW PTA Balloon Catheter: Model numbers: US: AMP015020152 AMP020150152 AMP025120152 AMP030080152 AMP040040152 AMP225210152 A…
FDA Device · Class II · 2015-11-18 · Medtronic Vascular - SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades Surgical drill bits, blades, burs, chisels, rasps, taps and rea…
FDA Device · Class II · 2015-11-18 · Stryker Sustainability Solutions - Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units
FDA Device · Class III · 2015-11-11 · C R Bard - GEMINI PET/CT System, a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-…
FDA Device · Class II · 2015-11-11 · Philips Medical Systems Cleveland - e.cam Gamma Camera, an emission computed tomography system
FDA Device · Class II · 2015-11-11 · Siemens Medical Solutions Usa - Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is a system intended for the disp…
FDA Device · Class II · 2015-11-11 · Brainlab Ag - MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS. UPDATE 11-4-2015: Model M0001SS
FDA Device · Class II · 2015-11-11 · Ge Medical Systems - Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack
FDA Device · Class II · 2015-11-11 · Resource Optimization And Innovation - Surgical Display, Model No. MDSC-2224 (24 inch), Model No. MDSC-2226 (26 inch) and Model No. MDSC-2242 (42 inch)
FDA Device · Class II · 2015-11-11 · Barco - Envoy 500 system includes the following product reference numbers and names: 55345 ENVOY 500 Glucose 55450 ENVOY 500 URIC ACID REAGENT KIT…
FDA Device · Class II · 2015-11-11 · Elitech Clinical Systems Sas - Eon 300 system includes the following product reference numbers and names: Reference no. 79345 Glucose (GPSL) Reference no. 79450 Uric acid…
FDA Device · Class II · 2015-11-11 · Elitech Clinical Systems Sas - Custom Pak 9319-27
FDA Device · Class II · 2015-11-11 · Alcon Research - FLAIR Endovascular Stent Graft, Product Code: FAS08070, FAF08070, Implant Size: 8mmx70mm The FLAIR Endovascular Stent Graft (implant) is a…
FDA Device · Class II · 2015-11-11 · Bard Peripheral Vascular - HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31
FDA Device · Class I · 2015-11-11 · Hamilton Medical - SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or catheter inserted into the patient'…
FDA Device · Class II · 2015-11-11 · Carefusion 303 - MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System
FDA Device · Class II · 2015-11-11 · Biomet Spine - MATResponder Tourniquet
FDA Device · Class II · 2015-11-11 · Pyng Medical - ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems that utilize the Trinder Reaction method
FDA Device · Class II · 2015-11-11 · Elitech Clinical Systems Sas - Arthroscopic Energy 50¿ Probe with Suction, Catalog number: AES-50S Peoduct Usage: For resection, ablation, and coagulation of soft tissue…
FDA Device · Class II · 2015-11-11 · Conmed - VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040, Unique Device Identifier No. 10758750005031, IVD -- Orth…
FDA Device · Class III · 2015-11-11 · Ortho Clinical Diagnostics - Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fix…
FDA Device · Class II · 2015-11-11 · Exactech - Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental sealant. -- ivoclar…
FDA Device · Class II · 2015-11-11 · Ivoclar A G - iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle
FDA Device · Class II · 2015-11-11 · Otto Bock Healthcare - Medtronic Achieve Cables, model 990066
FDA Device · Class II · 2015-11-11 · Medtronic - Eon 100 system included the following product reference numbers and names: Reference no. 77345- Glucose (GPSL) Reference no. 77450- Uric ac…
FDA Device · Class II · 2015-11-11 · Elitech Clinical Systems Sas - Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A
FDA Device · Class II · 2015-11-11 · Philips Medical Systems - Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path
FDA Device · Class II · 2015-11-11 · Baxter Healthcare - HeartStart MRx monitor/defibrillator Models M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage: The…
FDA Device · Class II · 2015-11-11 · Philips Medical Systems - The Centricity Universal Viewer Version is a device that displays medical images (including mammograms) and data from various imaging sourc…
FDA Device · Class II · 2015-11-11 · Ge Healthcare - Robotic hand accessory to InMotion Arm, rehabilitation robot
FDA Device · Class II · 2015-11-11 · Interactive Motion Technologies - ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantage5 Pressure Injectable PICC Kit Arrow¿ Pressure I…
FDA Device · Class II · 2015-11-11 · Arrow International - Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile
FDA Device · Class II · 2015-11-11 · Stryker Spine - BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A), Product Order Number Biotrue SVS - 7201, STERILE, Rx Only
FDA Device · Class II · 2015-11-11 · Bausch And Lomb Irb - Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector)
FDA Device · Class II · 2015-11-11 · Mako Surgical - AMSCO 400 and AMSCO C Small Steam Sterilizers
FDA Device · Class III · 2015-11-11 · Steris - The Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging…
FDA Device · Class II · 2015-11-11 · Ge Healthcare - EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) En…
FDA Device · Class II · 2015-11-11 · Dako North America - VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemist…
FDA Device · Class II · 2015-11-11 · Ortho Clinical Diagnostics - Regard, Item Number 830565001, CV0654A - PEDIATRIC HEART - Custom surgical kit for cardiovascular surgery
FDA Device · Class II · 2015-11-04 · Resource Optimization And Innovation - Regard, Item Number 830045, CV0443D - CV BUNDLE - Custom surgical kit for cardiovascular surgery
FDA Device · Class II · 2015-11-04 · Resource Optimization And Innovation - Signature Patient-Specific Surgical Guides
FDA Device · Class II · 2015-11-04 · Materialise N V - Regard, Item Number 830500003, Sterile, CV0578C - CV PACK - Custom surgical kit for surgery
FDA Device · Class II · 2015-11-04 · Resource Optimization And Innovation - ADVIA Chemistry XPT Chemistry Systems, Siemens Material Number (SMN) 10723034
FDA Device · Class II · 2015-11-04 · Siemens Healthcare Diagnostics - Synthes Threaded Plate Holder- Long for 3.5mm Locking Hold
FDA Device · Class II · 2015-11-04 · Synthes Usa Products - BG cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 048103
FDA Device · Class II · 2015-11-04 · Lifehealth - Ingenuity Core 128 Computed Tomography X-ray systems
FDA Device · Class II · 2015-11-04 · Philips Medical Systems Cleveland - Integra¿ Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devices and components used to perform bone marrow biopsies are pla…
FDA Device · Class II · 2015-11-04 · Integra Lifesciences D B A Integra Pain Management - Brilliance 16-Slice (Air) Computed Tomography X-ray systems
FDA Device · Class II · 2015-11-04 · Philips Medical Systems Cleveland - ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License
FDA Device · Class II · 2015-11-04 · Varian Medical Systems - 2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm
FDA Device · Class II · 2015-11-04 · Synthes Usa Products - Regard, Item Number 800500002, Sterile, CV0578B - CV PACK- Custom surgical kit for surgery
FDA Device · Class II · 2015-11-04 · Resource Optimization And Innovation - ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for In Vitro diagnostic use only
FDA Device · Class II · 2015-11-04 · Abbott Laboratories - Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replac…
FDA Device · Class II · 2015-11-04 · Encore Medical - Welch Allyn KleenSpec Corded Illumination System, Vaginal Speculum Lighting System, Model Number 78x Series Illuminator, REF 901070, Catalo…
FDA Device · Class II · 2015-11-04 · Welch Allyn - ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, MEVATRON M2/PRIMUS Mid-Energy, ARTISTE
FDA Device · Class II · 2015-11-04 · Siemens Medical Solutions Usa - BD CD3 (SK7) FITC
FDA Device · Class III · 2015-11-04 · Becton Dickinson And Bd Biosciences - Reverse Shoulder Prosthesis Stem Impaction Fixture REF 804-03-053 The Turon and RSP Impaction Fixtures are used in the operating room on th…
FDA Device · Class II · 2015-11-04 · Encore Medical - CC cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 039903
FDA Device · Class II · 2015-11-04 · Lifehealth - Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood access device for blood purification and for other treatments…
FDA Device · Class II · 2015-11-04 · Nipro Medical - Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy
FDA Device · Class II · 2015-11-04 · Elekta - Regard, Item Number 830054002, CV00625B - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery
FDA Device · Class II · 2015-11-04 · Resource Optimization And Innovation - Regard, Item Number 830019, CV0214H -Custom surgical kit for cardiovascular surgery
FDA Device · Class II · 2015-11-04 · Resource Optimization And Innovation - CIOS ALPHA
FDA Device · Class II · 2015-11-04 · Siemens Medical Solutions Usa - Regard, Item Number 800301001, Sterile, CV0708A - OPEN HEART- Custom surgical kit for cardiovascular surgery
FDA Device · Class II · 2015-11-04 · Resource Optimization And Innovation - Ingenuity Flex Computed Tomography X-ray systems
FDA Device · Class II · 2015-11-04 · Philips Medical Systems Cleveland - Regard, Item Number 830054001, CV00625A - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery
FDA Device · Class II · 2015-11-04 · Resource Optimization And Innovation - Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00 Product Usage: The CardioCall…
FDA Device · Class II · 2015-11-04 · Spacelabs Healthcare - Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement
FDA Device · Class II · 2015-11-04 · Sentinel Ch Spa - Turon Shoulder Impaction Fixture REF 804-15-102 The Turon and RSP Impaction Fixtures are used in the operating room on the back table to as…
FDA Device · Class II · 2015-11-04 · Encore Medical - Brilliance Big Bore (Oncology & Radiology) Computed Tomography X-ray systems
FDA Device · Class II · 2015-11-04 · Philips Medical Systems Cleveland - Brilliance 64 Computed Tomography X-ray systems
FDA Device · Class II · 2015-11-04 · Philips Medical Systems Cleveland - ACUSON SC2000 ultrasound systems model 10433816 Imaging system that provides the ability to measure anatomical structures and calculation p…
FDA Device · Class II · 2015-11-04 · Siemens Medical Solutions Usa - Perkin Elmer Specimen Gate, Screening Center
FDA Device · Class II · 2015-11-04 · Perkin Elmer Life Sciences - Ingenuity Core Computed Tomography X-ray systems
FDA Device · Class II · 2015-11-04 · Philips Medical Systems Cleveland - ConForMIS Unicondylar Knee Replacement System iUNI G2, Left Medial Catalog Number: M57220600210(US) M5722INT0600210 (OUS)
FDA Device · Class II · 2015-10-28 · Conformis - Thinflap System Case The cases hold surgical instrumentation in place during handling and storage
FDA Device · Class II · 2015-10-28 · Biomet Microfixation - All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software
FDA Device · Class II · 2015-10-28 · Philips Medical Systems - Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile Part Number: 7209234 Intended Use: For arthroscopic (knee and…
FDA Device · Class II · 2015-10-28 · Smith And Nephew Endoscopy Div - Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 8.5 mm, Sterile Part Number: 7209237 Intended Use: For arthroscopic (knee and…
FDA Device · Class II · 2015-10-28 · Smith And Nephew Endoscopy Div
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