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.
- AQUAPAK 340 SW, 340 ML W/404 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or ste…
FDA Device · Class II · 2015-02-18 · Teleflex Medical - The SurgiWrap Bioresorbable Adhesion Barrier Film
FDA Device · Class II · 2015-02-18 · Mast Biosurgery Usa - MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB) Right Product Usage: MEDPOR Implants in block, sheet and pre-fo…
FDA Device · Class II · 2015-02-18 · Stryker Craniomaxillofacial Division - MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg
FDA Device · Class I · 2015-02-18 · Teleflex Medical - Timberline Cranial Caudal and Posterior Blades, 40 - 180mm Model # 8734-2XXX, 8734-5XXX is a reusable device provided within an aluminum st…
FDA Device · Class II · 2015-02-18 · Biomet Spine - ARROW Epidural Needle Component (product number AN-05501)
FDA Device · Class II · 2015-02-18 · Arrow International - Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces
FDA Device · Class II · 2015-02-18 · Synthes - Telluride Percutaneous Rod Inserter Long, Model #7706-1904
FDA Device · Class II · 2015-02-18 · Biomet Spine - ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730
FDA Device · Class II · 2015-02-18 · Siemens Medical Solutions Usa - The Siemens Symbia S series is intended to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and…
FDA Device · Class II · 2015-02-18 · Siemens Medical Solutions Usa - AQUAPAK 340 SW, 340 ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water…
FDA Device · Class II · 2015-02-18 · Teleflex Medical - VisiPlugST for the Lacrimal Efficiency Test
FDA Device · Class III · 2015-02-18 · Lacrimedics - MEDPOR BARRIER Sheets Rectangle Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing ap…
FDA Device · Class II · 2015-02-18 · Stryker Craniomaxillofacial Division - AQUAPAK 340 SW, 340, ML W/040, ADAPTOR, JAPA. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile wate…
FDA Device · Class II · 2015-02-18 · Teleflex Medical - Hemodialysis Catheters and PICCs: Product identification: MCDLTSL24P (SF X 24CM LT HEMO-CATH), MC061422 (14FX15CM SLX DBL LMN ST CATH), MRC…
FDA Device · Class II · 2015-02-18 · Medical Components - da Vinci Si Surgical System, IS3000
FDA Device · Class II · 2015-02-11 · Intuitive Surgical - Animas Vibe Insulin Infusion Pump
FDA Device · Class II · 2015-02-11 · Animas - FORUM Archive and Viewer, version 3.1, v 3.1.1, (DVD Format) and v 3.2, v 3.2.1.(DVD and USB Flash Drive Format)
FDA Device · Class II · 2015-02-11 · Carl Zeiss Meditec Ag - Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan BennettTM 980 Ventilator System is designed fo…
FDA Device · Class II · 2015-02-11 · Covidien Formerly Nellcor Puritan Bennett - Plum A+ Infusion System with Hospira MedNet List 20792-04-25, Pole Clamp Assembly Part Number 820-95443-008
FDA Device · Class II · 2015-02-11 · Hospira - BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection
FDA Device · Class II · 2015-02-11 · Becton Dickinson And - ACUSON SC2000 Ultrasound System, Model 10433816, component 10040596 - UILK2. The SC2000 ultrasound imaging system is intended for the follo…
FDA Device · Class II · 2015-02-11 · Siemens Medical Solutions Usa - Zimmer PERSONA Tibial Articular Surface Inserter
FDA Device · Class II · 2015-02-11 · Zimmer - DrugCheck Ketamine Dip Test 31317-3P PRO-EU-SWE, 31226-3-CA-GML, 30842 TR, 30108C, 30108C CAN, 30108C EU, and 30108C INT. This assay provid…
FDA Device · Class II · 2015-02-11 · Express Diagnostics Int L - KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, Rx only, STERILE R. For use with spinal fixation de…
FDA Device · Class II · 2015-02-11 · Medtronic Sofamor Danek Usa - G- Series Beds
FDA Device · Class II · 2015-02-11 · Invacare - Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E Intended for cementless application in a total hip arthroplasty proc…
FDA Device · Class II · 2015-02-11 · Stryker Howmedica Osteonics - SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory information system to be used in a medical research or clinical labora…
FDA Device · Class II · 2015-02-11 · Scc Soft Computer - Fresenius Crit Line in a Clip (CLiC) with SW version 2.51 Model Number: CL10041001
FDA Device · Class II · 2015-02-11 · Fresenius Medical Care Holdings - 16cm Minimally Invasive Attachment
FDA Device · Class II · 2015-02-11 · The Anspach Effort - Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to facilitate intubation
FDA Device · Class II · 2015-02-11 · Cardinal Health - Covidien Trellis-8 Peripheral Infusion System
FDA Device · Class I · 2015-02-11 · Covidien - LINAC Accelerators: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, Mevatron M2/Primus Mi…
FDA Device · Class II · 2015-02-11 · Siemens Medical Solutions Usa - Covidien Trellis-6 Peripheral Infusion System
FDA Device · Class I · 2015-02-11 · Covidien - MobileDiagnost wDR motorized portable diagnostic X-ray systems
FDA Device · Class II · 2015-02-11 · Sedecal - ABL90 FLEX analyzer
FDA Device · Class II · 2015-02-11 · Radiometer America - Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001
FDA Device · Class II · 2015-02-11 · Shape Medical Systems - Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid path
FDA Device · Class II · 2015-02-11 · Baxter Healthcare - Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
FDA Device · Class II · 2015-02-11 · Roche Diagnostics Operations - SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to administer fluid and medications through a n…
FDA Device · Class II · 2015-02-11 · Carefusion 303 - Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Catalog Number: 42-5279-002-00 thru 42-5279-009-04
FDA Device · Class II · 2015-02-11 · Zimmer - Beckman Coulter, Uric Acid Assay, Catalog No. OSR6X98
FDA Device · Class II · 2015-02-04 · Beckman Coulter - Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1
FDA Device · Class II · 2015-02-04 · Sunrise Medical Us - The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop (operator console),…
FDA Device · Class II · 2015-02-04 · Ge Healthcare - HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only -- Fresenius Kabi U…
FDA Device · Class II · 2015-02-04 · Fresenius Kabi Usa - Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing
FDA Device · Class III · 2015-02-04 · Arrow International - The Synthes Mandible External Fixator
FDA Device · Class II · 2015-02-04 · Synthes - Beckman Coulter, Lactate Assay, Catalog No. OSR6X93
FDA Device · Class II · 2015-02-04 · Beckman Coulter - Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16
FDA Device · Class II · 2015-02-04 · Beckman Coulter - Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Heparin for Gases and Electrolytes
FDA Device · Class III · 2015-02-04 · Smiths Medical Asd - Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-…
FDA Device · Class II · 2015-02-04 · Siemens Medical Solutions Usa - 2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be used for bending and/or cutting Mandible Locking Plat…
FDA Device · Class II · 2015-02-04 · Synthes - Beckman Coulter, Lipase Assay, Catalog No. OSR6X30
FDA Device · Class II · 2015-02-04 · Beckman Coulter - VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only)
FDA Device · Class II · 2015-02-04 · Innokas Medical Oy - ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T Hemodialysis Machine, 2008K Hemodialysis Delivery E…
FDA Device · Class II · 2015-02-04 · Fresenius Medical Care Holdings - Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Containers, Approximate Length 85" (2.2 m)
FDA Device · Class II · 2015-02-04 · Baxter Healthcare - Quickie Q7 Adult Rigid Wheelchair Model EIR4
FDA Device · Class II · 2015-02-04 · Sunrise Medical Us - Syngo.plaza: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, di…
FDA Device · Class II · 2015-02-04 · Siemens Medical Solutions Usa - Verasense Knee System, Model SYK-TRCR 02
FDA Device · Class II · 2015-02-04 · Orthosensor - Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
FDA Device · Class II · 2015-02-04 · Clinical Innovations - HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis
FDA Device · Class II · 2015-02-04 · Baxter Healthcare - BrightView model number: 882478 BrightView X model number: 882480 BrightView XCT model number: 882482 and 882454 Medical Device for imaging
FDA Device · Class II · 2015-02-04 · Philips Medical Systems Cleveland - Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventric…
FDA Device · Class II · 2015-02-04 · Aesculap - Airo Mobile Intraoperative CT I Airo
FDA Device · Class II · 2015-02-04 · Mobius Imaging - TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet Tegris OR Integration System is designed to be used as the central operatin…
FDA Device · Class II · 2015-01-28 · Maquet Medical Systems Usa - Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0166, exp. 31-Jul-2015: Product Usage: Multi-Lume…
FDA Device · Class II · 2015-01-28 · Arrow International - CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046
FDA Device · Class II · 2015-01-28 · Bd Biosciences Systems And Reagents - The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis Catheterization Set, Long-Term Access,…
FDA Device · Class II · 2015-01-28 · Arrow International - cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test
FDA Device · Class III · 2015-01-28 · Roche Molecular Systems - Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and re…
FDA Device · Class II · 2015-01-28 · Cordis - FLUTTER Percussor respiratory device, packaged one unit per clear plastic package
FDA Device · Class II · 2015-01-28 · Aptalis Pharmatech - Powered stretcher chair used during facial and eye surgeries
FDA Device · Class II · 2015-01-28 · Transmotion Medical - Philips IntelliVue TcG10
FDA Device · Class II · 2015-01-28 · Philips Medical Systems - Anti-Lambda APC-H7, Catalog Number 656157
FDA Device · Class II · 2015-01-28 · Bd Biosciences Systems And Reagents - VITROS Software Version 3.1 utilized on the following systems: 1) 4600 Chemistry Systems (VITROS 5,1 FS System family member, 2) 5600 Integ…
FDA Device · Class III · 2015-01-28 · Ortho Clinical Diagnostics - PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. ImmucorGamma LIFECODES PF4 IgG (catalog numbers HAT13G, H…
FDA Device · Class II · 2015-01-28 · Genetic Testing Institute - Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho license
FDA Device · Class II · 2015-01-28 · Siemens Medical Solutions Usa - Ferno Model 35X PROFlexx Stretchers, one unit per package
FDA Device · Class II · 2015-01-28 · Ferno Washington - Fitness Gear Inversion table (Style STE00059FG or Style STE00118FG), Distributed by ASLI, Wilmington, DE (on carton), Paradigm Health & Wel…
FDA Device · Class II · 2015-01-28 · Dick S Sporting Goods - Lotus TAVR 23mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System
FDA Device · Class I · 2015-01-21 · Boston Scientific - lnline Persuader- PedFuse Pedicle Screw System
FDA Device · Class II · 2015-01-21 · Spinefrontier - VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Catalog Number 6802445, IVD --- Ortho Clinical Diagnostics
FDA Device · Class II · 2015-01-21 · Ortho Clinical Diagnostics - MUM-1 (Multiple myeloma oncogene-1), catalog number PRM352 AA
FDA Device · Class II · 2015-01-21 · Biocare Medical - GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner
FDA Device · Class II · 2015-01-21 · Ge Healthcare - MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer
FDA Device · Class II · 2015-01-21 · Mentor Texas - Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous dental implant drill set
FDA Device · Class II · 2015-01-21 · Straumann Usa - GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize
FDA Device · Class II · 2015-01-21 · Ge Oec Medical Systems - GE Healthcare, Discovery IGS 730 & Discovery IGS 740
FDA Device · Class II · 2015-01-21 · Ge Healthcare - iPlan RT Dose is a stereotactic radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned,…
FDA Device · Class II · 2015-01-21 · Brainlab Ag - Symbia T and Symbia T2 computer tomography systems
FDA Device · Class II · 2015-01-21 · Siemens Medical Solutions Usa - Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094141, 10280959: dedicated angiography systems developed for sing…
FDA Device · Class II · 2015-01-21 · Siemens Medical Solutions Usa - VITROS 5600 Integrated System, Catalog Number 6802413, IVD --- Ortho Clinical Diagnostics
FDA Device · Class II · 2015-01-21 · Ortho Clinical Diagnostics - Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries
FDA Device · Class II · 2015-01-21 · Ziemer Usa - POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc
FDA Device · Class II · 2015-01-21 · Medtronic Sofamor Danek Usa - SOMATOM Force
FDA Device · Class II · 2015-01-21 · Siemens Medical Solutions Usa - Columbia Agar with 5% Sheep Blood Columbia Agar with 5% Sheep Blood is a general purpose culture medium used for the growth and recovery of…
FDA Device · Class II · 2015-01-21 · Becton Dickinson And - Artis Q, and Artis Q.zen ceiling systems
FDA Device · Class II · 2015-01-21 · Siemens Medical Solutions Usa - Labeled in part: I Color Complete / Color Lens, blister packing, 14.5mm. (Additional colors include: 1) Illusion style, Chestnut Brown, Vio…
FDA Device · Class II · 2015-01-21 · Intertrade Imports - IC PROFILER-MR - Model 1123
FDA Device · Class II · 2015-01-21 · Sun Nuclear - Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205
FDA Device · Class II · 2015-01-21 · Biomet Spine
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)