FDA Device · 2016
FDA Device recalls in 2016
RecallRadar indexes 3,246 FDA Device recall notices published in 2016. By classification: 116 Class I, 3,050 Class II, 80 Class III.
- TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY Product Usage: Indicated to aid in tissu…
FDA Device · Class II · 2016-05-11 · Applied Medical Technology - TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize
FDA Device · Class II · 2016-05-11 · Applied Medical Technology - Poly-bags containing the strap labeled with "Adult" sticker
FDA Device · Class II · 2016-05-11 · Ferno Washington - VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Carolina 27712
FDA Device · Class II · 2016-05-11 · Biomerieux - MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, Model numbers 10432914, 10432915
FDA Device · Class II · 2016-05-11 · Siemens Medical Solutions Usa - GE, Revolution CT. The system is intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications
FDA Device · Class II · 2016-05-11 · Ge Medical Systems - Medtronic CareLink" Monitor (2490C) and Medtronic CareLink Express" Monitor (2020B) Product Usage: The 2490C CareLink Home Monitors and 202…
FDA Device · Class II · 2016-05-11 · Medtronic Cardiac Rhythm And Heart Failure - Analyst¿ MD Version 1.6.1 and 1.6.2 Software used with the following instruments: API 3200MD" LC/MS/MS System, Instrument Part Number: 5024…
FDA Device · Class II · 2016-05-11 · Ab Sciex - Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The Dialog+ can be used for implementing and monitoring hemodialysis…
FDA Device · Class I · 2016-05-11 · B Braun Medical - INFINITI Ultrasound Pack
FDA Device · Class II · 2016-05-11 · Alcon Research - Poly-bags containing splint strap labeled with "Pediatric" sticker
FDA Device · Class II · 2016-05-11 · Ferno Washington - Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery
FDA Device · Class II · 2016-05-11 · Medtronic Sofamor Danek Usa Dallas Distribution - Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B, 9000A/2B This system is designed to acquire CT images, PET i…
FDA Device · Class II · 2016-05-11 · Toshiba American Medical Systems - The Livongo Health In Touch¿ Blood Glucose Monitoring System (BGMS), is an Over-The-Counter (OTC) system designed for the self- monitoring…
FDA Device · Class II · 2016-05-11 · Livongo Health - Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Serial # >200318 and < 2039222 The Dialog+ can be used for implementi…
FDA Device · Class I · 2016-05-11 · B Braun Medical - ACUSON SC2000 Ultrasound imaging system with software version VB10C and using transesophageal (TEE) transducer Z6Ms, V5Ms or V7M. Model num…
FDA Device · Class II · 2016-05-11 · Siemens Medical Solutions Usa - Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128203, D128204, D128205, D128206 The Biosense Webster Pentaray…
FDA Device · Class II · 2016-05-11 · Biosense Webster - Smart CR Digital Computed Radiography System
FDA Device · Class II · 2016-05-11 · Fujifilm Medical Systems U - CARESTREAM Image Suite V4
FDA Device · Class II · 2016-05-11 · Carestream Health - HeartStart MRx Monitor/Defibrillator The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillat…
FDA Device · Class II · 2016-05-11 · Philips Electronics North America - Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL-BIC Product Code # 710200U Serial # 202136 and < 203837 The Dialog+ can be…
FDA Device · Class I · 2016-05-11 · B Braun Medical - Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V Product Code 710200K Serial # >202169 and < 203249 The Dialog+ can be used for…
FDA Device · Class I · 2016-05-11 · B Braun Medical - Wilson Implantation System Product Usage: Indicated to aid in tissue retraction during a surgical procedure
FDA Device · Class II · 2016-05-11 · Applied Medical Technology - Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208, D128209, D128210, D128211, D128212 The Biosense Webster Penta…
FDA Device · Class II · 2016-05-11 · Biosense Webster - GE Healthcare, Aisys and Aisys CS2. Intended to provide general inhalation anesthesia and ventilator support to a wide range of patients (n…
FDA Device · Class II · 2016-05-04 · Ge Medical Systems - ABX Pentra 400 (version 5.0.8 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use
FDA Device · Class II · 2016-05-04 · Horiba Instruments - Hardy Diagnostics GBS Detect Cat no
FDA Device · Class II · 2016-05-04 · Hardy Diagnostics - 5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile
FDA Device · Class II · 2016-05-04 · Synthes Usa Products - Drew Scientific Inc
FDA Device · Class II · 2016-05-04 · Jas Diagnostics Drew Scientific - Integra 3
FDA Device · Class II · 2016-05-04 · Research Instruments Site B - Trinity Acetabular System Product Usage - Total Hip Replacement
FDA Device · Class II · 2016-05-04 · Corin Usa - ACUSON X700 Ultrasound System with software version 1.0.04
FDA Device · Class II · 2016-05-04 · Siemens Medical Solutions Usa - Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic irradiation of head structures…
FDA Device · Class II · 2016-05-04 · Elekta - eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure)
FDA Device · Class II · 2016-05-04 · Philips Visicu - Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Cat
FDA Device · Class II · 2016-05-04 · Becton Dickinson And - EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000) with p5 software
FDA Device · Class II · 2016-05-04 · Intuitive Surgical - PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator
FDA Device · Class II · 2016-05-04 · Stryker Endoscopy - Pleur-evac Chest Drainage System, Dry Suction/Dry Seal Control, REF A-6000-08LF, Rx Only, Teleflex Medical
FDA Device · Class II · 2016-05-04 · Teleflex Medical - Panorama Patient Monitoring Network Mindray DS USA The Panorama Patient Monitoring can view recal time, store, print, graph and trend patie…
FDA Device · Class II · 2016-05-04 · Mindray Ds Usa - RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular…
FDA Device · Class II · 2016-05-04 · Mako Surgical - Pentra C400 (version 1.1.2 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use
FDA Device · Class II · 2016-05-04 · Horiba Instruments - Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03 Product Usage: Aquilion Lightning is a multislice he…
FDA Device · Class II · 2016-05-04 · Toshiba American Medical Systems - BD Trucount Absolute Counting Tubes: Model number: 340334 IVD
FDA Device · Class II · 2016-05-04 · Becton Dickinson And Bd Biosciences - ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only
FDA Device · Class II · 2016-05-04 · Ev3 - Automated peritoneal dialysis (APD) cycler
FDA Device · Class II · 2016-05-04 · Baxter Healthcare - X-Ray Diagnostic Table, Model No. YSF-300 Use in combination with an X-ray high voltage generator, an X-ray tube unit, an Image intensifier…
FDA Device · Class II · 2016-05-04 · Shimadzu Medical Systems - Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80
FDA Device · Class II · 2016-05-04 · Hansen Medical - reVive Light Therapy Pain Relief Device (Model Number: RVPNSYS) Product Usage: The reVive Light Therapy Pain Relief Device is a device desi…
FDA Device · Class II · 2016-05-04 · Led Technologies - CF InPlex ASR Card
FDA Device · Class II · 2016-05-04 · Hologic - Trinity Acetabular Shell Product Usage: Total Hip Replacement
FDA Device · Class II · 2016-05-04 · Corin Usa - Trinity Acetabular Shell Product Usage Total Hip Replacement
FDA Device · Class II · 2016-05-04 · Corin Usa - Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm Material Number: M00576550 The stent system is a perma…
FDA Device · Class II · 2016-05-04 · Boston Scientific - Spirit One A-C Powered Hospital Bed
FDA Device · Class II · 2016-05-04 · Stryker Medical Division - Hologic InPlex CF Molecular Test (IVD)
FDA Device · Class II · 2016-05-04 · Hologic - SOMATOM Force, Computed Tomography x-ray system intended to generate and process cross-sectional images of patients by computer reconstruct…
FDA Device · Class II · 2016-05-04 · Siemens Medical Solutions Usa - 3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL
FDA Device · Class II · 2016-05-04 · 3m Health Care Business - NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body computed tomography X-ray system featuring a continuously rotating X-…
FDA Device · Class II · 2016-05-04 · Philips And Neusoft Medical Systems - Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems
FDA Device · Class II · 2016-05-04 · Roche Molecular Systems - enGen (TM) Laboratory Automation System configured with Thermo Scientific Recapper Module (230V or 110V -- COMMON/USUAL NAME: enGen (TM) Tr…
FDA Device · Class II · 2016-05-04 · Ortho Clinical Diagnostics - Spirit One A-C Powered Hospital Bed
FDA Device · Class II · 2016-05-04 · Stryker Medical Division - Siemens SOMATOM Definition, SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM Definition Edge
FDA Device · Class II · 2016-04-27 · Siemens Medical Solutions Usa - ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD The ADVIA 560 Hematology System is a fully-automated, high-qualit…
FDA Device · Class II · 2016-04-27 · Siemens Healthcare Diagnostics - Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001
FDA Device · Class I · 2016-04-27 · Boston Scientific - TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE R, REF 12 000 027, S&N 7500282, Smith & Nephew Orthopaedics A…
FDA Device · Class II · 2016-04-27 · Smith And Nephew - TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE R, REF 12 000 0013, S&N 7500268, Smith & Nephew Orthopaedics…
FDA Device · Class II · 2016-04-27 · Smith And Nephew - TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 2 RIGHT, STERILE R, REF 12 000 009, S&N 7500264, Smith & Nephew Orthopaedics AG…
FDA Device · Class II · 2016-04-27 · Smith And Nephew - TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE R, REF 12 000 025, S&N 7500280, Smith & Nephew Orthopaedics AG…
FDA Device · Class II · 2016-04-27 · Smith And Nephew - Ossur Lil Angel Vest P3 Lambswool
FDA Device · Class II · 2016-04-27 · Ossur H F - iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0.0.127 (USA only) and 2016.1.0.127 (out of US) Opthalmic: iVue…
FDA Device · Class II · 2016-04-27 · Optovue - Ossur Lil Angel Vest P2 Sorbatex
FDA Device · Class II · 2016-04-27 · Ossur H F - TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 12 RIGHT, STERILE R, REF 12 000 028, S&N 7500283, Smith & Nephew Orthopaedics A…
FDA Device · Class II · 2016-04-27 · Smith And Nephew - TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000 005, S&N 7500260, Smith & Nephew Orthopaedics AG P…
FDA Device · Class II · 2016-04-27 · Smith And Nephew - TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE R, REF 12 000 0011, S&N 7500266, Smith & Nephew Orthopaedics A…
FDA Device · Class II · 2016-04-27 · Smith And Nephew - OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming proficient at reading specimens with antibody levels near…
FDA Device · Class III · 2016-04-27 · Orasure Technologies - Acorn 180 Curved Stairlift
FDA Device · Class II · 2016-04-27 · Acorn Stairlifts - IntelliSpace Portal DX/HX/EX AutoSPECT Pro Software Application, Philips Medical Systems, Cleveland, OH. Provides software applications use…
FDA Device · Class II · 2016-04-27 · Philips Medical Systems Cleveland - Siemens SOMATOM Definition: Intended to produce cross-sectional images of the body
FDA Device · Class II · 2016-04-27 · Siemens Medical Solutions Usa - Ossur Lil Angel Vest P2 Lambswool
FDA Device · Class II · 2016-04-27 · Ossur H F - TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 6 LEFT, STERILE R, REF 12 000 018, S&N 7500273, Smith & Nephew Orthopaedics AG P…
FDA Device · Class II · 2016-04-27 · Smith And Nephew - MEVION S250 for Proton Radiation Therapy
FDA Device · Class II · 2016-04-27 · Mevion Medical Systems - Robotic Arm Interactive Orthopedic System (RIO)
FDA Device · Class II · 2016-04-27 · Mako Surgical - TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 4 RIGHT, STERILE R, REF 12 000 024, S&N 7500279, Smith & Nephew Orthopaedics AG…
FDA Device · Class II · 2016-04-27 · Smith And Nephew - Cervical Spine Locking Plate (CSLP) System, 4mm Cancellous Self Tapping Screw, Length 16mm Lot # 9666776 and 4mm Cortex Standard Screw, Len…
FDA Device · Class II · 2016-04-27 · Synthes Usa Products - TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000 019, S&N 7500274, Smith & Nephew Orthopaedics AG P…
FDA Device · Class II · 2016-04-27 · Smith And Nephew - Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit
FDA Device · Class III · 2016-04-27 · Biocare Medical - TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 2 LEFT, STERILE R, REF 12 000 002, S&N 7500257, Smith & Nephew Orthopaedics AG P…
FDA Device · Class II · 2016-04-27 · Smith And Nephew - Self-Cath¿ Pediatric Catheter Size CH 06, Product # 5044101400, Catakig # 306
FDA Device · Class II · 2016-04-27 · Coloplast Manufacturing Us - Siemens SOMATOM Definition Flash
FDA Device · Class II · 2016-04-27 · Siemens Medical Solutions Usa - Ad-Tech Electrode Connection System/Cables
FDA Device · Class II · 2016-04-27 · Ad Tech Medical Instrument - CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD
FDA Device · Class II · 2016-04-27 · Abbott Laboratories - Ossur Lil Angel Vest P2 Kodel
FDA Device · Class II · 2016-04-27 · Ossur H F - Ossur Lil Angel Vest P3 Sorbatex
FDA Device · Class II · 2016-04-27 · Ossur H F - Siemens SOMATOM Definition AS
FDA Device · Class II · 2016-04-27 · Siemens Medical Solutions Usa - Ossur Lil Angel Vest P3 Kodel
FDA Device · Class II · 2016-04-27 · Ossur H F - GDC-10 360 SOFT 10MM X 20CM SR Detachable Coil Sterile
FDA Device · Class II · 2016-04-27 · Stryker Neurovascular - TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 4 LEFT, STERILE R, REF 12 000 017, S&N 7500272, Smith & Nephew Orthopaedics AG P…
FDA Device · Class II · 2016-04-27 · Smith And Nephew - GDC-18 360 11MM X 30CM Detachable Coil Sterile
FDA Device · Class II · 2016-04-27 · Stryker Neurovascular - Extended Brilliance Workspace NM Nuclear medicine image display and processing application suite
FDA Device · Class II · 2016-04-27 · Philips Medical Systems Cleveland - The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit patient(s) physiological measurements and data to…
FDA Device · Class II · 2016-04-27 · Spacelabs Healthcare - Extended Brilliance Workspace NM Special Nuclear medicine image display and processing application suite
FDA Device · Class II · 2016-04-27 · Philips Medical Systems Cleveland
Other years
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