FDA Device · 2014
FDA Device recalls in 2014
RecallRadar indexes 3,059 FDA Device recall notices published in 2014. By classification: 558 Class I, 2,441 Class II, 60 Class III.
- MIS Rod 2, a component of the NewPort System
FDA Device · Class II · 2014-07-09 · Integra Lifesciences - McKesson Medi-Pak, Laceration Trays with Cotton O.R. Towels, Sterile, Single Use, Latex Free, 20 Each per Case, Rx only, Distributed by: Mc…
FDA Device · Class II · 2014-07-09 · Medical Action Industries - BrightView XCT: product code 882482, BrightView X- upgraded with the XCT Flat Panel Detector (FPD): product code 882454
FDA Device · Class II · 2014-07-09 · Philips Medical Systems Cleveland - illumipro-10 Incubator/Reader, Meridian Bioscience, Inc
FDA Device · Class II · 2014-07-09 · Meridian Bioscience - Laceration/Suture Removal, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC
FDA Device · Class II · 2014-07-09 · Medical Action Industries - NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 7. Part of the NexGen syste…
FDA Device · Class II · 2014-07-09 · Zimmer - Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral
FDA Device · Class II · 2014-07-09 · Blue Belt Technologies Mn - NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 2. Part of the NexGen syste…
FDA Device · Class II · 2014-07-09 · Zimmer - HydroFinity Hydrophilic guidewire
FDA Device · Class I · 2014-07-02 · Nitinol Devices And Components - HydroFinity Hydrophilic guidewire
FDA Device · Class I · 2014-07-02 · Nitinol Devices And Components - ANSPACH***REF-98-0062***Custom Device eMax2 Plus Hand Control***Rx Only*** This device is intended to be used with Anspach Systems
FDA Device · Class II · 2014-07-02 · The Anspach Effort - ANSPACH***REF 98-0001***eMax Hand Control***Rx Only*** This device is intended to be used with Anspach Systems
FDA Device · Class II · 2014-07-02 · The Anspach Effort - NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-303 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesi…
FDA Device · Class II · 2014-07-02 · Nxstage Medical - ANSPACH***REF 98-0029***8 mm Coarse Threaded Headless Bone Screw***Rx Only*** This device is intended to be used with Anspach Systems
FDA Device · Class II · 2014-07-02 · The Anspach Effort - NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-407 Lactate 40, Potassium 1, Sodium 140, Calcium 3, Magnesi…
FDA Device · Class II · 2014-07-02 · Nxstage Medical - ANSPACH***REF SP-3012-00***13 mm Drill with Depth Stop for Short Heavy Duty Attachment***Rx Only*** This device is intended to be used with…
FDA Device · Class II · 2014-07-02 · The Anspach Effort - ANSPACH***REF SP-5000-00***Threaders, Arthroscopic Suture Anchor***Rx Only*** This device is intended to be used with Anspach Systems
FDA Device · Class II · 2014-07-02 · The Anspach Effort - Siemens Healthcare ADVIA Acid/Base Reagent 1 and 2 Kit containing ADVIA Centaur Acid Reagent bottles, lot number: 454778 Kit Catalog Number…
FDA Device · Class II · 2014-07-02 · Siemens Healthcare Diagnostics - Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum
FDA Device · Class II · 2014-07-02 · Jas Diagnostics - RUSCH, LaserTube (Rubber), Laser Resistant Tracheal Tube, cuffed, Teleflex Medical, Willy-Rusch, GmbH. A tracheal tube is a device inserted…
FDA Device · Class II · 2014-07-02 · Teleflex Medical - NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-306 Lactate 45, Potassium 2, Sodium 140, Calcium 3, Magnesi…
FDA Device · Class II · 2014-07-02 · Nxstage Medical - ANSPACH***REF 98-0037***Custom Device SC2102 with fast stop firmware***Rx Only*** This device is intended to be used with Anspach Systems
FDA Device · Class II · 2014-07-02 · The Anspach Effort - ANSPACH***REF 98-0025***Custom MDA Tube for use with MA-D20 Attachment***Rx Only*** This device is intended to be used with Anspach Systems
FDA Device · Class II · 2014-07-02 · The Anspach Effort - SteriGear Urinary Drain Bag with Fig Leaf Cover, 2000 ml, REF 10270, The Fig Leaf, SteriGear 362 S. University Avenue, provo, UT 84601, 1-8…
FDA Device · Class II · 2014-07-02 · Sterigear - Coulter DxH Cleaner 5L, Part No. 628022
FDA Device · Class II · 2014-07-02 · Beckman Coulter - ANSPACH***REF 98-0043***Custom Device eMax 2 Plus Hand Control that will work with a Speed Reducer***Rx Only*** This device is intended to…
FDA Device · Class II · 2014-07-02 · The Anspach Effort - MOSAIQ MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery
FDA Device · Class II · 2014-07-02 · Elekta - ANSPACH***REF SP-3101-00***Adjustable 25 Cm Mia Attachment, Custom***Rx Only*** This device is intended to be used with Anspach Systems
FDA Device · Class II · 2014-07-02 · The Anspach Effort - Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony LL 700 surgical lighting systems), Steris Corporation
FDA Device · Class II · 2014-07-02 · Steris - RT-5100 Refractor and RT-3100 Refractor
FDA Device · Class II · 2014-07-02 · Nidek - NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-307 Lactate 40, Potassium 1, Sodium 140, Calcium 3, Magnesi…
FDA Device · Class II · 2014-07-02 · Nxstage Medical - ANSPACH***MA Attachment, Straight version Custom***Rx Only*** This device is intended to be used with Anspach Systems
FDA Device · Class II · 2014-07-02 · The Anspach Effort - ANSPACH***1.85mm x 16 mm Fluted Router for MRI***Rx Only*** This device is intended to be used with Anspach Systems
FDA Device · Class II · 2014-07-02 · The Anspach Effort - NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-304 Lactate 45, Potassium 2, Sodium 140, Calcium 3,Magnesiu…
FDA Device · Class II · 2014-07-02 · Nxstage Medical - NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-305 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesi…
FDA Device · Class II · 2014-07-02 · Nxstage Medical - ANSPACH***Custom QD11 Attachment with thinner nose tube***Rx Only*** This device is intended to be used with Anspach Systems
FDA Device · Class II · 2014-07-02 · The Anspach Effort - IS4000 da Vinci Xi - Endoscope accessory
FDA Device · Class II · 2014-07-02 · Intuitive Surgical - ANSPACH***REF 98-0016***eMax 2 Modified Hand Control***Rx Only*** This device is intended to be used with Anspach Systems
FDA Device · Class II · 2014-07-02 · The Anspach Effort - ANSPACH***REF SP-3100-00***5mm Coarse Diamond Ball, 11.5 OAL***Rx Only*** This device is intended to be used with Anspach Systems
FDA Device · Class II · 2014-07-02 · The Anspach Effort - ANSPACH***Knotless Suture Anchor Deployment Tool, Custom***Rx Only*** This device is intended to be used with Anspach Systems
FDA Device · Class II · 2014-07-02 · The Anspach Effort - HydroFinity Hydrophilic guidewire
FDA Device · Class I · 2014-07-02 · Nitinol Devices And Components - Ingenia 1.5T, magnetic resonance imaging system
FDA Device · Class II · 2014-07-02 · Philips Medical Systems - Accell Evo3C Demineralized Bone Matrix, 5 cc, Model Number: 02-6000-050 , Lot Number: 132160
FDA Device · Class II · 2014-07-02 · Integra Lifesciences - HydroFinity Hydrophilic guidewire
FDA Device · Class I · 2014-07-02 · Nitinol Devices And Components - UniCel DxH 600 Coulter Cellular Analysis System, Part No. B23858
FDA Device · Class II · 2014-07-02 · Beckman Coulter - ANSPACH***REF SP-4601-00***1mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with…
FDA Device · Class II · 2014-07-02 · The Anspach Effort - ANSPACH***REF 98-0035***Custom eMax 2 Plus Motor with microMax Disconnect Sleeve***Rx Only*** This device is intended to be used with Anspa…
FDA Device · Class II · 2014-07-02 · The Anspach Effort - Ingenia 1.5T R5, magnetic resonance imaging system
FDA Device · Class II · 2014-07-02 · Philips Medical Systems - IF 8000
FDA Device · Class II · 2014-07-02 · Zynex Medical - Siemens LANTIS System
FDA Device · Class II · 2014-07-02 · Siemens Medical Solutions Usa - MAS Omni Immune PRO Controls
FDA Device · Class III · 2014-07-02 · Microgenics - Siemens StreamLAB(R) Analytical Workcell
FDA Device · Class II · 2014-07-02 · Siemens Healthcare Diagnostics - ANSPACH***REF 98-0020***Modified Arthroscopic Knotless Suture Anchor Deployment Tool with Suture Puller***Rx Only*** This device is intende…
FDA Device · Class II · 2014-07-02 · The Anspach Effort - ANSPACH***REF 98-0021***eMax2 Console with Irrigation***Rx Only*** This device is intended to be used with Anspach Systems
FDA Device · Class II · 2014-07-02 · The Anspach Effort - Coulter DxH Cleaner 10L, Part No. 628023
FDA Device · Class II · 2014-07-02 · Beckman Coulter - HydroFinity Hydrophilic guidewire
FDA Device · Class I · 2014-07-02 · Nitinol Devices And Components - ANSPACH***REF 98-0031***Custom Medium Attachment, with 5 mm Extended Tapered Tip***Rx Only*** This device is intended to be used with Anspa…
FDA Device · Class II · 2014-07-02 · The Anspach Effort - VerSys¿ Hip System, Beaded Fullcoat Stems, Zimmer, Inc., Warsaw, IN 46581
FDA Device · Class II · 2014-07-02 · Zimmer - NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-302 Lactate , 40, Potassium 1, Sodium 140, Calcium 3, Magne…
FDA Device · Class II · 2014-07-02 · Nxstage Medical - ANSPACH***REF SP-4603-00***3mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with…
FDA Device · Class II · 2014-07-02 · The Anspach Effort - ANSPACH***Custom XMax Motor, Pneumatic***Rx Only*** This device is intended to be used with Anspach Systems
FDA Device · Class II · 2014-07-02 · The Anspach Effort - ANSPACH***REF 98-0042***XMax Motor with Custom Hose***Rx Only*** This device is intended to be used with Anspach Systems
FDA Device · Class II · 2014-07-02 · The Anspach Effort - LAP LASER PICTOR 3D Multi Color Laser System PICTOR 3D is a LAP laser system which uses multi projection format that defines isocenters, fi…
FDA Device · Class II · 2014-07-02 · Lap - Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems, Model No. 98202 The Alere Triage BNP test is int…
FDA Device · Class III · 2014-07-02 · Alere San Diego - ANSPACH***Custom MCA5-1SD with Extended Exposure***Rx Only*** This device is intended to be used with Anspach Systems
FDA Device · Class II · 2014-07-02 · The Anspach Effort - ProBeam Proton Therapy System (HGA and HFB) Product Usage:ProBeam Proton Therapy System provides protons for precision radiotherapy of les…
FDA Device · Class II · 2014-07-02 · Varian Medical Systems Particle Therapy - Ingenia 3.0T R5, magnetic resonance imaging system
FDA Device · Class II · 2014-07-02 · Philips Medical Systems - ANSPACH***REF 98-0010***2.37mm Spiral Drill, for Short Attachment (Non-Sterile)***Rx Only*** This device is intended to be used with Anspac…
FDA Device · Class II · 2014-07-02 · The Anspach Effort - HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Angled Tip, 260 CM Length
FDA Device · Class I · 2014-07-02 · Nitinol Devices And Components - Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versions VB10G. Product Usage: Image Intensified Fluoros…
FDA Device · Class II · 2014-07-02 · Siemens Medical Solutions Usa - ANSPACH***Arthroscopic Knotless Suture Anchor***Rx Only*** This device is intended to be used with Anspach Systems
FDA Device · Class II · 2014-07-02 · The Anspach Effort - HydroFinity Hydrophilic guidewire
FDA Device · Class I · 2014-07-02 · Nitinol Devices And Components - IS4000 da Vinci Xi - Endoscope accessory
FDA Device · Class II · 2014-07-02 · Intuitive Surgical - HydroFinity Hydrophilic guidewire
FDA Device · Class I · 2014-07-02 · Nitinol Devices And Components - NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-301 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesi…
FDA Device · Class II · 2014-07-02 · Nxstage Medical - ANSPACH***REF 98-0008***7cm Medium Attachment Custom***Rx Only*** This device is intended to be used with Anspach Systems
FDA Device · Class II · 2014-07-02 · The Anspach Effort - Abacus 3.1, Pharmacy Calculator Product Usage: Provide pharmacy calculations for automated compounding
FDA Device · Class II · 2014-07-02 · Baxter Englewood - Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System & Brilliance CT Big Bore Radiology Whole Body Computed Tomograp…
FDA Device · Class II · 2014-07-02 · Philips Medical Systems Cleveland - ANSPACH***REF-98-0056***Custom Device Autolube III modified with a swivel***Rx Only*** This device is intended to be used with Anspach Syst…
FDA Device · Class II · 2014-07-02 · The Anspach Effort - ANSPACH***REF 98-0048***Custom Circular ePLUS-FP***Rx Only*** This device is intended to be used with Anspach Systems
FDA Device · Class II · 2014-07-02 · The Anspach Effort - ANSPACH***REF 98-0003***Sagittal microSaw Attachment Custom***Rx Only*** This device is intended to be used with Anspach Systems
FDA Device · Class II · 2014-07-02 · The Anspach Effort - ANSPACH***eMax2 Lower Profile Foot Pedal***Rx Only*** This device is intended to be used with Anspach Systems
FDA Device · Class II · 2014-07-02 · The Anspach Effort - ANSPACH***REF SP-5001-00***20 degree Angle Driver (MA-D20) - Custom***Rx Only*** This device is intended to be used with Anspach Systems
FDA Device · Class II · 2014-07-02 · The Anspach Effort - ANSPACH***REF 98-0019***Modified MDA Tube with MA-D20 Attachment***Rx Only*** This device is intended to be used with Anspach Systems
FDA Device · Class II · 2014-07-02 · The Anspach Effort - DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLOY. Elbow joint replacement prostheses are intende…
FDA Device · Class II · 2014-07-02 · Biomet - Integra UCR 3mm Hex, Large Axial Driver
FDA Device · Class II · 2014-07-02 · Seaspine - ANSPACH***REF 98-0012***Shoulder Implant 011mm Rod, 20cm Long, Custom***Rx Only*** This device is intended to be used with Anspach Systems
FDA Device · Class II · 2014-07-02 · The Anspach Effort - ANSPACH***REF 98-0034***Custom XMax Motor, Pneumatic with Hand Control and Custom Autolube III IRR Foot Pedal***Rx Only*** This device is i…
FDA Device · Class II · 2014-07-02 · The Anspach Effort - ANSPACH***REF 98-0044***Custom Device Speed Reducer with Bumper***Rx Only*** This device is intended to be used with Anspach Systems
FDA Device · Class II · 2014-07-02 · The Anspach Effort - ANSPACH***Modified QD11 Attachment with Soft Tissue Protector***Rx Only*** This device is intended to be used with Anspach Systems
FDA Device · Class II · 2014-07-02 · The Anspach Effort - UniCel DxH 800 Coulter Cellular Analysis System, Part No. 629029, B24465, and B24802
FDA Device · Class II · 2014-07-02 · Beckman Coulter - MAS Omni Immune Controls
FDA Device · Class III · 2014-07-02 · Microgenics - ANSPACH***REF SP-3014-00***4mm Fluted Ball for MRI***Rx Only*** This device is intended to be used with Anspach Systems
FDA Device · Class II · 2014-07-02 · The Anspach Effort - Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive or non-invasive ventilatory su…
FDA Device · Class II · 2014-07-02 · Nellcor Puritan Bennett Dba Covidien - Shaver Handpiece Sterilization Tray
FDA Device · Class II · 2014-07-02 · Stryker Endoscopy - ANSPACH***REF 98-0024***Nose Cone Cover***Rx Only*** This device is intended to be used with Anspach Systems
FDA Device · Class II · 2014-07-02 · The Anspach Effort - HydroFinity Hydrophilic guidewire
FDA Device · Class I · 2014-07-02 · Nitinol Devices And Components - Ingenia 3.0T, magnetic resonance imaging system
FDA Device · Class II · 2014-07-02 · Philips Medical Systems - Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR)
FDA Device · Class II · 2014-07-02 · Western Scott Fetzer - ANSPACH***REF 98-0023***Custom 5 cm Extension Bearing Sleeve***Rx Only*** This device is intended to be used with Anspach Systems
FDA Device · Class II · 2014-07-02 · The Anspach Effort
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