FDA Device · 2013
FDA Device recalls in 2013
RecallRadar indexes 2,249 FDA Device recall notices published in 2013. By classification: 177 Class I, 1,944 Class II, 128 Class III.
- Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - 3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics Proximal Femur Plating System combines implants and instruments i…
FDA Device · Class II · 2013-11-20 · Orthopediatrics - 2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use Catalog Number: 03-2962-3. Intended for use as the extracorporeal bl…
FDA Device · Class II · 2013-11-20 · Fresenius Medical Care Holdings - Combiset Blood Line with BVM for Hemodialysis use Catalog Number: 03-2965-9. Intended for use as the extracorporeal blood circuit during He…
FDA Device · Class II · 2013-11-20 · Fresenius Medical Care Holdings - Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0
FDA Device · Class II · 2013-11-20 · Raysearch Laboratories Ab - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - Plum A+ Infusion Pump
FDA Device · Class II · 2013-11-20 · Hospira - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - S-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are curved, rectangular slabs which have four protrusions…
FDA Device · Class II · 2013-11-20 · Spinefrontier - Applied Medical's Inzii¿ 12/15mm Retrieval System
FDA Device · Class II · 2013-11-20 · Applied Medical Resources - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - Composite Series Skull Clamp, one clamp per tote
FDA Device · Class II · 2013-11-20 · Integra Lifesciences - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 7.0 mm (21 Fr) OD wit…
FDA Device · Class II · 2013-11-20 · Terumo Cardiovascular Systems - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - *** 1) Plum A+ Infusion Pump
FDA Device · Class II · 2013-11-20 · Hospira - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, straight tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD wit…
FDA Device · Class II · 2013-11-20 · Terumo Cardiovascular Systems - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code: 281142 Product Usage: The Intermediary Tubing for FMS¿ Fluid Managemen…
FDA Device · Class II · 2013-11-20 · Depuy Mitek A Johnson And Johnson - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for…
FDA Device · Class II · 2013-11-20 · Hospira - Plum A+3 Infusion Pump System
FDA Device · Class II · 2013-11-20 · Hospira - Plum A+ Hyperbaric Infusion Pump
FDA Device · Class II · 2013-11-20 · Hospira - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and A700238, Rx only, Sterile EO. Intended for creating endocardial lesions dur…
FDA Device · Class II · 2013-11-20 · St Jude Medical - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange, angled tip, wire-reinforced with luer port, aortic cannula, 8.0 mm (24 Fr) OD with…
FDA Device · Class II · 2013-11-20 · Terumo Cardiovascular Systems - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - Plum A+ Infusion Pump
FDA Device · Class II · 2013-11-20 · Hospira - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for…
FDA Device · Class II · 2013-11-20 · Hospira - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001
FDA Device · Class II · 2013-11-20 · Nobel Biocare Usa - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used fo…
FDA Device · Class II · 2013-11-20 · Hospira - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - Draeger Movita 603x/DVE 803x Ceiling Supply Unit
FDA Device · Class II · 2013-11-20 · Draeger Medical - AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION), AW Server
FDA Device · Class II · 2013-11-20 · Ge Healthcare - VerSys¿ Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Heritage Hip System Revision Femoral Stems
FDA Device · Class II · 2013-11-20 · Zimmer - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for…
FDA Device · Class II · 2013-11-20 · Hospira - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - The Plum A+3 Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used fo…
FDA Device · Class II · 2013-11-20 · Hospira - Plum A+ Infusion Pump
FDA Device · Class II · 2013-11-20 · Hospira - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for…
FDA Device · Class II · 2013-11-20 · Hospira - Philips brand IntelliSpace PACS 4.4, Image Management System
FDA Device · Class II · 2013-11-20 · Philips Healthcare Informatics - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - Carestream Vue PACS
FDA Device · Class II · 2013-11-20 · Carestream Health - OmniPod Insulin Management System Starter Kit
FDA Device · Class II · 2013-11-13 · Insulet - CARESTREAM DRX -Mobile Retrofit Kit, Catalog number: 1019397
FDA Device · Class II · 2013-11-13 · Carestream Health - Portex¿ Saddleblock Tray with Drugs 22g Quincke (Without Introducer)
FDA Device · Class II · 2013-11-13 · Smiths Medical Asd - Dekompressor Percutaneous Discectomy Probe
FDA Device · Class II · 2013-11-13 · Stryker Instruments Div - MLS Torpedo Mini-Light Ophthalmic single-port illumination
FDA Device · Class II · 2013-11-13 · Insight Instruments - Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile
FDA Device · Class I · 2013-11-13 · Baylis Medical - GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188
FDA Device · Class II · 2013-11-13 · Smith And Nephew - Portex¿ Saddleblock Tray with Drugs 25g Quincke
FDA Device · Class II · 2013-11-13 · Smiths Medical Asd - Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225, Sterile, RX only For Single Use Only, Product Usa…
FDA Device · Class II · 2013-11-13 · Edwards Lifesciences - GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168
FDA Device · Class II · 2013-11-13 · Smith And Nephew - Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610)
FDA Device · Class II · 2013-11-13 · Bayer Healthcare - VitreaCore¿ software
FDA Device · Class II · 2013-11-13 · Vital Images - US Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and Cool Path Duo Ablation Catheter, MediGuide Enabled REF A700244, Rx only,…
FDA Device · Class II · 2013-11-13 · St Jude Medical - Ti-Magna Fx Washer Ti-Versa-FX¿II Femoral Fixation System S/C Plates The compression tube/plates of this trauma system are used with Ti-Ver…
FDA Device · Class II · 2013-11-13 · Zimmer - Patient Cart used in conjunction with the da Vinci S surgical and SI System
FDA Device · Class II · 2013-11-13 · Intuitive Surgical - COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas
FDA Device · Class II · 2013-11-13 · Roche Diagnostics Operations - Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids
FDA Device · Class II · 2013-11-13 · Ethicon Endo Surgery - Pinook Micro Massager Distributed by www.pinookusa.com Used to strengthen the abdominal muscles
FDA Device · Class II · 2013-11-13 · Pinook Usa - Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of the class of medical devices that are use…
FDA Device · Class II · 2013-11-13 · Elekta - Fresenius Liberty¿ Cycler Part Number: RTLR180111 Product Usage: The Liberty cycler is a portable device designed to perform acute and chro…
FDA Device · Class II · 2013-11-13 · Fresenius Medical Care Holdings - ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemistry Analyzer
FDA Device · Class II · 2013-11-13 · Beckman Coulter - HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonaduz, Switzerland
FDA Device · Class II · 2013-11-13 · Hamilton Medical - The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power (0.585 watt average power per transducer) ultrasound to faci…
FDA Device · Class II · 2013-11-13 · Ekos - Surgicutt fully automated incision making device for bleeding time determination
FDA Device · Class II · 2013-11-13 · Itc Nexus Dx - da Vinci Vision System Cart, a component of the da Vinci Si Surgical System IS3000
FDA Device · Class III · 2013-11-13 · Intuitive Surgical - Harmony Equipment Management System, Model #603X/80XX, STERIS Corporation, Mentor, OH Harmony Equipment Management Systems (EMS) are used i…
FDA Device · Class II · 2013-11-13 · Steris - Aquatec Ocean VIP, Aquatec Ocean Dual-VIP, Aquatec Ocean E-VIP mobile shower and toilet commode with tilting function
FDA Device · Class II · 2013-11-13 · Invacare - ORBIT PT. The ORBIT PT works in conjunction with an TRUMPF mobile operating table to automate the patient transport process
FDA Device · Class III · 2013-11-13 · Trumpf Medical Systems - ISE REF Valve, Part No. MU7638 for the AU480, AU680, and AU5800 Chemistry Analyzer
FDA Device · Class II · 2013-11-13 · Beckman Coulter - Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm
FDA Device · Class II · 2013-11-13 · Medtronic Vascular - Individual units labeled in part: REF: 4630022
FDA Device · Class II · 2013-11-13 · Richard Wolf Medical Instruments - ADVIA Centaur Intact PTH Calibrator (6 pack)
FDA Device · Class III · 2013-11-13 · Siemens Healthcare Diagnostics - Portex¿ Spinal Tray with Drugs 22g/25g Quincke
FDA Device · Class II · 2013-11-13 · Smiths Medical Asd - Portex¿ Spinal Tray with Drugs 25g Whitacre
FDA Device · Class II · 2013-11-13 · Smiths Medical Asd - Dual Luer Lock Cap The device is intended for use as a cap for male or female Luer ports on medical devices such as manifolds, stopcocks or…
FDA Device · Class II · 2013-11-13 · Baxter Healthcare
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