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.
- Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay
FDA Device · Class II · 2013-11-13 · Siemens Healthcare Diagnostics - Portex¿ Saddleblock Tray with Drugs 26g Quincke, 4745-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwi…
FDA Device · Class II · 2013-11-13 · Smiths Medical Asd - Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids, or in various kit configurations with…
FDA Device · Class II · 2013-11-13 · Ethicon Endo Surgery - OmniPod Insulin Management Product Demonstration Kit
FDA Device · Class II · 2013-11-13 · Insulet - Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum
FDA Device · Class II · 2013-11-13 · Seppim Sas - UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The UniCel DxH 800/DxH 600 analyzers are quantitative, multiparameter, automat…
FDA Device · Class II · 2013-11-13 · Beckman Coulter - Portex¿ Spinal Tray with Drugs 22g Whitacre/25g Whitacre
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 - Portex¿ Spinal Tray with Drugs 25g Whitacre
FDA Device · Class II · 2013-11-13 · Smiths Medical Asd - 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 Mini Massager Distributed by www.pinookusa.com
FDA Device · Class II · 2013-11-13 · Pinook Usa - pH 7.0 Buffer Solution Pint and Quart Bottles, Part Number 02.0030 for Pints and 02.0031 for Quarts
FDA Device · Class II · 2013-11-13 · Mesa Laboratories - DRX- Revolution, Catalog number: 101937, 1023415 & 1023423
FDA Device · Class II · 2013-11-13 · Carestream Health - Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software versions VB10D, VB10F, VB10C and VB10E. Fluroscopic X-Ra…
FDA Device · Class II · 2013-11-13 · Siemens Medical Solutions Usa - Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3
FDA Device · Class III · 2013-11-13 · Helix Medical - Portex¿ Regional Anesthesia Tray with Drugs
FDA Device · Class II · 2013-11-13 · Smiths Medical Asd - S5 Heart-lung machine, Stockert S5 System
FDA Device · Class II · 2013-11-13 · Sorin Group Deutschland - DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty, US-only)
FDA Device · Class II · 2013-11-13 · Carestream Health - Edwards Lifesciences Dispersion Aortic Perfusion Cannula with Duraflo Coating, Sterile, RX only For Single Use Only, Product Usage: Aortic…
FDA Device · Class II · 2013-11-13 · Edwards Lifesciences - Handset component of the Handicare USA's Minivator Bath Bliss Reclining Bath Lifts (Bath Bliss), Part Number BP300-100/BP300-400RSUS (hands…
FDA Device · Class II · 2013-11-13 · Handicare Accessibility - HemoCue¿ Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden The quantitative, rapid, turbidimetric immunoassay of a…
FDA Device · Class II · 2013-11-06 · Hemocue Ab - PIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of…
FDA Device · Class II · 2013-11-06 · Depuy Spine - CoCr Head (Not distributed in the United States) Used in total hip replacement
FDA Device · Class II · 2013-11-06 · Zimmer - Siemens RAPIDLab¿ 1265 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro…
FDA Device · Class II · 2013-11-06 · Siemens Healthcare Diagnostics - Aplio XG Diagnostic Ultrasound System SSA-790A Used for routine diagnostic imaging
FDA Device · Class II · 2013-11-06 · Toshiba American Medical Systems - BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT), one unit per box
FDA Device · Class II · 2013-11-06 · Philips Medical Systems Cleveland - Xario XG Diagnostic Ultrasound System SSA-680A Used for routine diagnostic imaging
FDA Device · Class II · 2013-11-06 · Toshiba American Medical Systems - Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestin…
FDA Device · Class II · 2013-11-06 · Fujinon - Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 mL, Luer Activated Valve, male Luer Lock Adapter, Sterile, non…
FDA Device · Class II · 2013-11-06 · Baxter Healthcare - Siemens RAPIDPoint¿ 500 system blood gas analyzer Product Usage: RAPIDPoint 500 System: The RAPIDPoint 500 system is designed for professio…
FDA Device · Class II · 2013-11-06 · Siemens Healthcare Diagnostics - Zimmer¿ Unicompartmental Knee Femoral Component
FDA Device · Class II · 2013-11-06 · Zimmer - Gender Solutions" Patello-Femoral Component
FDA Device · Class II · 2013-11-06 · Zimmer - NexGen CR-Flex Mobile Bearing Tibial Component 9 (Not distributed in the United States)
FDA Device · Class II · 2013-11-06 · Zimmer - Siemens RAPIDLab¿ 1240 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro…
FDA Device · Class II · 2013-11-06 · Siemens Healthcare Diagnostics - chromID Salmonella Agar, Reference No. 43621
FDA Device · Class II · 2013-11-06 · Biomerieux - The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare p…
FDA Device · Class II · 2013-11-06 · Ge Healthcare It - Carestream DRX-Revolution Mobile X-ray System
FDA Device · Class II · 2013-11-06 · Carestream Health - Natural-Knee¿ Flex Femoral Component
FDA Device · Class II · 2013-11-06 · Zimmer - Single Site Curved Needed Driver Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Acces…
FDA Device · Class II · 2013-11-06 · Intuitive Surgical - da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution Stereoscopic Viewer
FDA Device · Class II · 2013-11-06 · Intuitive Surgical - Xoran Minicat00158
FDA Device · Class II · 2013-11-06 · Xoran Technologies - Xoran MiniCAT00202
FDA Device · Class II · 2013-11-06 · Xoran Technologies - Single Site Bipolar Maryland Forceps Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci Single-Site Instruments and A…
FDA Device · Class II · 2013-11-06 · Intuitive Surgical - CPT¿ Femoral Stem (CPT 12/14 STEM SIZE 0 COCR
FDA Device · Class II · 2013-11-06 · Zimmer - Xoran MiniCAT CT Scanner
FDA Device · Class II · 2013-11-06 · Xoran Technologies - NexGen¿ Femoral Component (CR-FLEX GSF POR FEM, C-L
FDA Device · Class II · 2013-11-06 · Zimmer - PENTAX Endoscopic Accessories
FDA Device · Class I · 2013-11-06 · Pentax Medical - Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery System
FDA Device · Class II · 2013-11-06 · Medtronic Vascular - Natural-Knee¿ II Femoral Component
FDA Device · Class II · 2013-11-06 · Zimmer - Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial Stem Lateral Assembly, rHead Radial Stem 6mm Collar…
FDA Device · Class II · 2013-11-06 · Small Bone Innovations - Xoran Minicat00202
FDA Device · Class II · 2013-11-06 · Xoran Technologies - MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: MAQUET Cardiopulmonary AG Made in Germany
FDA Device · Class II · 2013-11-06 · Maquet Medical Systems Usa - Multipolar¿ Bipolar Cup METAL SHELL 38 MM OD through 71 MM OD. Indicated in fracture dislocation of the hip
FDA Device · Class II · 2013-11-06 · Zimmer - Medtronic Activa PC, model 37601, and Activa RC, model 37612, Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation
FDA Device · Class II · 2013-11-06 · Medtronic Neuromodulation - Ingenuity TF PET/CT Diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-Ray…
FDA Device · Class II · 2013-11-06 · Philips Medical Systems Cleveland - Edwards Lifesciences EMBOL-X Glide Protection System
FDA Device · Class I · 2013-11-06 · Edwards Lifesciences - Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from…
FDA Device · Class II · 2013-11-06 · Ge Healthcare It - Siemens RAPIDLab¿ 1260 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro…
FDA Device · Class II · 2013-11-06 · Siemens Healthcare Diagnostics - PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE LS Dilators and Holding Clip are intended for sequential dilation of sof…
FDA Device · Class II · 2013-11-06 · Depuy Spine - Synthes Application Instrument Sternal Zip Flex System intended for use in primary or secondary closure/repair of the sternum following ste…
FDA Device · Class II · 2013-11-06 · Synthes Usa Hq - HemoCue¿ Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, Sweden
FDA Device · Class II · 2013-11-06 · Hemocue Ab - Sidus" Head (Not distributed in the United States)
FDA Device · Class II · 2013-11-06 · Zimmer - pocH-100i
FDA Device · Class II · 2013-11-06 · Sysmex America - PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of s…
FDA Device · Class II · 2013-11-06 · Depuy Spine - REF 5100-088, TPS Micro Driver, For Use with Stryker Total Performance System Caution Federal Law (USA) restricts the device to use by or o…
FDA Device · Class II · 2013-11-06 · Stryker Instruments Div - Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation
FDA Device · Class II · 2013-11-06 · Medtronic Neuromodulation - Metasul¿ Head
FDA Device · Class II · 2013-11-06 · Zimmer - Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imaging
FDA Device · Class II · 2013-11-06 · Toshiba American Medical Systems - Siemens RAPIDPoint¿ 400 system blood gas analyzer Product Usage: These systems are intended for near-patient and laboratory testing of bloo…
FDA Device · Class II · 2013-11-06 · Siemens Healthcare Diagnostics - DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY 14608 Catalog Numbers 1019397, 1023415, 1023423 --- Made in U…
FDA Device · Class II · 2013-11-06 · Carestream Health - Cordis OPTEASE Vena Cava Filter Is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in t…
FDA Device · Class II · 2013-11-06 · Cordis - NexGen¿ Femoral Component (CR-FLEX GSF PRECOAT SZ C-L
FDA Device · Class II · 2013-11-06 · Zimmer - PIPELINE LS ACCESS SYSTEM, Holding Clip The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and e…
FDA Device · Class II · 2013-11-06 · Depuy Spine - Globus Medical MicroFuse Putty, 2.5cc and 10cc
FDA Device · Class II · 2013-11-06 · Globus Medical - COULTER LH 750 and LH 780 Analyzers
FDA Device · Class II · 2013-11-06 · Beckman Coulter - Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic
FDA Device · Class II · 2013-11-06 · Baxter Healthcare - Brand Names: Integra¿ Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters
FDA Device · Class II · 2013-11-06 · Integra - Breeze C Scooter is a motorized electric scooter for elderly people
FDA Device · Class II · 2013-11-06 · E Afikim - Xoran MiniCAT CT Scanner ID ENT00001
FDA Device · Class II · 2013-11-06 · Xoran Technologies - Siemens RAPIDLab¿ 1245 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro…
FDA Device · Class II · 2013-11-06 · Siemens Healthcare Diagnostics - Siemens RAPIDPoint¿¿ 405 system blood gas analyzer Product PUsage: These systems are intended for near-patient and laboratory testing of bl…
FDA Device · Class II · 2013-11-06 · Siemens Healthcare Diagnostics - PIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of…
FDA Device · Class II · 2013-11-06 · Depuy Spine - Xoran Mini CT Scanner
FDA Device · Class II · 2013-11-06 · Xoran Technologies - Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits, Clarity System Kits, MASCT Pa…
FDA Device · Class I · 2013-11-06 · Atossa Genetics - Versys¿ Beaded Fullcoat Femoral Stem (POR FULL-CT FEM ST 11X160MM
FDA Device · Class II · 2013-11-06 · Zimmer - Aplio MX Diagnostic Ultrasound System SSA-780A Used for routine diagnostic imaging
FDA Device · Class II · 2013-11-06 · Toshiba American Medical Systems - SmartSet¿ Endurance GMV, Gentamicin, REF 3105-040, Medium Viscosity Antibiotic Bone Cement, Sterile
FDA Device · Class II · 2013-10-30 · Depuy Orthopaedics - Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900
FDA Device · Class II · 2013-10-30 · Perkin Elmer Health Sciences - Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems in…
FDA Device · Class II · 2013-10-30 · Philips Medical Systems Cleveland - Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM1.S Rx Only, Manufacturer GMS- Gesellschaft fur medizinisch…
FDA Device · Class II · 2013-10-30 · Integra Lifesciences - Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It will be sold as a sof…
FDA Device · Class II · 2013-10-30 · Ge Healthcare It - Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology
FDA Device · Class II · 2013-10-30 · Convergent Dental - STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalog Number: 0030-4077, Product is manufactured and distributed b…
FDA Device · Class II · 2013-10-30 · Abbott Medical Optics - GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus
FDA Device · Class II · 2013-10-30 · Ge Healthcare Beijing Hangwei Medical Systems - Alere Triage¿ TOX Drug Screen Control 1 Product Generic Name: Quality Control Material Description of the product: Good Laboratory Practice…
FDA Device · Class III · 2013-10-30 · Alere San Diego - STAR Excimer Laser System, Model STAR S4 IR, Catalog Number: 0030-4864, Product is manufactured and distributed by AMO Manufacturing USA, L…
FDA Device · Class II · 2013-10-30 · Abbott Medical Optics - Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.SR Rx Only, Manufacturer GMS- Gesellschaft fur medizinisc…
FDA Device · Class II · 2013-10-30 · Integra Lifesciences - Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.S_.EU Rx Only, Manufacturer GMS- Gesellschaft fur medizin…
FDA Device · Class II · 2013-10-30 · Integra Lifesciences - FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System
FDA Device · Class III · 2013-10-30 · Bio Rad Laboratories - Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain Probe Kit REF IM3.ST_.EU Rx Only, Manufacturer GMS- Gesellschaft fur medizi…
FDA Device · Class II · 2013-10-30 · Integra Lifesciences
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