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.
- 20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atria of the heart
FDA Device · Class II · 2013-07-10 · Biosense Webster - - Calf Garment Standard Ref
FDA Device · Class II · 2013-07-10 · Surgical Instrument Service And Savings - - Turbosonics Mini-Flared ABS Tip, 45 Degree OZil 12 Degree, (Purplish/ Pink) 0.9mm Ref. 8065751177 Lot 123215 - TurboSonics¿ Mini-Flared A…
FDA Device · Class II · 2013-07-10 · Surgical Instrument Service And Savings - PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy
FDA Device · Class II · 2013-07-10 · Clorox Healthcare Holdings Dba Healthlink - - Cannulated Drill Bit for Mini TightRope Ref
FDA Device · Class II · 2013-07-10 · Surgical Instrument Service And Savings - -90 Degree L-Hook Tip Arthroscopic Electrode, for use with 7205440 Switchpen, (Blue) 170mm
FDA Device · Class II · 2013-07-10 · Surgical Instrument Service And Savings - VITROS 5600 Integrated System (product code 6802413) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitativ…
FDA Device · Class II · 2013-07-10 · Ortho Clinical Diagnostics - BASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and secure all instrumentation to be used with a surgical sys…
FDA Device · Class II · 2013-07-10 · Spinefrontier - Custom Procedural Trays: Merit's Custom Angio Kits A custom procedural tray is a combination of legally marketed medical devices placed int…
FDA Device · Class II · 2013-07-10 · Merit Medical Systems - S-LIFT Inserter Outer Sleeve Product Usage: The Inserter Sleeve is an optional instrument to add further compression of the Inserter into t…
FDA Device · Class II · 2013-07-10 · Spinefrontier - Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia
FDA Device · Class II · 2013-07-10 · Surgical Instrument Service And Savings - VITROS 4600 Chemistry System (VITROS 5,1 FS System family member)(product code 6802445) Product Usage: For use in the in vitro quantitative…
FDA Device · Class II · 2013-07-10 · Ortho Clinical Diagnostics - - ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Green) 10/11mm Ref. 511NA Lot 123215, 122647 - ENDOPATH Resposable…
FDA Device · Class II · 2013-07-10 · Surgical Instrument Service And Savings - -Scorpion Needle, For Use With Scorpion Suture Passer, (Blue)
FDA Device · Class II · 2013-07-10 · Surgical Instrument Service And Savings - ***REF SC2102***eMax 2 Plus Console, Single Port, no Irrigation***SN G16307882402*** Product Usage: The eMax console is intended to operate…
FDA Device · Class II · 2013-07-10 · The Anspach Effort - ORTHO¿ Assay Software (OAS) Server, Catalog # 6842840 Usage: The ORTHO¿ Summit System (OSS) is a modular, integrated system for use with li…
FDA Device · Class II · 2013-07-10 · Ortho Clinical Diagnostics - - Acorn Bur, Long, For Use With TPS Universal Drill, Long "AM" Attachment Head: 7.5mm Dia. x 9.5mm Length Ref. 5130-30-75 Lot 122665 - Cann…
FDA Device · Class II · 2013-07-10 · Surgical Instrument Service And Savings - Siemens MEVATRON series, PRIMART (limited release)PRIMUS and/or ONCOR or ARTIST Linac Systems with BEAMVIEW capability
FDA Device · Class II · 2013-07-10 · Siemens Medical Solutions Usa - GE Healthcare, Innova 3100 and Innova 4100 systems
FDA Device · Class II · 2013-07-10 · Ge Healthcare - HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy
FDA Device · Class II · 2013-07-10 · Clorox Healthcare Holdings Dba Healthlink - TPS Micro Reciprocating Small Tear Cross Cut Rasp 5.0mm x 11mm Ref. 5100-37-113 Lot 122518, 122447
FDA Device · Class II · 2013-07-10 · Surgical Instrument Service And Savings - InSpan Inserter, Right Assembly
FDA Device · Class II · 2013-07-10 · Spinefrontier - - Relieva Flex Sinus Guide Catheter (Green) Tip Shape: F-70 Ref
FDA Device · Class II · 2013-07-10 · Surgical Instrument Service And Savings - Large Tear Cross Cut Rasp 14mm x 7mm Ref. 5100-37-114 Lot 122347 Manual surgical instrument for general use
FDA Device · Class II · 2013-07-10 · Surgical Instrument Service And Savings - MAQUET Getinge Group Mobile Operating Table YUNO OTN GA 1433.01 EN 05
FDA Device · Class II · 2013-07-10 · Maquet Cardiovascular Us Sales - VITROS 3600 Immunodiagnostic System (product code 6802783) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qual…
FDA Device · Class II · 2013-07-10 · Ortho Clinical Diagnostics - Computed Tomography X-ray systems Product Usage: The Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 scanners are whole body Comput…
FDA Device · Class II · 2013-07-10 · Philips Medical Systems Cleveland - ***REF SC2101***eMax 2 Plus Console, Single Port, with Irrigation***SN G17307901802*** Product Usage: The RPM of the Motor Handpiece may be…
FDA Device · Class II · 2013-07-10 · The Anspach Effort - -ENDOPATH ETS-Flex Articulating Endoscopic Linear Cutter, (Blue) w/o Staples 35mm
FDA Device · Class II · 2013-07-10 · Surgical Instrument Service And Savings - - ConMed Linvatec Spectrum II Suture Hook Crescent, Medium (Teal) 4.0 x 20.0mm
FDA Device · Class II · 2013-07-10 · Surgical Instrument Service And Savings - Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used with ER920 Wireless Series Arrhythmia Event Recorder
FDA Device · Class II · 2013-07-10 · Braemar - BD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, used in conjunction with the appropriate extraction kits and reagents…
FDA Device · Class III · 2013-07-10 · Becton Dickinson And - - Average Medium Blade 9mm x 25mm x 0.38mm Ref. 2296-3-111 Lot 122590, 122447 - Cannulated Drill Bit, Quick Coupling, For 3.5 & 4mm Cannula…
FDA Device · Class II · 2013-07-10 · Surgical Instrument Service And Savings - ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy
FDA Device · Class II · 2013-07-10 · Clorox Healthcare Holdings Dba Healthlink - - Re-New II Endocut Scissor Tip, 16.51mm 5.0mm Ref. 3142 Lot 122295, 122308, 122455, 122875 Manual surgical instrument for general use
FDA Device · Class II · 2013-07-10 · Surgical Instrument Service And Savings - Delta Vaporizer An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the…
FDA Device · Class II · 2013-07-10 · Penlon - Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Large Nonsterile 4305-19-40
FDA Device · Class II · 2013-07-10 · Zimmer - StatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single Use Only, C.R. Bard, Inc
FDA Device · Class II · 2013-07-10 · Bard Access Systems - VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System is a compression pump used for the prevention of Deep Vein Thrombo…
FDA Device · Class II · 2013-07-10 · Djo - GENESYS Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI Registered Trade Mark Sutures Rx Only STERILE EO CONMED LINVATEC REF CFBC-4502
FDA Device · Class II · 2013-07-10 · Linvatec - Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060
FDA Device · Class II · 2013-07-03 · Terumo Medical - Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide
FDA Device · Class I · 2013-07-03 · Medtronic Neuromodulation - Brand Name: SV Elastomeric Infusion Device
FDA Device · Class II · 2013-07-03 · Baxter Healthcare - Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is manufactured and distributed by Microgenics Corporati…
FDA Device · Class II · 2013-07-03 · Microgenics - SYNCHRON System(s) Lactate (LACT) Reagent
FDA Device · Class II · 2013-07-03 · Beckman Coulter - INFUSE(R) Bone Graft,LARGE II KIT, REF 7510800, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
FDA Device · Class II · 2013-07-03 · Medtronic Sofamor Danek Usa - VITROS Chemistry Products K+ (Potassium) Slides (Reagent), REF/Catalog Number 815 7596, Product Usage: For in vitro diagnostic use only
FDA Device · Class III · 2013-07-03 · Ortho Clinical Diagnostics - Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Corporation
FDA Device · Class II · 2013-07-03 · Baxter Healthcare - Brand Name: Intermate Infusion Pump
FDA Device · Class II · 2013-07-03 · Baxter Healthcare - Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit
FDA Device · Class II · 2013-07-03 · Greatbatch Medical - CMC Saddle Product Usage: The Ascension CMC is intended to resurface the proximal end of the first metacarpal in cases of rheumatoid arthri…
FDA Device · Class III · 2013-07-03 · Integra Lifesciences - Multilite Dye Handpieces, an optional accessory of the RevLite SI Laser
FDA Device · Class II · 2013-07-03 · Conbio A Cynosure - Prism Medical C-Series Carry Bar, Class I, model number 360755
FDA Device · Class II · 2013-07-03 · Prism Medical Services Usa - INFUSE(R) Bone Graft, SMALL KIT, REF 7510200AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaed…
FDA Device · Class II · 2013-07-03 · Medtronic Sofamor Danek Usa - TRUE Dilatation Balloon Valvuloplasty Catheter, REF Numbers: 02045-11, 02245-12, 02445-12, and 02645-13
FDA Device · Class II · 2013-07-03 · Loma Vista Medical - CARESCAPE Monitor B850 Product Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor intended for use in mu…
FDA Device · Class II · 2013-07-03 · Ge Healthcare - Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems)
FDA Device · Class II · 2013-07-03 · Baxter Healthcare - CoaguChek XS System (PST) The CoaguChek XS PT test strips are part of the CoaguChek XS System
FDA Device · Class II · 2013-07-03 · Roche Diagnostics Operations - Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # LA6IMAD, Lot # 0006724224, 6F Product Usage: The…
FDA Device · Class II · 2013-07-03 · Medtronic Cardiac Rhythm Disease Management - CoaguChek XS System (HCP) The CoaguChek XS System is intended for use by professional healthcare providers for quantitative prothrombin tim…
FDA Device · Class II · 2013-07-03 · Roche Diagnostics Operations - Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems
FDA Device · Class II · 2013-07-03 · Philips Medical Systems Cleveland - Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide
FDA Device · Class I · 2013-07-03 · Medtronic Neuromodulation - Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. Contents: 60-cm pump segment with attached sutureless pump connecto…
FDA Device · Class I · 2013-07-03 · Medtronic Neuromodulation - Medtronic, Consulta¿ CRT-P, Model C4TR01, C3TR01 (not approved for US), and Syncra¿ CRT-P, Model C2TR01, Sterile EO. Dual chamber and atria…
FDA Device · Class II · 2013-07-03 · Medtronic Cardiac Rhythm Disease Management - CoaguChek XS Pro System The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantitatively determines prot…
FDA Device · Class II · 2013-07-03 · Roche Diagnostics Operations - GE Healthcare Senographe Essential System
FDA Device · Class II · 2013-07-03 · Ge Healthcare - Brand Name: Multiday lnfusor, Seven Day lnfusor and the Basal/Bolus lnfusor: Single day Infusor 2 ml/h, Single Day INFUSOR 2 ml/h System, H…
FDA Device · Class II · 2013-07-03 · Baxter Healthcare - Brand Name: Regional Analgesia Infusor System with Patient Control
FDA Device · Class II · 2013-07-03 · Baxter Healthcare - BD SafetyGlide Allergy
FDA Device · Class II · 2013-07-03 · Becton Dickinson And - The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities ass…
FDA Device · Class II · 2013-07-03 · Ge Healthcare It - DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor: Product Usage: Monitor, Physiological, Patient
FDA Device · Class II · 2013-07-03 · Medrad - Code Alert Advanced 4-Way Care Solution, CA520 System, PN 9600-1600, RF Technologies
FDA Device · Class II · 2013-07-03 · Rf Technologies - Brand Name: Intermate Infusion Pump
FDA Device · Class II · 2013-07-03 · Baxter Healthcare - Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, Mentor, OH 44060 QLC1677E, QRC1699E, QPC1721E and QFC1683E con…
FDA Device · Class II · 2013-07-03 · Steris - Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supplied in 10 ml or 18 ml reserv…
FDA Device · Class I · 2013-07-03 · Medtronic Neuromodulation - Medtronic Intrathecal Catheter, model 8731SC. Contents: 38.1-cm spinal segment with length markings and guide wire, 66-cm pump segment, 15…
FDA Device · Class I · 2013-07-03 · Medtronic Neuromodulation - MAQUET GETINGE GROUP Arterial Cannula OD Used to introduce blood and sterile solutions into the systemic circulation during pediatric extra…
FDA Device · Class II · 2013-07-03 · Maquet Cardiovascular Us Sales - Medtronic Sutureless Pump Connector Revision Kit, model 8578
FDA Device · Class I · 2013-07-03 · Medtronic Neuromodulation - INFUSE(R) Bone Graft, LARGE II KIT, REF 7510800AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthop…
FDA Device · Class II · 2013-07-03 · Medtronic Sofamor Danek Usa - VITROS Chemistry Products CRP Slides (Reagent), REF/Catalog Number 192 6740 and 809 7990, Product Usage: For in vitro diagnostic use only
FDA Device · Class III · 2013-07-03 · Ortho Clinical Diagnostics - Brand Name: Basal/Bolus Infusor
FDA Device · Class II · 2013-07-03 · Baxter Healthcare - INFUSE(R) Bone Graft, LARGE KIT, REF 7510600, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
FDA Device · Class II · 2013-07-03 · Medtronic Sofamor Danek Usa - CoaguChek XS Plus System The CoaguChek XS Plus system for use by professional healthcare providers for quantitative prothrombin time testin…
FDA Device · Class II · 2013-07-03 · Roche Diagnostics Operations - INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopae…
FDA Device · Class II · 2013-07-03 · Medtronic Sofamor Danek Usa - Medtronic INDURA 1P Intrathecal Catheter, model 8709SC. Contents: 81.4-cm catheter with length markers and guide wire, 15 T-gauge introduce…
FDA Device · Class I · 2013-07-03 · Medtronic Neuromodulation - INFUSE(R) Bone Graft, SMALL KIT, REF 7510200, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
FDA Device · Class II · 2013-07-03 · Medtronic Sofamor Danek Usa - Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supplied in 10 ml or 18 ml reserv…
FDA Device · Class I · 2013-07-03 · Medtronic Neuromodulation - Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound
FDA Device · Class II · 2013-07-03 · U Systems - Sarns " TCM II Temperature Control Module The Sarns" TCM II Temperature Control Module is a source of temperature-controlled water for bloo…
FDA Device · Class II · 2013-07-03 · Terumo Cardiovascular Systems - Pinnacle¿ Destination¿ Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve
FDA Device · Class II · 2013-07-03 · Terumo Medical - INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
FDA Device · Class II · 2013-07-03 · Medtronic Sofamor Danek Usa - Brand Name: Infusor SV and LV Elastomeric Infusion Devices
FDA Device · Class II · 2013-07-03 · Baxter Healthcare - Brand Name: Multirate Infusor Devices
FDA Device · Class II · 2013-07-03 · Baxter Healthcare - SybronEndo Elements Obturation Unit
FDA Device · Class II · 2013-06-26 · Ormco Sybronendo - Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057, 712062 Product Usage: Universal RAD…
FDA Device · Class II · 2013-06-26 · Philips Healthcare - IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System
FDA Device · Class II · 2013-06-26 · Idev Technologies - Tecan Freedom EVO with Touch Tools Suite Version 3.0 The intended use of the Touch Tools Suite is to run previously defined scripts and pro…
FDA Device · Class II · 2013-06-26 · Tecan Us - BC Hammock Mesh Sling (Large), product number, 537030
FDA Device · Class II · 2013-06-26 · Prism Medical Services Usa - Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 12 Digit P/N): 85008 (85008) 1053613 (989805628251) 1053614 (98980…
FDA Device · Class I · 2013-06-26 · Respironics California - Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system
FDA Device · Class II · 2013-06-26 · Philips Healthcare
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)