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.
- UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 10cc Product Code: RT53010 Donated Human Tiss…
FDA Device · Class II · 2013-01-16 · Surgical Tissue Network - Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were sold to Terumo UK to be included in a kit under Ter…
FDA Device · Class II · 2013-01-16 · California Medical Laboratories - Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364N Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistr…
FDA Device · Class II · 2013-01-16 · Siemens Healthcare Diagnostics - Siemens Chek-Stix Combo Pak (Distributed OUS) Catalog Number: 1364E Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: Wh…
FDA Device · Class III · 2013-01-16 · Siemens Healthcare Diagnostics - The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non Sterile Rx only
FDA Device · Class II · 2013-01-16 · Zimmer - STERRAD NX Cassettes, P/N 10133
FDA Device · Class II · 2013-01-16 · Advanced Sterilization Products - Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry (Distributed OUS Only) Catalog Number: 1360L Chek-Stix¿ Positive…
FDA Device · Class III · 2013-01-16 · Siemens Healthcare Diagnostics - CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons
FDA Device · Class II · 2013-01-16 · Maquet Cardiovascular - Laparoscope, general
FDA Device · Class II · 2013-01-16 · Applied Medical Resources - Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator…
FDA Device · Class II · 2013-01-16 · Philips Medical Systems North America Phillips - Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA
FDA Device · Class II · 2013-01-16 · Philips Medical Systems North America Phillips - (l) Visum Halogen Surgical Light, (2) Visum LED Surgical Light, (3) Stryker Flat Panel and Navigation Arm The Spring Arm Circlip is part of…
FDA Device · Class II · 2013-01-16 · Stryker Communications - Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry Catalog Number:1360 Chek-Stix¿ Positive and Negative Control Str…
FDA Device · Class III · 2013-01-16 · Siemens Healthcare Diagnostics - AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic Mechanical Chest compres…
FDA Device · Class II · 2013-01-16 · Zoll Circulation - UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 5cc Product Code: RT53005 Donated Human Tissu…
FDA Device · Class II · 2013-01-16 · Surgical Tissue Network - Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine Chemistry Catalog Number: 5019 When used with the CLINITEK ATLAS¿ Aut…
FDA Device · Class III · 2013-01-16 · Siemens Healthcare Diagnostics - Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364M Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistr…
FDA Device · Class III · 2013-01-16 · Siemens Healthcare Diagnostics - FlowGate Balloon Guide Catheter
FDA Device · Class II · 2013-01-16 · Concentric Medical - Plum A+3 Triple Channel Infusion Pumps
FDA Device · Class II · 2013-01-09 · Hospira - PENTRA C200, Part Number: A11A01629
FDA Device · Class II · 2013-01-09 · Horiba Instruments - Plum A+ Single Channel Infusion Pumps
FDA Device · Class II · 2013-01-09 · Hospira - Liko Standard Slingbar 450
FDA Device · Class II · 2013-01-09 · Hill Rom - ABX PENTRA AST CP, Part Number: A11A01629
FDA Device · Class II · 2013-01-09 · Horiba Instruments - Medical Surgical Bed, Model 3005S3EX Medical Surgical Bed The S3" MedSurg Bed, Model 3005 is intended to support and transport patients wit…
FDA Device · Class II · 2013-01-09 · Stryker Medical Division - Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130
FDA Device · Class II · 2013-01-09 · B Braun Medical - Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive Surfact, Carmeda BioActive Surfact and Trillium Biosurfa…
FDA Device · Class II · 2013-01-09 · Medtronic Cardiac Rhythm Disease Management - Fisher & Paykel Healthcare reusable breathing circuit
FDA Device · Class I · 2013-01-09 · Fisher And Paykel Healthcare - Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2 Driver System and the…
FDA Device · Class II · 2013-01-09 · Syncardia Systems - Analyzing system consists of a small and portable analyzer and plastic microcuvettes
FDA Device · Class III · 2013-01-09 · Hemocue Ab - Plum A+ Hyperbaric Single Channel Infusion Pumps
FDA Device · Class II · 2013-01-09 · Hospira - Medical Surgical Bed, Model 3002SEX Medical Surgical Bed The S3" MedSurg Bed, is intended to support and transport patients within the Med/…
FDA Device · Class II · 2013-01-09 · Stryker Medical Division - Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Minn…
FDA Device · Class III · 2013-01-09 · St Jude Medical - Maquet Yuno Extension Table Device Maquet GmbH & Co. KG Kehler Strabe 31 Baden-Wuerttemberg 76437 Rastatt,Germany Used to support the lower…
FDA Device · Class II · 2013-01-09 · Maquet - AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses
FDA Device · Class II · 2013-01-09 · Cooper Vision Caribbean - Abbott m2000sp Instrument
FDA Device · Class II · 2013-01-09 · Abbott Molecular - DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers i…
FDA Device · Class II · 2013-01-09 · Mindray Ds Usa D B A Mindray North America - Praxair Vantage Grab n Go - Gas Cylinder pressure regulator Catalog Number: OX-M-AEGNGVNTG Usage: Regulator reduces pressure in oxygen-cont…
FDA Device · Class I · 2013-01-02 · Praxair - Brookstone Heated Body Bean, electrically heated SKU numbers: 734863 (Blue), 734864 (Plum), 734865 (Red)
FDA Device · Class II · 2013-01-02 · Brookstone - GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask***M1091335 QT…
FDA Device · Class I · 2013-01-02 · Ge Healthcare - Diamigo i-Phone App The Diamigo app was intended for use as an educational tool in the management of diabetes
FDA Device · Class II · 2013-01-02 · Sanofi Aventis Us - Flowtron Trio DVT Pump
FDA Device · Class II · 2013-01-02 · Arjo - Biosense Webster MobiCath Bi-Directional Guiding Sheath
FDA Device · Class II · 2013-01-02 · Greatbatch Medical - Computed Tomography X-Ray System, Extended Brilliance Workspace (EBW), Model #728260 Philips Healthcare, Highland Heights, OH The Extended…
FDA Device · Class II · 2013-01-02 · Philips Medical Systems Cleveland - Zimmer Spine Ardis Inserter, Rx, non-sterile
FDA Device · Class I · 2013-01-02 · Zimmer - Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel DxC 600i Synchron Access Clinical System P…
FDA Device · Class II · 2013-01-02 · Beckman Coulter - Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805
FDA Device · Class II · 2013-01-02 · Beckman Coulter - Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042
FDA Device · Class III · 2013-01-02 · Radiometer America - COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrument used with CAP/CA and CAP/CTM.…
FDA Device · Class II · 2013-01-02 · Roche Molecular Systems - Stryker Howmedica Osteonics
FDA Device · Class II · 2013-01-02 · Stryker Howmedica Osteonics
Other years
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