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Medical device recalls reported in 2017

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ReportedRecallClassProductFirm
2017-09-20Z-3130-2017Class IIMakoplasty Partial Knee ApplicationMako Surgical Corporation
2017-09-20Z-3131-2017Class IITotal Hip ApplicationMako Surgical Corporation
2017-09-20Z-3132-2017Class IIFFR Link-FFR Signal Processing ModuleBoston Scientific Corporation
2017-09-20Z-3133-2017Class IIBaxter Amia Automated Peritoneal Dialysis Set with CassetteBaxter Healthcare Corp
2017-09-13Z-3085-2017Class ICS 100i Intra-Aortic Balloon PumpMaquet Datascope Corp - Cardiac Assist Division
2017-09-13Z-3086-2017Class ICS 100 Intra-Aortic Balloon PumpMaquet Datascope Corp - Cardiac Assist Division
2017-09-13Z-3087-2017Class ICS 300 Intra-Aortic Balloon PumpMaquet Datascope Corp - Cardiac Assist Division
2017-09-13Z-3103-2017Class IIMicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic CoatingMicrovention, Inc.
2017-09-13Z-3104-2017Class IIJTS External Drive Unit JTS Distal Femoral Extendible Implant Femur…Stanmore Implants Worldwide Ltd.
2017-09-13Z-3105-2017Class IIMerge Unity softwareMerge Healthcare, Inc.
2017-09-13Z-3107-2017Class IIPresourceCardinal Health 200, LLC
2017-09-13Z-3108-2017Class IIOn-X Prosthetic Heart Valve with Gelweave Valsalva GraftCryoLife, Inc.
2017-09-13Z-3110-2017Class IIMOSAIQ Medical Charged-Particle Radiation Therapy SystemElekta, Inc.
2017-09-13Z-3112-2017Class IIQualigenQualigen Inc
2017-09-13Z-3113-2017Class IICoulter LH 750Beckman Coulter Inc.
2017-09-13Z-3114-2017Class IICoulter HmX CP and Coulter HmX AL Analyzers The purpose of the HmX…Beckman Coulter Inc.
2017-09-06Z-0008-2018Class IIiVue with Normative DatabaseOptovue, Inc.
2017-09-06Z-0009-2018Class IIiFusionOptovue, Inc.
2017-09-06Z-0010-2018Class IIiVue 500 with iScanOptovue, Inc.
2017-09-06Z-3036-2017Class IISamsung GU60A system- Digital X-ray Imaging Systems are intended for…NeuroLogica Corporation
2017-09-06Z-3044-2017Class IINeusoft Medical NeuViz 64 Multi-slice CT Scanner SystemNeusoft Medical Systems Co., Ltd.
2017-09-06Z-3045-2017Class IINeusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The…Neusoft Medical Systems Co., Ltd.
2017-09-06Z-3070-2017Class IIToshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray…Toshiba American Medical Systems Inc
2017-09-06Z-3071-2017Class IICADDSmiths Medical ASD Inc.
2017-09-06Z-3072-2017Class IImcompass 2-channel Balloon Catheters The mcompass Biofeedback…Medspira, Llc
2017-09-06Z-3073-2017Class IIPOLYURETHANE ENFitKentec Medical Inc
2017-09-06Z-3074-2017Class IIPOLYURETHANE ENFitKentec Medical Inc
2017-09-06Z-3075-2017Class IIVITEK¿ 2 Compact 15Biomerieux Inc
2017-09-06Z-3076-2017Class IIVITEK¿ 2 Compact 30Biomerieux Inc
2017-09-06Z-3077-2017Class IIFogarty Adherent Clot Catheter Model Numbers 1408010 and 140806…Edwards Lifesciences, LLC
2017-09-06Z-3078-2017Class IIBurn SheetCertified Safety Mfg Inc
2017-09-06Z-3079-2017Class IIMEDLINE SIRUS Surgical GownMaster & Frank (Pinghu) Co., Ltd.
2017-09-06Z-3080-2017Class IIAirLifeVyaire Medical
2017-09-06Z-3081-2017Class IILX3 Floor Stand for LuxOR Ophthalmic MicroscopeAlcon Research, Ltd.
2017-09-06Z-3082-2017Class IICIVCO Arm SupportMed Tec Inc
2017-09-06Z-3083-2017Class IICIVCO Arm SupportMed Tec Inc
2017-09-06Z-3084-2017Class IIIAlere iScreen Dx Urine Drug Screen CardAmeditech Inc
2017-09-06Z-3088-2017Class IIArtis zee/zeego and Artis Q/QSiemens Medical Solutions USA, Inc
2017-09-06Z-3089-2017Class IIArtis zee/zeego and Artis Q/QSiemens Medical Solutions USA, Inc
2017-09-06Z-3090-2017Class IIArtis zee/zeego and Artis Q/QSiemens Medical Solutions USA, Inc
2017-09-06Z-3091-2017Class IIArtis zee/zeego and Artis Q/QSiemens Medical Solutions USA, Inc
2017-09-06Z-3092-2017Class IIArtis zee/zeego and Artis Q/QSiemens Medical Solutions USA, Inc
2017-09-06Z-3093-2017Class IIArtis zee/zeego and Artis Q/QSiemens Medical Solutions USA, Inc
2017-09-06Z-3094-2017Class IIArtis zee/zeego and Artis Q/QSiemens Medical Solutions USA, Inc
2017-09-06Z-3095-2017Class IIArtis zee/zeego and Artis Q/QSiemens Medical Solutions USA, Inc
2017-09-06Z-3096-2017Class IIArtis zee/zeego and Artis Q/QSiemens Medical Solutions USA, Inc
2017-09-06Z-3097-2017Class IIArtis zee/zeego and Artis Q/QSiemens Medical Solutions USA, Inc
2017-09-06Z-3098-2017Class IIArtis zee/zeego and Artis Q/QSiemens Medical Solutions USA, Inc
2017-09-06Z-3099-2017Class IIArtis zee/zeego and Artis Q/QSiemens Medical Solutions USA, Inc
2017-09-06Z-3100-2017Class IIsmith&nephew POLARSTEMSmith & Nephew, Inc.
2017-09-06Z-3101-2017Class IIUniCel DxH Slidemaker Stainer Coulter Cellular Analysis SystemBeckman Coulter Inc.
2017-09-06Z-3102-2017Class IIMODIFIED/SPECIAL INSTRUMENTEncore Medical, Lp
2017-08-30Z-3046-2017Class IIConvertors Robotic Drape with Attached LeggingsCardinal Health 200, LLC
2017-08-30Z-3047-2017Class IIVASER AmplifierSolta Medical Inc
2017-08-30Z-3048-2017Class IIVASER PRO AmplifierSolta Medical Inc
2017-08-30Z-3049-2017Class IIORA System with VerifEye+ CartAlcon Research, Ltd.
2017-08-30Z-3050-2017Class IIORA System with VerifEyeAlcon Research, Ltd.
2017-08-30Z-3051-2017Class IIMedtronic Straight Suction 9733449 EM ENTMedtronic Navigation, Inc.
2017-08-30Z-3052-2017Class IIMedtronic Curved Suction 70 9733450 EM ENTMedtronic Navigation, Inc.
2017-08-30Z-3053-2017Class IIMedtronic Curved Suction 90 9733451 EM ENTMedtronic Navigation, Inc.
2017-08-30Z-3054-2017Class IIMedtronic Suction 9734308 Small AxiEM ENTMedtronic Navigation, Inc.
2017-08-30Z-3055-2017Class IIMedtronic Instrument Set EM ENTMedtronic Navigation, Inc.
2017-08-30Z-3056-2017Class IIMedtronic Instrument Kit 9733908 Fusion ENTMedtronic Navigation, Inc.
2017-08-30Z-3057-2017Class IIMedtronic Set Supplemental INS AxiEM ENTMedtronic Navigation, Inc.
2017-08-30Z-3058-2017Class IIMedtronic ENT Prgm 9734636 Add Fusion Nav AxiEMMedtronic Navigation, Inc.
2017-08-30Z-3059-2017Class IIVarious custom surgical kits manufactured for CMSCustom Assemblies Inc
2017-08-30Z-3060-2017Class IITissu-Trans Filtron 100Shippert Medical Technologies
2017-08-30Z-3061-2017Class IITissu-Trans Filtron 250Shippert Medical Technologies
2017-08-30Z-3062-2017Class IITissu-Trans Filtron 500Shippert Medical Technologies
2017-08-30Z-3063-2017Class IITissu-Trans Filtron 1000Shippert Medical Technologies
2017-08-30Z-3064-2017Class IITissu-Trans Filtron 2000Shippert Medical Technologies
2017-08-30Z-3065-2017Class IITissu-Trans MEGA 1500Shippert Medical Technologies
2017-08-30Z-3066-2017Class IITissu-Trans SFILL 360Shippert Medical Technologies
2017-08-30Z-3067-2017Class IIUltrasound Video GastroscopePentax of America Inc
2017-08-30Z-3068-2017Class IIUltrasound Video GastroscopePentax of America Inc
2017-08-30Z-3069-2017Class IIDBS Lead Depth Stop contained in Medtronic Deep Brain StimulationMedtronic Neuromodulation
2017-08-23Z-3018-2017Class IITruliant Tibial Trial HandleExactech, Inc.
2017-08-23Z-3019-2017Class IIVNS Therapy¿ AspireHC¿ GeneratorCyberonics, Inc
2017-08-23Z-3020-2017Class IIVNS Therapy¿ AspireHC¿ GeneratorCyberonics, Inc
2017-08-23Z-3021-2017Class IIBrivo MR355GE Medical Systems, LLC
2017-08-23Z-3022-2017Class IIOptima MR450 1GE Medical Systems, LLC
2017-08-23Z-3023-2017Class IIOptima MR750 3GE Medical Systems, LLC
2017-08-23Z-3024-2017Class IIOptima MR450w 1GE Medical Systems, LLC
2017-08-23Z-3025-2017Class IIDiscovery MR750 3GE Medical Systems, LLC
2017-08-23Z-3026-2017Class IISIGNA CreatorGE Medical Systems, LLC
2017-08-23Z-3027-2017Class II1GE Medical Systems, LLC
2017-08-23Z-3028-2017Class II1GE Medical Systems, LLC
2017-08-23Z-3029-2017Class IISigna PET/MRGE Medical Systems, LLC
2017-08-23Z-3030-2017Class IIVersaSafe Plastic CannulaCareFusion 303, Inc.
2017-08-23Z-3031-2017Class IIPlum 360 Infusion SystemICU Medical Inc
2017-08-23Z-3032-2017Class IIThermaSureCenorin, LLC
2017-08-23Z-3033-2017Class IIThermaSureCenorin, LLC
2017-08-23Z-3034-2017Class IIThermaSureCenorin, LLC
2017-08-23Z-3035-2017Class IILeadCare II Blood Lead Test KitMagellan Diagnostics, Inc.
2017-08-23Z-3037-2017Class IIEMBLEM S-ICDBoston Scientific Corporation
2017-08-23Z-3038-2017Class IIEMBLEM MRI S-ICD Model 219Boston Scientific Corporation
2017-08-23Z-3039-2017Class IISQ-RX 1010 Pulse GeneratorBoston Scientific Corporation
2017-08-23Z-3040-2017Class IIHomeChoice Automated PD system Model numbers: 5C4471Baxter Healthcare Corporation
2017-08-23Z-3041-2017Class IIHomeChoice Pro Automated PD system Model numbers: 5C8310Baxter Healthcare Corporation
2017-08-23Z-3042-2017Class IIArctic Sun 5000 Temperature Management SystemC.R. Bard, Inc.
2017-08-23Z-3043-2017Class IIEncoreBoston Scientific Corporation
2017-08-16Z-2099-2017Class IZenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic…Cook Medical Incorporated
2017-08-16Z-2804-2017Class IISyringe BulbInternational Medsurg Connection, Inc.
2017-08-16Z-2805-2017Class IIHypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2806-2017Class IIHypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2807-2017Class IIHypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2808-2017Class IIHypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2809-2017Class IIHypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2810-2017Class IIHypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2811-2017Class IIHypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2812-2017Class IIHypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2813-2017Class IIHypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2814-2017Class IIHypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2815-2017Class IIHypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2816-2017Class IIHypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2817-2017Class IIHypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2818-2017Class IIHypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2819-2017Class IIHypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2820-2017Class IIHypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2821-2017Class IIHypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2822-2017Class IIHypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2823-2017Class IIHypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2824-2017Class IIHypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2825-2017Class IIPiston Syringe and Hypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2826-2017Class IIPiston Syringe and Hypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2827-2017Class IIPiston Syringe and Hypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2828-2017Class IIPiston Syringe and Hypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2829-2017Class IIPiston Syringe and Hypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2830-2017Class IIPiston Syringe and Hypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2831-2017Class IIPiston Syringe and Hypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2832-2017Class IIPiston Syringe and Hypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2833-2017Class IIPiston Syringe and Hypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2834-2017Class IIPiston Syringe and Hypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2835-201Class IIPiston Syringe and Hypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2836-201Class IIPiston Syringe and Hypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2837-201Class IIPiston Syringe and Hypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2838-201Class IIPiston Syringe and Hypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2839-2017Class IIPiston Syringe and Hypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2840-2017Class IIPiston Syringe and Hypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2841-2017Class IIPiston Syringe and Hypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2842-2017Class IIPiston Syringe and Hypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2843-2017Class IIPiston Syringe and Hypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2844-2017Class IIPiston Syringe and Hypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2845-2017Class IIPiston Syringe and Hypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2846-2017Class IIPiston Syringe and Hypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2847-2017Class IIPiston Syringe and Hypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2848-2017Class IIPiston Syringe and Hypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2849-2017Class IIPiston Syringe and Hypodermic NeedleInternational Medsurg Connection, Inc.
2017-08-16Z-2850-2017Class IIPiston SyringeInternational Medsurg Connection, Inc.
2017-08-16Z-2851-2017Class IIPiston SyringeInternational Medsurg Connection, Inc.
2017-08-16Z-2852-2017Class IIPiston SyringeInternational Medsurg Connection, Inc.
2017-08-16Z-2853-2017Class IIPiston SyringeInternational Medsurg Connection, Inc.
2017-08-16Z-2854-2017Class IIPiston SyringeInternational Medsurg Connection, Inc.
2017-08-16Z-2855-2017Class IIPiston SyringeInternational Medsurg Connection, Inc.
2017-08-16Z-2856-2017Class IIPiston SyringeInternational Medsurg Connection, Inc.
2017-08-16Z-2857-2017Class IIPiston SyringeInternational Medsurg Connection, Inc.
2017-08-16Z-2858-2017Class IIPiston SyringeInternational Medsurg Connection, Inc.
2017-08-16Z-2859-2017Class IIPiston SyringeInternational Medsurg Connection, Inc.
2017-08-16Z-2860-2017Class IIPiston SyringeInternational Medsurg Connection, Inc.
2017-08-16Z-2861-2017Class IIPiston SyringeInternational Medsurg Connection, Inc.
2017-08-16Z-2862-2017Class IIPiston SyringeInternational Medsurg Connection, Inc.
2017-08-16Z-2871-2017Class IISorin Group Aortic Arch CannulaSorin Group USA, Inc.
2017-08-16Z-2872-2017Class IIBARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with Drain ExtensionC.R. Bard, Inc.
2017-08-16Z-2873-2017Class IIPALLAS M/MAXIMIS 5Valorem Surgical LLC
2017-08-16Z-2874-2017Class IIPALLAS M/MAXIMIS 50mm Curved RodValorem Surgical LLC
2017-08-16Z-2875-2017Class IIPALLAS M/MAXIMIS 60mm Curved RodValorem Surgical LLC
2017-08-16Z-2876-2017Class IIPALLAS M/MAXIMIS Crosslink 50-70mmValorem Surgical LLC
2017-08-16Z-2877-2017Class IIPALLAS M/MAXIMIS Small CrosslinkValorem Surgical LLC
2017-08-16Z-2878-2017Class IIPALLAS M/MAXIMIS Large CrosslinkValorem Surgical LLC
2017-08-16Z-2879-2017Class IIPALLAS M/MAXIMIS 5Valorem Surgical LLC
2017-08-16Z-2880-2017Class IIPALLAS M/MAXIMIS 5Valorem Surgical LLC
2017-08-16Z-2881-2017Class IIPALLAS M/MAXIMIS MIS Poly Screw Driver BValorem Surgical LLC
2017-08-16Z-2882-2017Class IIPALLAS M/MAXIMIS 30mm RodValorem Surgical LLC
2017-08-16Z-2883-2017Class IIPALLAS M/MAXIMIS 35mm MIS rodValorem Surgical LLC
2017-08-16Z-2884-2017Class IIPALLAS M/MAXIMIS 40mm MIS rodValorem Surgical LLC
2017-08-16Z-2885-2017Class IIPALLAS M/MAXIMIS 45mm MISValorem Surgical LLC
2017-08-16Z-2886-2017Class IIPALLAS M/MAXIMIS 50mm MIS RodValorem Surgical LLC
2017-08-16Z-2887-2017Class IIPALLAS M/MAXIMIS 60mm MIS RodValorem Surgical LLC
2017-08-16Z-2888-2017Class IIPALLAS M/MAXIMIS 70mm MIS RodValorem Surgical LLC
2017-08-16Z-2889-2017Class IIPALLAS M/MAXIMIS 80mm MIS RodValorem Surgical LLC
2017-08-16Z-2890-2017Class IIPALLAS M/MAXIMIS 40mm MIS RodValorem Surgical LLC
2017-08-16Z-2891-2017Class IIPALLAS M/MAXIMIS 35mm MIS RodValorem Surgical LLC
2017-08-16Z-2892-2017Class IIPALLAS M/MAXIMIS 45mm MIS RodValorem Surgical LLC
2017-08-16Z-2893-2017Class IIPALLAS M/MAXIMIS 50mm MIS RodValorem Surgical LLC
2017-08-16Z-2894-2017Class IIPALLAS M/MAXIMIS 55mm MIS RodValorem Surgical LLC
2017-08-16Z-2895-2017Class IIPALLAS M/MAXIMIS 60mm MIS RodValorem Surgical LLC
2017-08-16Z-2896-2017Class IIPALLAS M/MAXIMIS 120mm MIS RodValorem Surgical LLC
2017-08-16Z-2897-2017Class IIPALLAS M/MAXIMIS Set ScrewValorem Surgical LLC
2017-08-16Z-2898-2017Class IIPALLAS M/MAXIMIS Poly Screw 5Valorem Surgical LLC
2017-08-16Z-2899-2017Class IIPALLAS M/MAXIMIS Poly Screw 5Valorem Surgical LLC
2017-08-16Z-2900-2017Class IIPALLAS M/MAXIMIS Poly Screw 6Valorem Surgical LLC
2017-08-16Z-2901-2017Class IIPALLAS M/MAXIMIS Poly Screw 6Valorem Surgical LLC
2017-08-16Z-2902-2017Class IIPALLAS M/MAXIMIS Poly Screw 6Valorem Surgical LLC
2017-08-16Z-2903-2017Class IIPALLAS M/MAXIMIS Poly Screw 6Valorem Surgical LLC
2017-08-16Z-2904-2017Class IIPALLAS M/MAXIMIS Poly Screw 7Valorem Surgical LLC
2017-08-16Z-2905-2017Class IIPALLAS M/MAXIMIS Poly Screw 7Valorem Surgical LLC
2017-08-16Z-2906-2017Class IIPALLAS M/MAXIMIS Poly Screw 7Valorem Surgical LLC
2017-08-16Z-2907-2017Class IIPALLAS M/MAXIMIS Poly Screw 7Valorem Surgical LLC
2017-08-16Z-2908-2017Class IIPALLAS M/MAXIMIS Poly Screw 5Valorem Surgical LLC
2017-08-16Z-2909-2017Class IIPALLAS M/MAXIMIS Poly Screw 5Valorem Surgical LLC

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