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Medical device recalls reported in 2015

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ReportedRecallClassProductFirm
2015-12-30Z-0392-2016Class IBoston ScientificBoston Scientific Corporation
2015-12-30Z-0422-2016Class IIFlexible Screw Driver SJ706RAesculap, Inc.
2015-12-30Z-0423-2016Class IIFlexible Bone AwlAesculap, Inc.
2015-12-30Z-0424-2016Class IIFlexible DrillAesculap, Inc.
2015-12-30Z-0436-2016Class IOptional PS500 Power Supply Unit for the Evita V500 Ventilator and…Draeger Medical, Inc.
2015-12-30Z-0439-2016Class IEtest¿ Piperacillin/tazobactamBiomerieux
2015-12-30Z-0440-2016Class IEtest¿ PIP/TAZO/CON-4 PTC 256 -pack of 30 tests USBiomerieux
2015-12-30Z-0441-2016Class IEtest¿ PIP/TAZO/CON-4 PTC 256Biomerieux
2015-12-30Z-0442-2016Class IEtest¿ PIP/TAZO/CON-4 PTC 256Biomerieux
2015-12-30Z-0445-2016Class IIAlaris Pump SmartSite Infusion SetCareFusion 303, Inc.
2015-12-30Z-0448-2016Class IITray Set containing multiple instruments and may contain the flexible…Aesculap, Inc.
2015-12-30Z-0449-2016Class IILabel reading in part as: "NexGen SystemZimmer Manufacturing B.V.
2015-12-30Z-0450-2016Class IIABiomet, Inc.
2015-12-30Z-0451-2016Class IIMobile X-ray system MobileDaRt Evolution/FDR Go Software The device…Shimadzu Medical Systems
2015-12-30Z-0452-2016Class IIZimmer UNIVERSAL Power System Loaner and Modular Electric/Battery…Zimmer, Inc.
2015-12-30Z-0453-2016Class IIZimmer UNIVERSAL Power System Loaner and Modular Electric/Battery…Zimmer, Inc.
2015-12-30Z-0454-2016Class IIAegis Torque Handle CATALOG NODePuy Spine, Inc.
2015-12-30Z-0455-2016Class IIAlaris EtCO2 ModuleCareFusion 303, Inc.
2015-12-30Z-0456-2016Class IIBD Vacutainer K2 EDTABecton Dickinson & Company
2015-12-30Z-0457-2016Class IIIDA-2006PBC Group International Inc
2015-12-30Z-0458-2016Class IIReagent Management SystemSiemens Healthcare Diagnostics Inc.
2015-12-30Z-0459-2016Class IIReagent Management SystemSiemens Healthcare Diagnostics Inc.
2015-12-30Z-0460-2016Class IIReagent Management SystemSiemens Healthcare Diagnostics Inc.
2015-12-30Z-0461-2016Class IIReagent Management SystemSiemens Healthcare Diagnostics Inc.
2015-12-30Z-0462-2016Class IIIntellaTip MiFi XP AsymmetricBoston Scientific Corp
2015-12-30Z-0463-2016Class IIIntellaTip MiFi XP AsymmetricBoston Scientific Corp
2015-12-30Z-0464-2016Class IIIntellaTip MiFi XP AsymmetricBoston Scientific Corp
2015-12-30Z-0465-2016Class IIIntellaTip MiFi XP AsymmetricBoston Scientific Corp
2015-12-30Z-0466-2016Class IIZimmer Oscillating FlatSynvasive Technology Inc
2015-12-30Z-0467-2016Class IIMAGNETOM systemsSiemens Medical Solutions USA, Inc
2015-12-30Z-0468-2016Class IIFactor VIII Chromogenic AssaySiemens Healthcare Diagnostics, Inc.
2015-12-30Z-0469-2016Class IIHook BladeInstratek, Incorporated
2015-12-30Z-0470-2016Class IIFB BrothHardy Diagnostics
2015-12-30Z-0471-2016Class IIBlack Mamba Suture PasserBiomet, Inc.
2015-12-30Z-0472-2016Class IIGreen Mamba Suture PasserBiomet, Inc.
2015-12-30Z-0473-2016Class IIVancomycin Screen AgarBecton Dickinson & Co.
2015-12-30Z-0474-2016Class IIEnterococcus Screen Agar QUAD PlateBecton Dickinson & Co.
2015-12-30Z-0475-2016Class IITotal Toe Instrument KitArthrosurface, Inc.
2015-12-30Z-0476-2016Class IIDressol-XRainbow Specialty & Health Products
2015-12-30Z-0477-2016Class IIDressit-XRainbow Specialty & Health Products
2015-12-30Z-0479-2016Class IIVAPR¿ TRIPOLAR 90" Degree Suction ElectrodesDePuy Mitek, Inc., a Johnson & Johnson Co.
2015-12-30Z-0480-2016Class IISynaptive Medical BrightMatter Navigator SystemSynaptive Medical, Inc.
2015-12-30Z-0481-2016Class IIArtis systems with large display from Siemens Medical Solutions USASiemens Medical Solutions USA, Inc
2015-12-30Z-0482-2016Class IIMicroCutter Xchange 30 Blue CartridgeCardica, Inc.
2015-12-30Z-0483-2016Class IIMicroCutter Xchange 30 Blue Curved Tip CartridgeCardica, Inc.
2015-12-30Z-0484-2016Class III1 Step 12 Panel CupAmeditech Inc
2015-12-30Z-0485-2016Class III10-Panel Pipette Drug ScreenAmeditech Inc
2015-12-30Z-0486-2016Class III11 Panel Dip CardAmeditech Inc
2015-12-30Z-0487-2016Class III11 Panel CardAmeditech Inc
2015-12-30Z-0488-2016Class III12-Panel Dip Drug Screen with adulterantAmeditech Inc
2015-12-30Z-0489-2016Class III6 Panel Cup Body and Lid w/AdultAmeditech Inc
2015-12-30Z-0490-2016Class IIIBZO Strip Dip CardAmeditech Inc
2015-12-30Z-0491-2016Class IIICLIA RDTC 12-Panel CupAmeditech Inc
2015-12-30Z-0492-2016Class IIIDrugCheck Waived 12 Panel Cup w/AdultAmeditech Inc
2015-12-30Z-0493-2016Class IIIDrugSmart 10 Test CupAmeditech Inc
2015-12-30Z-0494-2016Class IIIDrugSmart 11 Test CupAmeditech Inc
2015-12-30Z-0495-2016Class IIIDrugSmart 12 Test CupAmeditech Inc
2015-12-30Z-0496-2016Class IIIDrugSmart 9 Test CupAmeditech Inc
2015-12-30Z-0497-2016Class IIIDrugSmart Cup 10Ameditech Inc
2015-12-30Z-0498-2016Class IIIDrugSmart Cup THC/COC/AMP//MET/OPI2/BZOAmeditech Inc
2015-12-30Z-0499-2016Class IIIDrugSmart DipAmeditech Inc
2015-12-30Z-0500-2016Class IIIDrugSmart Dip AMP/OPI2/COC/THC/BZO TestAmeditech Inc
2015-12-30Z-0501-2016Class IIIEDI BZO Uncut SheetAmeditech Inc
2015-12-30Z-0502-2016Class IIIiCup DX 10 Panel w/AdulterantAmeditech Inc
2015-12-30Z-0503-2016Class IIIiCup DX 11 Panel w/ AdulterantAmeditech Inc
2015-12-30Z-0504-2016Class IIIiCup DX 12 Panel w/ AdulterantAmeditech Inc
2015-12-30Z-0505-2016Class IIIiCup DX 6 Panel w/AdulterantAmeditech Inc
2015-12-30Z-0506-2016Class IIIiCup DX 8 Panel w/AdulterantAmeditech Inc
2015-12-30Z-0507-2016Class IIIImmutest 10 Pnl Drug Screen Cup w/ AdultAmeditech Inc
2015-12-30Z-0508-2016Class IIIImmutest 11 Pnl Drug Screen Cup w/ AdultAmeditech Inc
2015-12-30Z-0509-2016Class IIIImmutest 5 Pnl Drug Cup w/ Adult -waivedAmeditech Inc
2015-12-30Z-0510-2016Class IIIImmutest 12 Panel Cup w/AdulterationAmeditech Inc
2015-12-30Z-0511-2016Class IIIImmuTest 12 Panel Dip CardAmeditech Inc
2015-12-30Z-0512-2016Class IIIImmuTest Cup 7-panel w/ AdulterationAmeditech Inc
2015-12-30Z-0513-2016Class IIIImmutest Cup CLIA Waived w/AdulterationAmeditech Inc
2015-12-30Z-0514-2016Class IIIMicro Screen 6 Panel Cup with AdultAmeditech Inc
2015-12-30Z-0515-2016Class IIIProScreen 10 Drug Panel Cassette TestAmeditech Inc
2015-12-30Z-0516-2016Class IIIProScreen 10 Panel CupAmeditech Inc
2015-12-30Z-0517-2016Class IIIProScProScreen 10 Panel Cup with AdulterantsAmeditech Inc
2015-12-30Z-0518-2016Class IIIProScreen 10 Panel Dip CardAmeditech Inc
2015-12-30Z-0519-2016Class IIIProScreen 10 Panel Dip Card w/AdultAmeditech Inc
2015-12-30Z-0520-2016Class IIIProScreen 12 Drug Cup w/AdulterationAmeditech Inc
2015-12-30Z-0521-2016Class IIIProScreen 12 Panel Cup w/AdultAmeditech Inc
2015-12-30Z-0522-2016Class IIIProScreen 12 Panel Dip CardAmeditech Inc
2015-12-30Z-0523-2016Class IIIProScreen 5 Panel Dip CardAmeditech Inc
2015-12-30Z-0524-2016Class IIIProScreen 5 Panel Dip Card w/AdultAmeditech Inc
2015-12-30Z-0525-2016Class IIIProScreen 6 Panel Cassette w/AdultAmeditech Inc
2015-12-30Z-0526-2016Class IIIProScreen 6 Panel Cup w/AdultAmeditech Inc
2015-12-30Z-0527-2016Class IIIProScreen 6 Panel Dip CardAmeditech Inc
2015-12-30Z-0528-2016Class IIIProScreen 6 Panel Dip Card w/AdultAmeditech Inc
2015-12-30Z-0529-2016Class IIIProScreen 6 Panel Dip Drug ScreenAmeditech Inc
2015-12-30Z-0530-2016Class IIIProScreen 7 Panel Dip CardAmeditech Inc
2015-12-30Z-0531-2016Class IIIProScreen 8 Panel Dip CardAmeditech Inc
2015-12-30Z-0532-2016Class IIIProScreen 8 Panel Dip Card w/AdultAmeditech Inc
2015-12-30Z-0533-2016Class IIIProScreen 8 Panel Dip Card w/AdultAmeditech Inc
2015-12-30Z-0534-2016Class IIIProScreen 9 Panel Cup w/AdulterantsAmeditech Inc
2015-12-30Z-0535-2016Class IIIProScreen CLIA Waived Cup 6 Drugs w/AdulAmeditech Inc
2015-12-30Z-0536-2016Class IIIProScreen CLIA Waived Cup with 6 DrugsAmeditech Inc
2015-12-30Z-0537-2016Class IIIProScreen CLIA Waived Cup with 8 DrugAmeditech Inc
2015-12-30Z-0538-2016Class IIIProScreen CLIA Wvd 12 Panel Cup w/AdultAmeditech Inc
2015-12-30Z-0539-2016Class IIIProScreen Cup CLIA with 6 Panel DrugAmeditech Inc
2015-12-30Z-0540-2016Class IIIRealityCHECK Tilt Cup 12 Panel + AdultAmeditech Inc
2015-12-30Z-0541-2016Class IIITHERMO FISHER 6 DRUG CASSETTEAmeditech Inc
2015-12-30Z-0542-2016Class IIITHERMO FISHER 8 DRUG CASSETTEAmeditech Inc
2015-12-30Z-0543-2016Class IICardinal Health Tiny ToesPhilips Electronics North America Corporation
2015-12-30Z-0544-2016Class IIBrilliance 64 Computed Tomography X-ray systemPhilips Medical Systems (Cleveland) Inc
2015-12-30Z-0545-2016Class IIBrilliance iCT Computed Tomography X-ray systemPhilips Medical Systems (Cleveland) Inc
2015-12-30Z-0546-2016Class IIBrilliance iCT SP Computed Tomography X-ray systemPhilips Medical Systems (Cleveland) Inc
2015-12-30Z-0547-2016Class IIIngenuity Core Computed Tomography X-ray systemPhilips Medical Systems (Cleveland) Inc
2015-12-30Z-0548-2016Class IIIngenuity Core 128 Computed Tomography X-ray systemPhilips Medical Systems (Cleveland) Inc
2015-12-30Z-0549-2016Class IIIngenuity CT Computed Tomography X-ray systemPhilips Medical Systems (Cleveland) Inc
2015-12-30Z-0550-2016Class IISyngo Imaging XS is a Picture Archiving and Communication SystemSiemens Medical Solutions USA, Inc
2015-12-30Z-0551-2016Class IITerumo Surflo Winged Infusion Set with Filter and Needle ProtectionTerumo Medical Corp
2015-12-30Z-0552-2016Class IIAirways Development LLC WaterPAP Positive Airway Pressure Device…Airways Development LLC
2015-12-23Z-0360-2016Class IPerseus A500 Anesthesia WorkstationDraeger Medical, Inc.
2015-12-23Z-0393-2016Class IOmniPod¿Insulet Corporation
2015-12-23Z-0394-2016Class IOmniPod¿Insulet Corporation
2015-12-23Z-0405-2016Class IIPhilips Healthcare Brilliance 64 Computed Tomography X-ray systemPhilips Electronics North America Corporation
2015-12-23Z-0406-2016Class IIPhilips Healthcare Ingenuity Core Computed Tomography X-ray systemPhilips Electronics North America Corporation
2015-12-23Z-0407-2016Class IIPhilips Healthcare Ingenuity Core 128 Computed Tomography X-ray systemPhilips Electronics North America Corporation
2015-12-23Z-0408-2016Class IIPhilips Healthcare Ingenuity CT Computed Tomography X-ray systemPhilips Electronics North America Corporation
2015-12-23Z-0412-2016Class IIDigital Temple Thermometer labeled under: BestmedBestmed, LLC
2015-12-23Z-0413-2016Class IIGE Healthcare Optima CL323i Product Usage: The angiographic X-ray…GE Medical Systems, LLC
2015-12-23Z-0414-2016Class IIGE Healthcare Optima IGS 320GE Medical Systems, LLC
2015-12-23Z-0415-2016Class IICatalog NoMOOG Medical Devices Group
2015-12-23Z-0416-2016Class IIVentriClear¿ II Ventricular Drainage Catheter SetCook Inc.
2015-12-23Z-0417-2016Class IICournand Modified 2-PC 19GStryker Instruments Div. of Stryker Corporation
2015-12-23Z-0418-2016Class IIFujifilm Medical Systems DuodenoscopeFujifilm Medical Systems U.S.A., Inc.
2015-12-23Z-0419-2016Class IIHudson RCI Adult Universal Ventilator CircuitTeleflex Medical
2015-12-23Z-0420-2016Class IIGlideScope Video LaryngoscopeVerathon, Inc.
2015-12-23Z-0421-2016Class IIGlideScope AVL Video LaryngoscopeVerathon, Inc.
2015-12-23Z-0425-2016Class IIMYLA CLINIC PATCH 3bioMerieux, Inc.
2015-12-23Z-0426-2016Class IIMYLA MASTER DVD 3bioMerieux, Inc.
2015-12-23Z-0427-2016Class IIMYLA CLINIC PATCH 3bioMerieux, Inc.
2015-12-23Z-0428-2016Class IIMYLA MASTER DVD V4bioMerieux, Inc.
2015-12-23Z-0429-2016Class IIMYLA MASTER DVD V4bioMerieux, Inc.
2015-12-23Z-0430-2016Class IIMYLA CLI V3bioMerieux, Inc.
2015-12-23Z-0431-2016Class IIMYLA CLI V3bioMerieux, Inc.
2015-12-23Z-0432-2016Class IIUniCel DxH 800 Coulter Cellular Analysis SystemBeckman Coulter Inc.
2015-12-23Z-0433-2016Class IIUniCel DxH 600 Coulter Cellular Analysis SystemBeckman Coulter Inc.
2015-12-23Z-0434-2016Class IIUniCel DxH 600 Coulter Cellular Analysis SystemBeckman Coulter Inc.
2015-12-23Z-0435-2016Class IIAbsorbENTSummit Medical, Inc.
2015-12-23Z-0437-2016Class IIMiniMed 620GMedtronic MiniMed Inc.
2015-12-23Z-0438-2016Class IIMiniMed 640GMedtronic MiniMed Inc.
2015-12-23Z-0443-2016Class IIOxoid Gentamicin Antimicrobial Susceptibility Testing DiscRemel Inc
2015-12-23Z-0444-2016Class IIUnolok Blunt Fill Needle 18G x 1Myco Medical Supplies Inc
2015-12-23Z-0446-2016Class IIIntravascularEdwards Lifesciences, LLC
2015-12-23Z-0447-2016Class IIMOSAIQ Oncology Information SystemElekta, Inc.
2015-12-16Z-0371-2016Class IIValeant Pharmaceuticals North America Model NoValeant Pharmaceuticals North America LLC
2015-12-16Z-0372-2016Class IISmith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE…Smith & Nephew, Inc.
2015-12-16Z-0373-2016Class IISmith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE…Smith & Nephew, Inc.
2015-12-16Z-0374-2016Class IIPhilips IntelliVue Information Center iXPhilips Medical Systems, Inc.
2015-12-16Z-0375-2016Class IITrochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA…Synthes (USA) Products LLC
2015-12-16Z-0376-2016Class IIAMS 4674 Custom PackWindstone Medical Packaging, Inc.
2015-12-16Z-0377-2016Class IIAMS 4675 Angio PackWindstone Medical Packaging, Inc.
2015-12-16Z-0378-2016Class IILeMaitre Over-the-Wire Embolectomy Catheter 3FLeMaitre Vascular, Inc.
2015-12-16Z-0379-2016Class IILeMaitre Over-the-Wire Embolectomy Catheter 3FLeMaitre Vascular, Inc.
2015-12-16Z-0380-2016Class IILeMaitre Over-the-Wire Embolectomy Catheter 4FLeMaitre Vascular, Inc.
2015-12-16Z-0381-2016Class IILeMaitre Over-the-Wire Embolectomy Catheter 5F PlusLeMaitre Vascular, Inc.
2015-12-16Z-0382-2016Class IILeMaitre Over-the-Wire Embolectomy Catheter 7FLeMaitre Vascular, Inc.
2015-12-16Z-0383-2016Class IILeMaitre Over-the-Wire Embolectomy Catheter 5F PlusLeMaitre Vascular, Inc.
2015-12-16Z-0384-2016Class IILeMaitre Over-the-Wire Embolectomy Catheter 6FLeMaitre Vascular, Inc.
2015-12-16Z-0385-2016Class IILeMaitre Over-the-Wire Embolectomy Catheter 6FLeMaitre Vascular, Inc.
2015-12-16Z-0386-2016Class IILeMaitre Single Lumen Embolectomy Catheter 3FLeMaitre Vascular, Inc.
2015-12-16Z-0387-2016Class IILeMaitre Single Lumen Embolectomy Catheter 4FLeMaitre Vascular, Inc.
2015-12-16Z-0388-2016Class IILeMaitre Single Lumen Embolectomy Catheter 5FLeMaitre Vascular, Inc.
2015-12-16Z-0389-2016Class IILeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6FLeMaitre Vascular, Inc.
2015-12-16Z-0390-2016Class IILeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2FLeMaitre Vascular, Inc.
2015-12-16Z-0391-2016Class IIRBTBioHorizons Implant Systems Inc
2015-12-16Z-0395-2016Class IIThe "Pacifier Activated Lullaby"Powers Medical Devices, LLC
2015-12-16Z-0396-2016Class IIDGDEImplant Direct Sybron Manufacturing, LLC
2015-12-16Z-0397-2016Class IIIBSIn2Bones, SAS
2015-12-16Z-0398-2016Class IIThin-Flex Venous CannulaEdwards Lifesciences, LLC
2015-12-16Z-0399-2016Class IIThe eCareManager systemVisicu, Inc.
2015-12-16Z-0400-2016Class IIBrilliance CTPhilips Medical Systems (Cleveland) Inc
2015-12-16Z-0401-2016Class IIGE HealthcareGE Medical Systems, LLC
2015-12-16Z-0402-2016Class IIOne Step ButtonBoston Scientific Corp
2015-12-16Z-0403-2016Class IIOlympus ENDOEYE HD II Video TelescopesOlympus Corporation of the Americas
2015-12-16Z-0404-2016Class IIZimmerSTERILMED, INC.
2015-12-16Z-0409-2016Class IIBrilliance 64 Computed Tomography X-Ray SystemPhilips Medical Systems (Cleveland) Inc
2015-12-16Z-0410-2016Class IIPersona EM Proximal TubeZimmer, Inc.
2015-12-16Z-0411-2016Class IIPersona EM Distal RodZimmer, Inc.
2015-12-09Z-0342-2016Class IIMedtronic InSync IIIMedtronic Inc.
2015-12-09Z-0343-2016Class IICopper NiTi Preformed ArchwiresOrmco/Sybronendo
2015-12-09Z-0344-2016Class IITwo-stage and three-stage IStryker Medical Division of Stryker Corporation
2015-12-09Z-0345-2016Class IIHYDRO-TEMPDeRoyal Industries Inc
2015-12-09Z-0346-2016Class IIPhilips Healthcare Allura Xper Series: Allura Xper FD10 Allura Xper…Philips Medical Systems, Inc.
2015-12-09Z-0347-2016Class IIPhilips Healthcare Allure BiPlane Series: Model 722013 Allura Xper…Philips Medical Systems, Inc.
2015-12-09Z-0348-2016Class IIPhilips Healthcare INTEGRIS cardio system Model : 722121 Product…Philips Medical Systems, Inc.
2015-12-09Z-0349-2016Class IIPhilips Healthcare INTEGRIS vascular System Model : 722122 Product…Philips Medical Systems, Inc.
2015-12-09Z-0350-2016Class IIPhilips Healthcare INTEGRIS H5000F/Allura 9F Model : 722017 Product…Philips Medical Systems, Inc.
2015-12-09Z-0351-2016Class IIPhilips Healthcare Xper cardio systems Model : 722123 Product Usage:…Philips Medical Systems, Inc.
2015-12-09Z-0352-2016Class IIPhilips Healthcare Xper vascular system Model : 722124 Product Usage:…Philips Medical Systems, Inc.
2015-12-09Z-0353-2016Class IIPhilips Healthcare Xper cardio systems R7Philips Medical Systems, Inc.
2015-12-09Z-0354-2016Class IIPhilips Healthcare Xper vascular systems R7Philips Medical Systems, Inc.
2015-12-09Z-0355-2016Class IIU-SDN 2 Part Ultra Modified Seldinger NeedlesProcedure Products, Inc.
2015-12-09Z-0356-2016Class IIProTrack MicrocatheterBaylis Medical Corp *
2015-12-09Z-0357-2016Class IIIOL Master 5Carl Zeiss Meditec AG
2015-12-09Z-0358-2016Class IIIOL Master 500: Software versions 7Carl Zeiss Meditec AG
2015-12-09Z-0359-2016Class IIAltrus Thermal Tissue Fusion Energy SourcesConMed Corporation

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