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Medical device recalls reported in 2019

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ReportedRecallClassProductFirm
2019-12-25Z-0114-2020Class IIAestiva MRIGE Healthcare, LLC
2019-12-25Z-0115-2020Class IIAestiva 7900GE Healthcare, LLC
2019-12-25Z-0116-2020Class IIAespire 7100GE Healthcare, LLC
2019-12-25Z-0117-2020Class IIAestiva 7100GE Healthcare, LLC
2019-12-25Z-0679-2020Class IIRoche Homocysteine-In vitro test for the quantitative determination…Roche Diagnostics Operations, Inc.
2019-12-25Z-0680-2020Class IIVisuMax Software Version 2Carl Zeiss Meditec, Inc.
2019-12-25Z-0682-2020Class IIA1CNow+ SystemsPolymer Technology Systems
2019-12-25Z-0683-2020Class IIA1CNow SELF CHECKPolymer Technology Systems
2019-12-25Z-0684-2020Class IIWalgreens At-Home A1C Test KitPolymer Technology Systems
2019-12-25Z-0685-2020Class IIReliOn FastA1C TestPolymer Technology Systems
2019-12-25Z-0686-2020Class IICVS Health At Home A1C Test KitPolymer Technology Systems
2019-12-25Z-0687-2020Class IIElasto-Gel Absorbent Wound DressingSouthwest Technologies Inc
2019-12-25Z-0688-2020Class IIArrow EZ-IO Intraosseous Vascular Access System 15mm…Teleflex Medical
2019-12-25Z-0689-2020Class IIArrow EZ-IO Intraosseous Vascular Access System 25mm…Teleflex Medical
2019-12-25Z-0690-2020Class IIArrow EZ-IO Intraosseous Vascular Access System 45mm…Teleflex Medical
2019-12-25Z-0691-2020Class IIAscension¿ Silicone PIP-Silicone PIP Sz 1Integra Lifesciences Sales Llc
2019-12-25Z-0692-2020Class IIIQuickTox 5 Panel Drug Screen DipCardAmeditech Inc
2019-12-25Z-0693-2020Class IIMedtronic AffinityMedtronic Perfusion Systems
2019-12-25Z-0694-2020Class IITEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular LensesTekia, Inc.
2019-12-25Z-0695-2020Class IIArtis zee/ zeego Interventional Fluoroscopic X-Ray SystemSiemens Medical Solutions USA, Inc
2019-12-25Z-0696-2020Class IIsmith&nephew PROFIX MalletSmith & Nephew, Inc.
2019-12-25Z-0697-2020Class IILow Volume Cartridge IFUNxStage Medical, Inc.
2019-12-25Z-0698-2020Class IIAnesthesia Pediatric Circuit 72"Medline Industries Inc
2019-12-25Z-0699-2020Class IIINatrelle Saline-Filled Breast ImplantAllergan PLC
2019-12-25Z-0700-2020Class IIINatrelle Silicone Filled Breast Implants for the following Styles and…Allergan PLC
2019-12-25Z-0701-2020Class IIINatrelle Inspira Sillicone-Filled Breast Implants for the following…Allergan PLC
2019-12-25Z-0702-2020Class IIINATRELLE Resterilizable Sizers for the styles and sizes: Style 15Allergan PLC
2019-12-25Z-0703-2020Class IIHUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135Teleflex Medical
2019-12-25Z-0704-2020Class IIHydroDot brand: Wave Prep 4 ozBio-Signal Group Corp.
2019-12-25Z-0705-2020Class IIHydroDot brand: Wave Prep Single use cupsBio-Signal Group Corp.
2019-12-25Z-0706-2020Class IIDeRoyal KNEE BRACEDeRoyal Industries Inc
2019-12-25Z-0707-2020Class IIMedtronic Adapter Percutaneous PinMedtronic Navigation, Inc.
2019-12-25Z-0708-2020Class IIRhondium OVC3 One Visit CrownRHONDIUM LIMITED
2019-12-25Z-0709-2020Class IIOARTRAC PROSTATE IMMOBILIZATION ENDORECTAL BALLOON DEVICE KITAngiodynamics, Inc.
2019-12-25Z-0710-2020Class IIOARtrac PLUS CLINICAL DETECTOR UNIT Catalog Number: OTS-V2-PlusAngiodynamics, Inc.
2019-12-25Z-0711-2020Class IIMICRO-PSD ElectronAngiodynamics, Inc.
2019-12-25Z-0712-2020Class IIMICRO-PSD HDRAngiodynamics, Inc.
2019-12-25Z-0713-2020Class IIMICRO-PSD EXTERNAL BEAM PHOTONAngiodynamics, Inc.
2019-12-25Z-0714-2020Class IIAlliance Tech MedicalAlliance Tech Medical, Inc
2019-12-25Z-0715-2020Class IIArrow Berman Angiographic Catheter 50cc Item Number: AI-07130Arrow International Inc
2019-12-25Z-0716-2020Class IIArrow Berman Angiographic Catheter 60cm Item Number: AI-07130-JArrow International Inc
2019-12-25Z-0717-2020Class IIAngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D…Boston Scientific Corporation
2019-12-25Z-0718-2020Class IILIFESTREAM Balloon Expandable Vascular Covered StentBard Peripheral Vascular Inc
2019-12-18Z-0587-2020Class ICrossCath Support CatheterCook Inc.
2019-12-18Z-0588-2020Class ICrossCath Support CatheterCook Inc.
2019-12-18Z-0589-2020Class ICrossCath Support CatheterCook Inc.
2019-12-18Z-0590-2020Class ICrossCath Support CatheterCook Inc.
2019-12-18Z-0610-2020Class IMedfusion Syringe PumpSmiths Medical ASD Inc.
2019-12-18Z-0611-2020Class IIEMPOWR Locking Femoral ImpactorEncore Medical, Lp
2019-12-18Z-0613-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0614-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0615-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0616-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0617-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0618-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0619-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0620-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0621-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0622-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0623-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0624-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0625-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0626-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0627-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0628-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0629-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0630-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0631-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0632-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0633-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0634-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0635-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0636-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0637-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0638-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0639-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0640-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0641-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0642-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0643-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0644-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0645-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0646-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0647-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0648-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0649-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0650-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0651-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0652-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0653-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0654-2020Class IIC7000Integra LifeSciences Corp.
2019-12-18Z-0655-2020Class IICoated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile…CP Medical Inc
2019-12-18Z-0656-2020Class IILigamax 5 mm Endoscopic Multiple Clip ApplierEthicon Endo-Surgery Inc
2019-12-18Z-0657-2020Class IIPassive Biopsy Needle KitMedtronic Navigation, Inc.
2019-12-18Z-0658-2020Class IIBiopsy Needle FPU KitMedtronic Navigation, Inc.
2019-12-18Z-0659-2020Class IIBiopsy Needle FPU KitMedtronic Navigation, Inc.
2019-12-18Z-0660-2020Class IISKINFUSE Resuce Calming Complex Kit containing: SKINFUSE LIFT HGBellus Medical
2019-12-18Z-0661-2020Class IIOral-BYoung Dental Manufacturing Co, LLC
2019-12-18Z-0662-2020Class IIP28Paragon 28, Inc.
2019-12-18Z-0663-2020Class IIVNS Therapy Program GMDN: 44077 Model # 3000 V1LivaNova USA Inc
2019-12-18Z-0664-2020Class IIRadiofrequency Grounding PadAbbott Medical
2019-12-18Z-0665-2020Class IIHealix Knotless ADV BR 4DePuy Mitek, Inc., a Johnson & Johnson Co.
2019-12-18Z-0666-2020Class IIHealix Knotless ADV BR 5DePuy Mitek, Inc., a Johnson & Johnson Co.
2019-12-18Z-0667-2020Class IIHabib EUS RFABoston Scientific Corporation
2019-12-18Z-0668-2020Class IIHabib EUS RFABoston Scientific Corporation
2019-12-18Z-0669-2020Class IIElecsys Anti-HAV IgM assay-for the in vitro qualitative detection of…Roche Diagnostics Operations, Inc.
2019-12-18Z-0670-2020Class IIMonaco Radiation Treatment Planning SystemElekta Inc
2019-12-18Z-0671-2020Class IIOptilite C-Reactive Protein KitThe Binding Site Group, Ltd.
2019-12-18Z-0672-2020Class IIiTotal CR Knee Replacement System Model Number: TCR-111-1111-010102Conformis, Inc.
2019-12-18Z-0673-2020Class IIBOND Polymer Refine Detection KitLeica Microsystems, Inc.
2019-12-18Z-0674-2020Class IIPhilips Volcano FFR software used in the following systems connected…Volcano Corporation
2019-12-18Z-0675-2020Class IICognisionNeuronetrix Solutions, LLC dba Cognision
2019-12-18Z-0676-2020Class IIMRIdian Linac Radiation Therapy System Model 10000 and 20000Viewray, Inc.
2019-12-18Z-0677-2020Class IIMaquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion…GETINGE US SALES LLC
2019-12-18Z-0678-2020Class IIMaquet CardiopulmonaryMaquet Cardiovascular Us Sales, Llc
2019-12-11Z-0508-2020Class ISynchromed II programmable pumpMedtronic Neuromodulation
2019-12-11Z-0538-2020Class IGiraffe OmniBed infant warmerGE Healthcare, LLC
2019-12-11Z-0539-2020Class IGiraffe OmniBed CarestationGE Healthcare, LLC
2019-12-11Z-0540-2020Class IGiraffe Incubator CarestationGE Healthcare, LLC
2019-12-11Z-0541-2020Class IGiraffe Incubator infant warmerGE Healthcare, LLC
2019-12-11Z-0586-2020Class IIEvolution Loading Car and Transfer Carriage- Accessory to the…Steris Corporation
2019-12-11Z-0591-2020Class IIBRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3Brasseler USA I Lp
2019-12-11Z-0592-2020Class IIColor Cuff Disposable Tourniquet CuffStryker Instruments Div. of Stryker Corporation
2019-12-11Z-0593-2020Class IIColor Cuff Disposable Tourniquet CuffStryker Instruments Div. of Stryker Corporation
2019-12-11Z-0594-2020Class IIBiomet Orthopedics Intramedullary Bone Saw Cam Assembly…Zimmer Biomet, Inc.
2019-12-11Z-0595-2020Class IIBiomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM-…Zimmer Biomet, Inc.
2019-12-11Z-0596-2020Class IIEasyOne Pro Respiratory Analysis System Pulmonary Function Testing…NDDd Medical Technologies, Inc.
2019-12-11Z-0597-2020Class IIEasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function…NDDd Medical Technologies, Inc.
2019-12-11Z-0598-2020Class IIXEN Gel StentAllergan PLC
2019-12-11Z-0599-2020Class IIPANTERA Proximal Humerus Fracture Plate SystemToby Orthopaedics, Inc.
2019-12-11Z-0600-2020Class IIQuantam 2000 Electrosurgical GeneratorCooperSurgical, Inc.
2019-12-11Z-0601-2020Class IIQuantam 2000 Electrosurgical GeneratorCooperSurgical, Inc.
2019-12-11Z-0602-2020Class IIQuantam 2000 Electrosurgical GeneratorCooperSurgical, Inc.
2019-12-11Z-0603-2020Class IIProximal Humerus PlateMiami Device Solutions, LLC.
2019-12-11Z-0604-2020Class IIEagle 3000 SterilizerSteris Corporation
2019-12-11Z-0606-2020Class IIITLC-2000 Therapeutic Medical Laser SystemTheralase Inc.
2019-12-11Z-0607-2020Class IIITLC-2000 Therapeutic Medical Laser SystemTheralase Inc.
2019-12-11Z-0608-2020Class IIHeartStart XL+ Defibrillator/MonitorPhilips North America, LLC
2019-12-11Z-0609-2020Class IIAlcon Air Optix Night & Day AquaLens.com
2019-12-04Z-0512-2020Class IIRocket KCH Fetal Bladder Drainage Catheter Model: R57405Rocket Medical Plc
2019-12-04Z-0513-2020Class IIEVENCARE G3 Blood Glucose Test StripsMedline Industries Inc
2019-12-04Z-0514-2020Class IIStryker X-Change Medial Wall Mesh SmallHowmedica Osteonics Corp.
2019-12-04Z-0516-2020Class IIUniCel DxH Slidemaker StainerBeckman Coulter, Inc.
2019-12-04Z-0517-2020Class IIASI 2Zimmer Biomet, Inc.
2019-12-04Z-0518-2020Class IISite~Rite 8 Ultrasound Systems-intended for diagnostic ultrasound…Becton Dickinson & Company
2019-12-04Z-0519-2020Class IICompressZimmer Biomet, Inc.
2019-12-04Z-0520-2020Class IICOMP RVRS Shoulder BaseplatesZimmer Biomet, Inc.
2019-12-04Z-0521-2020Class IIACROMIUM FLANGE SETZimmer Biomet, Inc.
2019-12-04Z-0522-2020Class IIHENNESSY LEFT CONST GLENOID HAZimmer Biomet, Inc.
2019-12-04Z-0523-2020Class IIVarious Hip systemsZimmer Biomet, Inc.
2019-12-04Z-0524-2020Class IIComprehensive HHR Tess CleatZimmer Biomet, Inc.
2019-12-04Z-0525-2020Class IIComprehensive RS Cleat CAPZimmer Biomet, Inc.
2019-12-04Z-0526-2020Class IIVarious Custom ProductsZimmer Biomet, Inc.
2019-12-04Z-0527-2020Class IICopeland HA Resurfacing HeadZimmer Biomet, Inc.
2019-12-04Z-0528-2020Class IIHA PinsZimmer Biomet, Inc.
2019-12-04Z-0529-2020Class IIGUIDE WIRE 2Zimmer Biomet, Inc.
2019-12-04Z-0530-2020Class IIBALL NOSE GUIDE WIRE 80CMZimmer Biomet, Inc.
2019-12-04Z-0531-2020Class II2Zimmer Biomet, Inc.
2019-12-04Z-0532-2020Class IILT DISC ULNAZimmer Biomet, Inc.
2019-12-04Z-0533-2020Class IIBIOMOD PORCOAT HA GLENTRAYZimmer Biomet, Inc.
2019-12-04Z-0534-2020Class IIStratum Foot Plating System-NL LP Screw 3Nextremity Solutions
2019-12-04Z-0535-2020Class IIFoundationOne CDx test reportFoundation Medicine, Inc.
2019-12-04Z-0536-2020Class IIIPlatelet Aggregation KitHelena Laboratories, Corp.
2019-12-04Z-0537-2020Class IIICollagen ReagentHelena Laboratories, Corp.
2019-12-04Z-0542-2020Class IImyCordella Patient Kit without ECGENDOTRONIX
2019-12-04Z-0543-2020Class IIAlinity ci Level SensorAbbott Gmbh & Co. KG
2019-12-04Z-0544-2020Class IIAccessory kitAbbott Gmbh & Co. KG
2019-12-04Z-0545-2020Class IIAccessory kitAbbott Gmbh & Co. KG
2019-12-04Z-0546-2020Class IIIIntersomatic JULIET Ti OL cageSPINEART SA
2019-12-04Z-0547-2020Class IIV-TwinVital Scientific N.V.
2019-12-04Z-0548-2020Class IIBoston Scientific Advanix Pancreatic StentBoston Scientific Corporation
2019-12-04Z-0549-2020Class IIBoston Advanix Pancreatic StentBoston Scientific Corporation
2019-12-04Z-0550-2020Class IIBoston Scientific Advanix Pancreatic StentBoston Scientific Corporation
2019-12-04Z-0551-2020Class IIAdvanix Pancreatic StentBoston Scientific Corporation
2019-12-04Z-0552-2020Class IIBoston Scientific Advanix Pancreatic StentBoston Scientific Corporation
2019-12-04Z-0553-2020Class IIBoston Scientific Advanix Pancreatic StentBoston Scientific Corporation
2019-12-04Z-0554-2020Class IIBoston Scientific Advanix Pancreatic StentBoston Scientific Corporation
2019-12-04Z-0555-2020Class IIBoston Scientific Advanix Pancreatic StentBoston Scientific Corporation
2019-12-04Z-0556-2020Class IIBoston Scientific Advanix Pancreatic StentBoston Scientific Corporation
2019-12-04Z-0557-2020Class IIBoston Scientific Advanix Pancreatic StentBoston Scientific Corporation
2019-12-04Z-0558-2020Class IIBoston Scientific Advanix Pancreatic StentBoston Scientific Corporation
2019-12-04Z-0559-2020Class IIBoston Scientific Advanix Pancreatic StentBoston Scientific Corporation
2019-12-04Z-0560-2020Class IIBoston Scientific Advanix Pancreatic StentBoston Scientific Corporation
2019-12-04Z-0562-2020Class IISWANSON GREAT TOEWright Medical Technology, Inc.
2019-12-04Z-0563-2020Class IIORTHOLOC 3DI PLT SYS STERILEWright Medical Technology, Inc.
2019-12-04Z-0564-2020Class IIPRO-STIM 10cc INJECTABLEWright Medical Technology, Inc.
2019-12-04Z-0565-2020Class IIINBONE STEMWright Medical Technology, Inc.
2019-12-04Z-0566-2020Class IIVALOR SCREW 5Wright Medical Technology, Inc.
2019-12-04Z-0567-2020Class IIDart Fire HEADED SCREW 4Wright Medical Technology, Inc.
2019-12-04Z-0568-2020Class IIDarco STERILE HEADED DRILL BIT 4Wright Medical Technology, Inc.
2019-12-04Z-0569-2020Class IIEVANS OPENING WEDGE PLATE 10MMWright Medical Technology, Inc.
2019-12-04Z-0570-2020Class IISWANSON FINGER JOINT #1Wright Medical Technology, Inc.
2019-12-04Z-0571-2020Class IISWANSON FINGER JOINT #2Wright Medical Technology, Inc.
2019-12-04Z-0572-2020Class IISWANSON TRAPEZIUM IMPLANTWright Medical Technology, Inc.
2019-12-04Z-0573-2020Class IICPS CALCANEAL PLATE SML 54MMWright Medical Technology, Inc.
2019-12-04Z-0574-2020Class IIARCHITECT HAVAB-G CalibratorAbbott Gmbh & Co. KG
2019-12-04Z-0575-2020Class IIAlinity c Carbon Dioxide Reagent KitAbbott GmBH & Co. KG
2019-12-04Z-0576-2020Class IISpectranetics AngioSculpt PTCA Scoring Balloon CatheterSpectranetics Corporation
2019-12-04Z-0577-2020Class IIEmerge Monorail PTCA Dilatation CatheterBoston Scientific Corporation
2019-12-04Z-0578-2020Class IIGuidezilla II Guide Extension Catheter Sterilized using ethylene oxideBoston Scientific Corporation

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