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Medical device recalls reported in 2025

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ReportedRecallClassProductFirm
2025-01-29Z-0963-2025Class IIOtological Ventilation TubeAdept Medical Ltd
2025-01-29Z-0964-2025Class IIOtological Ventilation TubeAdept Medical Ltd
2025-01-29Z-0965-2025Class IIOtological Ventilation TubeAdept Medical Ltd
2025-01-29Z-0966-2025Class IIOtological Ventilation TubeAdept Medical Ltd
2025-01-29Z-0967-2025Class IIOtological Ventilation TubeAdept Medical Ltd
2025-01-29Z-0968-2025Class IIOtological Ventilation TubeAdept Medical Ltd
2025-01-29Z-0969-2025Class IIOtological Ventilation TubeAdept Medical Ltd
2025-01-29Z-0970-2025Class IIOtological Ventilation TubeAdept Medical Ltd
2025-01-29Z-0971-2025Class IIBD Pyxis MedStation ESCareFusion 303, Inc.
2025-01-29Z-0972-2025Class IIBD Pyxis MedStation ES AUXCareFusion 303, Inc.
2025-01-29Z-0973-2025Class IIBD Pyxis MedStation 4000 MainCareFusion 303, Inc.
2025-01-29Z-0974-2025Class IIBD Pyxis MedStation 4000 AUXCareFusion 303, Inc.
2025-01-29Z-0975-2025Class IIBD Pyxis Med ES AuxiliaryCareFusion 303, Inc.
2025-01-29Z-0976-2025Class IIBD Pyxis Med 4000 AuxiliaryCareFusion 303, Inc.
2025-01-29Z-0977-2025Class IICODMAN CERTAS Plus Programmable Valve Inline Small Valve OnlyIntegra LifeSciences Corp.
2025-01-29Z-0978-2025Class IICODMAN CERTAS Plus Programmable Valve Inline Small Valve OnlyIntegra LifeSciences Corp.
2025-01-29Z-0979-2025Class IICODMAN CERTAS Plus Programmable Valve Right Angle Valve OnlyIntegra LifeSciences Corp.
2025-01-29Z-0980-2025Class IIThe 3Stryker Corporation
2025-01-29Z-0981-2025Class IIstryker 3Stryker Corporation
2025-01-29Z-0982-2025Class IIstryker 3Stryker Corporation
2025-01-29Z-0983-2025Class IIBrand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog…O&M HALYARD, INC.
2025-01-29Z-0984-2025Class IIDLP Pediatric One-Piece Arterial CannulaeMedtronic Perfusion Systems
2025-01-29Z-0985-2025Class IIEOPA Arterial CannulaMedtronic Perfusion Systems
2025-01-29Z-0986-2025Class IISelect Series Angled Tip Arterial CannulaMedtronic Perfusion Systems
2025-01-29Z-0987-2025Class IIMerlinSt. Jude Medical
2025-01-29Z-0988-2025Class IICARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System…St. Jude Medical
2025-01-29Z-0989-2025Class IICARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System…St. Jude Medical
2025-01-29Z-0990-2025Class IIMicroventionMICROVENTION INC.
2025-01-29Z-0993-2025Class IIBrand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand…Olympus Corporation of the Americas
2025-01-29Z-0994-2025Class IIBrand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand…Olympus Corporation of the Americas
2025-01-29Z-0995-2025Class IIBrand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand…Olympus Corporation of the Americas
2025-01-29Z-0996-2025Class IIBrand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand…Olympus Corporation of the Americas
2025-01-29Z-0997-2025Class IIBrand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand…Olympus Corporation of the Americas
2025-01-29Z-0998-2025Class IIBrand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand…Olympus Corporation of the Americas
2025-01-29Z-0999-2025Class IIBrand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand…Olympus Corporation of the Americas
2025-01-29Z-1000-2025Class IIBrand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand…Olympus Corporation of the Americas
2025-01-29Z-1001-2025Class IIBrand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand…Olympus Corporation of the Americas
2025-01-29Z-1002-2025Class IIBrand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand…Olympus Corporation of the Americas
2025-01-29Z-1003-2025Class IIBrand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand…Olympus Corporation of the Americas
2025-01-29Z-1004-2025Class IIBD PCR Cartridges used with MAX SystemBecton Dickinson & Co.
2025-01-29Z-1005-2025Class IIBrand Name: VITROS Product Name: VITROS 5600 Integrated System…Ortho-Clinical Diagnostics, INc.
2025-01-29Z-1006-2025Class IIBrand Name: VITROS Product Name: VITROS XT 7600 Integrated System…Ortho-Clinical Diagnostics, INc.
2025-01-29Z-1007-2025Class IIBrand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System…Ortho-Clinical Diagnostics, INc.
2025-01-29Z-1008-2025Class IIBrand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog…Integrity Implants Inc.
2025-01-29Z-1009-2025Class IIBaxter Solution Set with Duo-Vent SpikeBaxter Healthcare Corporation
2025-01-29Z-1010-2025Class IIBaxter Clearlink System Solution Set with Duo-Vent SpikeBaxter Healthcare Corporation
2025-01-29Z-1011-2025Class IIBaxter Continu-Flo Solution Set with Duo-Vent SpikeBaxter Healthcare Corporation
2025-01-29Z-1012-2025Class IIBrand Name: IMed Products Product Name: Dressing Change Kit with…Trinity Sterile, Inc.
2025-01-29Z-1013-2025Class IIBrand Name: Wolf-Pak Product Name: Dressing Change Kit with…Trinity Sterile, Inc.
2025-01-29Z-1014-2025Class IIBrand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth…Trinity Sterile, Inc.
2025-01-29Z-1015-2025Class IIBrand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with…Trinity Sterile, Inc.
2025-01-29Z-1016-2025Class IIBrand Name: Tacy MedicalTrinity Sterile, Inc.
2025-01-29Z-1017-2025Class IIRandox LipoproteinRandox Laboratories, Limited
2025-01-29Z-1018-2025Class IIRandox LipoproteinRandox Laboratories, Limited
2025-01-22Z-0713-2025Class ISheathTrokamed GmbH
2025-01-22Z-0714-2025Class ISheathTrokamed GmbH
2025-01-22Z-0715-2025Class ISheathTrokamed GmbH
2025-01-22Z-0716-2025Class ISheathTrokamed GmbH
2025-01-22Z-0764-2025Class IMedline Fluid Delivery Set with Drip Chamber: 1) FDSMEDLINE INDUSTRIES, LP - Northfield
2025-01-22Z-0765-2025Class IMedline Fluid Delivery Set with Drip Chamber: 1) MTOMEDLINE INDUSTRIES, LP - Northfield
2025-01-22Z-0821-2025Class INeo-Tee T-Piece ResuscitatorMercury Enterprises, Inc. dba Mercury Medical
2025-01-22Z-0822-2025Class IACCOLADE DR PacemakerBoston Scientific Corporation
2025-01-22Z-0823-2025Class IPROPONENT DR PacemakerBoston Scientific Corporation
2025-01-22Z-0824-2025Class IESSENTIO DR PacemakerBoston Scientific Corporation
2025-01-22Z-0825-2025Class IALTRUA 2 DR PacemakerBoston Scientific Corporation
2025-01-22Z-0826-2025Class IVALITUDE CRT-PBoston Scientific Corporation
2025-01-22Z-0827-2025Class IVISIONIST CRT-PBoston Scientific Corporation
2025-01-22Z-0829-2025Class IImpella RP with SmartAssistAbiomed, Inc.
2025-01-22Z-0830-2025Class IImpella RP Flex with SmartAssistAbiomed, Inc.
2025-01-22Z-0831-2025Class Inuwellis AquaFlexFlow UF 500 PlusNuwellis Inc
2025-01-22Z-0832-2025Class IICook Medical Biodesign Otologic Butterfly GraftCook Biotech, Inc.
2025-01-22Z-0833-2025Class IICook Medical Biodesign Hiatal Hernia GraftCook Biotech, Inc.
2025-01-22Z-0834-2025Class IICook Medical Biodesign Dural GraftCook Biotech, Inc.
2025-01-22Z-0835-2025Class IIBrand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge…Alcon Research LLC
2025-01-22Z-0836-2025Class IIIdylla INSTRUMENTBiocartis Nv
2025-01-22Z-0837-2025Class IIKarl StorzKarl Storz Endoscopy
2025-01-22Z-0838-2025Class IINOA Medical Industries Behavioral Health Hospital bed side railsNOA Medical Industries Inc
2025-01-22Z-0839-2025Class IIAugustine Surgical IncAugustine Temperature Management, LLC
2025-01-22Z-0840-2025Class IIAugustine Surgical IncAugustine Temperature Management, LLC
2025-01-22Z-0841-2025Class IIHillrom Temperature Management ControllerAugustine Temperature Management, LLC
2025-01-22Z-0842-2025Class IIAugustine Surgical IncAugustine Temperature Management, LLC
2025-01-22Z-0843-2025Class IIAugustine Surgical IncAugustine Temperature Management, LLC
2025-01-22Z-0844-2025Class IIFolysil Silicone Foley CathetersColoplast Manufacturing US, LLC
2025-01-22Z-0845-2025Class IIX-Flow prostatectomy catheterColoplast Manufacturing US, LLC
2025-01-22Z-0846-2025Class IIStryker Blueprint Mixed Reality BP MxR Glenoid Pin GuideTornier S.A.S.
2025-01-22Z-0847-2025Class II8MMIntuitive Surgical, Inc.
2025-01-22Z-0848-2025Class II8MMIntuitive Surgical, Inc.
2025-01-22Z-0849-2025Class II8MMIntuitive Surgical, Inc.
2025-01-22Z-0850-2025Class II8MMIntuitive Surgical, Inc.
2025-01-22Z-0851-2025Class II8MMIntuitive Surgical, Inc.
2025-01-22Z-0852-2025Class II8MMIntuitive Surgical, Inc.
2025-01-22Z-0853-2025Class II8MMIntuitive Surgical, Inc.
2025-01-22Z-0854-2025Class II8MMIntuitive Surgical, Inc.
2025-01-22Z-0855-2025Class II8MMIntuitive Surgical, Inc.
2025-01-22Z-0856-2025Class II8MMIntuitive Surgical, Inc.
2025-01-22Z-0857-2025Class II8MMIntuitive Surgical, Inc.
2025-01-22Z-0858-2025Class II8MMIntuitive Surgical, Inc.
2025-01-22Z-0859-2025Class II8MMIntuitive Surgical, Inc.
2025-01-22Z-0860-2025Class II8MMIntuitive Surgical, Inc.
2025-01-22Z-0861-2025Class II8MMIntuitive Surgical, Inc.
2025-01-22Z-0862-2025Class II8MMIntuitive Surgical, Inc.
2025-01-22Z-0863-2025Class II8MMIntuitive Surgical, Inc.
2025-01-22Z-0864-2025Class II8MMIntuitive Surgical, Inc.
2025-01-22Z-0865-2025Class II8MMIntuitive Surgical, Inc.
2025-01-22Z-0866-2025Class II8MMIntuitive Surgical, Inc.
2025-01-22Z-0867-2025Class II8MMIntuitive Surgical, Inc.
2025-01-22Z-0868-2025Class II8MMIntuitive Surgical, Inc.
2025-01-22Z-0869-2025Class II8MMIntuitive Surgical, Inc.
2025-01-22Z-0870-2025Class II8MMIntuitive Surgical, Inc.
2025-01-22Z-0871-2025Class II8MMIntuitive Surgical, Inc.
2025-01-22Z-0872-2025Class II8MMIntuitive Surgical, Inc.
2025-01-22Z-0873-2025Class II8MMIntuitive Surgical, Inc.
2025-01-22Z-0874-2025Class II8MMIntuitive Surgical, Inc.
2025-01-22Z-0875-2025Class II8MMIntuitive Surgical, Inc.
2025-01-22Z-0876-2025Class II8MMIntuitive Surgical, Inc.
2025-01-22Z-0877-2025Class II8MMIntuitive Surgical, Inc.
2025-01-22Z-0878-2025Class II8MMIntuitive Surgical, Inc.
2025-01-22Z-0879-2025Class II8MMIntuitive Surgical, Inc.
2025-01-22Z-0880-2025Class II8MMIntuitive Surgical, Inc.
2025-01-22Z-0881-2025Class II8MMIntuitive Surgical, Inc.
2025-01-22Z-0882-2025Class II8MMIntuitive Surgical, Inc.
2025-01-22Z-0883-2025Class II8MMIntuitive Surgical, Inc.
2025-01-22Z-0884-2025Class IWelch AllynBaxter Healthcare Corporation
2025-01-22Z-0885-2025Class IWelch AllynBaxter Healthcare Corporation
2025-01-22Z-0886-2025Class IWelch AllynBaxter Healthcare Corporation
2025-01-22Z-0887-2025Class IBreathe TechnologiesBaxter Healthcare Corporation
2025-01-22Z-0888-2025Class IIGE Healthcare Infinia IGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
2025-01-22Z-0889-2025Class IIGE Healthcare Brivo NM 615GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
2025-01-22Z-0890-2025Class IIGE Healthcare Discovery NM 630GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
2025-01-22Z-0891-2025Class IIGE Healthcare Discovery NM/CT 670GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
2025-01-22Z-0892-2025Class IIGE Healthcare Discovery NM/CT 670 DRGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
2025-01-22Z-0893-2025Class IIGE Healthcare Discovery NM/CT 670 PROGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
2025-01-22Z-0894-2025Class IIGE Healthcare Discovery NM/CT 670 ESGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
2025-01-22Z-0895-2025Class IIGE Healthcare Discovery NM/CT 670 CZTGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
2025-01-22Z-0896-2025Class IIGE Healthcare Optima NM/CT 640GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
2025-01-22Z-0897-2025Class IIGE Healthcare Infinia IIGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
2025-01-22Z-0898-2025Class IIGE Healthcare Infinia I Hawkeye 1GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
2025-01-22Z-0899-2025Class IIGE Healthcare Infinia II Hawkeye 4GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
2025-01-22Z-0900-2025Class IIGE Healthcare Varicam Millennium VG Discovery VHGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
2025-01-22Z-0901-2025Class IIBrand Name: VITROS Chemistry Products Product Name: VITROS Chemistry…QUIDEL ORTHO
2025-01-22Z-0902-2025Class IIBrand Name: VITROS Chemistry Products Product Name: VITROS Chemistry…QUIDEL ORTHO
2025-01-22Z-0903-2025Class IIEsteem Synergy Stomahesive Skin BarrierConvaTec, Inc
2025-01-22Z-0904-2025Class IIMedtronic NanoCross Elite PTA catheterev3 Inc
2025-01-22Z-0905-2025Class IOlympus MAJ-891 Forceps/Irrigation PlugOlympus Corporation of the Americas
2025-01-22Z-0906-2025Class IIBD Pyxis MedStation ESCareFusion 303, Inc.
2025-01-22Z-0907-2025Class IIPanther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion…Hologic, Inc.
2025-01-22Z-0908-2025Class IICardinal Health Presource Kits: 1) KITCardinal Health 200, LLC
2025-01-22Z-0909-2025Class IICardinal Health Presource Kits: 1 ) TRIPLE ENDO PACKCardinal Health 200, LLC
2025-01-22Z-0910-2025Class IICardinal Health Presource Kits: 1 ) ANEURYSM PACKCardinal Health 200, LLC
2025-01-22Z-0911-2025Class IICardinal Health Presource Kits: 1 ) KITCardinal Health 200, LLC
2025-01-22Z-0912-2025Class IICardinal Health Presource Kits: 1 ) LARYNGOSCOPY PACKCardinal Health 200, LLC
2025-01-22Z-0913-2025Class IICardinal Health Presource Kits: 0 ) DESCRIPTION Catalog Number:…Cardinal Health 200, LLC
2025-01-22Z-0914-2025Class IICardinal Health Presource Kits: 1 ) KITCardinal Health 200, LLC
2025-01-22Z-0915-2025Class IICardinal Health Presource Kits: 1) CRANIOTOMY PACKCardinal Health 200, LLC
2025-01-22Z-0916-2025Class IICardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PKCardinal Health 200, LLC
2025-01-22Z-0917-2025Class IICardinal Health Presource Kits: 1) KITCardinal Health 200, LLC
2025-01-22Z-0918-2025Class IIPortrait Core ServicesGE Medical Systems, LLC
2025-01-22Z-0919-2025Class IIOsteoCove PuttyIsoTis OrthoBiologics, Inc.
2025-01-22Z-0920-2025Class IIImplant Epikut S Plus CM 16-Degrees 4SIN SISTEMA DE IMPLANTE NACIONAL S.A
2025-01-22Z-0921-2025Class IIDRG:HYBRiD-XL InsulinDRG International, Inc.
2025-01-22Z-0923-2025Class II8MMIntuitive Surgical, Inc.
2025-01-22Z-0924-2025Class II8MMIntuitive Surgical, Inc.
2025-01-22Z-0925-2025Class IIECONO STERILE brand medical procedure kits labeled as: 1) ECONO…Sklar Instruments
2025-01-22Z-0926-2025Class IIECONO STERILE brand medical procedure kits labeled as: 1) ECONO…Sklar Instruments
2025-01-22Z-0927-2025Class IIECONO STERILE medical procedure kits labeled as: ECONO STERILE…Sklar Instruments
2025-01-22Z-0928-2025Class IIECONO STERILE medical procedure kits labeled as: ECONO STERILE SIMS…Sklar Instruments
2025-01-22Z-0929-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE…Sklar Instruments
2025-01-22Z-0930-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE…Sklar Instruments
2025-01-22Z-0931-2025Class IIECONO STERILE medical procedure kits labeled as: ECONO STERILE"…Sklar Instruments
2025-01-22Z-0932-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE D/A…Sklar Instruments
2025-01-22Z-0933-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE…Sklar Instruments
2025-01-22Z-0934-2025Class IIECONO STERILE medical procedure kits labeled as: ECONO STERILE CEMENT…Sklar Instruments
2025-01-22Z-0935-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE…Sklar Instruments
2025-01-22Z-0936-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE…Sklar Instruments
2025-01-22Z-0937-2025Class IIECONO STERILE medical procedure kits labeled as: ECONO STERILE…Sklar Instruments
2025-01-22Z-0938-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE…Sklar Instruments
2025-01-22Z-0939-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE…Sklar Instruments
2025-01-22Z-0940-2025Class IIECONO STERILE medical procedure kits labeled as: ECONO STERILE BLAKE…Sklar Instruments
2025-01-22Z-0941-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE…Sklar Instruments
2025-01-22Z-0942-2025Class IIECONO STERILE medical procedure kits labeled as: ECONO STERILE…Sklar Instruments
2025-01-22Z-0943-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE…Sklar Instruments
2025-01-22Z-0944-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE…Sklar Instruments
2025-01-22Z-0945-2025Class IIECONO STERILE medical procedure kits labeled as: ECONO STERILE KOGAN…Sklar Instruments
2025-01-22Z-0946-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE…Sklar Instruments
2025-01-22Z-0947-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE…Sklar Instruments
2025-01-22Z-0948-2025Class IIECONO STERILE medical procedure kits labeled as: ECONO STERILE IUD…Sklar Instruments
2025-01-22Z-0949-2025Class IIECONO STERILE medical procedure kits labeled as: ECONO STERILE…Sklar Instruments
2025-01-22Z-0950-2025Class IIMedical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR…Sklar Instruments
2025-01-22Z-0951-2025Class IIECONO STERILE medical procedure kits labeled as: ECONO STERILE IRIS…Sklar Instruments
2025-01-22Z-0952-2025Class IIECONO STERILE medical procedure kits labeled as: ECONO STERILE…Sklar Instruments
2025-01-22Z-0953-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE…Sklar Instruments
2025-01-22Z-0954-2025Class IIECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE…Sklar Instruments
2025-01-22Z-0955-2025Class IIOsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone MatrixIsoTis OrthoBiologics, Inc.
2025-01-22Z-0956-2025Class IImuRata Vios Monitoring System Model 2050Murata Vios, Inc.
2025-01-22Z-0957-2025Class IIMcKesson Cardiology Hemo softwareA L I Technologies Ltd
2025-01-22Z-0958-2025Class IIChange Healthcare Cardiology Hemo softwareA L I Technologies Ltd
2025-01-22Z-0959-2025Class IIChange Healthcare Cardiology Hemodynamics softwareA L I Technologies Ltd
2025-01-22Z-0961-2025Class IIVerifyNow P2Y12 Platelet Reactivity TestAccriva Diagnostics, Inc.
2025-01-22Z-0962-2025Class IILithoCrushV Single Use Mechanical Lithotriptor VOlympus Corporation of the Americas
2025-01-15Z-0711-2025Class IVasoView HemoPro 2 Endoscopic Vessel Harvesting SystemMaquet Cardiovascular, LLC

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