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Medical device recalls reported in 2023

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ReportedRecallClassProductFirm
2023-02-15Z-1101-2023Class IIRipCord Syndesmosis ButtonTriMed Inc.
2023-02-15Z-1102-2023Class IIWishBone Medical Smart Correction Dual Joint Express StrutsWishbone Medical, Inc.
2023-02-15Z-1103-2023Class IISPiN Thoracic Navigation System Model: SYS-4000Olympus Corporation of the Americas
2023-02-15Z-1104-2023Class IIcobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the…Roche Molecular Systems, Inc.
2023-02-15Z-1105-2023Class IIcobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for…Roche Molecular Systems, Inc.
2023-02-15Z-1106-2023Class IIcobas Influenza A/B & RSV UCRoche Molecular Systems, Inc.
2023-02-15Z-1107-2023Class IITrackX Insight Base Modular Instrument TrackerTrackx Technology Inc
2023-02-15Z-1108-2023Class IIThe Covera Vascular Covered Stent is a flexibleBard Peripheral Vascular Inc
2023-02-08Z-0929-2023Class IProducts are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen…Universal Meditech Inc.
2023-02-08Z-0962-2023Class ICADD Administration SetSmiths Medical ASD Inc.
2023-02-08Z-0963-2023Class ICADD Administration SetSmiths Medical ASD Inc.
2023-02-08Z-0964-2023Class ICADD Administration SetSmiths Medical ASD Inc.
2023-02-08Z-0965-2023Class ICADD Administration SetSmiths Medical ASD Inc.
2023-02-08Z-0966-2023Class ICADD Administration SetSmiths Medical ASD Inc.
2023-02-08Z-1022-2023Class IISynCardia Total Artificial Heart SystemSynCardia Systems LLC
2023-02-08Z-1023-2023Class IIAffinity Fusion Oxygenator with Integrated Arterial Filter and…Medtronic Perfusion Systems
2023-02-08Z-1024-2023Class IIAffinity Fusion Oxygenator with Integrated Arterial Filter and…Medtronic Perfusion Systems
2023-02-08Z-1025-2023Class IIAffinity Fusion Oxygenator with Integrated Arterial Filter and…Medtronic Perfusion Systems
2023-02-08Z-1026-2023Class IIAffinity Fusion Oxygenator with Integrated Arterial Filter and…Medtronic Perfusion Systems
2023-02-08Z-1027-2023Class IICustom Pack Perfusion Tubing Packs containing Affinity Fusion…Medtronic Perfusion Systems
2023-02-08Z-1028-2023Class IICustom Pack Perfusion Tubing Packs containing Affinity Fusion…Medtronic Perfusion Systems
2023-02-08Z-1029-2023Class IINon-sterile procedural trays labeled as CRANIMEDLINE INDUSTRIES, LP - Northfield
2023-02-08Z-1030-2023Class IINon-sterile procedural trays labeled as LAPAROSCOPICMEDLINE INDUSTRIES, LP - Northfield
2023-02-08Z-1031-2023Class IINon-sterile procedural trays labeled as LAPAROTOMY CDSMEDLINE INDUSTRIES, LP - Northfield
2023-02-08Z-1032-2023Class IINon-sterile procedural trays labeled as MAJOR/MINORMEDLINE INDUSTRIES, LP - Northfield
2023-02-08Z-1033-2023Class IINon-sterile procedural trays labeled as ORTHO TRAUMAMEDLINE INDUSTRIES, LP - Northfield
2023-02-08Z-1034-2023Class IINon-sterile procedural trays labeled as THEDA CLARK TOTAL KNEE CDSMEDLINE INDUSTRIES, LP - Northfield
2023-02-08Z-1035-2023Class IINon-sterile procedural trays labeled as TOTAL KNEE KITMEDLINE INDUSTRIES, LP - Northfield
2023-02-08Z-1036-2023Class IIOSS Modular Arthrodesis NailBiomet, Inc.
2023-02-08Z-1037-2023Class IITurbett Surgical ContainerTurbett Surgical, Inc.
2023-02-08Z-1038-2023Class IITurbett Surgical ContainerTurbett Surgical, Inc.
2023-02-08Z-1039-2023Class IIAxiEM" Non-Invasive Patient TrackerMedtronic Navigation, Inc.
2023-02-08Z-1040-2023Class IISystem Material # Artis zee floor 10094135 Artis zee ceiling 10094137…Siemens Medical Solutions USA, Inc
2023-02-08Z-1041-2023Class IIMammotome MammoStar Biopsy Site IdentifiedCarbon Medical Technologies, Inc.
2023-02-08Z-1042-2023Class II(1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended…Biomet, Inc.
2023-02-08Z-1043-2023Class II(1) Vanguard Knee System PS Open Box Femoral; Left; 57.5 mm. Intended…Biomet, Inc.
2023-02-08Z-1044-2023Class IIBIOPSY MEDIUM 10MLCooperSurgical, Inc.
2023-02-08Z-1045-2023Class IIMEDLINE UNITE FOOT & ANKLE ScrewMEDLINE INDUSTRIES, LP - Northfield
2023-02-08Z-1046-2023Class IIMEDLINE UNITE FOOT & ANKLE ScrewMEDLINE INDUSTRIES, LP - Northfield
2023-02-08Z-1047-2023Class IIMEDLINE UNITE FOOT & ANKLE DRILL BITMEDLINE INDUSTRIES, LP - Northfield
2023-02-08Z-1048-2023Class IIGORE CARDIOFORM Septal OccluderW L Gore & Associates, Inc.
2023-02-08Z-1049-2023Class IILucid TCD 2NovaSignal Corp.
2023-02-08Z-1050-2023Class IINovaGuide Intelligent Ultrasound SystemNovaSignal Corp.
2023-02-08Z-1051-2023Class IICatalog Number / Product Description 0601600 2Bard Peripheral Vascular Inc
2023-02-01Z-0959-2023Class IGetinge Flow-i Anesthesia Systems Flow-i C20Getinge Usa Sales Inc
2023-02-01Z-0960-2023Class IGetinge Flow-c Anesthesia SystemGetinge Usa Sales Inc
2023-02-01Z-0961-2023Class IGetinge Flow-e Anesthesia SystemGetinge Usa Sales Inc
2023-02-01Z-1003-2023Class IISoftware : myNeedle Guide 2D licenseSiemens Medical Solutions USA, Inc
2023-02-01Z-1004-2023Class IIAgfa HealthCare Enterprise Imaging XERO ViewerAgfa Healthcare NV
2023-02-01Z-1005-2023Class IIVeritas Advanced Infusion PacksJohnson & Johnson Surgical Vision, Inc.
2023-02-01Z-1006-2023Class IIFUSION Dual Pump PacksJohnson & Johnson Surgical Vision, Inc.
2023-02-01Z-1007-2023Class IISingle-Use PacksJohnson & Johnson Surgical Vision, Inc.
2023-02-01Z-1008-2023Class IIRevogene SARS-CoV-2_IVD real-time RT-PCR test intended for the…Meridian Bioscience Inc
2023-02-01Z-1009-2023Class IIAlinity m SystemAbbott Molecular, Inc.
2023-02-01Z-1010-2023Class IISlick Set Cuffed Endotracheal Tube and Stylet SetTELEFLEX LLC
2023-02-01Z-1011-2023Class IIEndotracheal Tube labeled as the following: aTELEFLEX LLC
2023-02-01Z-1012-2023Class IIEndotracheal Tube labeled as the following: aTELEFLEX LLC
2023-02-01Z-1013-2023Class IIBaxter ElectrocardiographBaxter Healthcare Corporation
2023-02-01Z-1014-2023Class IIMyDay ToricCooperVision, Inc.
2023-02-01Z-1015-2023Class IICENTURION MEDICAL PRODUCTSMEDLINE INDUSTRIES, LP - Northfield
2023-02-01Z-1016-2023Class IIFuture Diagnostics STAT-IntraOperative-Intact-PTHFuture Diagnostics Solutions B.V.
2023-02-01Z-1017-2023Class IIInvisalign Express 10 REF 8512 Invisalign System Comprehensive REF…Align Technology Inc
2023-02-01Z-1018-2023Class IIOxford Partial Knee SystemBiomet, Inc.
2023-02-01Z-1019-2023Class IIAir-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF…SunMed Holdings, LLC
2023-02-01Z-1020-2023Class IIAirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size…SunMed Holdings, LLC
2023-02-01Z-1021-2023Class IIbiokitHSV-2 Rapid TestBiokit, S.A.
2023-01-25Z-0885-2023Class ICardiosave Hybrid Intra-Aortic Balloon PumpDatascope Corp.
2023-01-25Z-0886-2023Class ICardiosave Rescue Intra-Aortic Balloon PumpDatascope Corp.
2023-01-25Z-0926-2023Class ISHIP KITCardiac Assist, Inc
2023-01-25Z-0956-2023Class IIARTIS phenoSiemens Medical Solutions USA, Inc
2023-01-25Z-0957-2023Class IIMobiCT-32 AIRO Mobile CT ScannerMobius Imaging, LLC
2023-01-25Z-0958-2023Class IIIAlinity Reaction VesselsAbbott Laboratories
2023-01-25Z-0967-2023Class IICardinal Health Jackson-Pratt Channel DrainCardinal Health 200, LLC
2023-01-25Z-0968-2023Class IICardinal Health Jackson-Pratt Channel DrainCardinal Health 200, LLC
2023-01-25Z-0969-2023Class IICardinal Health Jackson-Pratt Channel DrainCardinal Health 200, LLC
2023-01-25Z-0970-2023Class IICardinal Health Jackson-Pratt Channel DrainCardinal Health 200, LLC
2023-01-25Z-0971-2023Class IICardinal Health Jackson-Pratt Channel DrainCardinal Health 200, LLC
2023-01-25Z-0972-2023Class IICardinal Health Jackson-Pratt Channel DrainCardinal Health 200, LLC
2023-01-25Z-0973-2023Class IICardinal Health Jackson-Pratt Channel DrainCardinal Health 200, LLC
2023-01-25Z-0974-2023Class IICardinal Health Jackson-Pratt Channel DrainCardinal Health 200, LLC
2023-01-25Z-0975-2023Class IICardinal Health Jackson-Pratt Channel DrainCardinal Health 200, LLC
2023-01-25Z-0976-2023Class IICardinal Health Jackson-Pratt Channel DrainCardinal Health 200, LLC
2023-01-25Z-0977-2023Class IICardinal Health Jackson-Pratt Channel DrainCardinal Health 200, LLC
2023-01-25Z-0978-2023Class IICardinal Health Jackson-Pratt Channel DrainCardinal Health 200, LLC
2023-01-25Z-0979-2023Class IICardinal Health Jackson-Pratt Channel DrainCardinal Health 200, LLC
2023-01-25Z-0980-2023Class IICardinal Health Jackson-Pratt Channel DrainCardinal Health 200, LLC
2023-01-25Z-0981-2023Class IICardinal Health Jackson-Pratt Channel DrainCardinal Health 200, LLC
2023-01-25Z-0982-2023Class IICardinal Health Jackson-Pratt Channel DrainCardinal Health 200, LLC
2023-01-25Z-0983-2023Class IICardinal Health Jackson-Pratt Channel DrainCardinal Health 200, LLC
2023-01-25Z-0984-2023Class IICardinal Health Jackson-Pratt Channel DrainCardinal Health 200, LLC
2023-01-25Z-0985-2023Class IICardinal Health Jackson-Pratt Channel DrainCardinal Health 200, LLC
2023-01-25Z-0986-2023Class IICardinal Health Jackson-Pratt Channel DrainCardinal Health 200, LLC
2023-01-25Z-0987-2023Class IICardinal Health Jackson-Pratt Channel DrainCardinal Health 200, LLC
2023-01-25Z-0988-2023Class IICardinal Health Jackson-Pratt Channel DrainCardinal Health 200, LLC
2023-01-25Z-0989-2023Class IICardinal Health Jackson-Pratt Channel DrainCardinal Health 200, LLC
2023-01-25Z-0990-2023Class IICardinal Health Jackson-Pratt Channel DrainCardinal Health 200, LLC
2023-01-25Z-0991-2023Class IICardinal Health Jackson-Pratt Channel DrainCardinal Health 200, LLC
2023-01-25Z-0992-2023Class IICardinal Health Jackson-Pratt Channel DrainCardinal Health 200, LLC
2023-01-25Z-0993-2023Class IICardinal Health Jackson-Pratt Channel DrainCardinal Health 200, LLC
2023-01-25Z-0994-2023Class IICardinal Health Jackson-Pratt Channel DrainCardinal Health 200, LLC
2023-01-25Z-0995-2023Class IIHemopro 2 with VasoshieldMaquet Cardiovascular, LLC
2023-01-25Z-0996-2023Class IIVasoshield Syringe PacksMaquet Cardiovascular, LLC
2023-01-25Z-0997-2023Class IIRELAY PROBolton Medical Inc.
2023-01-25Z-0998-2023Class IIRELAY PROBolton Medical Inc.
2023-01-25Z-0999-2023Class IIIR&D CBC-3D Hematology Control:R & D Systems, Inc.
2023-01-25Z-1000-2023Class IIAXIOM Luminos TFSiemens Medical Solutions USA, Inc
2023-01-25Z-1001-2023Class IIAXIOM Luminos AgileSiemens Medical Solutions USA, Inc
2023-01-25Z-1002-2023Class IILuminos Agile MaxSiemens Medical Solutions USA, Inc
2023-01-18Z-0773-2023Class IRSDLEmergent Protective Products USA Inc
2023-01-18Z-0877-2023Class IMAHURKAR 13Covidien LP
2023-01-18Z-0882-2023Class IPhilips Trilogy 100 VentilatorPhilips Respironics, Inc.
2023-01-18Z-0883-2023Class IPhilips Trilogy 200 VentilatorPhilips Respironics, Inc.
2023-01-18Z-0884-2023Class IPhilips Garbin VentilatorPhilips Respironics, Inc.
2023-01-18Z-0907-2023Class IIVENTANA PD-L1Ventana Medical Systems, Inc.
2023-01-18Z-0908-2023Class IIPhilips Fetal Spiral Electrode-intended for patients requiring fetal…Philips North America Llc
2023-01-18Z-0909-2023Class IICodman Surgical PattiesIntegra LifeSciences Corp.
2023-01-18Z-0910-2023Class IISource Administration SetBayer Medical Care, Inc.
2023-01-18Z-0911-2023Class IIVanta/Seqenita LT Clinician Programmer ApplicationMedtronic Neuromodulation
2023-01-18Z-0912-2023Class IIVanta/Seqenita LT Clinician Programmer ApplicationMedtronic Neuromodulation
2023-01-18Z-0913-2023Class IIVanta/Seqenita LT Clinician Programmer ApplicationMedtronic Neuromodulation
2023-01-18Z-0914-2023Class IIVanta/Seqenita LT Clinician Programmer ApplicationMedtronic Neuromodulation
2023-01-18Z-0915-2023Class IIVanta/Seqenita LT Clinician Programmer ApplicationMedtronic Neuromodulation
2023-01-18Z-0916-2023Class II6The Anspach Effort, Inc.
2023-01-18Z-0917-2023Class II6The Anspach Effort, Inc.
2023-01-18Z-0918-2023Class IIAdult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping…The Anspach Effort, Inc.
2023-01-18Z-0919-2023Class II6The Anspach Effort, Inc.
2023-01-18Z-0920-2023Class II7The Anspach Effort, Inc.
2023-01-18Z-0921-2023Class IIAdult CraniotomeThe Anspach Effort, Inc.
2023-01-18Z-0922-2023Class II7The Anspach Effort, Inc.
2023-01-18Z-0923-2023Class II6The Anspach Effort, Inc.
2023-01-18Z-0924-2023Class IIPediatric Craniotome Ref:CRANI-P-G1The Anspach Effort, Inc.
2023-01-18Z-0925-2023Class IIPrep-Fill Guarded Luer ConnectorInternational Medical Industries, Inc.
2023-01-18Z-0927-2023Class IIDeRoyal ORGAN RECOVERY PACK PGYBKDeRoyal Industries Inc
2023-01-18Z-0928-2023Class IIBD Pyxis MedBank SystemCareFusion 303, Inc.
2023-01-18Z-0930-2023Class IIMedline CISION Sterile BladesMEDLINE INDUSTRIES, LP - Northfield
2023-01-18Z-0931-2023Class IIStradis Healthcare Foley Catheter Insertion Tray with preconnected…Stradis Healthcare
2023-01-18Z-0932-2023Class IIPHS Lacertaion TrayStradis Healthcare
2023-01-18Z-0933-2023Class IIHenry Shein CYSTO SET UP PACKStradis Healthcare
2023-01-18Z-0934-2023Class IIHenry Shein GLOVESStradis Healthcare
2023-01-18Z-0935-2023Class IIPICC KITStradis Healthcare
2023-01-18Z-0936-2023Class IIHCT 500mL BAGSStradis Healthcare
2023-01-18Z-0937-2023Class IIHCT 50mL EVA BAGSStradis Healthcare
2023-01-18Z-0938-2023Class IIHCT 12 CC SYRINGE KITStradis Healthcare
2023-01-18Z-0939-2023Class IIHCT 6 CC SYRINGE KITStradis Healthcare
2023-01-18Z-0940-2023Class IIHCT CENTRAL LINE Insertion TrayStradis Healthcare
2023-01-18Z-0941-2023Class IIHCT MAX BARRIER PICC INSERTION TRAY 12 per caseStradis Healthcare
2023-01-18Z-0942-2023Class IIStradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per caseStradis Healthcare
2023-01-18Z-0943-2023Class IIMcCormick Medical Distribution PORT TRAYStradis Healthcare
2023-01-18Z-0944-2023Class IIStradis Healthcare TCTR Convenience KitStradis Healthcare
2023-01-18Z-0945-2023Class IITacy MedicalStradis Healthcare
2023-01-18Z-0946-2023Class IITacy MedicalStradis Healthcare
2023-01-18Z-0947-2023Class IITacy MedicalStradis Healthcare
2023-01-18Z-0948-2023Class IIVital Care Products NEONATAL PICC TRAYStradis Healthcare
2023-01-18Z-0949-2023Class IIIMMULITE 2000 ThyroglobulinSiemens Healthcare Diagnostics, Inc.
2023-01-18Z-0950-2023Class IIIMMULITE 2000 ThyroglobulinSiemens Healthcare Diagnostics, Inc.
2023-01-18Z-0951-2023Class IIBIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000Depuy Ireland UC
2023-01-18Z-0952-2023Class IIcobas infinity central labRoche Diagnostics Operations, Inc.
2023-01-18Z-0953-2023Class IIRadiaLux Lighted RetractorMedtronic Navigation, Inc.
2023-01-18Z-0954-2023Class IICoreLink LLCCoreLink LLC
2023-01-18Z-0955-2023Class IICOVIDIEN Emprint Ablation Catheter with Thermosphere TechnologyCovidien, LLC
2023-01-11Z-0774-2023Class II9 Gauge Disposable Trocars with Blunt Pushers for Use with…ENDO Pharmaceuticals Solutions, Inc.
2023-01-11Z-0775-2023Class IIProgrammable Diagnostic ComputerSiemens Medical Solutions USA, Inc
2023-01-11Z-0776-2023Class IIGuardian iOS appMedtronic MiniMed
2023-01-11Z-0777-2023Class IIBECKMAN COULTER IRISpec CA/CB/CC controlBeckman Coulter, Inc.
2023-01-11Z-0778-2023Class IIVERIFY Dual Species Self-Contained Biological IndicatorsSteris Corporation
2023-01-11Z-0779-2023Class IIVERIFY Dual Species Self-Contained Biological IndicatorsSteris Corporation
2023-01-11Z-0780-2023Class IIVERIFY Steam Test PackSteris Corporation
2023-01-11Z-0781-2023Class IIVERIFY Steam Test PackSteris Corporation
2023-01-11Z-0782-2023Class IIBeaver EdgeAhead Stiletto/MVR KnifeBeaver Visitec International, Inc.
2023-01-11Z-0783-2023Class IIAPI LISTERIA 10 STRIPS+10 MEDIABiomerieux Inc
2023-01-11Z-0784-2023Class IIAPI 20 E 25 STRIPSBiomerieux Inc
2023-01-11Z-0785-2023Class IIAPI 20 C AUX 25 STRIPS+25 MEDIABiomerieux Inc
2023-01-11Z-0786-2023Class IIAPI STAPH 25 STRIPS+25 MEDIABiomerieux Inc
2023-01-11Z-0787-2023Class IIVITEK 2 REAGENT GN TEST KIT VTK2 20 CARDSBiomerieux Inc
2023-01-11Z-0788-2023Class IIVITEK 2 REAGENT GP TEST KIT VTK2 20 CARDSBiomerieux Inc
2023-01-11Z-0789-2023Class IIVITEK 2 REAGENT YST TEST KIT VTK2 20 CARDSBiomerieux Inc
2023-01-11Z-0790-2023Class IIVITEK 2 REAGENT BCL TEST KIT VTK2 20 CARDSBiomerieux Inc
2023-01-11Z-0791-2023Class IIVITEK 2 REAGENT NH TEST KIT VTK2 20 CARDSBiomerieux Inc
2023-01-11Z-0792-2023Class IIVITEK 2 REAGENT AST-GP67 TEST KIT 20 CARDSBiomerieux Inc
2023-01-11Z-0793-2023Class IIPREVI COLOR GRAM REAGENT IODINE-BBiomerieux Inc
2023-01-11Z-0794-2023Class IIPREVI COLOR GRAM REAGENT NOZZLE CLEANING SOLUTIONBiomerieux Inc
2023-01-11Z-0795-2023Class IIVIDAS CLINICALVIDAS VARICELBiomerieux Inc
2023-01-11Z-0796-2023Class IIVIDAS CLINICAL VIDAS MEASLES IGG 60TESTSBiomerieux Inc
2023-01-11Z-0797-2023Class IIVIDAS CLINICAL VIDAS RUB IGG 60 TESTSBiomerieux Inc
2023-01-11Z-0798-2023Class IIVIDAS CLINICAL VIDAS LISTERIA 60TBiomerieux Inc
2023-01-11Z-0799-2023Class IIVIDAS CLINICAL VIDAS SALMONELLA 60TBiomerieux Inc
2023-01-11Z-0800-2023Class IIVIDAS CLINICAL QCV-QUALITY CONTROL VIDAS 60TBiomerieux Inc
2023-01-11Z-0801-2023Class IIPPM CLINICAL CRAPONNE CLINICAL CHROMID CANDIDA 20 PLATESBiomerieux Inc
2023-01-11Z-0802-2023Class IIPPM CLINICAL CHROMID MRSA 20 PLT USBiomerieux Inc
2023-01-11Z-0803-2023Class IIPPM CLINICAL CRAPONNE CHROMID VRE 20 PLT USBiomerieux Inc
2023-01-11Z-0804-2023Class IIPPM CLINICAL CRAPONNE CHROMID CBiomerieux Inc
2023-01-11Z-0805-2023Class IIBIOBALL ABiomerieux Inc
2023-01-11Z-0806-2023Class IIBIOBALL BBiomerieux Inc
2023-01-11Z-0807-2023Class IIBIOBALL PBiomerieux Inc
2023-01-11Z-0808-2023Class IIAPI VP1 VP2 REAGENTSBiomerieux Inc
2023-01-11Z-0809-2023Class IIAPI NIT1 NIT2 REAGENTSBiomerieux Inc
2023-01-11Z-0810-2023Class IIAPI JAMES 2AMPBiomerieux Inc
2023-01-11Z-0811-2023Class IITEMPO REAGENTS TEMPO CONTROL KITBiomerieux Inc
2023-01-11Z-0812-2023Class IIASTUTE REAGENT ASTUTE ELECTRONIC QUALITY CTRL DEVICE USBiomerieux Inc
2023-01-11Z-0813-2023Class IIPPM INDUSTRY COMBOURG LPT BROTHBiomerieux Inc

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