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Medical device recalls reported in 2020

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ReportedRecallClassProductFirm
2020-06-10Z-2253-2020Class IIMultifire VersaTrack Auto Suture Hernia StaplerCovidien Llc
2020-06-10Z-2254-2020Class IIMultifire Endo Hernia 0 12mm Stapler with 4Covidien Llc
2020-06-10Z-2255-2020Class IIMultifire Endo Hernia 0 12mm Stapler with 4Covidien Llc
2020-06-10Z-2256-2020Class IIProxiDiagnost N90Philips North America, LLC
2020-06-10Z-2257-2020Class IIARTIS icono systems with Quantification Application SWSiemens Medical Solutions USA, Inc
2020-06-10Z-2258-2020Class IISystemGE Healthcare, LLC
2020-06-10Z-2259-2020Class IISystemGE Healthcare, LLC
2020-06-10Z-2260-2020Class IIda Vinci SP surgical systemIntuitive Surgical, Inc.
2020-06-10Z-2261-2020Class IIXhibit CentralSpacelabs Healthcare, Inc.
2020-06-10Z-2264-2020Class IIIPerkinElmer 226 Sample Collection DevicePerkinElmer Health Sciences, Inc.
2020-06-03Z-1727-2020Class IINikon Metrology XTH cabinet x-ray Systems which includes variations…Nikon Metrology
2020-06-03Z-2039-2020Class IMedtronic Confida Expandable SheathMedtronic Vascular Galway DBA Medtronic Ireland
2020-06-03Z-2055-2020Class IHeartware HVAD Pump Implant KitHeartware, Inc.
2020-06-03Z-2056-2020Class IHeartware HVAD Pump Implant KitHeartware, Inc.
2020-06-03Z-2057-2020Class IHeartware HVAD Pump Implant KitHeartware, Inc.
2020-06-03Z-2058-2020Class IHeartware HVAD Pump Outflow GraftHeartware, Inc.
2020-06-03Z-2059-2020Class IHeartware HVAD Pump Implant accessoriesHeartware, Inc.
2020-06-03Z-2100-2020Class IIKangaroo Joey Safety Screw Spike with Flush BagCardinal Health Inc.
2020-06-03Z-2101-2020Class IIKangaroo Joey Safety Screw Spike SetCardinal Health Inc.
2020-06-03Z-2102-2020Class IIKangaroo Connect ENPlus Spike Set Anti-free FlowCardinal Health Inc.
2020-06-03Z-2103-2020Class IIKangaroo Epump Safety Screw Spike with Flush BagCardinal Health Inc.
2020-06-03Z-2104-2020Class IIKangaroo Epump Safety Screw Spike SetCardinal Health Inc.
2020-06-03Z-2105-2020Class IIKangaroo 924 Safety Screw Spike SetCardinal Health Inc.
2020-06-03Z-2106-2020Class IIGuardian Connect App CSS7200 iOS and Guardian Connect Transmitter…Medtronic Inc.
2020-06-03Z-2107-2020Class IIRef 801168Quest Medical, Inc.
2020-06-03Z-2108-2020Class IIARTIS PhenoSiemens Medical Solutions USA, Inc
2020-06-03Z-2109-2020Class IISkater Introducer Set 6F x 18cmArgon Medical Devices, Inc
2020-06-03Z-2110-2020Class IIOptilite Optilite Rheumatoid Factor KitThe Binding Site Group, Ltd.
2020-06-03Z-2111-2020Class IIGiraffe ShuttleGE Healthcare, LLC
2020-06-03Z-2112-2020Class IICooperSurgical Dilator/Sound SetCooperSurgical, Inc.
2020-06-03Z-2114-2020Class IIFlexLab Automation System used with the following Modules: High…Inpeco S.A.
2020-06-03Z-2115-2020Class IIAccelerator a3600 Automation System used with the following Modules:…Inpeco S.A.
2020-06-03Z-2116-2020Class IIVACUETTE Blood Transfer UnitC.A. Greiner & Sohne Gesellschaftmbh
2020-06-03Z-2117-2020Class IIARCHITECT iGentamicin Reagent KitAbbott Gmbh & Co. KG
2020-06-03Z-2118-2020Class IIClearview Total Uterine ManipulatorClinical Innovations, LLC
2020-06-03Z-2119-2020Class IIArtisanTM 70 cm 2 x 8 Surgical Lead KitBoston Scientific Neuromodulation Corporation
2020-06-03Z-2120-2020Class IIThirty-fiveBoston Scientific Neuromodulation Corporation
2020-06-03Z-2121-2020Class IILinearTM 3-4 50 cm 8 Contact Lead KitBoston Scientific Neuromodulation Corporation
2020-06-03Z-2122-2020Class IIThe LinearTM 3-4 70 cm 8 Contact Lead KitBoston Scientific Neuromodulation Corporation
2020-06-03Z-2123-2020Class IIPrecision TM M8 AdapterBoston Scientific Neuromodulation Corporation
2020-06-03Z-2124-2020Class IIFifty-fiveBoston Scientific Neuromodulation Corporation
2020-06-03Z-2125-2020Class IIFifty-fiveBoston Scientific Neuromodulation Corporation
2020-06-03Z-2126-2020Class IISamco Bio-Tite Sterile Specimen ContainerThermo Fisher Scientific (Monterrey)
2020-06-03Z-2127-2020Class IICios Alpha Image-Intensified Fluoroscopic X-Ray SystemSiemens Medical Solutions USA, Inc
2020-06-03Z-2128-2020Class IICios Spin Image-Intensified Fluoroscopic X-Ray SystemSiemens Medical Solutions USA, Inc
2020-06-03Z-2129-2020Class IISprotte NeedleTELEFLEX MEDICAL INC
2020-06-03Z-2130-2020Class IISprotte NeedleTELEFLEX MEDICAL INC
2020-06-03Z-2131-2020Class IIda Vinci SP CameraIntuitive Surgical, Inc.
2020-06-03Z-2132-2020Class IIJOURNEY II UNI RESECTION PREP TRIALSmith & Nephew, Inc.
2020-06-03Z-2133-2020Class IIJOURNEY II UNI RESECTION PREP TRIALSmith & Nephew, Inc.
2020-06-03Z-2134-2020Class IIPhilips Sterilizable Defibrillator Internal PaddlesPhilips North America, LLC
2020-06-03Z-2135-2020Class IIBody Weight SupportMOTEK MEDICAL B.V.
2020-06-03Z-2136-2020Class IIISE Electrolyte ReferenceBeckman Coulter Inc.
2020-06-03Z-2137-2020Class IIPhilips HeartStart XL Monitor/Defibrillators Model number: M4735APhilips North America, LLC
2020-06-03Z-2138-2020Class IIABL90 FLEX PLUSRadiometer Medical ApS
2020-06-03Z-2139-2020Class IIABL90 FLEXRadiometer Medical ApS
2020-06-03Z-2140-2020Class IIFlexLab Automation System with Advia2120LAS Interface ModuleInpeco S.A.
2020-06-03Z-2141-2020Class IIAccelerator a3600 Automation System with Advia2120LAS Interface ModuleInpeco S.A.
2020-06-03Z-2142-2020Class IIAptio Automation System with Advia2120LAS Interface ModuleInpeco S.A.
2020-06-03Z-2143-2020Class IIBridge Occlusion BalloonSpectranetics Corporation
2020-06-03Z-2144-2020Class IIExtremities Item Number: 1)113954 Hybrid Glenoid Glenoid BaseBiomet, Inc.
2020-06-03Z-2145-2020Class IIHip Products Item Number: 1) 110010462 RingLoc Hip SystemBiomet, Inc.
2020-06-03Z-2146-2020Class IIKnee Products: 141356 Regenerex Series-A Patella 3 PegBiomet, Inc.
2020-06-03Z-2147-2020Class IIKnee Products: 150414 Orthopedic Salvage SystemBiomet, Inc.
2020-06-03Z-2148-2020Class IIKnee Products: 154335 Oxford Partial Knee SystemBiomet, Inc.
2020-06-03Z-2149-2020Class IIKnee Products: 155308 Knees AGC Knee System PS Molded Tibial ComponentBiomet, Inc.
2020-06-03Z-2150-2020Class IIKnee Products: 183622 Vanguard Knee System PS Tibial BearingBiomet, Inc.
2020-06-03Z-2151-2020Class IIKnee Products: 189260 Vanguard Knee SystemBiomet, Inc.
2020-06-03Z-2152-2020Class IIKnee Products: 189420 Vanguard Knee SystemBiomet, Inc.
2020-06-03Z-2153-2020Class IIKnee Products: 183742 Vanguard Knee SystemBiomet, Inc.
2020-06-03Z-2154-2020Class IIKnee Products: 184762 Knees Vanguard Knee SystemBiomet, Inc.
2020-06-03Z-2155-2020Class IIKnee Products: US154709 Knees Vanguard M Partial Knee System…Biomet, Inc.
2020-06-03Z-2156-2020Class IIKnee Products: TMJPM-1510 Microfixation Custom Made DeviceBiomet, Inc.
2020-06-03Z-2157-2020Class IIPhilips HeartStart MRx Monitor/Defibrillators Model numbers M3535APhilips North America, LLC
2020-06-03Z-2158-2020Class IIEpix latis GRASPERApplied Medical Resources Corp
2020-06-03Z-2159-2020Class IIEpix latis GRASPERApplied Medical Resources Corp
2020-06-03Z-2160-2020Class IIDRApplied Medical Resources Corp
2020-06-03Z-2161-2020Class IIClip Applier KitApplied Medical Resources Corp
2020-06-03Z-2162-2020Class IIGENTLEWAVE REF: FG-002-0001Sonendo Inc
2020-06-03Z-2163-2020Class IIPanther Fusion Extraction Reagent-SHologic, Inc
2020-05-27Z-1995-2020Class IMedtronic Nexframe Stereotactic System and StealthStation Cranial…Medtronic Navigation, Inc.
2020-05-27Z-2008-2020Class IIK2MK2M, Inc
2020-05-27Z-2009-2020Class IIK2MK2M, Inc
2020-05-27Z-2010-2020Class IIK2MK2M, Inc
2020-05-27Z-2011-2020Class IIK2MK2M, Inc
2020-05-27Z-2012-2020Class IIK2MK2M, Inc
2020-05-27Z-2013-2020Class IIK2MK2M, Inc
2020-05-27Z-2014-2020Class IIK2MK2M, Inc
2020-05-27Z-2015-2020Class IIK2MK2M, Inc
2020-05-27Z-2016-2020Class IIK2MK2M, Inc
2020-05-27Z-2017-2020Class IIK2MK2M, Inc
2020-05-27Z-2018-2020Class IIK2MK2M, Inc
2020-05-27Z-2019-2020Class IIK2MK2M, Inc
2020-05-27Z-2020-2020Class IIK2MK2M, Inc
2020-05-27Z-2021-2020Class IIK2MK2M, Inc
2020-05-27Z-2022-2020Class IIK2MK2M, Inc
2020-05-27Z-2023-2020Class IIK2MK2M, Inc
2020-05-27Z-2024-2020Class IIK2MK2M, Inc
2020-05-27Z-2025-2020Class IIK2MK2M, Inc
2020-05-27Z-2026-2020Class IIK2MK2M, Inc
2020-05-27Z-2027-2020Class IIK2MK2M, Inc
2020-05-27Z-2028-2020Class IIK2MK2M, Inc
2020-05-27Z-2029-2020Class IIK2MK2M, Inc
2020-05-27Z-2030-2020Class IIK2MK2M, Inc
2020-05-27Z-2031-2020Class IIK2MK2M, Inc
2020-05-27Z-2032-2020Class IIAB HiResolution Bionic Ear SystemAdvanced Bionics, LLC
2020-05-27Z-2033-2020Class IIAB HiResolution Bionic Ear SystemAdvanced Bionics, LLC
2020-05-27Z-2034-2020Class IISTEALTH SPRING CLIP 6mm latisApplied Medical Resources Corp
2020-05-27Z-2035-2020Class IISTEALTH SPRING CLIP 6mm latisApplied Medical Resources Corp
2020-05-27Z-2036-2020Class IISTEALTH SPRING CLIP 6mm latisApplied Medical Resources Corp
2020-05-27Z-2037-2020Class IISTEALTH SPRING CLIP 6mm latisApplied Medical Resources Corp
2020-05-27Z-2038-2020Class IIIOrthopedic manual Surgical Instrument handle for Simple Locking Intra…Pega Medical Inc.
2020-05-27Z-2040-2020Class IICustom convenience kits containing Medline brand Sterile…Medline Industries Inc
2020-05-27Z-2041-2020Class IIIImmersiveView software version 2Immersivetouch Inc
2020-05-27Z-2042-2020Class IISELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1Medline Industries Inc
2020-05-27Z-2043-2020Class IISELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 mlMedline Industries Inc
2020-05-27Z-2044-2020Class IISELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 10 Fr 3 mlMedline Industries Inc
2020-05-27Z-2045-2020Class IIAMS 700 100 mLBoston Scientific Corporation
2020-05-27Z-2046-2020Class IIBD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining…Becton Dickinson & Co.
2020-05-27Z-2047-2020Class IIBD BBLTM Gram Crystal Violet 3Becton Dickinson & Co.
2020-05-27Z-2048-2020Class IIBD BBLTM Gram Stain Kit with Stabilized Iodine-- IVD For the…Becton Dickinson & Co.
2020-05-27Z-2049-2020Class IIB-Hydroxybutyrate LiquiColorCardinal Health Inc.
2020-05-27Z-2050-2020Class IIProfessional Urine Drug ControlCardinal Health Inc.
2020-05-27Z-2051-2020Class IIStrep B Carrot Broth One-StepCardinal Health Inc.
2020-05-27Z-2052-2020Class IIConformable Thoracic Stent GraftW L Gore & Associates, Inc.
2020-05-27Z-2053-2020Class IIPhilips HeartStart XL Defibrillator/MonitorPhilips North America, LLC
2020-05-27Z-2054-2020Class IICranio/Sculpt CSkeletal Kinetics, Llc
2020-05-27Z-2060-2020Class IIRenuvion/ J-Plasma Precise Open HandpieceBovie Medical Corporation
2020-05-27Z-2061-2020Class IIRenuvion/ J-Plasma Precise HandpieceBovie Medical Corporation
2020-05-27Z-2062-2020Class IIOryx Cervical Screw CaddyInnovasis, Inc
2020-05-27Z-2063-2020Class IIFrames Direct Prescription Spectacle Lenses included in the frame…Frames Direct
2020-05-27Z-2064-2020Class IIHeartStart MRx Processor Board PCA Replacement Kits 453563478461Philips North America, LLC
2020-05-27Z-2065-2020Class IIBD Posiflush SF Saline Flush SyringeBecton Dickinson & Company
2020-05-27Z-2066-2020Class IIPrismaflex Control UnitBaxter Healthcare Corporation
2020-05-27Z-2067-2020Class IIDFINE Vertebral Hydraulic Assemblies: Hydraulic AssemblyMerit Medical Systems, Inc.
2020-05-27Z-2068-2020Class IIDFINE Vertebral Assemblies: Hydraulic-Master Syringe AssemblyMerit Medical Systems, Inc.
2020-05-27Z-2069-2020Class IITorFlex Transseptal Guiding SheathBaylis Medical Company Inc.
2020-05-27Z-2070-2020Class IINRG RF Transseptal KitBaylis Medical Company Inc.
2020-05-27Z-2071-2020Class IIThe Optilite Clinical Chemistry AnalyzerThe Binding Site Group, Ltd.
2020-05-27Z-2072-2020Class IIKiwi Complete Vacuum Delivery SystemClinical Innovations, LLC
2020-05-27Z-2073-2020Class IICapsoCam Plus *** SystemCapso Vision, Inc.
2020-05-27Z-2074-2020Class IIDako Autostainer instruments: Autostainer Link 48Dako Denmark A/S
2020-05-27Z-2075-2020Class IIBARD MYPICC KIT 5F Dual-LumenBecton Dickinson & Company
2020-05-27Z-2076-2020Class IIBARD MYPICC KIT 5F Triple-LumenBecton Dickinson & Company
2020-05-27Z-2077-2020Class IIBARD MYPICC KIT 4F Single-LumenBecton Dickinson & Company
2020-05-27Z-2078-2020Class IIBARD MYPICC KIT 5F Dual-LumenBecton Dickinson & Company
2020-05-27Z-2079-2020Class IIBARD MYPICC KIT 5F Triple-LumenBecton Dickinson & Company
2020-05-27Z-2080-2020Class IIBARD MYPICC KIT 3F Single-LumenBecton Dickinson & Company
2020-05-27Z-2081-2020Class IIBARD MYPICC KIT 4F Dual-LumenBecton Dickinson & Company
2020-05-27Z-2082-2020Class IIBARD MYPICC KIT 5F Dual-LumenBecton Dickinson & Company
2020-05-27Z-2083-2020Class IINelDerm Hydrogel DressingNelson Innovaions, Llc
2020-05-27Z-2084-2020Class IIStryker Orthopaedics-Restoration Anatomic Hemispherical ShellHowmedica Osteonics Corp.
2020-05-27Z-2085-2020Class IIStryker Orthopaedics-Restoration Anatomic Hemispherical ShellHowmedica Osteonics Corp.
2020-05-27Z-2086-2020Class IIStryker Orthopaedics-Restoration Anatomic Hemispherical ShellHowmedica Osteonics Corp.
2020-05-27Z-2087-2020Class IIStryker Orthopaedics-Restoration Anatomic Hemispherical ShellHowmedica Osteonics Corp.
2020-05-27Z-2088-2020Class IIStryker Orthopaedics-Restoration Anatomic Hemispherical ShellHowmedica Osteonics Corp.
2020-05-27Z-2089-2020Class IIStryker Orthopaedics-Restoration Anatomic Hemispherical ShellHowmedica Osteonics Corp.
2020-05-27Z-2090-2020Class IIStryker Orthopaedics-Restoration Anatomic Hemispherical ShellHowmedica Osteonics Corp.
2020-05-27Z-2091-2020Class IIStryker Orthopaedics-Restoration Anatomic Hemispherical ShellHowmedica Osteonics Corp.
2020-05-27Z-2092-2020Class IIStryker Orthopaedics-Restoration Anatomic Hemispherical ShellHowmedica Osteonics Corp.
2020-05-27Z-2093-2020Class IIStryker Orthopaedics-Restoration Anatomic Hemispherical ShellHowmedica Osteonics Corp.
2020-05-27Z-2094-2020Class IIStryker Orthopaedics-Restoration Anatomic Hemispherical ShellHowmedica Osteonics Corp.
2020-05-27Z-2095-2020Class IIStryker Orthopaedics-Restoration Anatomic Hemispherical ShellHowmedica Osteonics Corp.
2020-05-27Z-2096-2020Class IIStryker Orthopaedics-Restoration Anatomic Hemispherical ShellHowmedica Osteonics Corp.
2020-05-27Z-2097-2020Class IIStryker Orthopaedics-Restoration Anatomic Hemispherical ShellHowmedica Osteonics Corp.
2020-05-27Z-2098-2020Class IIStryker Orthopaedics-Restoration Anatomic Hemispherical ShellHowmedica Osteonics Corp.
2020-05-27Z-2099-2020Class IIStryker Orthopaedics-Restoration Anatomic Hemispherical ShellHowmedica Osteonics Corp.
2020-05-20Z-1928-2020Class IIOxymetry CableEdwards Lifesciences, LLC
2020-05-20Z-1929-2020Class IIEMPOWR Acetabular SystemEncore Medical, LP
2020-05-20Z-1930-2020Class IIVITROS Chemistry Products CKMB SlidesOrtho-Clinical Diagnostics
2020-05-20Z-1931-2020Class IIVITROS Chemistry Products CKMB SlidesOrtho-Clinical Diagnostics
2020-05-20Z-1932-2020Class IIPhilips Zenition 50Philips North America, LLC
2020-05-20Z-1933-2020Class IIPhilips Zenition 70Philips North America, LLC
2020-05-20Z-1934-2020Class IICuattroDR System SoftwareCuattro LLC
2020-05-20Z-1935-2020Class IIStryker Power-PRO TL cot-powered ambulance cot Model Number 6550Stryker Medical Division of Stryker Corporation
2020-05-20Z-1936-2020Class IIArterial Line Kit 20ga X 3"Argon Medical Devices, Inc
2020-05-20Z-1937-2020Class IIArterial Line Kit 20ga X 3"Argon Medical Devices, Inc
2020-05-20Z-1938-2020Class IIPAC Tray/5 Catheter Introducer Tray 8FArgon Medical Devices, Inc
2020-05-20Z-1939-2020Class IISWIN 2017 databaseRemel Inc.
2020-05-20Z-1940-2020Class IIFormula 418 Renal Balloon-Expandable StentCook Inc.
2020-05-20Z-1941-2020Class IIVERTEX SELECT MULTI AXIAL SCREWMedtronic Sofamor Danek USA Inc
2020-05-20Z-1942-2020Class IIIInsufflation tubing to be used with varies insufflator unitsKarl Storz Endoscopy
2020-05-20Z-1943-2020Class IIEVA Floor LiftsHandicare AB
2020-05-20Z-1944-2020Class IIiChem¿VELOCITY Urine Chemistry System-Beckman Coulter Inc.
2020-05-20Z-1945-2020Class IIiQ200 Series Urine Microscopy Analyzer- All part numbersBeckman Coulter Inc.
2020-05-20Z-1946-2020Class IIPowerGlide ST Midline Catheter Maximal Barrier Kit-18 gaugeBecton Dickinson & Company
2020-05-20Z-1947-2020Class IIQuickie/Zippie powered wheelchairSunrise Medical (US) LLC
2020-05-20Z-1948-2020Class IITandemHeart Pump KitCardiac Assist, Inc
2020-05-20Z-1949-2020Class IITandemHeart pump is assembled into kits: TandemHeart KitCardiac Assist, Inc
2020-05-20Z-1950-2020Class IITandemHeart pump is assembled into kits: TandemHeart KitCardiac Assist, Inc
2020-05-20Z-1951-2020Class IITandemHeart pump is assembled into kits: ProtekDuo KitCardiac Assist, Inc
2020-05-20Z-1952-2020Class IITandemHeart pump is assembled into kits: ProtekDuo KitCardiac Assist, Inc
2020-05-20Z-1953-2020Class IITandemHeart pump is assembled into kits: ProtekDuo KitCardiac Assist, Inc
2020-05-20Z-1954-2020Class IITandemHeart pump is assembled into kits: TandemLung KitCardiac Assist, Inc
2020-05-20Z-1955-2020Class IITandemHeart pump is assembled into kits: TandemLife Kit Product:…Cardiac Assist, Inc
2020-05-20Z-1956-2020Class IICustom Sheath Introducer Kit REF K21-00031Merit Medical Systems, Inc.
2020-05-20Z-1957-2020Class IISiemens Cios Alpha VA20-mobile X-Ray system Material # 10308191 The…Siemens Medical Solutions USA, Inc
2020-05-20Z-1958-2020Class IISiemens Cios Alpha VA30-mobile X-Ray systemSiemens Medical Solutions USA, Inc
2020-05-20Z-1959-2020Class IISiemens Cios Spin VA30-mobile X-Ray systemSiemens Medical Solutions USA, Inc
2020-05-20Z-1960-2020Class IIda Vinci Xi Surgical SystemIntuitive Surgical, Inc.

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