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Medical device recalls reported in 2013

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ReportedRecallClassProductFirm
2013-09-04Z-2105-2013Class IIMedtronic Custom Perfusion System with Carmeda BioActive SurfaceMedtronic Inc. Cardiac Rhythm Disease Management
2013-09-04Z-2106-2013Class IIMedtronic Custom Perfusion System with Trillium BioSurfaceMedtronic Inc. Cardiac Rhythm Disease Management
2013-09-04Z-2107-2013Class IISpineNet Bone Marrow Aspiration Needle KitSpineNet
2013-09-04Z-2108-2013Class IIAxiom Artis systemsSiemens Medical Solutions USA, Inc
2013-09-04Z-2109-2013Class IIACCU-CHECK FastClix Lancing DeviceRoche Diagnostics Operations, Inc.
2013-09-04Z-2110-2013Class IIPrepStain AGBecton Dickinson & Co.
2013-09-04Z-2111-2013Class IIPrepStain Tecan US-IBecton Dickinson & Co.
2013-09-04Z-2112-2013Class IIPrepStain Tecan US-IIBecton Dickinson & Co.
2013-09-04Z-2113-2013Class IIDeRoyal Insufflation Tubing sets: 1) REF 28-0206 Insufflation TubingDeRoyal Industries Inc
2013-09-04Z-2114-2013Class IIADVIA 120 Hematology AnalyzerSiemens Healthcare Diagnostics
2013-09-04Z-2115-2013Class IIGE HealthcareGE Healthcare, LLC
2013-09-04Z-2116-2013Class IISOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULEGE Healthcare, LLC
2013-09-04Z-2117-2013Class IIGE HealthcareGE Healthcare, LLC
2013-09-04Z-2118-2013Class IIBenchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FSVentana Medical Systems Inc
2013-09-04Z-2130-2013Class IIStryker Howmedica Osteonics Triathlon tibial alignment ankle clamp…Stryker Howmedica Osteonics Corp.
2013-08-28Z-1964-2013Class IIPhilips Healthcare MobileDiagnostwDR systemPhilips Healthcare Inc.
2013-08-28Z-1967-2013Class IIThe Discovery NM/CT 570c CT Standalone Scan The Discovery NM/CT 570c…GE Healthcare, LLC
2013-08-28Z-1976-2013Class IStryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4)…Stryker Spine
2013-08-28Z-1979-2013Class IIBoston ScientificBoston Scientific CRM Corp
2013-08-28Z-1980-2013Class IICHAMPION Medical ReclinerInvacare Corporation
2013-08-28Z-1981-2013Class IIMoore Hip Prosthesis Long Fenestrated StemZimmer, Inc.
2013-08-28Z-1982-2013Class IIEndoGastric Solutions EsophyX2 Device with Serosa Fastener and…Endogastric Solutions Inc
2013-08-28Z-1983-2013Class IIGYRUS ACMIGyrus Medical, Inc
2013-08-28Z-1984-2013Class IIProduct Name: nanoPOINT Injector SystemMedicel Ag
2013-08-28Z-1985-2013Class IIEdwards Lifesciences Suction Wand Model S099BSorin Group USA, Inc.
2013-08-28Z-1986-2013Class IIMedtronic MiniMed Paradigm ReservoirsMedtronic MiniMed
2013-08-28Z-1987-2013Class IIPleuraGuide Disposable Chest Tube KitAtrium Medical Corporation
2013-08-28Z-1988-2013Class IIDistributed in USA: Product Number: 40-2894: Reinforced Wound ClosureAspen Surgical Products, Inc.
2013-08-28Z-1989-2013Class IIGE HealthcareGE Healthcare, LLC
2013-08-28Z-1990-2013Class IIIConvaTec Flexi-Seal SIGNAL Fecal Management SystemConvatec Inc.
2013-08-28Z-1991-2013Class IIIConvaTec Flexi-Seal SIGNAL +Convatec Inc.
2013-08-28Z-1992-2013Class IIStryker Visum 300 Ceiling-mounted Exam LightStryker Communications
2013-08-28Z-1994-2013Class IIGetinge Assure Accufast Biological IndicatorsGetinge USA Inc
2013-08-28Z-1995-2013Class IIBlue Belt TechnologiesBlue Belt Technologies MN
2013-08-28Z-1996-2013Class IIGENESISSmith & Nephew Inc
2013-08-28Z-1997-2013Class IIHemoccult ICTBeckman Coulter Inc.
2013-08-28Z-1998-2013Class II00597001101 Femur CR PRECOAT FEM COMP SIZE AMLZimmer, Inc.
2013-08-28Z-1999-2013Class II00597001131 Femur CR PRC SURF HDN FEM CO-NID AMLZimmer, Inc.
2013-08-28Z-2000-2013Class II00597201101 Femur CR POROUS FEM COMP SIZE AML RxZimmer, Inc.
2013-08-28Z-2001-2013Class II65597201131 Femur CR POR FEM SURF HDN HATCP AML RxZimmer, Inc.
2013-08-28Z-2002-2013Class II00597201131 Femur CR POR SURF HDN FEM CO-NID AML RxZimmer, Inc.
2013-08-28Z-2003-2013Class II65597201101 Femur CR POR FEM HATCP SIZE AML RxZimmer, Inc.
2013-08-28Z-2004-2013Class II00597601201 Femur CRA PRECOAT FEM COMP SIZE B/L RxZimmer, Inc.
2013-08-28Z-2005-2013Class II00595601201 Femur CR-FLEX OPT FEM B-L Rx SterileZimmer, Inc.
2013-08-28Z-2006-2013Class II00595001201 Femur CR-FLEX PCT FEM B-L RxZimmer, Inc.
2013-08-28Z-2007-2013Class II00595201201 Femur CR-FLEX POR FEM B-L RxZimmer, Inc.
2013-08-28Z-2008-2013Class II65595201201 Femur CR-FLEX POR HATCP FEM B-L RxZimmer, Inc.
2013-08-28Z-2009-2013Class II00597001303 Femur CR PRC FEM COMP SIZE CML RxZimmer, Inc.
2013-08-28Z-2010-2013Class II00597001333 Femur CR PRC SURF HDN FEM CO-NID CML RxZimmer, Inc.
2013-08-28Z-2011-2013Class II00597201303 Femur CR POR FM COMP SIZE CML RxZimmer, Inc.
2013-08-28Z-2012-2013Class II00597201333 Femur CR POR SURF HDN FEM CO-NID CMLZimmer, Inc.
2013-08-28Z-2013-2013Class II65597201333 Femur CR POR FEM SURF HDN HATCP CMLZimmer, Inc.
2013-08-28Z-2014-2013Class II00587806126 Patella MICRO POROUS PAT 26MM X 10MMZimmer, Inc.
2013-08-28Z-2015-2013Class II00597206126 Patella ALL POLY PAT COMP MICRO 26DIAZimmer, Inc.
2013-08-28Z-2016-2013Class II00595202010 Articular Surface XLPE CR ART SURF 1Zimmer, Inc.
2013-08-28Z-2017-2013Class II90595202017 Articular Surface XLPE CR ART SURF AE12/PUR 17Zimmer, Inc.
2013-08-28Z-2018-2013Class II00597002009 Articular Surface CR ART SURF 12/PURPLE 9Zimmer, Inc.
2013-08-28Z-2019-2013Class II90597002009 Articular Surface CR ART SURF 12/PURPLE 09MMZimmer, Inc.
2013-08-28Z-2020-2013Class II00597202009 Articular Surface CR ART SURF 12/PURPLE 09Zimmer, Inc.
2013-08-28Z-2021-2013Class II00597602010 Articular Surface AC ART SURF 12/PUR 10Zimmer, Inc.
2013-08-28Z-2022-2013Class II00595203110 Articular Surface XLPE CR ART SURF 3Zimmer, Inc.
2013-08-28Z-2023-2013Class II90595203117 Articular Surface XLPE CR ART SURF AE34/STYEL 17Zimmer, Inc.
2013-08-28Z-2024-2013Class II00597003109 Articular Surface CR ART SURF 34/STRIPE YEL 9Zimmer, Inc.
2013-08-28Z-2025-2013Class II90597003109 Articular Surface CR ART SURF 34/STR YEL 09MMZimmer, Inc.
2013-08-28Z-2026-2013Class II00597203109 Articular Surface CR ART SURF 34/STRIPE YEL 09Zimmer, Inc.
2013-08-28Z-2027-2013Class II00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10Zimmer, Inc.
2013-08-28Z-2028-2013Class II00595204110 Articular Surface XLPE CR ART SURF 5-6/STRGRN 10Zimmer, Inc.
2013-08-28Z-2029-2013Class II90595204117 Articular Surface XLPE CR ART SURF AE56/STGRN 17Zimmer, Inc.
2013-08-28Z-2030-2013Class II00597004109 Articular Surface CR ART SURF 56/STRIPE GREEN 9Zimmer, Inc.
2013-08-28Z-2031-2013Class II90597004109 Articular Surface CR ART SURF AE56/STR GRN 09MMZimmer, Inc.
2013-08-28Z-2032-2013Class II00597204109 Articular Surface CR ART SURF 56/STRIPE GRN 9Zimmer, Inc.
2013-08-28Z-2033-2013Class II00597604110 Articular Surface AC ART SURF 56/STRIPED GRN 10Zimmer, Inc.
2013-08-28Z-2034-2013Class II00597101101 Provisional CR PROV FRM COMP SIZE AMLZimmer, Inc.
2013-08-28Z-2035-2013Class II00595501201 Provisional CR-FLEX FEM PROV SZ B-LZimmer, Inc.
2013-08-28Z-2036-2013Class II00598706201 Provisional CRA FEM PROV/CUT GDE SZ BMLZimmer, Inc.
2013-08-28Z-2037-2013Class II00597106126 Provisional ALL POLY PAT PROV MICRO SZ 26Zimmer, Inc.
2013-08-28Z-2038-2013Class II00597106126 Provisional MIC POROUS PAT PROV 26MMX10MMZimmer, Inc.
2013-08-28Z-2039-2013Class II00597502010 Provisional AC ART SURF PROV 12/PUR 10Zimmer, Inc.
2013-08-28Z-2040-2013Class II00597503110 Provisional AC ARTSURF PROV 34/STRIPE YEL10Zimmer, Inc.
2013-08-28Z-2041-2013Class II00597504110 Provisional AC ART SURF PROV 56/STR GRN 10Zimmer, Inc.
2013-08-28Z-2042-2013Class II00597102010 Provisional CR ART SURF PROV 12/PURPLE 10Zimmer, Inc.
2013-08-28Z-2043-2013Class II00597103110 Provisional CR ART SURF PROV 34/STR YEL 10Zimmer, Inc.
2013-08-28Z-2044-2013Class II00597104110 Provisional CR ART SURF PROV 56/STR GRN 10Zimmer, Inc.
2013-08-21Z-1877-2013Class IICarestream DRX Evolution SystemCarestream Health Inc.
2013-08-21Z-1897-2013Class INova Max Glucose Test StripsNova Biomedical Corporation
2013-08-21Z-1898-2013Class INova Max Glucose Test StripsNova Biomedical Corporation
2013-08-21Z-1899-2013Class INova Max Glucose Test StripsNova Biomedical Corporation
2013-08-21Z-1900-2013Class INova Max Glucose Test StripsNova Biomedical Corporation
2013-08-21Z-1901-2013Class INova Max Glucose Test StripsNova Biomedical Corporation
2013-08-21Z-1902-2013Class INova Max Glucose Test StripsNova Biomedical Corporation
2013-08-21Z-1903-2013Class INova Max Plus Monitor SystemNova Biomedical Corporation
2013-08-21Z-1904-2013Class INova Max Glucose Test StripsNova Biomedical Corporation
2013-08-21Z-1905-2013Class INova Max Plus Monitor SystemNova Biomedical Corporation
2013-08-21Z-1906-2013Class INova Max Plus Monitor SystemNova Biomedical Corporation
2013-08-21Z-1934-2013Class IITray SurgicalMedtronic Xomed, Inc.
2013-08-21Z-1935-2013Class II5Synthes USA HQ, Inc.
2013-08-21Z-1936-2013Class IIC-QUR MeshAtrium Medical Corporation
2013-08-21Z-1937-2013Class IIC-QUR Edge MeshAtrium Medical Corporation
2013-08-21Z-1938-2013Class IIC-QUR V-Patch MeshAtrium Medical Corporation
2013-08-21Z-1939-2013Class IIC-QUR TacShield MeshAtrium Medical Corporation
2013-08-21Z-1940-2013Class IIGE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography…GE Healthcare, LLC
2013-08-21Z-1941-2013Class II3OrthoPediatrics Corp
2013-08-21Z-1942-2013Class IIGE HealthcareGE Healthcare, LLC
2013-08-21Z-1943-2013Class IISIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE 3GE Healthcare, LLC
2013-08-21Z-1944-2013Class IIGE HealthcareGE Healthcare, LLC
2013-08-21Z-1945-2013Class IISiemens AXIOM Artis zeego x-raySiemens Medical Solutions USA, Inc
2013-08-21Z-1946-2013Class IIIsoGel AIR 84Stryker Medical Division of Stryker Corporation
2013-08-21Z-1947-2013Class II1) Adult Manual ResuscitatorCarefusion 2200 Inc
2013-08-21Z-1948-2013Class IIColorimetricOrtho-Clinical Diagnostics
2013-08-21Z-1949-2013Class IICELLTRACKS AUTOPREP SystemVeridex, LLC
2013-08-21Z-1950-2013Class IICELLTRACKS ANALYZER IIVeridex, LLC
2013-08-21Z-1951-2013Class IIISE Electrolyte Reference reagentBeckman Coulter Inc.
2013-08-21Z-1952-2013Class IISynthes Flexible Medullary ReamerSynthes USA HQ, Inc.
2013-08-21Z-1953-2013Class IIREF 00-4309-071-36 Trabecular Metal Reverse Shoulder System…Zimmer, Inc.
2013-08-21Z-1954-2013Class IIREF 00-4309-071-40 Trabecular Metal Reverse Shoulder System…Zimmer, Inc.
2013-08-21Z-1955-2013Class IIFisherbrand Sterile SwabFisher Scientific Co
2013-08-21Z-1956-2013Class IIStealthStation S7 Framelink Software version 5Medtronic Navigation, Inc.
2013-08-21Z-1957-2013Class IIInvue Solid DriverSpineFrontier, Inc.
2013-08-21Z-1958-2013Class IICase Lid and BaseSpineFrontier, Inc.
2013-08-21Z-1959-2013Class IIDisposable Temperature ProbesVital Signs Devices, a GE Healthcare Company
2013-08-21Z-1960-2013Class IIBiomet 3i Dental ImplantBiomet 3i, LLC
2013-08-21Z-1961-2013Class IIBiomet 3i Dental ImplantBiomet 3i, LLC
2013-08-21Z-1962-2013Class IIIRemel X/pect Flu A&B Control SwabsRemel Inc
2013-08-21Z-1963-2013Class IIEdwards Lifesciences Anastaflo Intravascular ShuntEdwards Lifesciences, LLC
2013-08-21Z-1965-2013Class IIArrow InternationalArrow International Inc
2013-08-21Z-1966-2013Class IIMedtronic Affinity Pediatric Arterial FilterMedtronic Inc. Cardiac Rhythm Disease Management
2013-08-21Z-1968-2013Class IITerumo¿ Advanced Perfusion System 1: 100/120V ACTerumo Cardiovascular Systems Corporation
2013-08-21Z-1969-2013Class IITerumo¿ Advanced Perfusion System 1: 220/240V ACTerumo Cardiovascular Systems Corporation
2013-08-21Z-1970-2013Class IIIADVIA Centaur Calibrator ASiemens Healthcare Diagnostics, Inc
2013-08-21Z-1971-2013Class IIepoc BGEM Test CardEpocal
2013-08-21Z-1972-2013Class IIEdwards EndoReturn Arterial CannulaEdwards Lifesciences, LLC
2013-08-21Z-1973-2013Class IITerumo¿ Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation
2013-08-21Z-1974-2013Class IITerumo¿ Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation
2013-08-21Z-1975-2013Class IISiemens syngoSiemens Medical Solutions USA, Inc
2013-08-21Z-1977-2013Class II100/120V ACTerumo Cardiovascular Systems Corporation
2013-08-21Z-1978-2013Class II220/240V ACTerumo Cardiovascular Systems Corporation
2013-08-14Z-0476-2013Class IIEnterprise 8000 BedArjo, Inc. dba ArjoHuntleigh
2013-08-14Z-0477-2013Class IIEnterprise 9000 BedArjo, Inc. dba ArjoHuntleigh
2013-08-14Z-0833-2013Class IIVENTANAVentana Medical Systems Inc
2013-08-14Z-0834-2013Class IIVENTANAVentana Medical Systems Inc
2013-08-14Z-1835-2013Class IAlaris PC unitCareFusion 303, Inc.
2013-08-14Z-1850-2013Class IList NoHospira Inc.
2013-08-14Z-1851-2013Class IList NoHospira Inc.
2013-08-14Z-1852-2013Class IList NoHospira Inc.
2013-08-14Z-1853-2013Class IList NoHospira Inc.
2013-08-14Z-1854-2013Class IList NoHospira Inc.
2013-08-14Z-1855-2013Class IList NoHospira Inc.
2013-08-14Z-1856-2013Class IList NoHospira Inc.
2013-08-14Z-1857-2013Class IList NoHospira Inc.
2013-08-14Z-1858-2013Class IList NoHospira Inc.
2013-08-14Z-1871-2013Class IIDrill GuideSpineFrontier, Inc.
2013-08-14Z-1872-2013Class IINon-sterile Viscot Surgical Skin Markers Part Number 1437-100…Precision Dynamics Corporation
2013-08-14Z-1873-2013Class IIBeckman Coulter AU5800 Clinical Chemistry AnalyzerBeckman Coulter Inc.
2013-08-14Z-1874-2013Class IMRidium 1145 Dose Reduction SystemIradimed Corporation
2013-08-14Z-1875-2013Class IIMobiletta Mira Mobile X-ray SystemSiemens Medical Solutions USA, Inc
2013-08-14Z-1876-2013Class IIMedtronic Mullins Transseptal Adult 7FMedtronic Inc. Cardiac Rhythm Disease Management
2013-08-14Z-1878-2013Class IISonopet Ultrasonic Aspirator ConsoleStryker Instruments Div. of Stryker Corporation
2013-08-14Z-1879-2013Class IISonopet Ultrasonic Aspirator Console 5450-851-000Stryker Instruments Div. of Stryker Corporation
2013-08-14Z-1880-2013Class IISonopet Ultrasonic Aspirator Console 5450-852-000Stryker Instruments Div. of Stryker Corporation
2013-08-14Z-1881-2013Class IIADVIA Centaur Systems TSH3 Ultra ReadyPackSiemens Healthcare Diagnostics, Inc
2013-08-14Z-1882-2013Class IIDimension TSH Flex Reagent CartridgeSiemens Healthcare Diagnostics, Inc
2013-08-14Z-1883-2013Class IIDimension EXL LOCI Module TSHL Flex Reagent CartridgeSiemens Healthcare Diagnostics, Inc
2013-08-14Z-1884-2013Class IIDimension Vista System TSH Flex Reagent CartridgeSiemens Healthcare Diagnostics, Inc
2013-08-14Z-1885-2013Class IIIMMULITE Systems Third Generation TSHSiemens Healthcare Diagnostics, Inc
2013-08-14Z-1886-2013Class IIIMMULITE Systems Rapid TSHSiemens Healthcare Diagnostics, Inc
2013-08-14Z-1887-2013Class ICordis OPTEASE Retrieval Inferior Vena CavaCordis Corporation
2013-08-14Z-1888-2013Class IICVS Pharmacy Wound Closure Adhesive Surgical Tape Strips 30 strips…ASO, LLC
2013-08-14Z-1889-2013Class IIDiscount Drug Mart Wound Closure Adhesive Surgical Tape Strips 30…ASO, LLC
2013-08-14Z-1890-2013Class IIDuane ReadeASO, LLC
2013-08-14Z-1891-2013Class IIHEB Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 inASO, LLC
2013-08-14Z-1892-2013Class IILeader Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 inASO, LLC
2013-08-14Z-1893-2013Class IIMeijer Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 inASO, LLC
2013-08-14Z-1894-2013Class IIPremier Value Wound Closure Adhesive Surgical Tape Strips 30 strips…ASO, LLC
2013-08-14Z-1895-2013Class IITopCare Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 inASO, LLC
2013-08-14Z-1896-2013Class IIWalgreensASO, LLC
2013-08-14Z-1907-2013Class IIbioMerieux Vitek 2 Systems Software version 6Biomerieux Inc
2013-08-14Z-1908-2013Class IIbioMerieux Vitek 2 Systems Software version 6Biomerieux Inc
2013-08-14Z-1909-2013Class IIbioMerieux Vitek 2 Systems Software version 6Biomerieux Inc
2013-08-14Z-1910-2013Class IIbioMerieux Vitek 2 Systems Software version 6Biomerieux Inc
2013-08-14Z-1911-2013Class IIbioMerieux Vitek 2 Systems Software version 6Biomerieux Inc
2013-08-14Z-1912-2013Class IIbioMerieux Vitek 2 Systems Software version 6Biomerieux Inc
2013-08-14Z-1913-2013Class IIbioMerieux Vitek 2 Systems Software version 6Biomerieux Inc
2013-08-14Z-1914-2013Class IIbioMerieux Vitek 2 Systems Software version 6Biomerieux Inc
2013-08-14Z-1915-2013Class IIbioMerieux Vitek 2 Systems Software version 6Biomerieux Inc
2013-08-14Z-1916-2013Class IIbioMerieux Vitek 2 Systems Software version 6Biomerieux Inc
2013-08-14Z-1917-2013Class IIbioMerieux Vitek 2 Systems Software version 6Biomerieux Inc
2013-08-14Z-1918-2013Class IIbioMerieux Vitek 2 Systems Software version 6Biomerieux Inc
2013-08-14Z-1919-2013Class IIbioMerieux Vitek 2 Systems Software version 6Biomerieux Inc
2013-08-14Z-1920-2013Class IIbioMerieux Vitek 2 Systems Software version 6Biomerieux Inc
2013-08-14Z-1921-2013Class IIbioMerieux Vitek 2 Systems Software version 6Biomerieux Inc
2013-08-14Z-1922-2013Class IINestle NutritionNestle HealthCare Nutrition
2013-08-14Z-1923-2013Class IIBD Vacutainer Multiple Sample and Direct Draw Luer Adapter BD…Becton Dickinson & Company
2013-08-14Z-1924-2013Class IIDimension Tacrolimus Flex reagent cartridgeSiemens Healthcare Diagnostics, Inc.
2013-08-14Z-1925-2013Class IIDimensionSiemens Healthcare Diagnostics, Inc.
2013-08-14Z-1926-2013Class IIRev E PedFuse Return Screw InserterSpineFrontier, Inc.
2013-08-14Z-1927-2013Class IIInvue Split DriverSpineFrontier, Inc.
2013-08-14Z-1928-2013Class IIR3Smith & Nephew Inc
2013-08-14Z-1929-2013Class IIR3Smith & Nephew Inc
2013-08-14Z-1930-2013Class IITCM4 series Base UnitsRadiometer America Inc
2013-08-14Z-1931-2013Class IIMHI-TM2000 Linear Accelerator SystemMITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK

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