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Medical device recalls reported in 2014

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ReportedRecallClassProductFirm
2014-05-28Z-1640-2014Class IIGE HealthcareGE Healthcare, LLC
2014-05-28Z-1642-2014Class IIMXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM…Fujifilm Medical System USA, Inc.
2014-05-28Z-1643-2014Class IIPolyflux RevaclearGambro Renal Products, Incorporated
2014-05-28Z-1644-2014Class IIPolyflux Revaclear MaxGambro Renal Products, Incorporated
2014-05-28Z-1645-2014Class II550 TxT Treatment Table of the Digital Linear AcceleratorSiemens Medical Solutions USA, Inc
2014-05-28Z-1646-2014Class IIPhilips XREPhilips Healthcare Informatics, Inc.
2014-05-28Z-1647-2014Class IIDimension Vista¿ CSA and CSAE The Cyclosporine method is an in vitro…Siemens Healthcare Diagnostics, Inc.
2014-05-28Z-1648-2014Class IIVITROS TT4 Calibrator For the quantitative measurement of total…Ortho-Clinical Diagnostics
2014-05-28Z-1649-2014Class IIEsmark Elastic BandageMedline Industries Inc
2014-05-28Z-1650-2014Class IISW-2008 Snuggle Warm Sterile Cardiac Connective Warming BlanketSmiths Medical ASD, Inc.
2014-05-28Z-1651-2014Class IIGluma Desensitizer Power Gel Product Usage: Usage: This is a class 2…Heraeus Kulzer, LLC.
2014-05-21Z-1566-2014Class IABACUS TPN Calculation SoftwareBaxter Corporation Englewood
2014-05-21Z-1567-2014Class IAlaris Pump model 8100 with software version 9CareFusion 303, Inc.
2014-05-21Z-1571-2014Class IIMedStream Programmable Infusion PumpCodman & Shurtleff, Inc.
2014-05-21Z-1572-2014Class IIMedStream Programmable Infusion PumpCodman & Shurtleff, Inc.
2014-05-21Z-1573-2014Class IISCC SA HIS version 4SCC Soft Computer
2014-05-21Z-1574-2014Class IIANSPACH Cutting burThe Anspach Effort, Inc.
2014-05-21Z-1575-2014Class IINavioPFSTM SystemBlue Belt Technologies MN
2014-05-21Z-1576-2014Class IIEnaly 1000 BT-12 Ozone GeneratorWilliam C. Domb, D.M.D., A Professional Corporation
2014-05-21Z-1577-2014Class IIRecalled product is a component of the Newport Medical Instruments…Nellcor Puritan Bennett Inc. (dba Covidien LP)
2014-05-21Z-1603-2014Class IIDROP LOK" Knee Brace***LATEX FREE" Product Usage: Used in the…Zimmer, Inc.
2014-05-21Z-1604-2014Class IICartilage Knee Brace***LATEX FREE" Product Usage: Used in the…Zimmer, Inc.
2014-05-21Z-1605-2014Class IIHinged Knee Support***LATEX FREE" Product Usage: Provide added…Zimmer, Inc.
2014-05-21Z-1606-2014Class IITennis Elbow SupportZimmer, Inc.
2014-05-21Z-1607-2014Class IIHeartWare HVAD Pump Implant KitHeartWare Inc
2014-05-21Z-1608-2014Class IIUltrasound needlesRM Temena GmbH
2014-05-21Z-1609-2014Class IIUltrasound USB needlesRM Temena GmbH
2014-05-21Z-1610-2014Class IIPS-C Femoral Nonporous Rt Sz 6Ortho Development Corporation
2014-05-21Z-1611-2014Class IIDPM 6 Monitor in use with a Multi Parameter ModuleMindray DS USA, Inc. dba Mindray North America
2014-05-21Z-1612-2014Class IIMucus Specimen Trap 40 ccMedline Industries Inc
2014-05-21Z-1613-2014Class IISyngo Dynamics v9Siemens Medical Solutions USA, Inc
2014-05-21Z-1614-2014Class IICoaxial Micro-Introducer KitGreatbatch Medical
2014-05-21Z-1615-2014Class IIExploR 7x26mm Modular Radial StemBiomet, Inc.
2014-05-21Z-1616-2014Class IIACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact…Roche Diagnostics Operations, Inc.
2014-05-21Z-1617-2014Class IIMcKesson Radiology-PACSMckesson Medical Immaging
2014-05-21Z-1618-2014Class IIFresenius 2008T Hemodialysis Machine with Revision K Actuator Test…Fresenius Medical Care Holdings, Inc.
2014-05-21Z-1619-2014Class IIRevision K Actuator Test Boards sold as replacement parts for use…Fresenius Medical Care Holdings, Inc.
2014-05-21Z-1620-2014Class IIRAPIDFILL Syringe StripBaxter Corporation Englewood
2014-05-21Z-1621-2014Class IIInterValve V8 Balloon Aortic Valvuloplasty CatheterInterValve Inc
2014-05-14Z-1528-2014Class IIINOmax DSIRINO Therapeutics (dba Ikaria)
2014-05-14Z-1537-2014Class IIVariant II beta-thalassemia Short Program Model Numbers 270-2103Bio-Rad Laboratories, Inc.
2014-05-14Z-1538-2014Class IIJoseph Lamelas Atrial Lift SystemBiorep Technologies
2014-05-14Z-1540-2014Class IIAlere Triage BNP Test for the Beckman Coulter Access Family of…Alere San Diego, Inc.
2014-05-14Z-1541-2014Class IIRetractaBedMed-Mizer, Inc.
2014-05-14Z-1542-2014Class IIRetractaBedMed-Mizer, Inc.
2014-05-14Z-1543-2014Class IIRetractaBedMed-Mizer, Inc.
2014-05-14Z-1544-2014Class II12-Instrument Sterilization TrayStryker Endoscopy
2014-05-14Z-1545-2014Class IIICLINITEK Status+ AnalyzerSiemens Healthcare Diagnostics Inc
2014-05-14Z-1546-2014Class IAlere INRatio2 PT/INR Professional Test StripsAlere San Diego, Inc.
2014-05-14Z-1547-2014Class IIGiraffe¿ Infant Warmers integrated with Nellcor SpO2GE Healthcare
2014-05-14Z-1548-2014Class IIPanda¿ iRes Infant Warmers integrated with Nellcor SpO2GE Healthcare
2014-05-14Z-1549-2014Class IIPanda¿ Freestanding Infant WarmersGE Healthcare
2014-05-14Z-1550-2014Class IIPanda¿ Wall-Mount Infant WarmersGE Healthcare
2014-05-14Z-1551-2014Class IINellcor SpO2 Upgrade kitGE Healthcare
2014-05-14Z-1552-2014Class IITX1 Tissue Removal SystemTenex Health Inc
2014-05-14Z-1553-2014Class IIADVIA Centaur XP Immunoassay systemSiemens Healthcare Diagnostics
2014-05-14Z-1554-2014Class IIBausch & LombBausch & Lomb Inc- Greenville Solutions Plant
2014-05-14Z-1555-2014Class IINonabsorbable Surgical SutureTeleflex Medical
2014-05-14Z-1556-2014Class IITeleflex MedicalTeleflex Medical
2014-05-14Z-1557-2014Class IITeleflex MedicalTeleflex Medical
2014-05-14Z-1558-2014Class IIFixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated SutureTeleflex Medical
2014-05-14Z-1559-2014Class IIBard Fixt Suture Braided PolyesterTeleflex Medical
2014-05-14Z-1560-2014Class IIDeknatel Teleflex Medical Stainless Steel 2Teleflex Medical
2014-05-14Z-1561-2014Class IIDeknatel Teleflex Medical Silk Black Braided Silk Suture…Teleflex Medical
2014-05-14Z-1562-2014Class IIAlloFuse DBM Putty 5ccAlloSource, Inc.
2014-05-14Z-1563-2014Class IIMar Cor PurificationMar Cor Purification
2014-05-14Z-1564-2014Class IISiemens ADVIA Centaur Folate Cat NoSiemens Healthcare Diagnostics, Inc
2014-05-14Z-1565-2014Class IISpineFrontier S-Lift Lock Shaft InserterSpineFrontier, Inc.
2014-05-14Z-1568-2014Class IIRefill Kit 8551/856XMedtronic Neuromodulation
2014-05-14Z-1569-2014Class IIShimadzu Digital Radiography X-Ray SystemShimadzu Medical Systems
2014-05-14Z-1570-2014Class IIMedtronic SynchroMed¿ II Implantable Drug Infusion PumpMedtronic Neuromodulation
2014-05-07Z-1482-2014Class IAbbott Acclaim Infusion Pump Designed to deliver parenteral infusions…Hospira Inc.
2014-05-07Z-1483-2014Class IHospira Acclaim Encore Infusion Pump Designed to deliver parenteral…Hospira Inc.
2014-05-07Z-1510-2014Class IINuclear gamma camerasPhilips Medical Systems (Cleveland) Inc
2014-05-07Z-1511-2014Class IIGE HealthcareGE Healthcare, LLC
2014-05-07Z-1512-2014Class IGemStar Docking StationHospira Inc.
2014-05-07Z-1513-2014Class IIExacTrac 6Brainlab AG
2014-05-07Z-1514-2014Class IIHexaPOD evo RT CouchtopElekta, Inc.
2014-05-07Z-1515-2014Class IIThe Osteo-Clage System consists of stainless steel cable/sleeves and…Acumed LLC
2014-05-07Z-1516-2014Class IIThe Acumed Tension Band Pin is a fixation pin which isAcumed LLC
2014-05-07Z-1517-2014Class IIIMMULITE /IMMULITE 1000 Systems TIE Total IgESiemens Healthcare Diagnostics
2014-05-07Z-1518-2014Class IIIMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgESiemens Healthcare Diagnostics
2014-05-07Z-1519-2014Class IIVITROS Chemistry Products Specialty DiluentOrtho-Clinical Diagnostics
2014-05-07Z-1520-2014Class IIVITROS Chemistry Products FS Diluent Pack 3Ortho-Clinical Diagnostics
2014-05-07Z-1521-2014Class IIFisherbrand Sterile SwabsFisher Scientific Co
2014-05-07Z-1522-2014Class IIIntegra CUSA Excel Disposable WrenchIntegra LifeSciences Corp.
2014-05-07Z-1524-2014Class IIMedtronic neurostimulatorsMedtronic Neuromodulation
2014-05-07Z-1525-2014Class IIMedtronic Activa RCMedtronic Neuromodulation
2014-05-07Z-1526-2014Class IIMedtronicMedtronic Neuromodulation
2014-05-07Z-1527-2014Class IIIPolypVac 3Laurimed LLC
2014-05-07Z-1529-2014Class IIAlfa Wassermann Diagnostic TechnologiesAlfa Wassermann, Inc.
2014-05-07Z-1530-2014Class IIAlfa Wassermann Diagnostic TechnologiesAlfa Wassermann, Inc.
2014-05-07Z-1531-2014Class IIIMMULITE/IMMULITE 1000 Systems AndrostenedioneSiemens Healthcare Diagnostics
2014-05-07Z-1532-2014Class IIIMMULITE 2000/2000 XPi Systems AndrostenedioneSiemens Healthcare Diagnostics
2014-05-07Z-1533-2014Class IIGE Healthcare Discovery MR450GE Healthcare, LLC
2014-05-07Z-1534-2014Class IICAPIOTeleflex Medical
2014-05-07Z-1535-2014Class IIDekna-lokTeleflex Medical
2014-05-07Z-1536-2014Class IIAnti EpCam PEBD Biosciences, Systems & Reagents
2014-04-30Z-1471-2014Class IHeartware HVAD Pump Implant KitHeartWare Inc
2014-04-30Z-1472-2014Class IIFassier-Duval IM Telescopic SystemPega Medical Inc.
2014-04-30Z-1473-2014Class IIOxoid Legionella Latex TestRemel Inc
2014-04-30Z-1474-2014Class IIOxoid Legionella Pneumo Groups 2-14Remel Inc
2014-04-30Z-1475-2014Class IIZYM B ReagentBioMerieux SA
2014-04-30Z-1476-2014Class IIFB ReagentBioMerieux SA
2014-04-30Z-1477-2014Class IIAPI NIHBioMerieux SA
2014-04-30Z-1478-2014Class IIAPI ListeriaBioMerieux SA
2014-04-30Z-1479-2014Class IILifeShield LATEX-FREE HemoSet 100 mL Burette IHospira Inc.
2014-04-30Z-1480-2014Class IIGE HealthcareGE Healthcare, LLC
2014-04-30Z-1481-2014Class IIRaySearch Ray Station Radiation Therapy Treatment Planning SystemRAYSEARCH LABORATORIES AB
2014-04-30Z-1484-2014Class ISIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library…Baxter Healthcare Corp.
2014-04-30Z-1485-2014Class IIMerit Laureate Hydrophilic Guide WireMerit Medical Systems, Inc.
2014-04-30Z-1486-2014Class IIMerit Laureate 0Merit Medical Systems, Inc.
2014-04-30Z-1487-2014Class IIiLab Ultrasound Imaging SystemBoston Scientific Corporation
2014-04-30Z-1488-2014Class IIGE Vivid E9 Ultrasound SystemGE Healthcare, LLC
2014-04-30Z-1489-2014Class IIev3 EverCross 0Ev3, Inc.
2014-04-30Z-1490-2014Class IIVITROS Chemistry Products CDM PROMOrtho-Clinical Diagnostics
2014-04-30Z-1491-2014Class IIIThe CEP 8 SpectrumGreenAbbott Molecular
2014-04-30Z-1492-2014Class IIProteus 235 Proton Therapy System Legacy Software version 7Ion Beam Applications S.A.
2014-04-30Z-1493-2014Class IIStryker PenAdapt"Stryker Instruments Div. of Stryker Corporation
2014-04-30Z-1494-2014Class IIArrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue…Arrow International Inc
2014-04-30Z-1495-2014Class IIPhilips MDC PACS R2Philips Medical Systems, Inc.
2014-04-30Z-1496-2014Class IITRABECULAR METAL MODULAR ACETABULAR SYSTEMZimmer, Inc.
2014-04-30Z-1497-2014Class IIMonofilament and Multifilament Non-absorbable Steel SutureTeleflex Medical
2014-04-30Z-1498-2014Class IIAmo-O Herbal StimulatorAltasource LLC dba Meta Labs LLC
2014-04-30Z-1499-2014Class IIMega-Gen His Personal LubricantAltasource LLC dba Meta Labs LLC
2014-04-30Z-1500-2014Class IINice-En-Smooth Berry BurstAltasource LLC dba Meta Labs LLC
2014-04-30Z-1501-2014Class IIHot IceAltasource LLC dba Meta Labs LLC
2014-04-30Z-1502-2014Class IIOn-Board ImagerVarian Medical Systems, Inc.
2014-04-30Z-1503-2014Class IIDigital DiagnostPhilips Medical Systems, Inc.
2014-04-30Z-1504-2014Class IISiemens ACUSON X700 Ultrasound Systems with software version 1Siemens Medical Solutions USA, Inc.
2014-04-30Z-1505-2014Class IIMULTIX FUSIONSiemens Medical Solutions USA, Inc
2014-04-30Z-1506-2014Class IISengstaken Tube and Sengstaken-Blakemore TubeTeleflex Medical
2014-04-30Z-1507-2014Class IIArrowgard Blue Plus Antimicrobial Multi-lumen Central Venous CatheterArrow International Inc
2014-04-30Z-1508-2014Class IIToxCup Drug Screen CupBranan Medical Corporation
2014-04-30Z-1509-2014Class IIMonodek Violet Synthetic Absorbable Surgical SuturesTeleflex Medical
2014-04-23Z-1442-2014Class ISpaceLabs Arkon Anesthesia Delivery System with Version 2Del Mar Reynolds Medical, Ltd.
2014-04-23Z-1453-2014Class IPipeline Embolization DeviceMicro Therapeutics Inc, Dba Ev3 Neurovascular
2014-04-23Z-1454-2014Class IAlligator Retrieval DeviceMicro Therapeutics Inc, Dba Ev3 Neurovascular
2014-04-23Z-1455-2014Class IIGambro Cartridge Blood SetGambro Renal Products, Incorporated
2014-04-23Z-1456-2014Class IISynthes CMF Battery Powered DriverSynthes, Inc.
2014-04-23Z-1457-2014Class IIThe Synthes Hohmann RetractorSynthes, Inc.
2014-04-23Z-1458-2014Class IIBIOMET 3i Endosseous Dental ImplantBiomet 3i, LLC
2014-04-23Z-1459-2014Class IISmartSite Extension SetCareFusion 303, Inc.
2014-04-23Z-1460-2014Class IIAXIOM Vertix MD Trauma systems radiographic X-raySiemens Medical Solutions USA, Inc
2014-04-23Z-1461-2014Class IIBrilliance CT 16Philips Medical Systems (Cleveland) Inc
2014-04-23Z-1462-2014Class IIThe OEC 9900 Elite mobile fluoroscopy systemGE OEC Medical Systems, Inc
2014-04-23Z-1463-2014Class IIFRAXEL DUAL 1550/1927 Laser SystemSolta Medical, Inc.
2014-04-23Z-1464-2014Class IIIngenuity Core 128Philips Medical Systems (Cleveland) Inc
2014-04-23Z-1465-2014Class IITerumo Cardiovascular Procedure Kit- X-Coated Pump and Table Pack…Terumo Cardiovascular Systems Corp
2014-04-23Z-1466-2014Class IIEdwards Lifesciences Fem-Flex II Arterial and femoral CannulaeEdwards Lifesciences, LLC
2014-04-23Z-1467-2014Class IIEdwards Lifesciences Fem-Flex II Arterial and femoral Cannulae with…Edwards Lifesciences, LLC
2014-04-23Z-1468-2014Class IICODMAN CERTAS Programmable ValvesCodman & Shurtleff, Inc.
2014-04-23Z-1469-2014Class IIBrainlabBrainlab AG
2014-04-23Z-1470-2014Class IIVITROS Chemistry Products CRBM SlidesOrtho-Clinical Diagnostics
2014-04-16Z-1332-2014Class II5X300 MM Curved CannulaIntuitive Surgical, Inc.
2014-04-16Z-1333-2014Class II5X300 MM Curved CannulaIntuitive Surgical, Inc.
2014-04-16Z-1334-2014Class II5X250 MM Curved CannulaIntuitive Surgical, Inc.
2014-04-16Z-1335-2014Class II5X250 MM Curved CannulaIntuitive Surgical, Inc.
2014-04-16Z-1336-2014Class IIPlaytex Nurser Deluxe Double Electric Breast PumpEnergizer Personal Care
2014-04-16Z-1337-2014Class IISyphilis Test StripLumiQuick Diagnostics Inc.
2014-04-16Z-1338-2014Class IISyphilis Test Card Whole BloodLumiQuick Diagnostics Inc.
2014-04-16Z-1339-2014Class IIRickettsia IgG/IgM Test Card LumiQuickLumiQuick Diagnostics Inc.
2014-04-16Z-1340-2014Class IIDengue IgG/IgMLumiQuick Diagnostics Inc.
2014-04-16Z-1341-2014Class IIHLumiQuick Diagnostics Inc.
2014-04-16Z-1342-2014Class IIHLumiQuick Diagnostics Inc.
2014-04-16Z-1343-2014Class IISalmonella typhi Antigen Test CardLumiQuick Diagnostics Inc.
2014-04-16Z-1344-2014Class IIRotavirus Test Card LumiQuickLumiQuick Diagnostics Inc.
2014-04-16Z-1345-2014Class IIAdenovirus Antigen Test CardLumiQuick Diagnostics Inc.
2014-04-16Z-1346-2014Class IIAdeno/Rota Combo Test CardLumiQuick Diagnostics Inc.
2014-04-16Z-1347-2014Class IILegionella Test CardLumiQuick Diagnostics Inc.
2014-04-16Z-1348-2014Class IIHLumiQuick Diagnostics Inc.
2014-04-16Z-1349-2014Class IIStrep A Test CardLumiQuick Diagnostics Inc.
2014-04-16Z-1350-2014Class IIMalaria pf Antigen Test CardLumiQuick Diagnostics Inc.
2014-04-16Z-1351-2014Class IIMalaria pf Antigen Test CardLumiQuick Diagnostics Inc.
2014-04-16Z-1352-2014Class IIMalaria pan Antigen TestLumiQuick Diagnostics Inc.
2014-04-16Z-1353-2014Class IISalmonella typhi/paratyphi Antigen TestLumiQuick Diagnostics Inc.
2014-04-16Z-1354-2014Class IISalmonella typhi IgG/IgM Duo TestLumiQuick Diagnostics Inc.
2014-04-16Z-1355-2014Class IISyphilis Test CardLumiQuick Diagnostics Inc.
2014-04-16Z-1356-2014Class IITuberculosis Antibody Test Card SerumLumiQuick Diagnostics Inc.
2014-04-16Z-1357-2014Class IIMalaria pf/pan Antigen Test CardLumiQuick Diagnostics Inc.
2014-04-16Z-1358-2014Class IIDengue NS1 Antigen Test CardLumiQuick Diagnostics Inc.
2014-04-16Z-1359-2014Class IIDengue NS1 Ag/IgG/M Ab Duo Test CardLumiQuick Diagnostics Inc.
2014-04-16Z-1360-2014Class IIFecal Occult Blood Test CardLumiQuick Diagnostics Inc.
2014-04-16Z-1361-2014Class IIPSA Test CardLumiQuick Diagnostics Inc.
2014-04-16Z-1362-2014Class IIPSA Test CardLumiQuick Diagnostics Inc.
2014-04-16Z-1363-2014Class IIFecal Occult Blood Test StripLumiQuick Diagnostics Inc.
2014-04-16Z-1364-2014Class IIAlcohol TestLumiQuick Diagnostics Inc.
2014-04-16Z-1365-2014Class IITramadol Test CardLumiQuick Diagnostics Inc.
2014-04-16Z-1366-2014Class IITramadol StripLumiQuick Diagnostics Inc.
2014-04-16Z-1367-2014Class IIDrugs of Abuse Panel Test DeviceLumiQuick Diagnostics Inc.
2014-04-16Z-1368-2014Class IIAmphetamine StripLumiQuick Diagnostics Inc.
2014-04-16Z-1369-2014Class IIAmphetamine Test CardLumiQuick Diagnostics Inc.
2014-04-16Z-1370-2014Class IIBarbiturate StripLumiQuick Diagnostics Inc.
2014-04-16Z-1371-2014Class IIBarbiturate Test CardLumiQuick Diagnostics Inc.
2014-04-16Z-1372-2014Class IIBenzodiazepine StripLumiQuick Diagnostics Inc.
2014-04-16Z-1373-2014Class IIBenzodiazepine Test CardLumiQuick Diagnostics Inc.
2014-04-16Z-1374-2014Class IICocaine StripLumiQuick Diagnostics Inc.
2014-04-16Z-1375-2014Class IICocaine Test CardLumiQuick Diagnostics Inc.
2014-04-16Z-1376-2014Class IIEDDP StripLumiQuick Diagnostics Inc.
2014-04-16Z-1377-2014Class IIEDDP Test CardLumiQuick Diagnostics Inc.

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