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Medical device recalls reported in 2015

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ReportedRecallClassProductFirm
2015-06-17Z-1733-2015Class IIAccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek…Roche Diabetes Care, Inc.
2015-06-17Z-1734-2015Class IIAccuChek Spirit insulin infusion pumpRoche Diabetes Care, Inc.
2015-06-17Z-1735-2015Class IIR3Smith & Nephew, Inc.
2015-06-17Z-1736-2015Class IIR3Smith & Nephew, Inc.
2015-06-17Z-1737-2015Class IIR3Smith & Nephew, Inc.
2015-06-17Z-1738-2015Class IIR3Smith & Nephew, Inc.
2015-06-17Z-1739-2015Class IIR3Smith & Nephew, Inc.
2015-06-17Z-1740-2015Class IIIRELIEVA FLEX Sinus Guide Catheter F-70Acclarent, Inc.
2015-06-17Z-1741-2015Class IIUnilateral external fixation ankle clamp Product Usage: Unilateral…Biomet, Inc.
2015-06-17Z-1742-2015Class IIVITROS 4600 Chemistry SystemOrtho-Clinical Diagnostics
2015-06-17Z-1743-2015Class IIVITROS 5600 Chemistry SystemOrtho-Clinical Diagnostics
2015-06-17Z-1744-2015Class IIThe Optigun Ratchet is a hand-held cement gun for use with OptivacBIOMET FRANCE S.A.R.L.
2015-06-17Z-1745-2015Class IIAGFA DX-D 100 is a mobile digital radiography x-ray systemAGFA Healthcare Corp.
2015-06-17Z-1746-2015Class IIBBL Port A Cul tubesBecton Dickinson & Co.
2015-06-17Z-1747-2015Class IIBBL Port A Cul tubes with Swabs Sterile PackBecton Dickinson & Co.
2015-06-17Z-1748-2015Class IIRemel Blood AgarRemel Inc
2015-06-17Z-1749-2015Class IIORTHOFIX Firebird Spinal Fixation System 6Orthofix, Inc
2015-06-17Z-1750-2015Class IIAstral 100ResMed Ltd.
2015-06-17Z-1751-2015Class IIHeartWare Ventricular Assist SystemHeartWare Inc
2015-06-17Z-1752-2015Class IIGyrus ACMI Diego Elite TubesetGyrus Acmi, Incorporated
2015-06-17Z-1753-2015Class IIGyrus ACMI Diego Elite TubesetGyrus Acmi, Incorporated
2015-06-17Z-1754-2015Class IIIMallory/Head Primary Hip SystemBiomet, Inc.
2015-06-17Z-1755-2015Class IIIComprehensive Shoulder SystemBiomet, Inc.
2015-06-17Z-1756-2015Class IIIMCK Maximum Congruent Knee SystemBiomet, Inc.
2015-06-17Z-1757-2015Class IIIBiomet Cobalt-Chrome Femoral ComponentsBiomet, Inc.
2015-06-17Z-1758-2015Class IIEdwards Lifesciences IntraClude Intra-Aortic Occlusion DeviceEdwards Lifesciences, LLC
2015-06-17Z-1759-2015Class IIMX 16 SlicePhilips Medical Systems (Cleveland) Inc
2015-06-17Z-1760-2015Class IIMX 16 Slice Phase IIPhilips Medical Systems (Cleveland) Inc
2015-06-17Z-1761-2015Class IIBrilliance CT 64 channel with EssencePhilips Medical Systems (Cleveland) Inc
2015-06-17Z-1762-2015Class IIBrilliance CT 40Philips Medical Systems (Cleveland) Inc
2015-06-17Z-1763-2015Class IIBrilliance CT 40Philips Medical Systems (Cleveland) Inc
2015-06-17Z-1764-2015Class IIBrilliance CT Big Bore RadiologyPhilips Medical Systems (Cleveland) Inc
2015-06-17Z-1765-2015Class IIBrilliance CT 16 Slice AirPhilips Medical Systems (Cleveland) Inc
2015-06-17Z-1766-2015Class IIBrilliance CT 6 Slice AirPhilips Medical Systems (Cleveland) Inc
2015-06-17Z-1767-2015Class IIExtended Brilliance WorkstationPhilips Medical Systems (Cleveland) Inc
2015-06-17Z-1768-2015Class IIBrilliance iCTPhilips Medical Systems (Cleveland) Inc
2015-06-17Z-1769-2015Class IIiCT SPPhilips Medical Systems (Cleveland) Inc
2015-06-17Z-1770-2015Class IIIngenuity FlexPhilips Medical Systems (Cleveland) Inc
2015-06-17Z-1771-2015Class IIIngenuity CorePhilips Medical Systems (Cleveland) Inc
2015-06-17Z-1772-2015Class IIIngenuity Core 128Philips Medical Systems (Cleveland) Inc
2015-06-17Z-1773-2015Class IIIngenuity CTPhilips Medical Systems (Cleveland) Inc
2015-06-17Z-1774-2015Class IIFORTEPhilips Medical Systems (Cleveland) Inc
2015-06-17Z-1775-2015Class IIAXISPhilips Medical Systems (Cleveland) Inc
2015-06-17Z-1776-2015Class IIGemini 16 PET/CT SystemPhilips Medical Systems (Cleveland) Inc
2015-06-17Z-1777-2015Class IIForte-JetStream AZPhilips Medical Systems (Cleveland) Inc
2015-06-17Z-1778-2015Class IIPrecedence 16Philips Medical Systems (Cleveland) Inc
2015-06-17Z-1779-2015Class IIPrecedence 6Philips Medical Systems (Cleveland) Inc
2015-06-17Z-1780-2015Class IIIngenuity PET/MRPhilips Medical Systems (Cleveland) Inc
2015-06-17Z-1781-2015Class IIGemini GXL 16 SlicePhilips Medical Systems (Cleveland) Inc
2015-06-17Z-1782-2015Class IIGemini LXL 16 SlicePhilips Medical Systems (Cleveland) Inc
2015-06-17Z-1783-2015Class IITruFlight Select PET/CT 16-slicePhilips Medical Systems (Cleveland) Inc
2015-06-17Z-1784-2015Class IICardioMD IIIPhilips Medical Systems (Cleveland) Inc
2015-06-17Z-1785-2015Class IIIngenuity TFPhilips Medical Systems (Cleveland) Inc
2015-06-17Z-1786-2015Class IIGEMINI TF PET/CT 16 SlicePhilips Medical Systems (Cleveland) Inc
2015-06-17Z-1787-2015Class IIGEMINI TF PET/CT 64 SlicePhilips Medical Systems (Cleveland) Inc
2015-06-17Z-1788-2015Class IIGEMINI TF ReadyPhilips Medical Systems (Cleveland) Inc
2015-06-17Z-1789-2015Class IIGEMINI TF Big BorePhilips Medical Systems (Cleveland) Inc
2015-06-17Z-1790-2015Class IIBrightView XPhilips Medical Systems (Cleveland) Inc
2015-06-17Z-1791-2015Class IIBrightView SPECTPhilips Medical Systems (Cleveland) Inc
2015-06-17Z-1792-2015Class IIBrightView XCTPhilips Medical Systems (Cleveland) Inc
2015-06-17Z-1793-2015Class IIDiamond Select Brilliance CT 16Philips Medical Systems (Cleveland) Inc
2015-06-10Z-1637-2015Class ISynovis VASCU-GUARD Peripheral Vascular Patch in the following sizes…Synovis Surgical Innovations, Inc.
2015-06-10Z-1692-2015Class IISmiths MedicalSmiths Medical ASD, Inc.
2015-06-10Z-1694-2015Class IICortical Screw for M/DN Intramedullary FixationZimmer, Inc.
2015-06-10Z-1695-2015Class IIBrilliance iCT Computed Tomography X-ray systemPhilips Medical Systems (Cleveland) Inc
2015-06-10Z-1696-2015Class IIPRI Femoral Impactor Block for knee prosthesis surgeryZimmer, Inc.
2015-06-10Z-1697-2015Class IIActCel advanced bleeding control Topical Hemostatic Dressing 2in X 2inCoreva Health Science LLC
2015-06-10Z-1700-2015Class IISwan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number…Edwards Lifesciences, LLC
2015-06-10Z-1701-2015Class IITibial Alignment GuideZimmer CAS
2015-06-10Z-1702-2015Class IIThe Alcon Custom PakAlcon Research, Ltd.
2015-06-10Z-1703-2015Class IIDade Actin Activated Cephaloplastin ReagentSiemens Healthcare Diagnostics, Inc.
2015-06-10Z-1704-2015Class IIsyngo Workflow SLRSiemens Medical Solutions USA, Inc
2015-06-10Z-1705-2015Class IISyngoSiemens Medical Solutions USA, Inc
2015-06-10Z-1707-2015Class IIIVITROS Immunodiagnostic Products Signal ReagentORTHO-CLINICAL DIAGNOSTICS
2015-06-10Z-1708-2015Class IIDimension Vista Systems LOCI Thyroid Stimulating HormoneSiemens Healthcare Diagnostics, Inc.
2015-06-10Z-1709-2015Class II0MRP, LLC dba AMUSA
2015-06-10Z-1710-2015Class IIEC-5000 Excimer Laser Corneal Surgery SystemNidek Inc
2015-06-10Z-1711-2015Class II3Synthes, Inc.
2015-06-10Z-1712-2015Class IIOncentra Brachy radiation therapy planning software designed to…Elekta, Inc.
2015-06-10Z-1713-2015Class IIFactor deficient plasma for the Siemens BCS¿ / BCS¿ XP SystemSiemens Healthcare Diagnostics, Inc.
2015-06-03Z-1609-2015Class ICareFusion AVEA ventilatorCarefusion 211 Inc dba Carefusion
2015-06-03Z-1644-2015Class IISOMATOM Emotion 6Siemens Medical Solutions USA, Inc
2015-06-03Z-1645-2015Class IISOMATOM Emotion 16Siemens Medical Solutions USA, Inc
2015-06-03Z-1646-2015Class IISOMATOM PerspectiveSiemens Medical Solutions USA, Inc
2015-06-03Z-1647-2015Class IIMX8000 DualvPhilips Medical Systems (Cleveland) Inc
2015-06-03Z-1648-2015Class IIBrilliance CT Big Bore OncologyPhilips Medical Systems (Cleveland) Inc
2015-06-03Z-1649-2015Class IIBrilliance CT 64Philips Medical Systems (Cleveland) Inc
2015-06-03Z-1650-2015Class IIBrilliance CT 40Philips Medical Systems (Cleveland) Inc
2015-06-03Z-1651-2015Class IIBrilliance CT 16 PowerPhilips Medical Systems (Cleveland) Inc
2015-06-03Z-1652-2015Class IIBrilliance CT 16 WaterPhilips Medical Systems (Cleveland) Inc
2015-06-03Z-1653-2015Class IIBrilliance CT 16 AirPhilips Medical Systems (Cleveland) Inc
2015-06-03Z-1654-2015Class IIBrilliance CT 10 AirPhilips Medical Systems (Cleveland) Inc
2015-06-03Z-1655-2015Class IIBrilliance CT 6 AirPhilips Medical Systems (Cleveland) Inc
2015-06-03Z-1656-2015Class IIBrilliance iCTPhilips Medical Systems (Cleveland) Inc
2015-06-03Z-1657-2015Class IIIngenuity CTPhilips Medical Systems (Cleveland) Inc
2015-06-03Z-1658-2015Class IIWater bottlesSiemens Medical Solutions Diagnostics
2015-06-03Z-1659-2015Class IILiquid Waste BottleSiemens Medical Solutions Diagnostics
2015-06-03Z-1660-2015Class IIAccessory KitSiemens Medical Solutions Diagnostics
2015-06-03Z-1661-2015Class IIDirect Water feed KitSiemens Medical Solutions Diagnostics
2015-06-03Z-1662-2015Class IIWater Feed KitSiemens Medical Solutions Diagnostics
2015-06-03Z-1663-2015Class IILiquid Waste Bottle KitSiemens Medical Solutions Diagnostics
2015-06-03Z-1664-2015Class IIElastic Ankle SupportUnited Surgical Associates
2015-06-03Z-1665-2015Class IIElastic Knee SupportUnited Surgical Associates
2015-06-03Z-1666-2015Class IIKeo BraceUnited Surgical Associates
2015-06-03Z-1667-2015Class IISIEMENS Ysio MaxSiemens Medical Solutions USA, Inc
2015-06-03Z-1668-2015Class IISIEMENS Axiom Luminos dRF MaxSiemens Medical Solutions USA, Inc
2015-06-03Z-1669-2015Class IISIEMENS Luminos Agile MaxSiemens Medical Solutions USA, Inc
2015-06-03Z-1670-2015Class IISIEMENS Uroskop Omnia MaxSiemens Medical Solutions USA, Inc
2015-06-03Z-1671-2015Class IIEliteCore Full Core Biopsy DeviceStryker Instruments Div. of Stryker Corporation
2015-06-03Z-1672-2015Class IILCS COMPLETE RPS Femoral ImplantsDePuy Orthopaedics, Inc.
2015-06-03Z-1673-2015Class IILCS COMPLETE RPS insertsDePuy Orthopaedics, Inc.
2015-06-03Z-1674-2015Class IIEXPEDIUM Spine System/Synapse SystemDePuy Spine, Inc.
2015-06-03Z-1675-2015Class IIPanorama Patient Monitoring NetworkMindray DS USA, Inc. dba Mindray North America
2015-06-03Z-1676-2015Class IIID2-40Biocare Medical, LLC
2015-06-03Z-1677-2015Class IIAlere i Influenza A & B Product Usage: The Alere i Influenza A and B…Alere Scarborough, Inc. dba Binax, Inc.
2015-06-03Z-1678-2015Class IIKimVent Turbo-Cleaning Closed Suction System for AdultsHalyard Health, Inc
2015-06-03Z-1679-2015Class IIRaySearch RayStation 2RAYSEARCH LABORATORIES AB
2015-06-03Z-1680-2015Class IID-fendGE Healthcare
2015-06-03Z-1681-2015Class IIMedtronic SynchroMed II Implantable Infusion PumpsMedtronic Neuromodulation
2015-06-03Z-1682-2015Class IIIngenuity TF Positron Emission TomographyPhilips Medical Systems (Cleveland) Inc
2015-06-03Z-1683-2015Class IICatalys Precision Laser System-CatalysOptimedica Corporation
2015-06-03Z-1684-2015Class IICODMAN 3000 Series Refill Set- Huber needlesCodman & Shurtleff, Inc.
2015-06-03Z-1685-2015Class IIIVolk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6Volk Optical Inc
2015-06-03Z-1686-2015Class IIMEDRAD¿ Stellant CT Injector System with Certegra WorkstationMedrad Inc dba Bayer R&I
2015-06-03Z-1687-2015Class II100/120V ACTerumo Cardiovascular Systems Corporation
2015-06-03Z-1688-2015Class IIBase for Terumo Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation
2015-06-03Z-1689-2015Class IIQuadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The…Maquet Cardiovascular Us Sales, Llc
2015-06-03Z-1690-2015Class IIHLS/HIT Set Advanced with Bioline and/or Softline Coating Console…Maquet Cardiovascular Us Sales, Llc
2015-06-03Z-1691-2015Class IISMARTABLATE RF Generator SystemBiosense Webster, Inc.
2015-05-27Z-1554-2015Class IIPhilips Healthcare DigitalDiagnost System X-RayPhilips Medical Systems, Inc.
2015-05-27Z-1555-2015Class IIPhilips Healthcare DuraDiagnost X- RayPhilips Medical Systems, Inc.
2015-05-27Z-1617-2015Class IIMedtronic DBS Extension Kit for Deep Brain StimulationMedtronic Neuromodulation
2015-05-27Z-1618-2015Class IIThe Integra Camino ICP Monitor is a compactIntegra LifeSciences Corp.
2015-05-27Z-1619-2015Class IIThe Integra Licox Pt02 Monitors are compactIntegra LifeSciences Corp.
2015-05-27Z-1620-2015Class IIThe Integra Licox Pt02 Monitors are compactIntegra LifeSciences Corp.
2015-05-27Z-1621-2015Class IIMYLA server HP Proliant: DL380-G8 and ML350-G6 version 3bioMerieux, Inc.
2015-05-27Z-1622-2015Class IIHomocysteine test systemRoche Diagnostics Operations, Inc.
2015-05-27Z-1623-2015Class IICT LightSpeed 16 and Discovery ST Pet/CT DSTGE Healthcare
2015-05-27Z-1624-2015Class IIPHALINXWright Medical Technology, Inc.
2015-05-27Z-1625-2015Class IIPHALINXWright Medical Technology, Inc.
2015-05-27Z-1626-2015Class IIPHALINXWright Medical Technology, Inc.
2015-05-27Z-1627-2015Class IIPHALINXWright Medical Technology, Inc.
2015-05-27Z-1628-2015Class IIABACUS SEBaxter Corporation Englewood
2015-05-27Z-1629-2015Class IIIMMULITE/IMMULITE 1000 Systems TBGSiemens Healthcare Diagnostics, Inc.
2015-05-27Z-1630-2015Class IICarter-Thomason II Port Closure SystemCooperSurgical, Inc.
2015-05-27Z-1631-2015Class IIEPIQ 5 Ultrasound System versions 1Philips Ultrasound, Inc.
2015-05-27Z-1632-2015Class IIEPIQ 7 Ultrasound System versions 1Philips Ultrasound, Inc.
2015-05-27Z-1633-2015Class IIStryker Howmedica Osteonics RESTORATION Acetabular Augment SystemStryker Howmedica Osteonics Corp.
2015-05-27Z-1634-2015Class IIStryker Orthopaedics Scorpio femoral componentStryker Howmedica Osteonics Corp.
2015-05-27Z-1635-2015Class IIStryker Orthopaedics Triathlon femoral componentStryker Howmedica Osteonics Corp.
2015-05-27Z-1636-2015Class IIMelaFind DeviceMELA Sciences, Inc.
2015-05-27Z-1639-2015Class IIMucolytic Agent 1 pint/473 mlRichard-Allan Scientific Company
2015-05-27Z-1640-2015Class IILerner Laboratories MucolexxRichard-Allan Scientific Company
2015-05-27Z-1641-2015Class IIENDOPATH ECHELON" Vascular White Reload for Advanced Placement TipEthicon Endo-Surgery Inc
2015-05-27Z-1642-2015Class IIDeRoyalDeRoyal Industries Inc
2015-05-27Z-1643-2015Class IIPinnacle3 Software Version 10Philips Medical Systems, Inc.
2015-05-20Z-1596-2015Class IIIThermoFlo 1 HMEArc Medical Inc
2015-05-20Z-1597-2015Class IIISpinal Elements 5Spinal Elements, Inc
2015-05-20Z-1598-2015Class IINuclear Gamma CamerasPhilips Medical Systems (Cleveland) Inc
2015-05-20Z-1599-2015Class IIVenaSealCovidien LLC
2015-05-20Z-1600-2015Class IITFN-ADVANCED Proximal Femoral Nailing SystemSynthes, Inc.
2015-05-20Z-1601-2015Class IIVitek 2 AST-YS06 REF 412 610Biomerieux Inc
2015-05-20Z-1602-2015Class IIVitek 2 AST-YS07 REF 414 967Biomerieux Inc
2015-05-20Z-1603-2015Class IIVitek 2 AST-YS01 REF 22 108Biomerieux Inc
2015-05-20Z-1604-2015Class IHeartWare Ventricular Assist SystemHeartWare Inc
2015-05-20Z-1605-2015Class IITapered HD Upgrade SetBioHorizons Implant Systems Inc
2015-05-20Z-1606-2015Class IIGE HealthcareGE Healthcare
2015-05-20Z-1607-2015Class IINuclear gamma camerasPhilips Medical Systems (Cleveland) Inc
2015-05-20Z-1608-2015Class IISpacelabs qube Compact MonitorSpacelabs Healthcare Inc
2015-05-20Z-1610-2015Class IIIZimmer 100 mL Hemovac Device Hemovac Mini EvacuatorZimmer Surgical Inc
2015-05-20Z-1611-2015Class IIFujiMedical Synapse Cardiovascular I ProSolv CardioVascularFujifilm Medical Systems U.S.A., Inc.
2015-05-20Z-1612-2015Class IIFujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse…Fujifilm Medical Systems U.S.A., Inc.
2015-05-20Z-1613-2015Class IIReTurn beltHandicare USA, Inc.
2015-05-20Z-1614-2015Class IIKinemax Stem ExtendersStryker Howmedica Osteonics Corp.
2015-05-20Z-1615-2015Class IIDimension EXL with LMSiemens Healthcare Diagnostics, Inc.
2015-05-20Z-1616-2015Class IICOULTER DxH DiluentBeckman Coulter Inc.
2015-05-13Z-1395-2015Class IIGE Discovery MR950 MRI systemGE Healthcare
2015-05-13Z-1460-2015Class IIEOSEos Imaging Inc
2015-05-13Z-1562-2015Class II3/16 inStryker Instruments Div. of Stryker Corporation
2015-05-13Z-1563-2015Class II3/16 inStryker Instruments Div. of Stryker Corporation
2015-05-13Z-1564-2015Class II1/8 inStryker Instruments Div. of Stryker Corporation
2015-05-13Z-1565-2015Class II1/8 inStryker Instruments Div. of Stryker Corporation
2015-05-13Z-1566-2015Class II1/4 inStryker Instruments Div. of Stryker Corporation
2015-05-13Z-1567-2015Class II1/4 inStryker Instruments Div. of Stryker Corporation
2015-05-13Z-1568-2015Class II3/16 inStryker Instruments Div. of Stryker Corporation
2015-05-13Z-1569-2015Class II1/4 inStryker Instruments Div. of Stryker Corporation
2015-05-13Z-1570-2015Class II3/16 inStryker Instruments Div. of Stryker Corporation
2015-05-13Z-1571-2015Class II1/8 inStryker Instruments Div. of Stryker Corporation
2015-05-13Z-1572-2015Class II1/4 inStryker Instruments Div. of Stryker Corporation
2015-05-13Z-1573-2015Class IIAmbulating Bulb Ambulating Bulb: The Ambulating Bulb comprises four…Stryker Instruments Div. of Stryker Corporation
2015-05-13Z-1574-2015Class IIMHI-TM2000 Linear Accelerator SystemMITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
2015-05-13Z-1575-2015Class IINexGen AugmentZimmer, Inc.
2015-05-13Z-1576-2015Class IICONTIPLEX Continuous Peripheral Nerve Block TrayB. Braun Medical, Inc.
2015-05-13Z-1577-2015Class IIUltraview SL Command ModulesSpacelabs Healthcare Inc
2015-05-13Z-1578-2015Class IIEPIQ 5 Ultrasound System with Pediatric Cardiology optionPhilips Ultrasound, Inc.
2015-05-13Z-1579-2015Class IIEPIQ 7 Ultrasound System with Pediatric Cardiology optionPhilips Ultrasound, Inc.
2015-05-13Z-1580-2015Class IIViewRay SystemViewray Incorporated
2015-05-13Z-1581-2015Class IIACUSON SC2000 volume imaging ultrasound systems at software versions…Siemens Medical Solutions USA, Inc.
2015-05-13Z-1582-2015Class IIExacTrac 6Brainlab AG
2015-05-13Z-1583-2015Class IIAXIOM ARISTOS FXSiemens Medical Solutions USA, Inc

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