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Medical device recalls reported in 2013

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ReportedRecallClassProductFirm
2013-04-10Z-0993-2013Class IAnimasAnimas Corporation
2013-04-10Z-1014-2013Class ISmiths MedicalSmiths Medical ASD, Inc.
2013-04-10Z-1024-2013Class IIZ-800 Volumetric Infusion SystemZyno Medical LLC
2013-04-10Z-1025-2013Class IIIDual Tip MarkerViscot Medical LLC
2013-04-10Z-1026-2013Class IISTERRAD 100NX Sterilization SystemAdvanced Sterilization Products
2013-04-10Z-1027-2013Class IISTERRAD 200 Sterilization SystemAdvanced Sterilization Products
2013-04-10Z-1028-2013Class IIRoche Molecular Systems cobas x 480 System 50 mL reagent reservoirRoche Diagnostics Operations, Inc.
2013-04-10Z-1029-2013Class IIIngenuity TF PET/CTPhilips Medical Systems (Cleveland) Inc
2013-04-10Z-1030-2013Class IIIntegra Ojemann Cortical StimulatorIntegra Burlington MA, Inc.
2013-04-10Z-1031-2013Class IIMedtronic Prostiva RF Therapy GeneratorMedtronic Neuromodulation
2013-04-10Z-1032-2013Class IIAccess Immunoassay SystemBeckman Coulter Inc.
2013-04-10Z-1033-2013Class IIAccess 2 Immunoassay SystemBeckman Coulter Inc.
2013-04-10Z-1034-2013Class IISynchron LXi 725 Clinical SystemBeckman Coulter Inc.
2013-04-10Z-1035-2013Class IIUniCel DxC 600i Synchron Access Clinical SystemBeckman Coulter Inc.
2013-04-10Z-1036-2013Class IISIEMENS brand COHERENCE RT Therapist versions RTT MR1Siemens Medical Solutions USA, Inc
2013-04-10Z-1037-2013Class IISIEMENS brand COHERENCE RT Therapist versions RTT MR1Siemens Medical Solutions USA, Inc
2013-04-10Z-1038-2013Class IISIEMENS brand COHERENCE RT Therapist versions RTT MR1Siemens Medical Solutions USA, Inc
2013-04-10Z-1039-2013Class IISIEMENS brand COHERENCE RT Therapist versions RTT MR1Siemens Medical Solutions USA, Inc
2013-04-10Z-1040-2013Class IISIEMENS brand COHERENCE RT Therapist versions RTT MR1Siemens Medical Solutions USA, Inc
2013-04-10Z-1041-2013Class IISIEMENS brand COHERENCE RT Therapist versions RTT MR1Siemens Medical Solutions USA, Inc
2013-04-10Z-1042-2013Class IISIEMENS brand COHERENCE RT Therapist versions RTT MR1Siemens Medical Solutions USA, Inc
2013-04-10Z-1043-2013Class IISIEMENS brand COHERENCE RT Therapist versions RTT MR1Siemens Medical Solutions USA, Inc
2013-04-10Z-1044-2013Class IISIEMENS brand COHERENCE RT Therapist versions RTT MR1Siemens Medical Solutions USA, Inc
2013-04-10Z-1045-2013Class IIZimmer NexPosureZimmer, Inc.
2013-04-10Z-1046-2013Class IIISiemens DimensionSiemens Healthcare Diagnostics, Inc.
2013-04-10Z-1047-2013Class IIISiemens DimensionSiemens Healthcare Diagnostics, Inc.
2013-04-10Z-1048-2013Class IIISiemens DimensionSiemens Healthcare Diagnostics, Inc.
2013-04-10Z-1049-2013Class IISiemens DimensionSiemens Healthcare Diagnostics, Inc.
2013-04-10Z-1050-2013Class IIIABX Micros IM2Horiba Instruments, Inc dba Horiba Medical
2013-04-10Z-1053-2013Class IILEEP REDIKIT Product NoCooper Surgical, Inc.
2013-04-10Z-1054-2013Class IILeMaitre Stent Guide: 1102-00LeMaitre Vascular, Inc.
2013-04-10Z-1055-2013Class IIGlow 'N Tell 20 cm Tape: 1100-00LeMaitre Vascular, Inc.
2013-04-10Z-1056-2013Class IIIBD Vacutainer C&S Transfer Straw Kit C&S Preservative Plus Urine TubeBecton Dickinson & Company
2013-04-10Z-1057-2013Class IIArrow/Teleflex Medical Berman Angiographic Balloon Catheter and…Arrow International Inc
2013-04-10Z-1059-2013Class IITest Strips packaged in the OC-Light Manual iFOBT KitPolymedco, Inc
2013-04-10Z-1060-2013Class IITest Strips packaged in the OC-Light Manual iFOBT KitPolymedco, Inc
2013-04-03Z-0975-2013Class IIIntraosseous Fixation SystemOrthohelix Surgical Designs Inc
2013-04-03Z-0976-2013Class IIBD MAX PCR Cartridges Catalog #437519Becton Dickinson & Co.
2013-04-03Z-0977-2013Class IIBS-200 Chemistry Analyzer Designed for clinical laboratory useMindray DS USA, Inc. d.b.a. Mindray North America
2013-04-03Z-0978-2013Class IINeedle CountersCardinal Health
2013-04-03Z-0979-2013Class IINeedle Counters with Blade DisarmerCardinal Health
2013-04-03Z-0980-2013Class IINeedle Counters with Blade DisarmerCardinal Health
2013-04-03Z-0981-2013Class IINeedle CountersCardinal Health
2013-04-03Z-0982-2013Class IINeedle Counters with Blade DisarmerCardinal Health
2013-04-03Z-0983-2013Class IINeedle CountersCardinal Health
2013-04-03Z-0984-2013Class IINeedle CountersCardinal Health
2013-04-03Z-0985-2013Class IINeedle Counters with Blade DisarmerCardinal Health
2013-04-03Z-0986-2013Class IINeedle Counters with Blade DisarmerCardinal Health
2013-04-03Z-0987-2013Class IIARCHITECT HBsAg Qualitative AssayAbbott Laboratories, Inc
2013-04-03Z-0988-2013Class IIISiemens Dimension VistaSiemens Healthcare Diagnostics, Inc.
2013-04-03Z-0989-2013Class IIVITEK 2 60 computer system when equipped with the following…Biomerieux Inc
2013-04-03Z-0990-2013Class IIVITEK 2 XL computer system when equipped with the following…Biomerieux Inc
2013-04-03Z-0991-2013Class IIVITEK 2 Compact computer system when equipped with the following…Biomerieux Inc
2013-04-03Z-0992-2013Class IISiemens Axiom Artis zeego systems with software version VC14Siemens Medical Solutions USA, Inc
2013-04-03Z-0994-2013Class IIToshiba Infinix-i X-Ray SystemToshiba American Medical Systems Inc
2013-04-03Z-0995-2013Class IIKIMGUARD Container FiltersKimberly-Clark Corporation
2013-04-03Z-0996-2013Class IIMedfusion Model 3500 Syringe PumpSmiths Medical ASD, Inc.
2013-04-03Z-0997-2013Class IIArtis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA…Siemens Medical Solutions USA, Inc
2013-04-03Z-0998-2013Class IISTERRAD 200 System CarriageAdvanced Sterilization Products
2013-04-03Z-1001-2013Class IIISeppCareFusion 213, LLC
2013-04-03Z-1002-2013Class IIVitrea Enterprise SuiteVital Images, Inc.
2013-04-03Z-1004-2013Class IIICooper Surgical Incontinence Ring Flexible Pessary #4Cooper Surgical, Inc.
2013-04-03Z-1005-2013Class IIICooper Surgical Incontinence Dish w/ Support Pessary #5Cooper Surgical, Inc.
2013-04-03Z-1006-2013Class IIICooper Surgical Incontinence Dish w/ Support Pessary #0Cooper Surgical, Inc.
2013-04-03Z-1007-2013Class IIICooper Surgical Incontinence Dish Folding Pessary #0Cooper Surgical, Inc.
2013-04-03Z-1008-2013Class IIICooper Surgical Incontinence Dish Folding Pessary #0Cooper Surgical, Inc.
2013-04-03Z-1009-2013Class IIICooper Surgical Gellhorn Flexible Pessary -2 3/4"Cooper Surgical, Inc.
2013-04-03Z-1010-2013Class IIICooper Surgical Gellhorn Flexible Pessary 3"Cooper Surgical, Inc.
2013-04-03Z-1011-2013Class IIICooper Surgical Cube Pessary 1 5/8""Cooper Surgical, Inc.
2013-04-03Z-1012-2013Class IIICooper Surgical Cube Pessary w/Drainage Holes #0"1"Cooper Surgical, Inc.
2013-04-03Z-1013-2013Class IIbioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility CardBiomerieux Inc
2013-04-03Z-1015-2013Class IIPyxis Anesthesia System Model 2000CareFusion Corporation
2013-04-03Z-1016-2013Class IISynthes Dens Instrument SetSynthes USA HQ, Inc.
2013-04-03Z-1017-2013Class IIMedtronic Archer Super Stiff Guidewire 0Medtronic Inc. Cardiac Rhythm Disease Management
2013-04-03Z-1018-2013Class IIOmniflex DiaphragmCooper Surgical, Inc.
2013-04-03Z-1019-2013Class IIMedtronic Archer 0Medtronic Inc. Cardiac Rhythm Disease Management
2013-04-03Z-1021-2013Class IIMicrobiologics KWIK-QC SLIDESMicrobiologics Inc
2013-04-03Z-1022-2013Class IIGen-Probe LIFECODES PF4 Enhanced assayGenetic Testing Institute,inc
2013-04-03Z-1023-2013Class II20-Pole Eco CableBiosense Webster, Inc.
2013-03-27Z-0952-2013Class IIExtremity MedicalExtremity Medical LLC
2013-03-27Z-0953-2013Class IIOptetrak Logic Comprehensive Knee Prosthesis SystemExactech, Inc.
2013-03-27Z-0954-2013Class IIBiomet Spine Polaris 5Ebi, Llc
2013-03-27Z-0955-2013Class IVascular SolutionsVascular Solutions, Inc.
2013-03-27Z-0956-2013Class IIVariable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius…Synthes USA HQ, Inc.
2013-03-27Z-0957-2013Class IISiemens DimensionSiemens Healthcare Diagnostics, Inc.
2013-03-27Z-0958-2013Class IICreatinineBeckman Coulter Inc.
2013-03-27Z-0959-2013Class IIAllen Traction BootAllen Medical Systems, Inc.
2013-03-27Z-0960-2013Class IIDePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000DePuy Spine, Inc.
2013-03-27Z-0961-2013Class IIDePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT Catalog Number:…DePuy Spine, Inc.
2013-03-27Z-0962-2013Class IIDePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number:…DePuy Spine, Inc.
2013-03-27Z-0963-2013Class IIDePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000DePuy Spine, Inc.
2013-03-27Z-0964-2013Class IIHowmedica Osteonics CorpStryker Howmedica Osteonics Corp.
2013-03-27Z-0965-2013Class IIBoston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse…Boston Scientific CRM Corp
2013-03-27Z-0966-2013Class III20 Diopter Binocular Indirect OphthalmoscopeVolk Optical Inc
2013-03-27Z-0967-2013Class IIILLICO Straight CP TI RodAlphatec Spine, Inc.
2013-03-27Z-0968-2013Class ISpacelabs BleaseSirius Anesthesia WorkstationDel Mar Reynolds Medical, Ltd.
2013-03-27Z-0969-2013Class IISterile Access & Return Line SetMolded Products Inc
2013-03-27Z-0970-2013Class IICR MD1AGFA Corp.
2013-03-27Z-0971-2013Class IISpecialist 2 IM RodDePuy Orthopaedics, Inc.
2013-03-27Z-0972-2013Class IIReClaim Reamer ExtensionDePuy Orthopaedics, Inc.
2013-03-27Z-0973-2013Class IIPrimaConnex Tapered Implant TCKeystone Dental Inc
2013-03-27Z-0974-2013Class IIINTIO IncIntio Inc
2013-03-20Z-0919-2013Class IICommand Instrument Broach HandleStryker Howmedica Osteonics Corp.
2013-03-20Z-0920-2013Class IIIntegra CUSA excelIntegra LifeSciences Corp.
2013-03-20Z-0921-2013Class II3Genesys Orthopedic Systems, LLC
2013-03-20Z-0922-2013Class IIEndotrig Trigger Release Sterile Micro Hook Blade Product Usage: The…Instratek, Incorporated
2013-03-20Z-0923-2013Class IIGenesis Straight Esthetic 4Keystone Dental Inc
2013-03-20Z-0924-2013Class IIGenesis Straight Esthetic 5Keystone Dental Inc
2013-03-20Z-0925-2013Class IIREF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile…Biomet, Inc.
2013-03-20Z-0926-2013Class IIMedtronic O-arm Imaging System Product Usage: image-intensified…Medtronic Navigation, Inc.
2013-03-20Z-0927-2013Class IIANTI-BORRELIAInnominata Dba Genbio
2013-03-20Z-0928-2013Class IIIsoline Implantable Defibrillation LeadSorin Group USA, Inc.
2013-03-20Z-0929-2013Class IIAMO Sensar Intraocular LensesAbbott Medical Optics Inc (AMO)
2013-03-20Z-0930-2013Class IIACUSON S2000 Automated Breast Volume ScannerSiemens Medical Solutions USA, Inc.
2013-03-20Z-0931-2013Class IIElekta Synergy XVIElekta, Inc.
2013-03-20Z-0932-2013Class IICynch Lordotic T-PLlF ImplantSpine Smith Partners LP
2013-03-20Z-0933-2013Class IIISiemens Total Iron Binding CapacitySiemens Healthcare Diagnostics, Inc.
2013-03-20Z-0934-2013Class IIGE HealthcareGE Healthcare, LLC
2013-03-20Z-0935-2013Class IIOptima MR450wGE Healthcare, LLC
2013-03-20Z-0936-2013Class IIBacterin ElutiaBacterin International, Inc.
2013-03-20Z-0937-2013Class IIChurchill Medical SystemsVygon Corporation
2013-03-20Z-0938-2013Class IISynthes Spine 5Synthes USA HQ, Inc.
2013-03-20Z-0939-2013Class IIDraeger Infinity Acute Care SystemDraeger Medical, Inc.
2013-03-20Z-0940-2013Class IGOPump Elastometric infusion PumpKit with/ and without accesssories…Symbios Medical Products, LLC
2013-03-20Z-0941-2013Class IILarge Combination Clamp/Large External Fixation SystemSynthes USA HQ, Inc.
2013-03-20Z-0942-2013Class IISynthes Titanium Midface DistractorSynthes USA HQ, Inc.
2013-03-20Z-0943-2013Class IIINTERNAL HEX RECON SCREWSmith & Nephew Inc
2013-03-20Z-0944-2013Class IIINTERNAL HEX RECON SCREWSmith & Nephew Inc
2013-03-20Z-0945-2013Class IIBrilliance 6Philips Medical Systems (Cleveland) Inc
2013-03-20Z-0946-2013Class IINicolet EEG Wireless Amplifier 32/64 ChannelNatus Neurology Incorporated
2013-03-20Z-0947-2013Class IIGE Healthcare AdvantxGE Healthcare, LLC
2013-03-20Z-0948-2013Class IISiemens Somatom CTs equipped with software syngo CT2010ASiemens Medical Solutions USA, Inc
2013-03-20Z-0949-2013Class IITotalCare SpO2RT2 bedHill-Rom, Inc.
2013-03-20Z-0950-2013Class IIBrilliance 64 and Ingenuity Computed Tomography X-Ray Systems The…Philips Medical Systems (Cleveland) Inc
2013-03-20Z-0951-2013Class IIVial Label: 1) LIATEST VWF:Ag BufferDiagnostica Stago, Inc.
2013-03-13Z-0892-2013Class IAd-Tech Medical Instrument Corporation Macro Micro Subdural ElectrodeAd-Tech Medical Instrument Corporation
2013-03-13Z-0900-2013Class IIPhilips Digital Diagnost Stationary radiographic systemPhilips Healthcare Inc.
2013-03-13Z-0901-2013Class IIGE Healthcare Volume Viewer Plus 5GE Healthcare, LLC
2013-03-13Z-0902-2013Class IICentury Console BaseSalyer Prn Biomedical
2013-03-13Z-0903-2013Class IISynthes Multi-Vector Distractor BodySynthes USA HQ, Inc.
2013-03-13Z-0904-2013Class IISynthes Multi-Vector DistractorSynthes USA HQ, Inc.
2013-03-13Z-0905-2013Class IISynthes Multi-Vector DistractorSynthes USA HQ, Inc.
2013-03-13Z-0906-2013Class IIPhilips Medical System Extended Brilliance WorkspacePhilips Medical Systems (Cleveland) Inc
2013-03-13Z-0907-2013Class IISIEMENS brand ARTISTE syngo RT TherapistSiemens Medical Solutions USA, Inc
2013-03-13Z-0908-2013Class IIMedtronic DPL Single Stage Venous Cannula with Metal TipMedtronic Inc. Cardiac Rhythm Disease Management
2013-03-13Z-0909-2013Class IIHickman 9Bard Access Systems
2013-03-13Z-0910-2013Class IILeonard 10Bard Access Systems
2013-03-13Z-0911-2013Class IIIBD Vacutainer PST Gel and Lithium HeparinBecton Dickinson & Company
2013-03-13Z-0912-2013Class IIAtricure IncAtricure Inc
2013-03-13Z-0913-2013Class IIBeckman Coulter AU5800 Clinical Chemistry AnalyzerBeckman Coulter Inc.
2013-03-13Z-0914-2013Class IILifeguard Infusion Set with SmartsiteChurchill Medical Systems, Inc.
2013-03-13Z-0915-2013Class IIAMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of…Steris Corporation
2013-03-13Z-0916-2013Class IIID3000 Advantage Drive SystemLinvatec Corp. dba ConMed Linvatec
2013-03-13Z-0917-2013Class IIID3000I Advantage Drive SystemLinvatec Corp. dba ConMed Linvatec
2013-03-13Z-0918-2013Class IIPSX PROXIMATE Skin Staple ExtractorEthicon Endo-Surgery Inc
2013-03-06Z-0703-2013Class IIGE Healthcare Definium 5000 / 5220493 X-Ray SystemGE Healthcare, LLC
2013-03-06Z-0704-2013Class IIGE Healthcare Definium 5000/5220493-2 X-Ray SystemGE Healthcare, LLC
2013-03-06Z-0761-2013Class IIGE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray SystemGE Healthcare, LLC
2013-03-06Z-0786-2013Class IIMx8000 IDT Whole Body Computed Tomography X-ray system Distributed by…Philips Medical Systems (Cleveland) Inc
2013-03-06Z-0873-2013Class IIKY SENSITIVE TM JELLY Personal LubricantMc-NEIL-PPC, Inc.
2013-03-06Z-0874-2013Class IIKY SilkE Vaginal Moisturizer and Personal LubricantMc-NEIL-PPC, Inc.
2013-03-06Z-0875-2013Class IIKY TINGLING JELLY Personal LubricantMc-NEIL-PPC, Inc.
2013-03-06Z-0876-2013Class IIIAvex CX SuiteUltradent Products, Inc.
2013-03-06Z-0877-2013Class IIQuietCare-Networked productIntel-GE Care Innovations LLC
2013-03-06Z-0878-2013Class IIVersafitcup Impacting Ring Model Number: 01Medacta Usa Inc
2013-03-06Z-0879-2013Class IIBMC RF Cannula Curved Sharp RadiOpaqueBaylis Medical Company Inc.
2013-03-06Z-0880-2013Class IIPhilips Medical SystemsPhilips Medical Systems (Cleveland) Inc
2013-03-06Z-0881-2013Class IIPhilips Medical SystemsPhilips Medical Systems (Cleveland) Inc
2013-03-06Z-0882-2013Class IIPhilips Medical SystemsPhilips Medical Systems (Cleveland) Inc
2013-03-06Z-0883-2013Class IIPhilips Medical SystemsPhilips Medical Systems (Cleveland) Inc
2013-03-06Z-0884-2013Class IIPhilips DigitalDiagnost X-Ray System with Eleva Software 2Philips Healthcare Inc.
2013-03-06Z-0885-2013Class IIElektaElekta, Inc.
2013-03-06Z-0886-2013Class IIIntegraIntegra LifeSciences Corp.
2013-03-06Z-0887-2013Class IIAesculap Bipolar Generator Foot PedalAesculap, Inc.
2013-03-06Z-0888-2013Class IIVACUETTE Cellestis 1 ml QuantiFERON¿Cellestis Inc
2013-03-06Z-0889-2013Class IIVacuette Cellestis 1 ml QuantiFERON¿ TB ANTIGENCellestis Inc
2013-03-06Z-0890-2013Class IIAtrapro Antipruritic HydrogelOculus Innovative Sciences Inc
2013-03-06Z-0891-2013Class IITechnocut PlusMyco Medical Supplies Inc
2013-03-06Z-0893-2013Class IIStryker XIA 3 Iliac ScrewdriverStryker Spine
2013-03-06Z-0894-2013Class IIAdvanced Neuromodulation SystemsAdvanced Neuromodulation Systems Inc.
2013-03-06Z-0895-2013Class IIOrthofix ISKD Limb LengthenerOrthofix, Inc
2013-03-06Z-0896-2013Class IIFirebird Spinal Fixation SystemOrthofix, Inc
2013-03-06Z-0897-2013Class IIIngenuity TF PET/CTPhilips Medical Systems (Cleveland) Inc
2013-03-06Z-0898-2013Class IIREF CMS-CT6T225Medical Components, Inc dba MedComp
2013-03-06Z-0899-2013Class IIPhilips MX 16-Slice CT Scanner SystemPhilips Medical Systems (Cleveland) Inc
2013-02-27Z-0825-2013Class IIHealthTronics Endocare 3Healthtronics, Inc.
2013-02-27Z-0826-2013Class IIELECTROLASE HYFRECATORConMed Corporation
2013-02-27Z-0827-2013Class IIELECTROLASEConMed Corporation
2013-02-27Z-0828-2013Class ILPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are…DePuy Orthopaedics, Inc.
2013-02-27Z-0829-2013Class ILPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are…DePuy Orthopaedics, Inc.
2013-02-27Z-0830-2013Class ILPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are…DePuy Orthopaedics, Inc.
2013-02-27Z-0831-2013Class ILPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are…DePuy Orthopaedics, Inc.
2013-02-27Z-0832-2013Class IICareFusion SmartSite Gravity Blood Set Model 42082ECarefusion 303 Inc
2013-02-27Z-0835-2013Class IIVACUETTE Safety Blood Collection Set + Luer AdapterGreiner Bio-One North America, Inc.
2013-02-27Z-0836-2013Class IIIAnimasAnimas Corporation
2013-02-27Z-0837-2013Class IIPro Time Microcoagulation System/ Pro Time 3 CuvetteInternational Technidyne Corp.
2013-02-27Z-0838-2013Class IILifeStyles ZERO 10 uber-thin lubricated latex condomsAnsell Healthcare Products LLC
2013-02-27Z-0839-2013Class IIMaquet ELS Cannula 15 FRMaquet Cardiovascular Us Sales, Llc
2013-02-27Z-0840-2013Class IISTRYKER Sustainability SolutionsStryker Sustainability Solutions
2013-02-27Z-0841-2013Class IIMonaco RTP SystemElekta, Inc.

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