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Medical device recalls reported in 2012

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ReportedRecallClassProductFirm
2012-12-26Z-0494-2013Class IIGE HealthcareGE Healthcare, LLC
2012-12-26Z-0514-2013Class IPatient Circuit used with the Life Pulse High Frequency VentilatorBunnell, Inc.
2012-12-26Z-0524-2013Class IIGE Healthcare Carescape Patient Data Module with v2GE Healthcare, LLC
2012-12-26Z-0526-2013Class IIEEG NeuroAmpEEG Info
2012-12-26Z-0527-2013Class IIEBI XFIX DFS Rail SystemBiomet, Inc.
2012-12-26Z-0528-2013Class IIMindray V12 Size: 320 mm X 320 mm X 450 mm NMindray DS USA, Inc. d.b.a. Mindray North America
2012-12-26Z-0529-2013Class IIDePuy Mitek 11 MM Fully Fluted ReamerDePuy Mitek, Inc., a Johnson & Johnson Co.
2012-12-26Z-0531-2013Class IIVarian brand ARIA Radiation OncologyVarian Medical Systems, Inc. Oncology Systems
2012-12-26Z-0532-2013Class IIMedline Total Knee CDSMedline Industries Inc
2012-12-26Z-0533-2013Class IIBiomet Offset Tibial Tray 2Biomet, Inc.
2012-12-26Z-0534-2013Class IIArobella Medical 6mm Qurette used with the Arobella Medical AR1000…Arobella Medical, LLC
2012-12-26Z-0535-2013Class IITitan Spine Endoskeleton TA Implant productsTITAN SPINE, LLC
2012-12-26Z-0536-2013Class IIBiomet Polaris 5Ebi, Llc
2012-12-26Z-0537-2013Class IICOONMAD/MORREY TOTAL ELBOW ELBOW COMPONENT REPLACEMENT SET BUSHINGS &…Zimmer, Inc.
2012-12-26Z-0538-2013Class IICoonrad/Morrey New Ulnar Revision Kit for Use with…Zimmer, Inc.
2012-12-26Z-0539-2013Class IIPersona The Personalized Knee SystemZimmer, Inc.
2012-12-26Z-0540-2013Class IIPersona The Personalized Knee SystemZimmer, Inc.
2012-12-26Z-0541-2013Class IIPersona The Personalized Knee SystemZimmer, Inc.
2012-12-26Z-0542-2013Class IIPersona The Personalized Knee SystemZimmer, Inc.
2012-12-26Z-0543-2013Class IIPersona The Personalized Knee SystemZimmer, Inc.
2012-12-26Z-0544-2013Class IIPersona The Personalized Knee SystemZimmer, Inc.
2012-12-26Z-0545-2013Class IIPersonaZimmer, Inc.
2012-12-26Z-0546-2013Class IIPersonaZimmer, Inc.
2012-12-26Z-0547-2013Class IIPersonaZimmer, Inc.
2012-12-26Z-0548-2013Class IIPersonaZimmer, Inc.
2012-12-26Z-0549-2013Class IIPersonaZimmer, Inc.
2012-12-26Z-0550-2013Class IIPersonaZimmer, Inc.
2012-12-26Z-0551-2013Class IIPersonaZimmer, Inc.
2012-12-26Z-0552-2013Class IIPersonaZimmer, Inc.
2012-12-26Z-0553-2013Class IIPersonaZimmer, Inc.
2012-12-26Z-0554-2013Class IIPersonaZimmer, Inc.
2012-12-26Z-0555-2013Class IIPersonaZimmer, Inc.
2012-12-26Z-0556-2013Class IIInvacare Height AdjustableInvacare Corporation
2012-12-26Z-0557-2013Class IIThyssenKrupp Accessibility LEVANT StairliftThyssenKrupp Access Corp
2012-12-26Z-0558-2013Class IIMAYFIELD Composite Series Base UnitIntegra LifeSciences Corporation
2012-12-26Z-0559-2013Class IIMAYFIELD Composite Series Skull ClampsIntegra LifeSciences Corporation
2012-12-26Z-0560-2013Class IIAdvantage Workstation Volume Share 2GE Healthcare, LLC
2012-12-26Z-0561-2013Class IIAutoTac Delivery HandleBioHorizons Implant Systems Inc
2012-12-26Z-0562-2013Class IITitanium Tack Starter KitBioHorizons Implant Systems Inc
2012-12-26Z-0563-2013Class IICoverStainer Slide Rack The CoverStainer Slide Rack is an accessory…Dako Denmark A/S
2012-12-26Z-0564-2013Class IICase Carton: BD Oral Dispensing Syringe 1 mL Clear with Tip Cap BDBecton Dickinson & Company
2012-12-26Z-0565-2013Class IIBleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are…Del Mar Reynolds Medical, Ltd.
2012-12-26Z-0566-2013Class IIThe Stryker Model 6390Stryker Medical Division of Stryker Corporation
2012-12-26Z-0567-2013Class IIMedtronicMedtronic Neuromodulation
2012-12-26Z-0568-2013Class IIMedline Angio Drape Pack Radiology-LFMedline Industries Inc
2012-12-26Z-0569-2013Class IIPinnacle Cancellous Screw Packaging: Product is housed within a…DePuy Orthopaedics, Inc.
2012-12-26Z-0570-2013Class IIBD Phoenix PMIC-108 PanelsBecton Dickinson & Co.
2012-12-26Z-0571-2013Class IISpineSix consists of a motorized treatment table that is controlled…BioMotion Medical Systems, LLC
2012-12-26Z-0572-2013Class IIThe Access hLH assay is a paramagnetic particleBeckman Coulter Inc.
2012-12-26Z-0573-2013Class IISOL SYS 8IN CALCAR SZ12 Packaging: Product is packed within a poly…DePuy Orthopaedics, Inc.
2012-12-26Z-0574-2013Class IISOL SYS F 8 CALC 13DePuy Orthopaedics, Inc.
2012-12-26Z-0575-2013Class IISOL SYS 8IN CALC 1DePuy Orthopaedics, Inc.
2012-12-26Z-0576-2013Class IISOL SYS 8IN CALC 1DePuy Orthopaedics, Inc.
2012-12-26Z-0577-2013Class IISOL SYS 8IN CALC 1DePuy Orthopaedics, Inc.
2012-12-26Z-0578-2013Class IISOL SYS 8IN CALC 1DePuy Orthopaedics, Inc.
2012-12-26Z-0579-2013Class IISOL SYS F 9 CALC L 13DePuy Orthopaedics, Inc.
2012-12-26Z-0580-2013Class IISOL SYS L 9IN CALC 2DePuy Orthopaedics, Inc.
2012-12-26Z-0581-2013Class IISOL SYS L 9IN CALC 2DePuy Orthopaedics, Inc.
2012-12-26Z-0582-2013Class IISOL SYS L 9IN CALC 2DePuy Orthopaedics, Inc.
2012-12-26Z-0583-2013Class IISOL SYS L 9IN CALC 2DePuy Orthopaedics, Inc.
2012-12-26Z-0584-2013Class IISOL SYS L 9IN CALC 2DePuy Orthopaedics, Inc.
2012-12-26Z-0585-2013Class IISOL SYS L 9IN CALC 2DePuy Orthopaedics, Inc.
2012-12-26Z-0586-2013Class IISOL SYS F 9 CALC L 13DePuy Orthopaedics, Inc.
2012-12-26Z-0587-2013Class IISOL SYS R 9IN CALC 2DePuy Orthopaedics, Inc.
2012-12-26Z-0588-2013Class IISOL SYS R 9IN CALC 2DePuy Orthopaedics, Inc.
2012-12-26Z-0589-2013Class IISOL SYS R 9IN CALC 2DePuy Orthopaedics, Inc.
2012-12-26Z-0590-2013Class IISOL SYS R 9IN CALC 2DePuy Orthopaedics, Inc.
2012-12-26Z-0591-2013Class IISOL SYS R 9IN CALC 2DePuy Orthopaedics, Inc.
2012-12-26Z-0592-2013Class IISOL SYS R 9IN CALC 2DePuy Orthopaedics, Inc.
2012-12-26Z-0593-2013Class IIBausch + Lomb Stellaris PC Vision Enhancement SystemBausch & Lomb Inc
2012-12-26Z-0595-2013Class IIMedradMedrad Inc
2012-12-26Z-0596-2013Class IIMedradMedrad Inc
2012-12-26Z-0597-2013Class IIMedradMedrad Inc
2012-12-26Z-0598-2013Class IIMedradMedrad Inc
2012-12-26Z-0599-2013Class IIMedradMedrad Inc
2012-12-26Z-0600-2013Class IIMedradMedrad Inc
2012-12-26Z-0601-2013Class IIMedradMedrad Inc
2012-12-26Z-0602-2013Class IIMedradMedrad Inc
2012-12-26Z-0603-2013Class IIMedradMedrad Inc
2012-12-26Z-0604-2013Class IIMedradMedrad Inc
2012-12-26Z-0605-2013Class IIMedradMedrad Inc
2012-12-26Z-0607-2013Class IISegmented Cervix Applicator SetVarian Medical Systems, Inc.
2012-12-19Z-0478-2013Class IThe GlideScope Video LaryngoscopeVerathon, Inc.
2012-12-19Z-0481-2013Class IIPlum A+ Single Channel Infusion Pumps with Plug-and-Play Modules that…Hospira Inc.
2012-12-19Z-0482-2013Class IIPlum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet…Hospira Inc.
2012-12-19Z-0483-2013Class IIPlum A+ Single Channel Infusion Pumps with Hospira Mednet Software…Hospira Inc.
2012-12-19Z-0484-2013Class IIData Station AMPLILINK software is an instrument user interface/ data…Roche Molecular Systems, Inc.
2012-12-19Z-0485-2013Class IIThe MagNA Pure LCRoche Molecular Systems, Inc.
2012-12-19Z-0486-2013Class IIThe MagNA Pure 96 SystemRoche Molecular Systems, Inc.
2012-12-19Z-0487-2013Class IILightCycler 1Roche Molecular Systems, Inc.
2012-12-19Z-0488-2013Class IILightCycler 2Roche Molecular Systems, Inc.
2012-12-19Z-0489-2013Class IIThe COBAS 8000 data manager modular analyzer seriesRoche Molecular Systems, Inc.
2012-12-19Z-0490-2013Class IIThe COBAS INTEGRA 400/400 plus systemRoche Molecular Systems, Inc.
2012-12-19Z-0491-2013Class IIDataInnovationsRoche Molecular Systems, Inc.
2012-12-19Z-0492-2013Class IIDataCara GM is an information management system that provides data…Roche Molecular Systems, Inc.
2012-12-19Z-0493-2013Class IIDataCare POC  is an information management system that provides data…Roche Molecular Systems, Inc.
2012-12-19Z-0495-2013Class IIPhilips IntelliVue Information Center/Client and Philips IntelliVue…Philips Healthcare Inc.
2012-12-19Z-0496-2013Class ISynchroMed ELMedtronic Neuromodulation
2012-12-19Z-0497-2013Class IMedtronic SynchroMed IIMedtronic Neuromodulation
2012-12-19Z-0498-2013Class IIReusableCovidien LLC dba Uni-Patch
2012-12-19Z-0499-2013Class IIReusableCovidien LLC dba Uni-Patch
2012-12-19Z-0500-2013Class IIPerforma reusable and self-adhering TENS/NMES/FES stimulating…Covidien LLC dba Uni-Patch
2012-12-19Z-0501-2013Class IIEmpi STIMC RE Self Adhesive electrodesCovidien LLC dba Uni-Patch
2012-12-19Z-0502-2013Class IIWANG Transbronchial Aspiration Needles CatConMed Corporation
2012-12-19Z-0503-2013Class IIWANG Transbronchial Aspiration Needles CatConMed Corporation
2012-12-19Z-0504-2013Class IIWANG Transbronchial Aspiration Needles CatConMed Corporation
2012-12-19Z-0505-2013Class IIWANG Transbronchial Aspiration Needles CatConMed Corporation
2012-12-19Z-0506-2013Class IISiemens Healthcare BNPSiemens Healthcare Diagnostics, Inc
2012-12-19Z-0507-2013Class IISiemens Healthcare BR Assay for CA 27Siemens Healthcare Diagnostics, Inc
2012-12-19Z-0508-2013Class IISiemens Healthcare ADVIA Centaur CA 19-9 250 Test 10491244 50 Test…Siemens Healthcare Diagnostics, Inc
2012-12-19Z-0509-2013Class IISiemens Healthcare ADVIA Centaur DHEA-504Siemens Healthcare Diagnostics, Inc
2012-12-19Z-0510-2013Class IISiemens Healthcare ADVIA Centaur DigitoxinSiemens Healthcare Diagnostics, Inc
2012-12-19Z-0511-2013Class IISiemens Healthcare ADVIA Centaur FolateSiemens Healthcare Diagnostics, Inc
2012-12-19Z-0512-2013Class IISiemens Healthcare ADVIA Centaur Theophylline 2Siemens Healthcare Diagnostics, Inc
2012-12-19Z-0513-2013Class IIDPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USAMindray DS USA, Inc. d.b.a. Mindray North America
2012-12-19Z-0515-2013Class IIMAVIG PORTEGRA 2 system operated in conjuction with a Siemens AX…Siemens Medical Solutions USA, Inc
2012-12-19Z-0517-2013Class IIBaby QuasarQuasar Bio-Tech, Inc. dba Silver Bay LLC
2012-12-19Z-0518-2013Class IIQuasar MD is an infrared LED lamp that is labeled in part: "***QUASAR…Quasar Bio-Tech, Inc. dba Silver Bay LLC
2012-12-19Z-0519-2013Class IIQuasar Power Pack contains a Baby Quasar and a Baby BlueQuasar Bio-Tech, Inc. dba Silver Bay LLC
2012-12-19Z-0520-2013Class IISTERRAD CYCLESURE 24 Biological IndicatorAdvanced Sterilization Products
2012-12-19Z-0521-2013Class IINovocastra Ready-to-Use Mouse Monoclonal Antibody Terminal…Leica Microsystems, Inc.
2012-12-19Z-0522-2013Class IICobas b 123 POC system cobas b 123 POC system is fully automated POC…Roche Diagnostics Operations, Inc.
2012-12-19Z-0523-2013Class IIBD BBL Taxo XV Factor StripsBecton Dickinson & Co.
2012-12-12Z-0447-2013Class IThe product has the Catalogue/Part number 60010Natus Medical Incorporated
2012-12-12Z-0452-2013Class IIDimension VistaSiemens Healthcare Diagnostics, Inc.
2012-12-12Z-0453-2013Class IIOmniGuide BP-ROBOTICOmniGuide, Inc.
2012-12-12Z-0454-2013Class IINeptune¿ 2 RoverStryker Instruments Div. of Stryker Corporation
2012-12-12Z-0455-2013Class IINeptune¿ 2 RoverStryker Instruments Div. of Stryker Corporation
2012-12-12Z-0456-2013Class II24 Fr 8mm Sft Flow Str Wire W/L The Sarns Aortic Cannula is indicated…Terumo Cardiovascular Systems Corporation
2012-12-12Z-0457-2013Class II24 Fr 8mm Sft Flow Straight Wir The Sarns Aortic Cannula is indicated…Terumo Cardiovascular Systems Corporation
2012-12-12Z-0458-2013Class II24 Fr 8mm Sft Flow Straight The Sarns Aortic Cannula is indicated for…Terumo Cardiovascular Systems Corporation
2012-12-12Z-0459-2013Class II18 Fr 6mm Sft Flow Angled Wire The Sarns Aortic Cannula is indicated…Terumo Cardiovascular Systems Corporation
2012-12-12Z-0460-2013Class II18 Fr 6mm Sft Flow Ang Wire W/L The Sarns Aortic Cannula is indicated…Terumo Cardiovascular Systems Corporation
2012-12-12Z-0461-2013Class II24 Fr 8mm Soft Flow Ang Wire W/L The Sarns Aortic Cannula is…Terumo Cardiovascular Systems Corporation
2012-12-12Z-0462-2013Class II24 Fr 8mm Soft Flow Ang W/L The Sarns Aortic Cannula is indicated for…Terumo Cardiovascular Systems Corporation
2012-12-12Z-0463-2013Class IISekisui DiagnosticsSekisui Diagnostics Llc
2012-12-12Z-0464-2013Class IICustom Procedural Trays: Merit's Custom Total Hip PackMerit Medical Systems, Inc.
2012-12-12Z-0465-2013Class IISiemens syngoSiemens Medical Solutions USA, Inc
2012-12-12Z-0466-2013Class IINeuViz 16 Multi-Sliced CT Scanner SystemPhilips And Neusoft Medical Systems Co., Ltd.
2012-12-12Z-0467-2013Class IIBiOM Rechargeable Li Ion 22iwalk inc
2012-12-12Z-0468-2013Class IIInvivo Corporation Expression MRI Patient Monitoring SystemInvivo Corporation
2012-12-12Z-0469-2013Class IIStryker Orthopaedics FEMORAL OFFSET BUSHING TRITHION REVISION…Stryker Howmedica Osteonics Corp.
2012-12-12Z-0470-2013Class IIStryker Orthopaedics TIBIAL OFFSET BUSHING TRIATHLON REVISION…Stryker Howmedica Osteonics Corp.
2012-12-12Z-0471-2013Class IIOSS Reamer Sleeve REF132-472661 KNEE REAMER SLEEVE 8Biomet, Inc.
2012-12-12Z-0472-2013Class IIOSS Reamer Sleeve REF132-472662 KNEE REAMER SLEEVE 13Biomet, Inc.
2012-12-12Z-0473-2013Class IICobas 8000 Modular Analyzer SeriesRoche Diagnostics Operations, Inc.
2012-12-12Z-0474-2013Class IIBio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion ImplantedBiomet, Inc.
2012-12-12Z-0475-2013Class IIPhilips Digital Diagnost Software Version R2Philips Healthcare Inc.
2012-12-12Z-0480-2013Class IISiemens Mobilette MiraSiemens Medical Solutions USA, Inc
2012-12-05Z-0161-2013Class IMedpro Elastomeric Infusion PumpFirst Medical Source LLC
2012-12-05Z-0435-2013Class II100/120V ACTerumo Cardiovascular Systems Corporation
2012-12-05Z-0436-2013Class II220/240V ACTerumo Cardiovascular Systems Corporation
2012-12-05Z-0437-2013Class IINexGen CompleteKnee Solution Stemmed Nonaugmentable Tibial component…Zimmer, Inc.
2012-12-05Z-0438-2013Class IIIO FiX X-Post ReamerExtremity Medical LLC
2012-12-05Z-0439-2013Class IICooper Surgical RUMI ArchCooper Surgical, Inc.
2012-12-05Z-0440-2013Class IICooper Surgical Advincula ArchCooper Surgical, Inc.
2012-12-05Z-0441-2013Class IIThe Vertex Max Drill Tube is a component within the Navigated Vertex…Medtronic Navigation, Inc.
2012-12-05Z-0442-2013Class IIEcho Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless…Biomet, Inc.
2012-12-05Z-0443-2013Class IIDevices includes a Multi Port Inflator or without Multi Port InflatorParks Medical Electronics, Inc
2012-12-05Z-0444-2013Class IIPentron Clinical Metrex ResearchMetrex Research, LLC.
2012-12-05Z-0445-2013Class IIThe Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The…Diamedix Corporation
2012-12-05Z-0446-2013Class IIThe brand name is MRidium Series 1000 MR Infusion SetsIradimed Corporation
2012-12-05Z-0448-2013Class IIGE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE…GE Healthcare, LLC
2012-12-05Z-0449-2013Class IIGE Healthcare Optima XR 220amx 15kw Mobile X-Ray System The GE…GE Healthcare, LLC
2012-12-05Z-0450-2013Class IIGE Healthcare Optima XR 200 amx with Digital UpgradeGE Healthcare, LLC
2012-12-05Z-0451-2013Class IIKimberly-Clark Patient Warming SystemKimberly-Clark Corporation
2012-11-28Z-0197-2013Class IIGE Healthcare Optima XR 200amx with digital upgrade Mobile general…GE Healthcare, LLC
2012-11-28Z-0198-2013Class IIGE Healthcare Optima XR 220amx Mobile general purpose radiographic…GE Healthcare, LLC
2012-11-28Z-0199-2013Class IIGE Healthcare Optima 200amx Mobile general purpose radiographic…GE Healthcare, LLC
2012-11-28Z-0200-2013Class IIGE Healthcare Brivo XR 285 Mobile general purpose radiographic…GE Healthcare, LLC
2012-11-28Z-0290-2013Class IMindray A3 Anesthesia Delivery System Manufactured in China for…Mindray DS USA, Inc. d.b.a. Mindray North America
2012-11-28Z-0291-2013Class IMindray A5 Anesthesia Delivery System Manufactured in China for…Mindray DS USA, Inc. d.b.a. Mindray North America
2012-11-28Z-0292-2013Class IETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin…Ethicon, Inc.
2012-11-28Z-0293-2013Class IETHICON SURGIFLO HEMOSTATIC MATRIX Distributed by ETHICON ETHICONEthicon, Inc.
2012-11-28Z-0297-2013Class IIProduct is Full OSSEOTITE 2 Tapered Certain ImplantBiomet 3i, LLC
2012-11-28Z-0298-2013Class IIProduct is Full OSSEOTITE Parallel Walled Certain ImplantBiomet 3i, LLC
2012-11-28Z-0299-2013Class IIbioMerieux BacT/ALERT Control ModuleBiomerieux Inc
2012-11-28Z-0300-2013Class IIbioMerieux BacT/ALERT Combo ModuleBiomerieux Inc
2012-11-28Z-0301-2013Class IIbioMerieux BacT/ALERT 3D 60Biomerieux Inc
2012-11-28Z-0302-2013Class IIbioMerieux KitBiomerieux Inc
2012-11-28Z-0303-2013Class IIbioMerieux KitBiomerieux Inc
2012-11-28Z-0304-2013Class IIbioMerieux KitBiomerieux Inc
2012-11-28Z-0305-2013Class IIbioMerieux KitBiomerieux Inc
2012-11-28Z-0306-2013Class IIbioMerieux KitBiomerieux Inc
2012-11-28Z-0307-2013Class IIbioMerieux KitBiomerieux Inc
2012-11-28Z-0308-2013Class IIbioMerieux KitBiomerieux Inc
2012-11-28Z-0309-2013Class IIbioMerieux KitBiomerieux Inc
2012-11-28Z-0310-2013Class IIbioMerieux KitBiomerieux Inc
2012-11-28Z-0311-2013Class IIbioMerieux KitBiomerieux Inc
2012-11-28Z-0312-2013Class IIbioMerieux KitBiomerieux Inc
2012-11-28Z-0313-2013Class IIbioMerieux KitBiomerieux Inc
2012-11-28Z-0314-2013Class IIbioMerieux KitBiomerieux Inc
2012-11-28Z-0315-2013Class IIbioMerieux KitBiomerieux Inc
2012-11-28Z-0316-2013Class IIbioMerieux KitBiomerieux Inc
2012-11-28Z-0317-2013Class IIbioMerieux KitBiomerieux Inc
2012-11-28Z-0318-2013Class IIbioMerieux BacT/ALERT Control ModuleBiomerieux Inc
2012-11-28Z-0319-2013Class IIbioMerieux BacT/ALERT Combo ModuleBiomerieux Inc
2012-11-28Z-0320-2013Class IIbioMerieux BacT/ALERT Combo ModuleBiomerieux Inc
2012-11-28Z-0321-2013Class IIbioMerieux KitBiomerieux Inc
2012-11-28Z-0322-2013Class IIbioMerieux KitBiomerieux Inc

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