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Medical device recalls reported in 2014

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ReportedRecallClassProductFirm
2014-01-29Z-0798-2014Class IIDR 7500 with FF WS These products are permanently installed…Carestream Health, Inc.
2014-01-29Z-0799-2014Class IICompensator Slider Lambda 6x20 componentZeiss, Carl Inc
2014-01-29Z-0800-2014Class IISiemens ADVIA 1200 and ADVIA 1650 Chemistry SystemsSiemens Healthcare Diagnostics, Inc.
2014-01-29Z-0801-2014Class IIComputed Tomography X-Ray SystemPhilips Medical Systems (Cleveland) Inc
2014-01-29Z-0802-2014Class IICivco Belly BoardCivco Medical Instruments Inc
2014-01-29Z-0803-2014Class IICivco Belly Board MRICivco Medical Instruments Inc
2014-01-29Z-0804-2014Class IIVideo Monitor Suspensions that may be on the following Fluoroscopic…GE Healthcare, LLC
2014-01-29Z-0805-2014Class IIORCHESTRA/ORCHESTRA PLUS ProgrammerSorin Group Italia S.r.l.
2014-01-29Z-0806-2014Class IIGE HealthcareGE Healthcare, LLC
2014-01-29Z-0807-2014Class IISOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULEGE Healthcare, LLC
2014-01-29Z-0808-2014Class IIGE HealthcareGE Healthcare, LLC
2014-01-29Z-0809-2014Class IIPulmonary Hemi-Artery SG Used in heart surgeryCryoLife, Inc.
2014-01-29Z-0810-2014Class IIMedrad Veris MR Monitor units The system is intended to monitor…Medrad Mr Inc
2014-01-29Z-0811-2014Class II1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic…Ziemer Usa Inc
2014-01-29Z-0812-2014Class IIVital Signs Anesthesia Circuits The Ventilator Circuit is intended…Vital Signs Colorado Inc.
2014-01-29Z-0813-2014Class IIAMS-530 7 Microbore Trifurcated Extension sets Product Usage:…Churchill Medical Systems, Inc.
2014-01-29Z-0814-2014Class IIMRI Low Profile Single Lumen port with Open-Ended 6Bard Access Systems
2014-01-29Z-0815-2014Class IITitanium Single Lumen Low-Profile portBard Access Systems
2014-01-29Z-0816-2014Class IIABL90 FLEX Analyzer Radiometer Medical ApSRadiometer America Inc
2014-01-29Z-0817-2014Class IIVITROS Chemistry Products COCM ReagentOrtho-Clinical Diagnostics
2014-01-29Z-0818-2014Class IIDimension Vista Cyclosporine Flex reagent cartridge an in vitro…Siemens Healthcare Diagnostics, Inc.
2014-01-29Z-0819-2014Class IIComposix L/P with Echo PS 10" X 13" Product Code 0144113 The Composix…Davol, Inc., Subs. C. R. Bard, Inc.
2014-01-29Z-0820-2014Class IIComposix L/P with Echo PS 6" X 8" Product Code 0144680 The Composix…Davol, Inc., Subs. C. R. Bard, Inc.
2014-01-29Z-0821-2014Class IIPuritan Bennett 840 Series Ventilator PB840 Operators Manual…Nellcor Puritan Bennett Inc. (dba Covidien LP)
2014-01-29Z-0822-2014Class IIPuritan Bennett 700 Series VentilatorsNellcor Puritan Bennett Inc. (dba Covidien LP)
2014-01-29Z-0823-2014Class IISiemens CentraLink" Data Management System V14Siemens Healthcare Diagnostics, Inc.
2014-01-22Z-0709-2014Class IIKing Systems KLTSD414 QuantityKing Systems Corp.
2014-01-22Z-0710-2014Class IIBoston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm…Boston Scientific Corporation
2014-01-22Z-0711-2014Class IIBoston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15…Boston Scientific Corporation
2014-01-22Z-0712-2014Class IIBoston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15…Boston Scientific Corporation
2014-01-22Z-0713-2014Class IIpO2 D999 membrane unitsRadiometer America Inc
2014-01-22Z-0714-2014Class IIDraeger Infinity Acute Care System Monitoring SolutionDraeger Medical Systems, Inc.
2014-01-22Z-0715-2014Class IIAnspach MCA Cutting BurrThe Anspach Effort, Inc.
2014-01-22Z-0716-2014Class IILocking Cortical Screw 3Biomet, Inc.
2014-01-22Z-0717-2014Class IILeica BIOSYSTEMSLeica Biosystems Newcastle Ltd.
2014-01-22Z-0718-2014Class IIAnspach Single Use Sterile Bone Cutting Burs and Irrigation ClipsThe Anspach Effort, Inc.
2014-01-22Z-0719-2014Class IITWISTER PLUS 22mm Rotatable Retrieval DeviceBoston Scientific Corporation
2014-01-22Z-0720-2014Class IITWISTER PLUS 22mm Rotatable Retrieval DeviceBoston Scientific Corporation
2014-01-22Z-0721-2014Class IITWISTER PLUS 22mm Rotatable Retrieval DeviceBoston Scientific Corporation
2014-01-22Z-0722-2014Class IITWISTER PLUS 26mm Rotatable Retrieval DeviceBoston Scientific Corporation
2014-01-22Z-0723-2014Class IITWISTER PLUS 26mm Rotatable Retrieval DeviceBoston Scientific Corporation
2014-01-22Z-0724-2014Class IITWISTER PLUS 26mm Rotatable Retrieval DeviceBoston Scientific Corporation
2014-01-22Z-0725-2014Class IIGE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile…GE Healthcare, LLC
2014-01-22Z-0726-2014Class IIAnspach Carbide Cutting Burrs: 2MM Carbide Fluted BallThe Anspach Effort, Inc.
2014-01-22Z-0727-2014Class IIAnspach Carbide Cutting Burrs: 1The Anspach Effort, Inc.
2014-01-22Z-0728-2014Class IIAnspach Carbide Cutting Burrs & Drums: 1The Anspach Effort, Inc.
2014-01-22Z-0729-2014Class IIAnspach Carbide Cutting Burrs & Drums: 2MM Carbide Fluted BallThe Anspach Effort, Inc.
2014-01-22Z-0730-2014Class IIPalacos¿ R+G Radioplaque Bone Cement 1 x 40 g SingleZimmer, Inc.
2014-01-22Z-0731-2014Class IICentricity PACS System versions 3Ge Healthcare It
2014-01-22Z-0732-2014Class IIVital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic UseVital Diagnostics, Inc.
2014-01-22Z-0733-2014Class IIConsult Diagnostics¿ Eon Calcium Reagent For In-Vitro Diagnostic Use…Vital Diagnostics, Inc.
2014-01-22Z-0734-2014Class IIOxoid Antimicrobial Susceptibility Testing DiscRemel Inc
2014-01-22Z-0735-2014Class IIAtrium Ocean Water Seal Chest Drain ATSAtrium Medical Corporation
2014-01-22Z-0736-2014Class IIAtrium Ocean Water Seal Chest Drain ATS Blood Recovery System with…Atrium Medical Corporation
2014-01-22Z-0737-2014Class IIAtrium Ocean Water Seal Chest Drain ATSAtrium Medical Corporation
2014-01-22Z-0738-2014Class IIAtrium Ocean Water Seal Chest Drain ATSAtrium Medical Corporation
2014-01-22Z-0739-2014Class IIAtrium Ocean Water Seal Chest Drain ATSAtrium Medical Corporation
2014-01-22Z-0740-2014Class IIAtrium Oasis Dry Suction Water Seal ATSAtrium Medical Corporation
2014-01-22Z-0741-2014Class IIAtrium Oasis Dry Suction Water Seal ATSAtrium Medical Corporation
2014-01-22Z-0742-2014Class IIAtrium Express Dry Seal ATSAtrium Medical Corporation
2014-01-22Z-0743-2014Class IIAtrium Express Dry Seal ATSAtrium Medical Corporation
2014-01-22Z-0744-2014Class IISTERRAD NX Sterilization SystemAdvanced Sterilization Products
2014-01-22Z-0745-2014Class IISTERRAD 50 Sterilization SystemAdvanced Sterilization Products
2014-01-22Z-0746-2014Class IISTERRAD 100S Sterilization SystemAdvanced Sterilization Products
2014-01-22Z-0747-2014Class IIGE Healthcare Carescape Patient Data Module The Patient Data ModuleGE Healthcare, LLC
2014-01-22Z-0748-2014Class IIMerge Mammo is a multi-modalityGE Healthcare It
2014-01-22Z-0749-2014Class IIMicro Curved AttachmentThe Anspach Effort, Inc.
2014-01-22Z-0750-2014Class IIMCA5-05SDThe Anspach Effort, Inc.
2014-01-22Z-0751-2014Class IIMCA5-06SDThe Anspach Effort, Inc.
2014-01-22Z-0752-2014Class IIMCA5-07SDThe Anspach Effort, Inc.
2014-01-22Z-0753-2014Class IIMCA5-08SDThe Anspach Effort, Inc.
2014-01-22Z-0754-2014Class IIMCA5-15SBThe Anspach Effort, Inc.
2014-01-22Z-0755-2014Class IIMCA5-15SDThe Anspach Effort, Inc.
2014-01-22Z-0756-2014Class IIMCA5-1SBThe Anspach Effort, Inc.
2014-01-22Z-0757-2014Class IIMCA5-1SDThe Anspach Effort, Inc.
2014-01-22Z-0758-2014Class IIMCA5-2SBThe Anspach Effort, Inc.
2014-01-22Z-0759-2014Class IIMCA5-2SDThe Anspach Effort, Inc.
2014-01-22Z-0760-2014Class IIMCA7-05SDThe Anspach Effort, Inc.
2014-01-22Z-0761-2014Class IIMCA7-06SDThe Anspach Effort, Inc.
2014-01-22Z-0762-2014Class IIMCA7-07SDThe Anspach Effort, Inc.
2014-01-22Z-0763-2014Class IIMCA7-08SDThe Anspach Effort, Inc.
2014-01-22Z-0764-2014Class IIMCA7-15SBThe Anspach Effort, Inc.
2014-01-22Z-0765-2014Class IIMCA7-15SDThe Anspach Effort, Inc.
2014-01-22Z-0766-2014Class IIMCA7-1SBThe Anspach Effort, Inc.
2014-01-22Z-0767-2014Class IIMCA7-1SDThe Anspach Effort, Inc.
2014-01-22Z-0768-2014Class IIMCA7-2SBThe Anspach Effort, Inc.
2014-01-22Z-0769-2014Class IIMCA7-2SDThe Anspach Effort, Inc.
2014-01-22Z-0770-2014Class IIWeckTeleflex Medical
2014-01-22Z-0771-2014Class IIWeckTeleflex Medical
2014-01-22Z-0772-2014Class IIBD Interlink threaded lock cannula This is a locking blunt plastic…Becton Dickinson & Company
2014-01-22Z-0773-2014Class IIImagecast PACS is an image management system intended to be used by…Ge Healthcare It
2014-01-22Z-0775-2014Class IIEstrogen Receptor AB-11Lab Vision Corporation
2014-01-22Z-0776-2014Class IIArena-L Trial HandleSpineFrontier, Inc.
2014-01-22Z-0777-2014Class IIArena-L 35x26 Trial Head I 10¿ LordoticSpineFrontier, Inc.
2014-01-22Z-0778-2014Class IIArena-L 38x28Trial Head I 10¿ LordoticSpineFrontier, Inc.
2014-01-22Z-0779-2014Class IIAnspach MIA 16The Anspach Effort, Inc.
2014-01-15Z-0491-2014Class IICarestream DRX-Revolution Mobile X-Ray System -- Made in UCarestream Health Inc.
2014-01-15Z-0529-2014Class IIEOS System X- ray beam Digital radiography system used in general…EOS Imaging
2014-01-15Z-0532-2014Class IISpectre Wireless Footswitch/Handswitch system Model 98/99Trans American Medical, Inc.
2014-01-15Z-0611-2014Class IPuritan Bennett 840 ventilator systems software part number…Covidien
2014-01-15Z-0621-2014Class IIIntegra Small Rickham -Style Reservoir Rx Only Sterile for Single Use…Integra LifeSciences Corp.
2014-01-15Z-0622-2014Class IIIntegra Large Rickham -Style Reservoir Rx Only Sterile for Single Use…Integra LifeSciences Corp.
2014-01-15Z-0623-2014Class IIAesculap Hi-Line XXS handpiece Hi-Line XXS handpieces are used with…Aesculap, Inc.
2014-01-15Z-0624-2014Class IIPedFuse Bone ProbeSpineFrontier, Inc.
2014-01-15Z-0625-2014Class IIHB1C FlexSiemens Healthcare Diagnostics, Inc.
2014-01-15Z-0626-2014Class IIHbA1c FlexSiemens Healthcare Diagnostics, Inc.
2014-01-15Z-0627-2014Class IIC-Plus" 10mm x 12mm Webless implants Pioneer Surgical's C-Plus " 10mm…RTI Surgical, Inc.
2014-01-15Z-0628-2014Class IIREF 42-411571 QTY 1 CATALOG CAUTIONMaterialise USA LLC
2014-01-15Z-0629-2014Class IIFresenius 2008 Series Hemodialysis Machines: Models: 2008HFresenius Medical Care Holdings, Inc.
2014-01-15Z-0630-2014Class IIStryker Color CuffStryker Instruments Div. of Stryker Corporation
2014-01-15Z-0631-2014Class IIAnspach BLACKMAX-NThe Anspach Effort, Inc.
2014-01-15Z-0632-2014Class IIAnspach B-Blue-S 11The Anspach Effort, Inc.
2014-01-15Z-0633-2014Class IIThe Propaq LT Series monitorsWelch Allyn Protocol, Inc
2014-01-15Z-0634-2014Class IITracer IV wheelchairsInvacare Corporation
2014-01-15Z-0635-2014Class IISandel Healthcare Safety Devices Weighted Safety Scalpel #3…Ansell Sandel Medical Industries LLC
2014-01-15Z-0636-2014Class IISandel Healthcare Safety Devices Weighted Safety Scalpel #3…Ansell Sandel Medical Industries LLC
2014-01-15Z-0637-2014Class IISandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long…Ansell Sandel Medical Industries LLC
2014-01-15Z-0638-2014Class IISandel Healthcare Safety Devices Weighted Safety Scalpel #3…Ansell Sandel Medical Industries LLC
2014-01-15Z-0639-2014Class IISandel Healthcare Safety Devices Weighted Safety Scalpel #3…Ansell Sandel Medical Industries LLC
2014-01-15Z-0640-2014Class IISandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long…Ansell Sandel Medical Industries LLC
2014-01-15Z-0641-2014Class IISandel Healthcare Safety Devices Weighted Safety Scalpel 4#…Ansell Sandel Medical Industries LLC
2014-01-15Z-0642-2014Class IIJelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin…Smiths Medical ASD, Inc.
2014-01-15Z-0643-2014Class IIJelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin…Smiths Medical ASD, Inc.
2014-01-15Z-0644-2014Class IIJelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin…Smiths Medical ASD, Inc.
2014-01-15Z-0645-2014Class IIJelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin…Smiths Medical ASD, Inc.
2014-01-15Z-0646-2014Class IIJelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin…Smiths Medical ASD, Inc.
2014-01-15Z-0647-2014Class IIOn Site Gas Systems POGS 33C Portable Oxygen Generation SystemOn Site Gas Systems Inc.
2014-01-15Z-0648-2014Class IISOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULEGE Healthcare, LLC
2014-01-15Z-0649-2014Class IICatalys Precision Laser SystemOptimedica Corporation
2014-01-15Z-0650-2014Class IINova StatStrip/StatSensor Hospital Blood Glucose MeterNova Biomedical Corporation
2014-01-15Z-0651-2014Class IIThe Vantage Digital Panoramic System delivers high-value features…Midmark Corp dba Progeny Inc
2014-01-15Z-0652-2014Class IIArthrocare SPORTS MEDICINEArthroCare Medical Corporation
2014-01-15Z-0653-2014Class IIProduct Brand NameAlere San Diego, Inc.
2014-01-15Z-0654-2014Class II***REF BLACKMAX-N***Swivel/Angle Motor Assembly***Rx Only***The…The Anspach Effort, Inc.
2014-01-15Z-0655-2014Class II***REF XMAX***XMax Handpiece***Rx Only***Manufacturer: The Anspach…The Anspach Effort, Inc.
2014-01-15Z-0656-2014Class II***REF MICROMAX***microMax Handpiece***Rx Only***Manufacturer: The…The Anspach Effort, Inc.
2014-01-15Z-0657-2014Class II***REF IMRI-MOTOR***iMRI HandpieceThe Anspach Effort, Inc.
2014-01-15Z-0658-2014Class IINanoClave ConnectorICU Medical, Inc.
2014-01-15Z-0659-2014Class II6"ICU Medical, Inc.
2014-01-15Z-0660-2014Class II6"ICU Medical, Inc.
2014-01-15Z-0661-2014Class II183 cmICU Medical, Inc.
2014-01-15Z-0662-2014Class II184 cmICU Medical, Inc.
2014-01-15Z-0663-2014Class II31 cmICU Medical, Inc.
2014-01-15Z-0664-2014Class IINanoClave StopcockICU Medical, Inc.
2014-01-15Z-0665-2014Class II17 cmICU Medical, Inc.
2014-01-15Z-0666-2014Class II6"ICU Medical, Inc.
2014-01-15Z-0667-2014Class II7"ICU Medical, Inc.
2014-01-15Z-0668-2014Class II7"ICU Medical, Inc.
2014-01-15Z-0669-2014Class II8"ICU Medical, Inc.
2014-01-15Z-0670-2014Class II78" Ext Set w/Check ValveICU Medical, Inc.
2014-01-15Z-0671-2014Class II11" Smallbore Bifuse Ext Set w/1ICU Medical, Inc.
2014-01-15Z-0672-2014Class II8"ICU Medical, Inc.
2014-01-15Z-0673-2014Class II8" Smallbore Pentafuse Ext Set w/5 NanoClave"ICU Medical, Inc.
2014-01-15Z-0674-2014Class II10" Smallbore Pentafuse Ext Set w/5 NanoClave"ICU Medical, Inc.
2014-01-15Z-0675-2014Class II87"ICU Medical, Inc.
2014-01-15Z-0676-2014Class II13" Smallbore Ext Set w/4 Gang 4-Way Stopcock w/BaseplateICU Medical, Inc.
2014-01-15Z-0677-2014Class II14"ICU Medical, Inc.
2014-01-15Z-0678-2014Class II103"ICU Medical, Inc.
2014-01-15Z-0679-2014Class II8" Ext Set w/NanoClave" StopcockICU Medical, Inc.
2014-01-15Z-0680-2014Class II6"ICU Medical, Inc.
2014-01-15Z-0681-2014Class II6"ICU Medical, Inc.
2014-01-15Z-0682-2014Class II7"ICU Medical, Inc.
2014-01-15Z-0683-2014Class II7"ICU Medical, Inc.
2014-01-15Z-0684-2014Class II7"ICU Medical, Inc.
2014-01-15Z-0685-2014Class II10"ICU Medical, Inc.
2014-01-15Z-0686-2014Class II106"ICU Medical, Inc.
2014-01-15Z-0687-2014Class II78" Ext Set w/2 BCV-Clave¿ICU Medical, Inc.
2014-01-15Z-0688-2014Class II7"ICU Medical, Inc.
2014-01-15Z-0689-2014Class II6"ICU Medical, Inc.
2014-01-15Z-0690-2014Class II6"ICU Medical, Inc.
2014-01-15Z-0691-2014Class II7"ICU Medical, Inc.
2014-01-15Z-0692-2014Class II10"ICU Medical, Inc.
2014-01-15Z-0693-2014Class II10"ICU Medical, Inc.
2014-01-15Z-0694-2014Class II7"ICU Medical, Inc.
2014-01-15Z-0695-2014Class II11" Smallbore Bifuse Ext Set w/1ICU Medical, Inc.
2014-01-15Z-0696-2014Class II13" Pentafuse Smallbore Ext Set w/NanoClave"ICU Medical, Inc.
2014-01-15Z-0697-2014Class II8"ICU Medical, Inc.
2014-01-15Z-0698-2014Class II30"ICU Medical, Inc.
2014-01-15Z-0699-2014Class II120" 10 Drop Primary Set w/2 BCV-CLAVE¿ICU Medical, Inc.
2014-01-15Z-0700-2014Class II5"ICU Medical, Inc.
2014-01-15Z-0701-2014Class II5" Smallbore Ext Set w/MicroClave¿ T-ConnectorICU Medical, Inc.
2014-01-15Z-0702-2014Class II5" Smallbore Ext Set w/MicroClave¿ T-ConnectorICU Medical, Inc.
2014-01-15Z-0703-2014Class II5" Smallbore Ext Set w/MicroClave¿ T-ConnectorICU Medical, Inc.
2014-01-15Z-0704-2014Class II28"ICU Medical, Inc.
2014-01-15Z-0705-2014Class II6ICU Medical, Inc.
2014-01-15Z-0706-2014Class II6"ICU Medical, Inc.
2014-01-15Z-0707-2014Class II17 cmICU Medical, Inc.
2014-01-15Z-0708-2014Class IIMultiples Anspach Micro Curved AttachmentsThe Anspach Effort, Inc.
2014-01-08Z-0584-2014Class IIPhilips Essenta DRPhilips Medical Systems, Inc.
2014-01-08Z-0585-2014Class IIFEM COND BUTTRESS PLTZimmer, Inc.
2014-01-08Z-0586-2014Class IITIBIO FEM/FEM NAILZimmer, Inc.
2014-01-08Z-0587-2014Class IIDIST LAT FEM LOCK PLTZimmer, Inc.
2014-01-08Z-0588-2014Class IIDIST LAT FEM LOCK PLTZimmer, Inc.
2014-01-08Z-0589-2014Class IIITST THREADED GUIDE PINZimmer, Inc.
2014-01-08Z-0590-2014Class IINGK Stem Ext 24 x 245mmZimmer, Inc.
2014-01-08Z-0591-2014Class IIFEM COND BUTTRESS PLTZimmer, Inc.
2014-01-08Z-0592-2014Class IITIB NAILZimmer, Inc.
2014-01-08Z-0593-2014Class IIPhilips HeartStart MRx Monitor/Defibrillator Models: M3536A Options…Philips Medical Systems, Inc.
2014-01-08Z-0594-2014Class IIAsante Comfort Infusion Set with 60cm tubing & 13mm cannula packaged…Asante Solutions, Inc.
2014-01-08Z-0595-2014Class IIAsante Comfort Infusion Set with 60cm tubing & 17mm cannula packaged…Asante Solutions, Inc.

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