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Medical device recalls reported in 2015

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ReportedRecallClassProductFirm
2015-04-15Z-1408-2015Class IIVasoNova Vascular Positioning SystemVasoNova, Inc.
2015-04-08Z-1336-2015Class IIBoston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL…Boston Scientific Corporation
2015-04-08Z-1337-2015Class IIFREEDOMAIREMicrotek Medical Inc
2015-04-08Z-1338-2015Class IIFREEDOMAIREMicrotek Medical Inc
2015-04-08Z-1339-2015Class IIFREEDOMAIREMicrotek Medical Inc
2015-04-08Z-1340-2015Class IIFREEDOMAIREMicrotek Medical Inc
2015-04-08Z-1341-2015Class IILAPAROSCOPIC TUBING SETMicrotek Medical Inc
2015-04-08Z-1342-2015Class IISmoke Evacuation Tubing Set for Coherent CPG HandpieceMicrotek Medical Inc
2015-04-08Z-1343-2015Class IITUBING 7/8' X 10'Microtek Medical Inc
2015-04-08Z-1344-2015Class IIVACUUM TUBING 7/8" X 6'Microtek Medical Inc
2015-04-08Z-1345-2015Class IIVACUUM TUBING 7/8" X 6'Microtek Medical Inc
2015-04-08Z-1346-2015Class IITUBING SET 7/8" X 6' WITH 1/4" x 24" TUBINGMicrotek Medical Inc
2015-04-08Z-1347-2015Class II(S) TUBE SET 1/4" X 10' (0.64 cm X 304.8 cm) with 7/8" (2.22 cm)…Microtek Medical Inc
2015-04-08Z-1348-2015Class IILASER RESISTANT WANDMicrotek Medical Inc
2015-04-08Z-1349-2015Class IIINTEGRAL WAND W/TUBINGMicrotek Medical Inc
2015-04-08Z-1350-2015Class IISkintact ECG Electrode FS-50Leonhard Lang Medizintechnik GmbH
2015-04-08Z-1351-2015Class IIMedcomp Duo-Flow 400XL CatheterMedical Components, Inc dba MedComp
2015-04-08Z-1352-2015Class IISynthes 130 Degree Aiming Arm and 125 Degree Aiming ArmSynthes, Inc.
2015-04-08Z-1353-2015Class IIVitagelOrthovita, Inc., dBA Stryker Orthobiologics.
2015-04-08Z-1354-2015Class IISyngoSiemens Medical Solutions USA, Inc
2015-04-08Z-1355-2015Class IIVarious Lots of Expel Drainage Catheter with TwistLoc Hub Biliary…Boston Scientific Corporation
2015-04-08Z-1356-2015Class IIMedtronic Dual Chamber Temporary External PacemakerMedtronic Inc. Cardiac Rhythm Disease Management
2015-04-08Z-1357-2015Class IIRECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical…DePuy Orthopaedics, Inc.
2015-04-08Z-1358-2015Class IIBard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber…C.R. Bard, Inc.
2015-04-08Z-1359-2015Class IIComputed Tomography X-ray SystemsPhilips Medical Systems (Cleveland) Inc
2015-04-08Z-1360-2015Class IIBrand Name: Persona¿ Anterior Referencing Sizer with Locking Boom The…Zimmer, Inc.
2015-04-08Z-1361-2015Class IIDouble Swivel Connector with Suction Port ConnectorKing Systems Corp.
2015-04-08Z-1362-2015Class IIGAP Nail 4Pega Medical Inc.
2015-04-08Z-1363-2015Class IIToggleLocBiomet, Inc.
2015-04-08Z-1364-2015Class IIZiploop Button Product Usage: The Ziploop Button is a non-resorbable…Biomet, Inc.
2015-04-08Z-1365-2015Class IICovidien Trellis 6 and Trellis 8 Peripheral Infusion SystemsMedtronic Inc. Cardiac Rhythm Disease Management
2015-04-08Z-1366-2015Class IIAutoject E1 Fixed needle deviceOwen Mumford USA, Inc.
2015-04-08Z-1367-2015Class IIYC-1800 OPHTHALMIC YAG LASER SYSTEMNidek Inc
2015-04-08Z-1368-2015Class IILIS27TQuest Medical, Inc.
2015-04-08Z-1369-2015Class IIACCU-CHEK Connect Diabetes Management AppRoche Diabetes Care, Inc.
2015-04-08Z-1370-2015Class IIBD FACSCaliburBD Biosciences, Systems & Reagents
2015-04-08Z-1371-2015Class IIEdwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8Edwards Lifesciences, LLC
2015-04-08Z-1372-2015Class IIBio-PLASTY CannulaBiologic Therapies, Inc
2015-04-08Z-1373-2015Class IIBio-MAC CannulaBiologic Therapies, Inc
2015-04-08Z-1374-2015Class IIBio-CORE CannulaBiologic Therapies, Inc
2015-04-08Z-1375-2015Class IICD123BD Biosciences, Systems & Reagents
2015-04-08Z-1376-2015Class IIGE HealthcareGE Healthcare
2015-04-01Z-1211-2015Class IIGE Inspection Technologies x|tome|x L240 an Cabinet X-ray systemGE Inspection Technologies, LP
2015-04-01Z-1225-2015Class IIGE Inspection Technologies x|argos 160D systemGE Inspection Technologies, LP
2015-04-01Z-1290-2015Class IDiamondback 360 Coronary Orbital Atherectomy SystemCardiovascular Systems, Inc.
2015-04-01Z-1302-2015Class IIda Vinci Xi Surgical SystemIntuitive Surgical, Inc.
2015-04-01Z-1303-2015Class IIda Vinci Xi Surgical SystemIntuitive Surgical, Inc.
2015-04-01Z-1304-2015Class IIda Vinci Xi Surgical SystemIntuitive Surgical, Inc.
2015-04-01Z-1305-2015Class IIGE HealthcareGE Healthcare
2015-04-01Z-1306-2015Class IIPenner Patient Stretcher/Transfer Lift System Models 391000-1 and…Penner Mfg Inc
2015-04-01Z-1307-2015Class IILithium Polymer Fiber Optic Module Batteries used in the Intera MR…Philips Medical Systems, Inc.
2015-04-01Z-1308-2015Class IIMAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13ASiemens Medical Solutions USA, Inc
2015-04-01Z-1309-2015Class IIIntraocular LensAaren Scientific, Incorporated
2015-04-01Z-1310-2015Class IIRayStation Radiation Therapy Treatment Planning SystemRAYSEARCH LABORATORIES AB
2015-04-01Z-1311-2015Class IIAlaris PC unitsCareFusion 303, Inc.
2015-04-01Z-1312-2015Class IITyvek Pouch/Roll with STERRAD Chemical IndicatorAdvanced Sterilization Products
2015-04-01Z-1313-2015Class IISynthes Electric Pen DriveSynthes, Inc.
2015-04-01Z-1314-2015Class IIVariable Angle Locking PegFlower Orthopedics Corporation
2015-04-01Z-1315-2015Class IILiquid Mouse Monoclonal Antibody CD15 used is laboratories to perform…Leica Microsystems, Inc.
2015-04-01Z-1316-2015Class IIExacTrac versions 6Brainlab AG
2015-04-01Z-1317-2015Class IIBD Q-Syte Luer Access Split SeptumBecton Dickinson & Company
2015-04-01Z-1318-2015Class IIDUAFITIn2Bones, SAS
2015-04-01Z-1319-2015Class IIDUAFITIn2Bones, SAS
2015-04-01Z-1320-2015Class IIIcobas¿ EGFR Mutation Test epidermal growth factor receptorRoche Molecular Systems, Inc.
2015-04-01Z-1321-2015Class IIADVIA Chemistry Systems Drug Calibrator ISiemens Healthcare Diagnostics, Inc.
2015-04-01Z-1322-2015Class IIThe Rheo Knee bionic prosthetic is to be used exclusively for…Ossur H / F
2015-04-01Z-1323-2015Class IICoblator II SystemArthroCare Medical Corporation
2015-04-01Z-1324-2015Class IIEndo TCS Driver Straight Hexalobe #6 P/N 5210-1004TITAN SPINE, LLC
2015-04-01Z-1325-2015Class IINexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLYZimmer Trabecular Metal Technology, Inc.
2015-04-01Z-1326-2015Class IIAmeda One-Hand Manual Breast PumpAmeda, Inc.
2015-04-01Z-1327-2015Class IIAmeda Dual Short Term HygieniKit Milk Collections SystemAmeda, Inc.
2015-03-25Z-0984-2015Class IIARTISTE MV SystemSiemens Medical Solutions USA, Inc
2015-03-25Z-1238-2015Class IIElekta Precise Treatment TableElekta, Inc.
2015-03-25Z-1268-2015Class IIML 7090 Calibrated LASIK BladeMed-logics Inc
2015-03-25Z-1269-2015Class IIMiniCap with Povidone-Iodine SolutionBaxter Healthcare Corp.
2015-03-25Z-1270-2015Class IIGE Healthcare Engstrom CarestationGE Healthcare
2015-03-25Z-1271-2015Class IIBD Posiflush Saline Flush Syringe 10 ml inlcuded in the following…Bard Access Systems
2015-03-25Z-1272-2015Class IIBD Posiflush Saline Flush Syringe 10 ml inlcuded in the following…Bard Access Systems
2015-03-25Z-1273-2015Class IIBD Posiflush Saline Flush Syringe 10 ml inlcuded in the following…Bard Access Systems
2015-03-25Z-1274-2015Class IIBD Posiflush Saline Flush Syringe 10 ml inlcuded in the following…Bard Access Systems
2015-03-25Z-1275-2015Class IIBD Posiflush Saline Flush Syringe 10 ml inlcuded in the following…Bard Access Systems
2015-03-25Z-1276-2015Class IMedtronicMedtronic Inc. Cardiac Rhythm Disease Management
2015-03-25Z-1277-2015Class IIMedstream 81"US Infusion Inc dba Trucare Biomedix-USA
2015-03-25Z-1278-2015Class IIPuritan absorbent foam tipped applicatorPuritan Medical Products Co., LLC
2015-03-25Z-1279-2015Class IIGE Healthcare Millennium VGGE Healthcare
2015-03-25Z-1280-2015Class IIPassport V MonitorMindray DS USA, Inc. dba Mindray North America
2015-03-25Z-1281-2015Class IIThumb Screw for the Synthes Recon Locking Aiming Arm for Lateral…Synthes, Inc.
2015-03-25Z-1282-2015Class IISiemens LANTIS Oncology Information System ServersSiemens Medical Solutions USA, Inc
2015-03-25Z-1283-2015Class IITriathlon Distal Capture Assembly Catalog No: 6541-1-723 The…Stryker Howmedica Osteonics Corp.
2015-03-25Z-1284-2015Class IITactiSys Quartz PackSt Jude Medical
2015-03-25Z-1285-2015Class IIGE HealthcareGE Healthcare
2015-03-25Z-1286-2015Class IICADD" Medication Cassette ReservoirSmiths Medical ASD, Inc.
2015-03-25Z-1287-2015Class IISignature TKA GDE/MDL Set 04-05Materialise N.V.
2015-03-25Z-1288-2015Class IILP Rotate Foot System prosthetic device for fitting lower extremity…Ossur H / F
2015-03-25Z-1289-2015Class IIIN Latex IgMSiemens Healthcare Diagnostics, Inc.
2015-03-25Z-1291-2015Class IIOuter cardboard box labeling: Pinnacle Cure SleeveSybron Dental Specialties
2015-03-25Z-1292-2015Class IIThe HomeChoice Pro APD System is a peritoneal dialysis systemBaxter Healthcare Corp.
2015-03-25Z-1293-2015Class IICrea A and B membranesRadiometer America Inc
2015-03-25Z-1294-2015Class IIILeMaitre Vascular Tumescent Catheter InversionLeMaitre Vascular, Inc.
2015-03-25Z-1295-2015Class IITransonic Hemodialysis MonitorTransonic Systems Inc
2015-03-25Z-1296-2015Class IISymbia E is a multi-purpose SPECT system used to detect or image the…Siemens Medical Solutions USA, Inc.
2015-03-25Z-1297-2015Class IIESiemens Medical Solutions USA, Inc.
2015-03-25Z-1298-2015Class IICooperSurgical Infant Heel Gel WarmersCooperSurgical, Inc.
2015-03-25Z-1299-2015Class IIFisher Brand Gel Infant Heel Gel WarmersCooperSurgical, Inc.
2015-03-25Z-1300-2015Class IIMediChoice WarmGel Infant Heel WarmerCooperSurgical, Inc.
2015-03-25Z-1301-2015Class IINovaPlus Brand Warm Gel Infant Heel Gel WarmerCooperSurgical, Inc.
2015-03-18Z-1079-2015Class IIJuno DFR X-ray systemVilla Radiology Systems LLC
2015-03-18Z-1247-2015Class IIPressure IQ Evolve MattressArjo Hospital Equipment AB
2015-03-18Z-1248-2015Class IIGE Healthcare Proteus XR/a with wall stand model number 2260354GE Healthcare
2015-03-18Z-1249-2015Class IIEVOLUTION MP TIBIAL BASEMicroport Orthopedics INC.
2015-03-18Z-1250-2015Class IIApolloPivotal Health Solutions
2015-03-18Z-1251-2015Class IIPhilips DuraDiagnost X-Ray systemPhilips Medical Systems, Inc.
2015-03-18Z-1252-2015Class IIRAPIDPoint 405 Blood Gas AnalyzerSiemens Healthcare Diagnostics Inc
2015-03-18Z-1253-2015Class IIRAPIDPoint 500 Blood Gas AnalyzerSiemens Healthcare Diagnostics Inc
2015-03-18Z-1254-2015Class IIRAPIDLab 1245 SystemSiemens Healthcare Diagnostics Inc
2015-03-18Z-1255-2015Class IIRAPIDLab 1265 SystemSiemens Healthcare Diagnostics Inc
2015-03-18Z-1256-2015Class IISiemens Healthcare Caps for capillary 100 uLSiemens Healthcare Diagnostics Inc
2015-03-18Z-1257-2015Class IISiemens Healthcare Caps for capillary 140/175 uLSiemens Healthcare Diagnostics Inc
2015-03-18Z-1258-2015Class IISiemens Healthcare Caps for capillary 50/60 uLSiemens Healthcare Diagnostics Inc
2015-03-18Z-1259-2015Class IIArrow Intra-Aortic Balloon Catheter Kit FiberoptixArrow International Inc
2015-03-18Z-1260-2015Class IISynthes Inserter for Titanium Elastic NailsSynthes, Inc.
2015-03-18Z-1261-2015Class IIAutostainer Link 48Dako North America Inc.
2015-03-18Z-1262-2015Class II- NTL-30 30ml Nutrio Enteral Feeding SyringeMedela Inc. EF Division
2015-03-18Z-1263-2015Class IIVITROS Hand-held Barcode ScannerOrtho-Clinical Diagnostics
2015-03-18Z-1264-2015Class IIICarton: Richard-Allan Scientific CYTO-STAINRichard-Allan Scientific Company
2015-03-18Z-1265-2015Class IIMAX-TL 9Southern Implants, Inc
2015-03-18Z-1266-2015Class IIPersona Trabecular Metal Tibial Plate / Persona TM Tibia-ProsthesisZimmer, Inc.
2015-03-18Z-1267-2015Class IISIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1…Siemens Medical Solutions USA, Inc
2015-03-11Z-1120-2015Class IIPhilips Medical System Allura Xper X-Ray AngiographicPhilips Medical Systems, Inc.
2015-03-11Z-1209-2015Class IIntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters:…Boston Scientific Corp
2015-03-11Z-1210-2015Class IIXoran MiniCAT X-ray imaging deviceXoran Technologies, LLC
2015-03-11Z-1216-2015Class IIRotoRest Delta Advanced Therapy SystemArjo Hospital Equipment AB
2015-03-11Z-1217-2015Class IIRotoprone Therapy SystemArjo Hospital Equipment AB
2015-03-11Z-1218-2015Class IITriaDyne Proventa Critical Care Therapy SystemArjo Hospital Equipment AB
2015-03-11Z-1219-2015Class IIZimmer Segmental SystemZimmer, Inc.
2015-03-11Z-1220-2015Class IIKimVent Closed Suction System for AdultsHalyard Health
2015-03-11Z-1221-2015Class IIKimVent Closed Suction System for AdultsHalyard Health
2015-03-11Z-1222-2015Class IIKimVent Wet PakHalyard Health
2015-03-11Z-1223-2015Class IIIkariaINO Therapeutics (dba Ikaria)
2015-03-11Z-1224-2015Class IIServo-I ventilator system CO2 analyzerMaquet Cardiovascular Us Sales, Llc
2015-03-11Z-1226-2015Class IIVacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci SIntuitive Surgical, Inc.
2015-03-11Z-1227-2015Class IIBaxterBaxter Corporation Englewood
2015-03-11Z-1228-2015Class IIICareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer…Medtronic MiniMed Inc.
2015-03-11Z-1229-2015Class IIADVIA Centaur Systems Progesterone KitSiemens Healthcare Diagnostics, Inc
2015-03-11Z-1230-2015Class IIADVIA Centaur Systems Progesterone KitSiemens Healthcare Diagnostics, Inc
2015-03-11Z-1231-2015Class IIADVIA Centaur Systems Progesterone KitSiemens Healthcare Diagnostics, Inc
2015-03-11Z-1232-2015Class IIOxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of…Remel Inc
2015-03-11Z-1233-2015Class IIARROW FiberOptix Intra-Aortic Balloon Catheter KitArrow International Inc
2015-03-11Z-1234-2015Class IIZip 8i Surgical Skin Closure DeviceZipline Medical
2015-03-11Z-1235-2015Class IIZip 8M Wound Closure DeviceZipline Medical
2015-03-11Z-1236-2015Class IIZip 16 Surgical Skin Closure DeviceZipline Medical
2015-03-11Z-1237-2015Class IIMonaco radiation therapy treatment planning systemElekta, Inc.
2015-03-11Z-1239-2015Class IICooperSurgical PESSARY KIT-CUBE#2CooperSurgical, Inc.
2015-03-11Z-1240-2015Class IIThe I-Cart is used to storeRichard Wolf Medical Instruments Corp.
2015-03-11Z-1241-2015Class IILFT v40 Femoral HeadStryker Howmedica Osteonics Corp.
2015-03-11Z-1242-2015Class IILASSO NAV Duo Loop eco CathetersBiosense Webster, Inc.
2015-03-11Z-1243-2015Class IIDynaLOC Breast Interventional Planning Software Versions 3iCAD, Inc.
2015-03-11Z-1244-2015Class IIFocal Sim radiation therapy treatment planning systemElekta, Inc.
2015-03-11Z-1245-2015Class IIAMIA v1Baxter Healthcare Corp.
2015-03-11Z-1246-2015Class IISMARTSET GHV Gentamicin Bone CementDePuy Orthopaedics, Inc.
2015-03-04Z-1044-2015Class IIPhilips Multi Diagnost Eleva IIPhilips Medical Systems, Inc.
2015-03-04Z-1045-2015Class IIPhilips Multi Diagnost Eleva with FlatDetectorPhilips Medical Systems, Inc.
2015-03-04Z-1071-2015Class IThe Plum A+ Infusion System is designed to meet the fluid delivery…Hospira Inc.
2015-03-04Z-1072-2015Class IThe Plum A+ Infusion System is designed to meet the fluid delivery…Hospira Inc.
2015-03-04Z-1073-2015Class IThe Plum A+ Infusion System is designed to meet the fluid delivery…Hospira Inc.
2015-03-04Z-1074-2015Class IThe Plum A+ Infusion System is designed to meet the fluid delivery…Hospira Inc.
2015-03-04Z-1075-2015Class IThe Plum A+ Infusion System is designed to meet the fluid delivery…Hospira Inc.
2015-03-04Z-1131-2015Class IHeartWare Ventricular Assist SystemHeartWare Inc
2015-03-04Z-1132-2015Class IICoCr Femoral HeadZimmer Gmbh
2015-03-04Z-1133-2015Class IIMetasul Femoral HeadZimmer Gmbh
2015-03-04Z-1134-2015Class IIBiolox Delta Femoral HeadZimmer Gmbh
2015-03-04Z-1135-2105Class IICoCr Femoral HeadZimmer Gmbh
2015-03-04Z-1136-2015Class IIMetasul Femoral HeadZimmer Gmbh
2015-03-04Z-1137-2015Class IITDX Electric WheelchairInvacare Corporation
2015-03-04Z-1138-2015Class IIFDX Electric WheelchairInvacare Corporation
2015-03-04Z-1139-2015Class IIStorm Series Electric WheelchairInvacare Corporation
2015-03-04Z-1140-2015Class IIMaquet CARDIOSAVE Hybrid Intra-Aortic Balloon PumpMaquet Datascope Corp - Cardiac Assist Division
2015-03-04Z-1141-2015Class IIEndoWrist One Vessel SealerIntuitive Surgical, Inc.
2015-03-04Z-1142-2015Class IIEndoWrist One Vessel SealerIntuitive Surgical, Inc.
2015-03-04Z-1143-2015Class IIStarburst MRI Semi-Flex Electrode DeviceAngiodynamics
2015-03-04Z-1144-2015Class IISpacelabs Healthcare XPREZZON Bedside MonitorSpacelabs Healthcare Inc
2015-03-04Z-1145-2015Class IISpacelabs Healthcare qube Compact MonitorSpacelabs Healthcare Inc
2015-03-04Z-1146-2015Class IISet Screw 5Biomet Spine, LLC
2015-03-04Z-1147-2015Class IIThe MedtronicMedtronic Neuromodulation
2015-03-04Z-1148-2015Class IINAMIC Convenience KitNavilyst Medical, Inc
2015-03-04Z-1149-2015Class IINAMIC Convenience KitNavilyst Medical, Inc
2015-03-04Z-1150-2015Class IINAMIC Convenience KitNavilyst Medical, Inc
2015-03-04Z-1151-2015Class IINAMIC Convenience KitNavilyst Medical, Inc
2015-03-04Z-1152-2015Class IINAMIC Convenience KitNavilyst Medical, Inc
2015-03-04Z-1153-2015Class IINAMIC Convenience KitNavilyst Medical, Inc
2015-03-04Z-1154-2015Class IINAMIC Convenience KitNavilyst Medical, Inc
2015-03-04Z-1155-2015Class IINAMIC Convenience KitNavilyst Medical, Inc
2015-03-04Z-1156-2015Class IINAMIC Convenience KitNavilyst Medical, Inc
2015-03-04Z-1157-2015Class IINAMIC Convenience KitNavilyst Medical, Inc
2015-03-04Z-1158-2015Class IINAMIC Convenience KitNavilyst Medical, Inc
2015-03-04Z-1159-2015Class IINAMIC Convenience KitNavilyst Medical, Inc
2015-03-04Z-1160-2015Class IINAMIC Convenience KitNavilyst Medical, Inc
2015-03-04Z-1161-2015Class IINAMIC Convenience KitNavilyst Medical, Inc
2015-03-04Z-1162-2015Class IINAMIC Convenience KitNavilyst Medical, Inc
2015-03-04Z-1163-2015Class IINAMIC Convenience KitNavilyst Medical, Inc

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