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Medical device recalls reported in 2018

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ReportedRecallClassProductFirm
2018-05-02Z-1532-2018Class IIBD Vacutainer¿ Push Button Blood Collection Set 0Becton Dickinson & Company
2018-05-02Z-1533-2018Class IIBD Vacutainer¿ Ultra TouchTM Push Button Blood Collection Set 0Becton Dickinson & Company
2018-05-02Z-1534-2018Class IIEvicel Accessory DeviceEthicon, Inc.
2018-05-02Z-1535-2018Class IIWidefield OCT software feature for the Spectralis HRA+OCT and variantsHeidelberg Engineering
2018-05-02Z-1536-2018Class IISmith & Nephew Whipknot Soft Tissue Cinch #5 SuturesSmith & Nephew, Inc.
2018-04-25Z-1374-2018Class IIFornier Phantom FiberTornier, Inc
2018-04-25Z-1375-2018Class IIWRIGHTWright Medical Technology, Inc.
2018-04-25Z-1376-2018Class IIWRIGHTWright Medical Technology, Inc.
2018-04-25Z-1377-2018Class IIMINC Benchtop IncubatorCook Inc.
2018-04-25Z-1378-2018Class IIMINC Benchtop IncubatorCook Inc.
2018-04-25Z-1379-2018Class IIGetinge AGSGetinge Disinfection Ab
2018-04-25Z-1380-2018Class IIGetinge AGSGetinge Disinfection Ab
2018-04-25Z-1381-2018Class IIZimmer Segmental System Proximal Femoral Component 38mm OffsetZimmer Biomet, Inc.
2018-04-25Z-1382-2018Class IIInfinity Acute Care SystemDraegar Medical Systems, Inc.
2018-04-25Z-1383-2018Class IIIntra-Aortic Balloon Catheter Mega 7Datascope Corporation
2018-04-25Z-1384-2018Class IIIntra-Aortic Balloon Catheter Mega 7Datascope Corporation
2018-04-25Z-1385-2018Class IIIntra-Aortic Balloon Catheter Mega 8FR 50cc Product Usage: The…Datascope Corporation
2018-04-25Z-1386-2018Class IISOUTHERN IMPLANTS REF IBR12d-13Southern Implants, (Pty.) Ltd.
2018-04-25Z-1387-2018Class IICold Storage SolutionPreservation Solutions, Inc.
2018-04-25Z-1388-2018Class IIHuman Fetal HemoglobinLife Technologies Corporation
2018-04-25Z-1389-2018Class IIPower-LOAD Cot Fastening SystemStryker Medical Division of Stryker Corporation
2018-04-25Z-1390-2018Class IIFluid Management Convenience KitsAngiodynamics Inc. (Navilyst Medical Inc.)
2018-04-25Z-1391-2018Class IISolid state x-ray imagerNeuroLogica Corporation
2018-04-25Z-1392-2018Class IIIngenuity TF PET/CTPhilips Medical Systems (Cleveland) Inc
2018-04-25Z-1393-2018Class IIGE Healthcare Lunar: a) DPX DuoGE Medical Systems Ultrasound & Primary Care Diagnostics, LL
2018-04-25Z-1394-2018Class IIGE Healthcare Lunar: a) DPX NTGE Medical Systems Ultrasound & Primary Care Diagnostics, LL
2018-04-25Z-1395-2018Class IIGE Healthcare: a) ProdigyGE Medical Systems Ultrasound & Primary Care Diagnostics, LL
2018-04-25Z-1396-2018Class IIBrilliance 64 with 4Philips Medical Systems (Cleveland) Inc
2018-04-25Z-1397-2018Class IIMEVATRON M2 / PRIMUS Mid-EnergySiemens Medical Solutions USA, Inc
2018-04-25Z-1398-2018Class IIONCOR Avant-gardeSiemens Medical Solutions USA, Inc
2018-04-25Z-1399-2018Class IIONCOR ExpressionSiemens Medical Solutions USA, Inc
2018-04-25Z-1400-2018Class IIONCOR ImpressionSiemens Medical Solutions USA, Inc
2018-04-25Z-1401-2018Class IIONCOR Impression PlusSiemens Medical Solutions USA, Inc
2018-04-25Z-1402-2018Class IIPRIMUS HISiemens Medical Solutions USA, Inc
2018-04-25Z-1403-2018Class IITeleflex MEDICAL HUDSON RCI One Way Valve wTeleflex Medical Europe Ltd
2018-04-25Z-1404-2018Class IIIngenuity FlexPhilips Medical Systems (Cleveland) Inc
2018-04-25Z-1405-2018Class IIIngenuity CTPhilips Medical Systems (Cleveland) Inc
2018-04-25Z-1406-2018Class IIIngenuity CorePhilips Medical Systems (Cleveland) Inc
2018-04-25Z-1407-2018Class IIIngenuity Core 128Philips Medical Systems (Cleveland) Inc
2018-04-25Z-1408-2018Class IIBrilliance iCTPhilips Medical Systems (Cleveland) Inc
2018-04-25Z-1409-2018Class IIBrilliance iCT SPPhilips Medical Systems (Cleveland) Inc
2018-04-25Z-1410-2018Class IIBrilliance Big BorePhilips Medical Systems (Cleveland) Inc
2018-04-25Z-1411-2018Class IIBrilliance Big BorePhilips Medical Systems (Cleveland) Inc
2018-04-25Z-1412-2018Class IIBrilliance 16 SlicePhilips Medical Systems (Cleveland) Inc
2018-04-25Z-1413-2018Class IIBrilliance 64Philips Medical Systems (Cleveland) Inc
2018-04-25Z-1414-2018Class IIIQon Spectral CTPhilips Medical Systems (Cleveland) Inc
2018-04-25Z-1415-2018Class IIBrilliance 6 SlicePhilips Medical Systems (Cleveland) Inc
2018-04-25Z-1416-2018Class IITerumo HX2 Temperature Management SystemTerumo Cardiovascular Systems Corporation
2018-04-25Z-1417-2018Class IISarns TCMTerumo Cardiovascular Systems Corporation
2018-04-25Z-1418-2018Class IISarns TCM IITerumo Cardiovascular Systems Corporation
2018-04-25Z-1419-2018Class IIICocaine Metabolite MICRO-PLATE EIAOraSure Technologies, Inc.
2018-04-25Z-1420-2018Class IIProduct: Milford Smartbase Model # 9934105 Pride SmartBase Pride…Autochair
2018-04-25Z-1421-2018Class IIManometerCarefusion 2200 Inc
2018-04-25Z-1422-2018Class IIJAMSHIDI NEEDLE BIOPSY [15G X 100MM DISPCarefusion 2200 Inc
2018-04-25Z-1423-2018Class IIILLINOISCarefusion 2200 Inc
2018-04-25Z-1424-2018Class IIJAMSHIDICarefusion 2200 Inc
2018-04-25Z-1425-2018Class IIJAMSHIDICarefusion 2200 Inc
2018-04-25Z-1426-2018Class IIThoracentesis/ Paracentesis Kit 10/CSCarefusion 2200 Inc
2018-04-25Z-1427-2018Class IIHalyard Closed Suction System for AdultsHalyard Health, Inc
2018-04-25Z-1428-2018Class IIHalyard Closed Suction System for AdultsHalyard Health, Inc
2018-04-25Z-1429-2018Class IIHalyard Closed Suction System for AdultsHalyard Health, Inc
2018-04-25Z-1430-2018Class IIMultiva systemsPhilips Electronics North America Corporation
2018-04-25Z-1431-2018Class IIIntera 0Philips Electronics North America Corporation
2018-04-25Z-1432-2018Class IIIntera 1Philips Electronics North America Corporation
2018-04-25Z-1433-2018Class IIIntera 1Philips Electronics North America Corporation
2018-04-25Z-1434-2018Class IIPanorama 1Philips Electronics North America Corporation
2018-04-25Z-1435-2018Class IIAchieva 1Philips Electronics North America Corporation
2018-04-25Z-1436-2018Class IIConversion SmarthPath to dStream for 1Philips Electronics North America Corporation
2018-04-25Z-1437-2018Class IIIngenia 1Philips Electronics North America Corporation
2018-04-25Z-1438-2018Class IIT5-NTPhilips Electronics North America Corporation
2018-04-25Z-1439-2018Class IIACS-NTPhilips Electronics North America Corporation
2018-04-25Z-1440-2018Class IIT10-NTPhilips Electronics North America Corporation
2018-04-25Z-1441-2018Class IIMultiva systemsPhilips Electronics North America Corporation
2018-04-25Z-1442-2018Class IIT5 Model 78104 Product Usage: Indicated for use as a diagnostic devicePhilips Electronics North America Corporation
2018-04-25Z-1443-2018Class IIStage-1 Tissue PunchKeystone Dental Inc
2018-04-25Z-1444-2018Class IIPatient-Fitted TemporomandibularTMJ Solutions Inc
2018-04-25Z-1460-2018Class IICook Vacuum PumpCook Inc.
2018-04-25Z-1461-2018Class IICook Vacuum PumpCook Inc.
2018-04-18Z-1314-2018Class IITerumo Cardiovascular Procedure Kits containing Pall LG6NS…Terumo Cardiovascular Systems Corp
2018-04-18Z-1315-2018Class IIIntelliVue X3 Patient MonitorPhilips Electronics North America Corporation
2018-04-18Z-1316-2018Class IIHomeSafe AutoAlert Pendant works in conjunction with a compatible…Lifeline Systems Company
2018-04-18Z-1317-2018Class IID-RAD Self-Tapping Locking Screw intended for the fixation of…Smith & Nephew, Inc.
2018-04-18Z-1318-2018Class IIRefractor Suspension ArmReliance Medical Products Inc
2018-04-18Z-1319-2018Class IIProgressa BedHill-Rom, Inc.
2018-04-18Z-1320-2018Class IIHematology Diluent M-30D used with BC-3200 and BC-3600 Hematology…Mindray DS USA, Inc. dba Mindray North America
2018-04-18Z-1321-2018Class IIHematology Diluent M-53D used with BC-5390 Hematology AnalyzerMindray DS USA, Inc. dba Mindray North America
2018-04-18Z-1322-2018Class IIIVITROS Immunodiagnostic Products TSH Reagent PackClinical Diagnostic Systems
2018-04-18Z-1323-2018Class II(1) MAC Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr.…Arrow International Inc
2018-04-18Z-1324-2018Class II(1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit…Arrow International Inc
2018-04-18Z-1325-2018Class IIArrow¿ Pressure Injectable Two-Lumen PICC KitArrow International Inc
2018-04-18Z-1326-2018Class IIAGB+ Multi Lumen Central Venous CatheterizationArrow International Inc
2018-04-18Z-1327-2018Class IIPressure Injectable ARROWArrow International Inc
2018-04-18Z-1328-2018Class IIMulti-Lumen Hemodialysis Catheterization Kit for High Volume InfusionsArrow International Inc
2018-04-18Z-1329-2018Class II(1) Percutaneous Sheath Introducer Kit with Integral Hemostasis…Arrow International Inc
2018-04-18Z-1330-2018Class II(1) Arterial Catheterization Kit, Part Number (PN): ASK-04018-CC; (2)…Arrow International Inc
2018-04-18Z-1331-2018Class II(1) Central Venous Catheterization Kit, Part Number (PN):…Arrow International Inc
2018-04-18Z-1332-2018Class II(1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen…Arrow International Inc
2018-04-18Z-1333-2018Class IIARROWg+ard Blue¿ CVC KitArrow International Inc
2018-04-18Z-1334-2018Class IIArrowg+ard BlueArrow International Inc
2018-04-18Z-1335-2018Class IIAGB+ Multi Lumen CVC KitArrow International Inc
2018-04-18Z-1336-2018Class IIARROWg+ard Blue¿ Two-Lumen Hemodialysis Catheterization Kit for High…Arrow International Inc
2018-04-18Z-1337-2018Class IIGyrus ACMI Round Cutting BurrsGyrus ACMI, Inc.
2018-04-18Z-1338-2018Class IIPDS Plus AntibacterialEthicon, Inc.
2018-04-18Z-1339-2018Class IIPDS Plus AntibacterialEthicon, Inc.
2018-04-18Z-1340-2018Class IIPDS Plus AntibacterialEthicon, Inc.
2018-04-18Z-1341-2018Class IIAQUIOS CL Flow Cytometer SystemBeckman Coulter Inc.
2018-04-18Z-1342-2018Class II6ICU Medical, Inc.
2018-04-18Z-1343-2018Class II6ICU Medical, Inc.
2018-04-18Z-1344-2018Class II7" Ext Set w/MicroClave¿ICU Medical, Inc.
2018-04-18Z-1345-2018Class II7" Smallbore Ext Set w/MicroClave¿ICU Medical, Inc.
2018-04-18Z-1346-2018Class II5"ICU Medical, Inc.
2018-04-18Z-1347-2018Class II14 cmICU Medical, Inc.
2018-04-18Z-1348-2018Class IIAUTO REF/KERATOMETER ARK-1sNidek Inc.
2018-04-18Z-1349-2018Class IIVOLISTA StandOP Surgical LightGETINGE US SALES LLC
2018-04-18Z-1350-2018Class IISpinal Jaxx Interbody Fusion DeviceNeuropro Spinal Jaxx
2018-04-18Z-1351-2018Class IIFoot Controls Model: S-N1 and S-N2 Product Usage: Variable foot…W & H DentalWerk Burmoos GMBH - Site 1
2018-04-18Z-1352-2018Class IIMagstim Rapid Therapy System consisting of: Rapid MainframeThe Magstim Company Limited
2018-04-18Z-1353-2018Class IIFirst aid/emergency kits containing Honeywell eyewash: CSM kit number…Certified Safety Mfg Inc
2018-04-18Z-1354-2018Class IIBardC.R. Bard, Inc.
2018-04-18Z-1355-2018Class IIBardC.R. Bard, Inc.
2018-04-18Z-1356-2018Class IIBardC.R. Bard, Inc.
2018-04-18Z-1357-2018Class IIBardC.R. Bard, Inc.
2018-04-18Z-1358-2018Class IIIDoyen-Collin Mouth Gag 120MM/ General InstrumentsAesculap Implant Systems LLC
2018-04-18Z-1359-2018Class IIIStrauss Penis Clamp 130MM/General InstrumentsAesculap Implant Systems LLC
2018-04-18Z-1360-2018Class IINormed Charcot Osteotome ChiselZimmer GmbH
2018-04-18Z-1362-2018Class IIBECKMAN COULTER iQ200 Series Urine Microscopy AnalyzerBeckman Coulter Inc.
2018-04-18Z-1363-2018Class IIORTHOFIXOrthofix, Inc
2018-04-18Z-1364-2018Class IIORTHOFIXOrthofix, Inc
2018-04-18Z-1365-2018Class IILiberty Select CyclerFresenius Medical Care Renal Therapies Group, LLC
2018-04-18Z-1366-2018Class IIiQ200 Series Urine Microscopy Analyzer with Barcode Reader Model…Beckman Coulter Inc.
2018-04-18Z-1367-2018Class IILatex Rebreathing Bags: Product Code Equivalent CodeTeleflex Medical Europe Ltd
2018-04-18Z-1368-2018Class IIRectal CathetersTeleflex Medical Europe Ltd
2018-04-18Z-1369-2018Class IISimplastic Suprapubic Puncture Instruments: Product Code Equivalent…Teleflex Medical Europe Ltd
2018-04-18Z-1370-2018Class IIBaker Jejunostomy Tubes: Product Code Equivalent CodeTeleflex Medical Europe Ltd
2018-04-18Z-1371-2018Class IIHamilton-C2 Ventilator Unit Intended to provide ventilator support to…Hamilton Medical AG
2018-04-18Z-1372-2018Class IIHamilton-C3 Ventilator Unit Intended to provide ventilator support to…Hamilton Medical AG
2018-04-18Z-1373-2018Class IIHex Driver Part Number HXDRIVER-2TriMed Inc.
2018-04-11Z-1276-2018Class IIPhadia Prime softwarePhadia Ab
2018-04-11Z-1277-2018Class IICORTRAK* 2 Nasogastric/NasointestinalHalyard Health, Inc
2018-04-11Z-1278-2018Class II2008 K2 Hemodialysis Machine with software version 5Fresenius Medical Care Renal Therapies Group, LLC
2018-04-11Z-1279-2018Class IIOncomine Dx Target Test User Guides and Assay Definition FileLife Technologies Corporation
2018-04-11Z-1280-2018Class IIPrismaflex Control UnitBaxter Healthcare Corporation
2018-04-11Z-1281-2018Class IIRadial Artery Catheterization KitArrow International Inc
2018-04-11Z-1282-2018Class IIRadial Artery Catheterization KitArrow International Inc
2018-04-11Z-1283-2018Class IIRadial Artery Catheterization KitArrow International Inc
2018-04-11Z-1284-2018Class IIRadial Artery Catheterization KitArrow International Inc
2018-04-11Z-1285-2018Class IIRadial Artery Catheterization KitArrow International Inc
2018-04-11Z-1286-2018Class IIRadial Artery Catheterization KitArrow International Inc
2018-04-11Z-1287-2018Class IIArterial Access TrayArrow International Inc
2018-04-11Z-1288-2018Class IISouthmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8Southmedic, Inc.
2018-04-11Z-1289-2018Class IIDynaCad software consist of an MR Analysis Server software and the…Invivo Corporation
2018-04-11Z-1290-2018Class IIDS Titanium Ligation ClipAesculap Implant Systems LLC
2018-04-11Z-1291-2018Class IIDS Titanium Ligation Clip AppliersAesculap Implant Systems LLC
2018-04-11Z-1292-2018Class IIUterine Electromyographic MonitorGE Healthcare, LLC
2018-04-11Z-1293-2018Class IIUterine Electromyographic Monitor -Monica IF24 Interface System…GE Healthcare, LLC
2018-04-11Z-1294-2018Class IIAlpha Air 6 ENT Microscope Microscope examination of the human earSeiler Instr. & Mfg. Co. Inc.
2018-04-11Z-1295-2018Class IILeadCare II Blood Lead Analyzer Part Numbers: 70-6760Magellan Diagnostics, Inc.
2018-04-11Z-1296-2018Class IILeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for…Magellan Diagnostics, Inc.
2018-04-11Z-1297-2018Class IILarge Volume Abdominal Paracentesis KitArrow International Inc
2018-04-11Z-1298-2018Class IIArrowClarke" PleuraSeal¿ Thoracentesis KitArrow International Inc
2018-04-11Z-1299-2018Class IIPneumothorax KitArrow International Inc
2018-04-11Z-1300-2018Class IIConfidence Plus Kit Spinal Cement SystemDePuy Spine, Inc.
2018-04-11Z-1301-2018Class IIBinding Site Optilite Beta-2-Microglobulin Urine KitThe Binding Site Group, Ltd.
2018-04-11Z-1302-2018Class IIGE Healthcare Centricity PACS-IWGE Healthcare
2018-04-11Z-1303-2018Class IISyngoSiemens Medical Solutions USA, Inc
2018-04-11Z-1304-2018Class IIDynavox T10 Speech Generating DeviceDynavox Systems Llc
2018-04-11Z-1305-2018Class IIDynavox T15 Speech Generating DeviceDynavox Systems Llc
2018-04-11Z-1306-2018Class IIAZimmer Biomet, Inc.
2018-04-11Z-1307-2018Class IIHydroSil Gripper Intermittent Catheters- 10" lengthsC.R. Bard, Inc.
2018-04-11Z-1308-2018Class IIMagic 3 Intermittent Catheters- 12 MaleC.R. Bard, Inc.
2018-04-11Z-1309-2018Class IIPersonal Intermittent Catheters- 16" and 10" lengthsC.R. Bard, Inc.
2018-04-11Z-1311-2018Class IIElecsys BRAHMS PCT Immunoassay for the in vitro quantitative…Roche Diagnostics Corporation
2018-04-11Z-1312-2018Class IIImmunoCAP Allergen c5Phadia US Inc
2018-04-11Z-1313-2018Class IIImmunoCAP Allergen c6Phadia US Inc
2018-04-04Z-1170-2018Class IIProclaim DRG Implantable Pulse GeneratorSt. Jude Medical, Inc.
2018-04-04Z-1172-2018Class IIHEMASHIELD Knitted Double Velour Cardiovascular FabricGETINGE US SALES LLC
2018-04-04Z-1173-2018Class IIZimmer Biomet Comprehensive Segmental Revision SystemBiomet, Inc.
2018-04-04Z-1174-2018Class IIMINI INFANT < 3KGConMed Corporation
2018-04-04Z-1175-2018Class IIMINI INFANT < 3KGConMed Corporation
2018-04-04Z-1176-2018Class IIMINI INFANT < 3KGConMed Corporation
2018-04-04Z-1177-2018Class IIMINI INFANT < 3KGConMed Corporation
2018-04-04Z-1178-2018Class IIMINI INFANT < 3KGConMed Corporation
2018-04-04Z-1179-2018Class IIISTAGE-1¿ RDS COC Abutment Plastic SleeveKeystone Dental Inc
2018-04-04Z-1180-2018Class IIBD Vacutainer¿ Barricor" Lithium Heparin Plasma Blood Collection…Becton Dickinson & Company
2018-04-04Z-1181-2018Class IIRotating IV Pole Rotating IV Pole falls under the category classified…Ohmeda Medical
2018-04-04Z-1182-2018Class IIFirst Step Flexible Endoscope Bedside Pre-Clean KitMadison Polymeric Engineering
2018-04-04Z-1183-2018Class IISofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer…Quidel Corporation
2018-04-04Z-1184-2018Class IIDimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an…Siemens Healthcare Diagnostics, Inc.
2018-04-04Z-1185-2018Class IINorm-Ject Tuberkulin SyringeCook Inc.
2018-04-04Z-1186-2018Class IIEchosight Jansen-Anderson Intratubal Transfer SetCook Inc.
2018-04-04Z-1187-2018Class IIMarrs Laparoscopic GIFT CathetersCook Inc.
2018-04-04Z-1188-2018Class II1Cook Inc.
2018-04-04Z-1189-2018Class IITapered Screw-Vent MTXZimmer Dental Inc
2018-04-04Z-1190-2018Class IITapered Screw-Vent MTXZimmer Dental Inc
2018-04-04Z-1191-2018Class IIZimmer M/L Taper Hip ProsthesisZimmer Biomet, Inc.
2018-04-04Z-1192-2018Class IIZimmer M/L Taper Hip ProsthesisZimmer Biomet, Inc.
2018-04-04Z-1193-2018Class IITeleflex MEDICAL WECK Visistat 35Teleflex Medical
2018-04-04Z-1194-2018Class IIARROW ENDURANCE" Extended Dwell Peripheral Catheter SystemArrow International Inc
2018-04-04Z-1195-2018Class IINucleic Acid test intended for screening for MRSA/SARoche Molecular Systems, Inc.
2018-04-04Z-1196-2018Class IIAIM Tibial Nails intramedullary fixation rodZimmer Biomet, Inc.

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