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Medical device recalls reported in 2017

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ReportedRecallClassProductFirm
2017-03-08Z-1331-2017Class IILaparoscopy PackWindstone Medical Packaging, Inc.
2017-03-08Z-1332-2017Class IILaparotomy PackWindstone Medical Packaging, Inc.
2017-03-08Z-1333-2017Class IILipo PackWindstone Medical Packaging, Inc.
2017-03-08Z-1334-2017Class IILiposuction PackWindstone Medical Packaging, Inc.
2017-03-08Z-1335-2017Class IILower Extremity PackWindstone Medical Packaging, Inc.
2017-03-08Z-1336-2017Class IILumbar Laminectomy PackWindstone Medical Packaging, Inc.
2017-03-08Z-1337-2017Class IIMajor Breast PackWindstone Medical Packaging, Inc.
2017-03-08Z-1338-2017Class IIMajor KitWindstone Medical Packaging, Inc.
2017-03-08Z-1339-2017Class IIMajor Laparotomy PackWindstone Medical Packaging, Inc.
2017-03-08Z-1340-2017Class IIMajor PackWindstone Medical Packaging, Inc.
2017-03-08Z-1341-2017Class IIMinor PackWindstone Medical Packaging, Inc.
2017-03-08Z-1342-2017Class IIMinor Procedure PackWindstone Medical Packaging, Inc.
2017-03-08Z-1343-2017Class IIMinor TrayWindstone Medical Packaging, Inc.
2017-03-08Z-1344-2017Class IIMinor/General/Ortho PackWindstone Medical Packaging, Inc.
2017-03-08Z-1345-2017Class IIMorris Hysto PackWindstone Medical Packaging, Inc.
2017-03-08Z-1346-2017Class IIMorris Lap PackWindstone Medical Packaging, Inc.
2017-03-08Z-1347-2017Class IINasal PackWindstone Medical Packaging, Inc.
2017-03-08Z-1348-2017Class IINewport Coast Basic PackWindstone Medical Packaging, Inc.
2017-03-08Z-1349-2017Class IIOcular Plastic PackWindstone Medical Packaging, Inc.
2017-03-08Z-1350-2017Class IIOpen Procedure PackWindstone Medical Packaging, Inc.
2017-03-08Z-1351-2017Class IIOpen Procedure Pack IIWindstone Medical Packaging, Inc.
2017-03-08Z-1352-2017Class IIOpgrande Hand PackWindstone Medical Packaging, Inc.
2017-03-08Z-1353-2017Class IIOrbitofacial PackWindstone Medical Packaging, Inc.
2017-03-08Z-1354-2017Class IIOrtho Minor PackWindstone Medical Packaging, Inc.
2017-03-08Z-1355-2017Class IIOrtho PackWindstone Medical Packaging, Inc.
2017-03-08Z-1356-2017Class IIPacemaker KitWindstone Medical Packaging, Inc.
2017-03-08Z-1357-2017Class IIPercutaneous Entry KitWindstone Medical Packaging, Inc.
2017-03-08Z-1358-2017Class IIPeri GYNWindstone Medical Packaging, Inc.
2017-03-08Z-1359-2017Class IIPlastic General PackWindstone Medical Packaging, Inc.
2017-03-08Z-1360-2017Class IIPlastic KitWindstone Medical Packaging, Inc.
2017-03-08Z-1361-2017Class IIPlastic PackWindstone Medical Packaging, Inc.
2017-03-08Z-1362-2017Class IIPlastic Surgery PackWindstone Medical Packaging, Inc.
2017-03-08Z-1363-2017Class IIPodiatry PackWindstone Medical Packaging, Inc.
2017-03-08Z-1364-2017Class IIReduction Mammoplasty PackWindstone Medical Packaging, Inc.
2017-03-08Z-1365-2017Class IIRobotic PackWindstone Medical Packaging, Inc.
2017-03-08Z-1366-2017Class IISet Up PackWindstone Medical Packaging, Inc.
2017-03-08Z-1367-2017Class IISet-Up PackWindstone Medical Packaging, Inc.
2017-03-08Z-1368-2017Class IIShoulder Arthroscopy PackWindstone Medical Packaging, Inc.
2017-03-08Z-1369-2017Class IIShoulder PackWindstone Medical Packaging, Inc.
2017-03-08Z-1370-2017Class IISpine PackWindstone Medical Packaging, Inc.
2017-03-08Z-1371-2017Class IIStem PackWindstone Medical Packaging, Inc.
2017-03-08Z-1372-2017Class IISurgical PackWindstone Medical Packaging, Inc.
2017-03-08Z-1373-2017Class IITotal Hip PackWindstone Medical Packaging, Inc.
2017-03-08Z-1374-2017Class IITotal Joint PackWindstone Medical Packaging, Inc.
2017-03-08Z-1375-2017Class IITotal Knee PackWindstone Medical Packaging, Inc.
2017-03-08Z-1376-2017Class IITransvaginal PackWindstone Medical Packaging, Inc.
2017-03-08Z-1377-2017Class IIUniversal PackWindstone Medical Packaging, Inc.
2017-03-08Z-1378-2017Class IIUpper Extremity PackWindstone Medical Packaging, Inc.
2017-03-08Z-1379-2017Class IIUpper Torso TrayWindstone Medical Packaging, Inc.
2017-03-08Z-1380-2017Class IIVascular PackWindstone Medical Packaging, Inc.
2017-03-08Z-1381-2017Class IIVein TrayWindstone Medical Packaging, Inc.
2017-03-08Z-1382-2017Class IIOP7543 Design Y Mandible OnlayMatrix Surgical Holdings, LLC
2017-03-08Z-1383-2017Class IIPRODISC Orthopedic Manual Surgical InstrumentSynthes (USA) Products LLC
2017-03-08Z-1384-2017Class IIiChemVELOCITY Urine Chemistry SystemBeckman Coulter Inc.
2017-03-08Z-1385-2017Class IIDR Systems Unity PACS softwareMerge Healthcare, Inc.
2017-03-08Z-1386-2017Class IICARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part…Maquet Datascope Corp - Cardiac Assist Division
2017-03-08Z-1387-2017Class IICheck-Flo Performer IntroducerCook Inc.
2017-03-08Z-1388-2017Class IICheck-Flo Performer Introducer SetCook Inc.
2017-03-08Z-1389-2017Class IICheck-Flo Hemostasis AssemblyCook Inc.
2017-03-08Z-1390-2017Class IIFlexor Radial Access SetCook Inc.
2017-03-08Z-1391-2017Class IIMicropuncture Check-Flo Performer Introducer SetCook Inc.
2017-03-08Z-1392-2017Class IICheck-Flo Introducer Hausdorf-Lock AtrialCook Inc.
2017-03-08Z-1393-2017Class IITriForce Peripheral Crossing SetCook Inc.
2017-03-08Z-1394-2017Class IIBD AffirM VPIII Microbial Identification TestBecton Dickinson & Co.
2017-03-08Z-1395-2017Class IISONNET Mini Battery Pack CableProduct Usage: The SONNET Mini Battery…MED-EL Elektromedizinische Gereate, Gmbh
2017-03-08Z-1396-2017Class IIMcKesson Radiology 12Mckesson Medical Imaging
2017-03-01Z-1152-2017Class IIOxford Knee System Tibial Resector Body Tube & Guides Product Usage:…Biomet U.K., Ltd.
2017-03-01Z-1153-2017Class IIOxford Partial Knee System Femoral Slap Hammer Product Usage:…Biomet U.K., Ltd.
2017-03-01Z-1154-2017Class IIOxford Unicompartmental Knee Phase 3 Tibial Impactor Product Usage:…Biomet U.K., Ltd.
2017-03-01Z-1155-2017Class IIOxford Partial Knee System Phase 3 Tibial Template Right Medial Size…Biomet U.K., Ltd.
2017-03-01Z-1156-2017Class IIOxford Partial Knee System Right Medial Tibial Trial Tray Size F…Biomet U.K., Ltd.
2017-03-01Z-1157-2017Class IIOxford Partial Knee System Left Medial Tibial Trial Tray Size F…Biomet U.K., Ltd.
2017-03-01Z-1158-2017Class IIOxford Partial Knee System Right Medial Tibial Trial Tray Size A…Biomet U.K., Ltd.
2017-03-01Z-1159-2017Class IIOxford Partial Knee System Left Medial Tibial Trial Tray Size A…Biomet U.K., Ltd.
2017-03-01Z-1160-2017Class IIOxford Partial Knee System Right Medial Tibial Trial Tray Size E…Biomet U.K., Ltd.
2017-03-01Z-1161-2017Class IIOxford Partial Knee System Left Medial Tibial Trial Tray Size E…Biomet U.K., Ltd.
2017-03-01Z-1162-2017Class IIOxford Partial Knee System Right Medial Tibial Trial Tray Size D…Biomet U.K., Ltd.
2017-03-01Z-1163-2017Class IIOxford Partial Knee System Left Medial Tibial Trial Tray Size D…Biomet U.K., Ltd.
2017-03-01Z-1164-2017Class IIOxford Partial Knee System Right Medial Tibial Trial Tray Size C…Biomet U.K., Ltd.
2017-03-01Z-1165-2017Class IIOxford Partial Knee System Right Medial Tibial Trial Tray Size C…Biomet U.K., Ltd.
2017-03-01Z-1166-2017Class IIOxford Partial Knee System Right Medial Tibial Trial Tray Size B…Biomet U.K., Ltd.
2017-03-01Z-1167-2017Class IIOxford Partial Knee System Left Medial Tibial Trial Tray Size B…Biomet U.K., Ltd.
2017-03-01Z-1168-2017Class IIOxford Unicompartmental Knee Phase 3 Shim Size 3 Product Usage:…Biomet U.K., Ltd.
2017-03-01Z-1169-2017Class IIOxford Unicompartmental Knee Phase 3 Shim Size 2 Product Usage:…Biomet U.K., Ltd.
2017-03-01Z-1170-2017Class IIOxford Unicompartmental Knee Phase 3 Shim Size 1 Product Usage:…Biomet U.K., Ltd.
2017-03-01Z-1171-2017Class IIOxford Partial Knee System Phase 3 Tibial Template Right Medial Size…Biomet U.K., Ltd.
2017-03-01Z-1172-2017Class IIOxford Partial Knee System Phase 3 Tibial Template Left Medial Size C…Biomet U.K., Ltd.
2017-03-01Z-1173-2017Class IIOxford Partial Knee System Phase 3 Tibial Template Right Medial Size…Biomet U.K., Ltd.
2017-03-01Z-1174-2017Class IIOxford Partial Knee System Phase 3 Tibial Template Left Medial Size B…Biomet U.K., Ltd.
2017-03-01Z-1175-2017Class IIOxford Partial Knee System Phase 3 Tibial Template Right Medial Size…Biomet U.K., Ltd.
2017-03-01Z-1223-2017Class IIIAMT BridleApplied Medical Technology Inc
2017-03-01Z-1224-2017Class IIIAMT 12 inch Right Angle Feeding Set with Y-Port Used with…Applied Medical Technology Inc
2017-03-01Z-1225-2017Class IITosoh Bioscience HLC-723G8 Analyzer for HbA1c testingTosoh Bioscience, Inc.
2017-03-01Z-1226-2017Class IIETEST XM256BioMerieux SA
2017-03-01Z-1227-2017Class IIN Latex HCY REAGENTSiemens Healthcare Diagnostics, Inc.
2017-03-01Z-1228-2017Class IIVascular catheter introduction kit The PICC is indicated for short or…Arrow International Inc
2017-03-01Z-1229-2017Class IIPhilips Efficia CMS200 Central Monitoring SystemPhilips Electronics North America Corporation
2017-03-01Z-1230-2017Class IIDIAMONDBACK 360 Peripheral 1Cardiovascular Systems Inc
2017-03-01Z-1231-2017Class IIInfluenza Transport Swab PackagesQuidel Corporation
2017-03-01Z-1232-2017Class IITitan" Stabilizer Attachment and Titan TM 360 Stabilizer AttachmentTerumo Cardiovascular Systems Corporation
2017-03-01Z-1233-2017Class IIJackson-Pratt Channel Drain Silicone RoundDegania Silicone, Ltd.
2017-03-01Z-1234-2017Class IICMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc…Custom Medical Specialties, Inc.
2017-03-01Z-1235-2017Class IIThe Sarns Centrifugal Pump is a single use device sterilized by…Terumo Cardiovascular Systems Corporation
2017-03-01Z-1236-2017Class IIIHidrex USA DP450Hidrex GmbH
2017-03-01Z-1237-2017Class IIIHidrex USA DVP1000Hidrex GmbH
2017-03-01Z-1238-2017Class IIIDaavlin AquexHidrex GmbH
2017-03-01Z-1239-2017Class IISmith & Nephew Dyonics Saw BladeSmith & Nephew, Inc.
2017-03-01Z-1240-2017Class IISmith & Nephew Dyonics Saw BladeSmith & Nephew, Inc.
2017-03-01Z-1241-2017Class IISmith & Nephew Dyonics Saw BladeSmith & Nephew, Inc.
2017-03-01Z-1242-2017Class IISmith & Nephew Dyonics Saw BladeSmith & Nephew, Inc.
2017-03-01Z-1243-2017Class IISmith & Nephew Dyonics Saw BladeSmith & Nephew, Inc.
2017-03-01Z-1244-2017Class IISmith & Nephew Dyonics Saw BladeSmith & Nephew, Inc.
2017-03-01Z-1245-2017Class IIKeyspan High-High Speed USB to Serial Adapter Product Usage: The…Tosoh Smd Inc
2017-03-01Z-1246-2017Class IIMerge Eye Station Import UtilityMerge Healthcare, Inc.
2017-03-01Z-1247-2017Class IIIDeRoyal Heart Tracecart REF 53-1769DeRoyal Industries Inc
2017-03-01Z-1248-2017Class IIISRHS DeRoyal Heart Tracecart REF 53-1913DeRoyal Industries Inc
2017-03-01Z-1249-2017Class IIDurex Pleasure PackReckitt Benckiser LLC
2017-03-01Z-1250-2017Class IIGrebSet Micro-Introducer KitVascular Solutions, Inc.
2017-02-22Z-1103-2017Class IComprehensive Reverse Shoulder System Humeral Tray Model 115340Zimmer Biomet, Inc.
2017-02-22Z-1123-2017Class ILIFEPAK 15 MonitorPhysio-Control, Inc.
2017-02-22Z-1186-2017Class IIBrightView XCTPhilips Medical Systems (Cleveland) Inc
2017-02-22Z-1187-2017Class IIBrightView X upgraded to XCT 882454Philips Medical Systems (Cleveland) Inc
2017-02-22Z-1188-2017Class IIDiscovery MR450 The systems are whole body magnetic resonance…GE Healthcare, LLC
2017-02-22Z-1189-2017Class IIBD Vacutainer Buffered Sodium Citrate:Becton Dickinson & Company
2017-02-22Z-1190-2017Class IIOffset Reamer HandleGreatbatch Medical
2017-02-22Z-1191-2017Class IILIMA Modular Revision Hip Stem Model 428-01-050_110 Product Usage:…Encore Medical, Lp
2017-02-22Z-1192-2017Class IIIntegra Cadence Total Ankle SystemIntegra LifeSciences Corp.
2017-02-22Z-1193-2017Class IIStryker Restoris RIO Reamer HandleMako Surgical Corporation
2017-02-22Z-1194-2017Class IIBONE MARROW ASPIRATION NEEDLE 15G x 2Argon Medical Devices, Inc
2017-02-22Z-1195-2017Class IIT-LOK BONE MARROW BIOPSY NEEDLE 8G x 4 EXT CANArgon Medical Devices, Inc
2017-02-22Z-1196-2017Class IIHARVEST NEEDLE 15GA X 2 Intended for the purpose of harvesting bone…Argon Medical Devices, Inc
2017-02-22Z-1197-2017Class IISTERRAD NX Sterilization SystemAdvanced Sterilization Products
2017-02-22Z-1198-2017Class IIArthrex Shoulder Suspension TowerAllen Medical Systems, Inc.
2017-02-22Z-1199-2017Class II6-hole Pubic Symphysis plateAcumed LLC
2017-02-22Z-1200-2017Class IIVIDAS 3 software vBioMerieux SA
2017-02-22Z-1201-2017Class IIHercules 360 Universal Stabilizing ArmTerumo Cardiovascular Systems Corporation
2017-02-22Z-1202-2017Class IIStarClose SE Vascular Closure SystemAbbott Vascular
2017-02-22Z-1203-2017Class IIThe Schiller PB 1000Merge Healthcare, Inc.
2017-02-22Z-1204-2017Class IICentraLink¿ Data Management System Software Versions: v13xSiemens Healthcare Diagnostics, Inc.
2017-02-22Z-1205-2017Class IIMaquet Ocean Water Seal Chest DrainAtrium Medical Corporation
2017-02-22Z-1206-2017Class IIMaquet Ocean Water Seal Chest DrainAtrium Medical Corporation
2017-02-22Z-1207-2017Class IIMaquet Oasis Dry Suction Water Seal Chest DrainAtrium Medical Corporation
2017-02-22Z-1208-2017Class IIMaquet Express Dry Seal Suction Chest DrainAtrium Medical Corporation
2017-02-22Z-1209-2017Class IIMaquet Express Dry Seal Suction OCEAN DRAINAtrium Medical Corporation
2017-02-22Z-1210-2017Class IIMaquet Express Dry Seal Suction OCEAN DRAINAtrium Medical Corporation
2017-02-22Z-1211-2017Class IIMaquet Express Dry Seal Suction OASIS DRAINAtrium Medical Corporation
2017-02-22Z-1212-2017Class IIARTISTE MV SystemSiemens Medical Solutions USA, Inc
2017-02-22Z-1213-2017Class IIONCOR Avant-gardeSiemens Medical Solutions USA, Inc
2017-02-22Z-1214-2017Class IIONCOR ImpressionSiemens Medical Solutions USA, Inc
2017-02-22Z-1215-2017Class IIPRIMUS Medical charged-particle radiation therapy system Product…Siemens Medical Solutions USA, Inc
2017-02-22Z-1216-2017Class IIIThe Enzyme 2 Calibrator is an in vitro diagnostic product for the…Siemens Healthcare Diagnostics, Inc.
2017-02-22Z-1217-2017Class IIIThe Enzyme II Calibrator is an in vitro diagnostic product for the…Siemens Healthcare Diagnostics, Inc.
2017-02-22Z-1218-2017Class IIGN200 Caiman HF generatorsAesculap Implant Systems LLC
2017-02-22Z-1219-2017Class IIVanguard Total KneeZimmer Biomet, Inc.
2017-02-22Z-1220-2017Class II1Zimmer Biomet, Inc.
2017-02-22Z-1221-2017Class IIAtrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008Atrium Medical Corporation
2017-02-22Z-1222-2017Class IIAtrium PVC 10 Fr Straight Thoracic Catheter Code Number: 8010Atrium Medical Corporation
2017-02-15Z-0927-2017Class IIMEDRAD Intego PET Infusion SystemBayer Healthcare
2017-02-15Z-1137-2017Class IICelerity ECG Cable Accessory PackAngiodynamics Inc. (Navilyst Medical Inc.)
2017-02-15Z-1138-2017Class IICarestream DRX-Revolution Mobile X-Ray SystemCarestream Health Inc
2017-02-15Z-1139-2017Class IIEmpowr PS Knee Tibial InsertEncore Medical, Lp
2017-02-15Z-1140-2017Class IIDimension¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The AMM…Siemens Healthcare Diagnostics, Inc.
2017-02-15Z-1141-2017Class IIDimension Vista¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The…Siemens Healthcare Diagnostics, Inc.
2017-02-15Z-1142-2017Class IIMerge Eye StationMerge Healthcare, Inc.
2017-02-15Z-1143-2017Class IILIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 optionPhysio-Control, Inc.
2017-02-15Z-1144-2017Class IILIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 optionPhysio-Control, Inc.
2017-02-15Z-1145-2017Class IIIHOTLINE Blood and Fluid WarmerSmiths Medical ASD, Inc.
2017-02-15Z-1146-2017Class IIThayer MiniSpacer Dual Spray MDI Adapter Counter Incrementing…Thayer Medical Corporation
2017-02-15Z-1148-2017Class IIAtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" ClipAtriCure, Inc.
2017-02-15Z-1149-2017Class IIQUINTUBE Monitor PackStryker Leibinger GmbH & Co. KG
2017-02-15Z-1150-2017Class II9805 Orbital Volume Sizer Set with TrayStryker Leibinger GmbH & Co. KG
2017-02-15Z-1151-2017Class IIInterFuse Tail Traction ToolVertebral Technologies, Inc.
2017-02-15Z-1176-2017Class IIMerge PACS softwareMerge Healthcare, Inc.
2017-02-15Z-1177-2017Class IISheridan/CFTeleflex Medical
2017-02-15Z-1178-2017Class IIBoston ScientificBoston Scientific Corporation
2017-02-15Z-1179-2017Class IIVITROS Chemistry Products UPRO SlidesOrtho-Clinical Diagnostics
2017-02-15Z-1180-2017Class IIMerge RadSuite softwareMerge Healthcare, Inc.
2017-02-15Z-1181-2017Class IIIVITROS Chemistry Products FS Calibrator 1Ortho-Clinical Diagnostics
2017-02-15Z-1182-2017Class IIBariatric BedInvacare Corporation
2017-02-15Z-1183-2017Class IIBariatric BedInvacare Corporation
2017-02-15Z-1184-2017Class IIFoot SectionInvacare Corporation
2017-02-15Z-1185-2017Class IIJunction BoxInvacare Corporation
2017-02-08Z-1036-2017Class IIOlympus Scientific Solutions Americas CorporationOlympus Scientific Solutions Americas
2017-02-08Z-1107-2017Class IIGenetic Screening ProcessorPerkinElmer Life and Analytical Sciences, Wallac, OY
2017-02-08Z-1108-2017Class IISpare Disk Remover ModulePerkinElmer Life and Analytical Sciences, Wallac, OY
2017-02-08Z-1109-2017Class IICryptococcal Antigen Lateral Flow AssayImmuno-Mycologics, Inc
2017-02-08Z-1110-2017Class IIRENOVIX Guided Healing Collagen Membrane Intended for use in oral…Biom'up
2017-02-08Z-1111-2017Class IISPS-1Organ Recovery Systems, Inc.
2017-02-08Z-1112-2017Class IISwishTapered ImplantImplant Direct Sybron Manufacturing, LLC
2017-02-08Z-1113-2017Class IICannulated Drill bit 2Flower Orthopedics Corporation
2017-02-08Z-1114-2017Class IIOrthopedic Salvage SystemZimmer Biomet, Inc.
2017-02-08Z-1115-2017Class IIVanguard Total Knee System Vanguard Open Box Femoral Components Item…Zimmer Biomet, Inc.
2017-02-08Z-1116-2017Class IISyngoSiemens Medical Solutions USA, Inc
2017-02-08Z-1117-2017Class IIVITROS Na+ SlidesOrtho-Clinical Diagnostics
2017-02-08Z-1118-2017Class IIMammomat Inspiration fullSiemens Medical Solutions USA, Inc
2017-02-08Z-1119-2017Class IIIMMULITE/IMMULITE 1000 SystemsSiemens Healthcare Diagnostics, Inc.
2017-02-08Z-1120-2017Class IIIMMULITE/IMMULITE 1000 SystemsSiemens Healthcare Diagnostics, Inc.
2017-02-08Z-1121-2017Class IIMedtronic Strata II / Strata NSC ValvesMedtronic Neurosurgery
2017-02-08Z-1122-2017Class IIMEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation…Mevion Medical Systems, Inc.
2017-02-08Z-1124-2017Class IISynthes Radial Head Prosthesis SystemSynthes (USA) Products LLC

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