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Medical device recalls reported in 2024

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ReportedRecallClassProductFirm
2024-03-06Z-1097-2024Class IMEDLINE KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1098-2024Class IMEDLINE KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1099-2024Class ICenturion KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1100-2024Class IMEDLINE KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1101-2024Class IMEDLINE KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1102-2024Class IMEDLINE KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1103-2024Class IMEDLINE KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1104-2024Class IMEDLINE KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1105-2024Class IMEDLINE KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1106-2024Class IMEDLINE KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1107-2024Class ICenturion KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1108-2024Class IMedline KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1109-2024Class IMedline KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1110-2024Class IMedline KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1111-2024Class IMedline KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1112-2024Class IMedline KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1113-2024Class IMedline KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1114-2024Class IMedline KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1115-2024Class IMedline KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1116-2024Class IMedline KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1117-2024Class IMedline KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1118-2024Class IMedline KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1119-2024Class IMedline KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1120-2024Class IMedline KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1121-2024Class IMedline KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1122-2024Class IMedline KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1123-2024Class IMedline KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1124-2024Class IMedline KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1125-2024Class IMedline KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1126-2024Class IMedline KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1127-2024Class IMedline KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1128-2024Class IMedline KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1129-2024Class ICenturion KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1130-2024Class ICenturion KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1131-2024Class ICenturion KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1132-2024Class ICenturion KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1133-2024Class ICenturion KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1134-2024Class ICenturion KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1135-2024Class ICenturion KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1136-2024Class ICenturion KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1137-2024Class ICenturion KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1138-2024Class ICenturion KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1162-2024Class IMedtronic Duet External Drainage and Monitoring SystemMedtronic Neurosurgery
2024-03-06Z-1163-2024Class IMedtronic Duet External Drainage and Monitoring SystemMedtronic Neurosurgery
2024-03-06Z-1164-2024Class IMedtronic Duet External Drainage and Monitoring SystemMedtronic Neurosurgery
2024-03-06Z-1165-2024Class IMedtronic Duet External Drainage and Monitoring SystemMedtronic Neurosurgery
2024-03-06Z-1166-2024Class IMedtronic Duet External Drainage and Monitoring SystemMedtronic Neurosurgery
2024-03-06Z-1182-2024Class IIIdentiTi ALIF Standalone Interbody System: Part Number/Description…Alphatec Spine, Inc.
2024-03-06Z-1183-2024Class IIZyno Medical Z800 Large Volume Infusion Pumps -Intended to provide…Zyno Medical LLC
2024-03-06Z-1184-2024Class IIRebstock Holding rod for fixation -For holding and fixation of…Medagent Inc
2024-03-06Z-1185-2024Class IISchiff ReagentEMD Millipore Corporation
2024-03-06Z-1188-2024Class IIIIn-vitro diagnostic kits:Abbott Molecular, Inc.
2024-03-06Z-1189-2024Class IIIIn-vitro diagnostic kits:Abbott Molecular, Inc.
2024-03-06Z-1190-2024Class IIIWash station: M1000 Wash Station Assembly & DITI SlideAbbott Molecular, Inc.
2024-03-06Z-1191-2024Class IINxStage Cartridge Express with SpeedswapNxStage MDS Corporation
2024-03-06Z-1192-2024Class IIGRAPHENANO DENTAL G-CAMGRAPHENANO DENTAL SL
2024-03-06Z-1193-2024Class IIRef No: 31156 / COMBO KIT CONTAINS INS-8301Integra LifeSciences Corp.
2024-03-06Z-1194-2024Class IIRef No: HITHSP04 / Integra Cranial Access KitIntegra LifeSciences Corp.
2024-03-06Z-1195-2024Class IIRef No: HITHSP06 / Integra Cranial Access KitIntegra LifeSciences Corp.
2024-03-06Z-1196-2024Class IIRef No: INS5HND / Integra Cranial access kitIntegra LifeSciences Corp.
2024-03-06Z-1197-2024Class IIRef No: INS7250 / Integra Cranial Access KitIntegra LifeSciences Corp.
2024-03-06Z-1198-2024Class IIRef No: INS7260 / Integra¿ Cranial Access KitIntegra LifeSciences Corp.
2024-03-06Z-1199-2024Class IIRef No: INS7270 / Integra¿ Cranial Access KitIntegra LifeSciences Corp.
2024-03-06Z-1200-2024Class IIINS7280 / Integra¿ Cranial Access KitIntegra LifeSciences Corp.
2024-03-06Z-1201-2024Class IIRef No: INSHITH / Integra¿ Cranial Access KitIntegra LifeSciences Corp.
2024-03-06Z-1202-2024Class IIRef No: INSHITHND / Integra¿ Cranial access kitIntegra LifeSciences Corp.
2024-03-06Z-1203-2024Class IIRef No: INSHITHRZN / Integra Cranial Access KitIntegra LifeSciences Corp.
2024-03-06Z-1204-2024Class IITensive Conductive Adhesive GelParker Laboratories, Inc.
2024-03-06Z-1205-2024Class IIColonoscopeOlympus Corporation of the Americas
2024-03-06Z-1206-2024Class IIColonoscopeOlympus Corporation of the Americas
2024-03-06Z-1207-2024Class IIColonoscopeOlympus Corporation of the Americas
2024-03-06Z-1208-2024Class IIColonoscopeOlympus Corporation of the Americas
2024-03-06Z-1209-2024Class IIColonoscopeOlympus Corporation of the Americas
2024-03-06Z-1210-2024Class IIColonoscopeOlympus Corporation of the Americas
2024-03-06Z-1211-2024Class IIColonoscopeOlympus Corporation of the Americas
2024-03-06Z-1212-2024Class IIColonoscopeOlympus Corporation of the Americas
2024-03-06Z-1213-2024Class IIColonoscopeOlympus Corporation of the Americas
2024-03-06Z-1214-2024Class IIColonoscopeOlympus Corporation of the Americas
2024-03-06Z-1215-2024Class IIUSTAR II Hip System Press-Fit Curved StemUnited Orthopedic Corporation
2024-03-06Z-1216-2024Class IIUSTAR II Knee System Cemented curved stemUnited Orthopedic Corporation
2024-03-06Z-1217-2024Class IIUSTAR II Knee System : Cemented Curved StemUnited Orthopedic Corporation
2024-03-06Z-1218-2024Class IIAcu-Loc and Acu-Loc 2 bone platesAcumed LLC
2024-03-06Z-1219-2024Class IILINK BiMobile Dual Mobility System E-Poly Liner for 28mm HeadWaldemar Link GmbH & Co. KG (Mfg Site)
2024-02-28Z-1001-2024Class IBaxter Exactamix Pro 1200Baxter Healthcare Corporation
2024-02-28Z-1002-2024Class IBaxter Exactamix Pro 2400Baxter Healthcare Corporation
2024-02-28Z-1043-2024Class IArgyle" Suction Catheter Tray with Chimney Valve Sterile Saline 18…Cardinal Health 200, LLC
2024-02-28Z-1044-2024Class ITRACH KIT W/HYDROGEN & SALICardinal Health 200, LLC
2024-02-28Z-1045-2024Class IDover" 100% SILICONE 400 ML U/M FOLEY TRAYCardinal Health 200, LLC
2024-02-28Z-1046-2024Class IDover URINE METER ADD-A-FOLEY TRAYCardinal Health 200, LLC
2024-02-28Z-1047-2024Class IDover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAYCardinal Health 200, LLC
2024-02-28Z-1048-2024Class IDover" 100% SILICONE 400 ML U/M FOLEY TRAYCardinal Health 200, LLC
2024-02-28Z-1049-2024Class IDover" IRRIGATION 1200 CC TRAYCardinal Health 200, LLC
2024-02-28Z-1050-2024Class IDover" 100% SILICONE FOLEY TRAYCardinal Health 200, LLC
2024-02-28Z-1051-2024Class IDover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAYCardinal Health 200, LLC
2024-02-28Z-1052-2024Class IDover" 100% SILICONE FOLEY TRAYCardinal Health 200, LLC
2024-02-28Z-1079-2024Class IAligned Medical SolutionsWindstone Medical Packaging, Inc.
2024-02-28Z-1080-2024Class IAligned Medical SolutionsWindstone Medical Packaging, Inc.
2024-02-28Z-1081-2024Class IAligned Medical SolutionsWindstone Medical Packaging, Inc.
2024-02-28Z-1082-2024Class IAligned Medical SolutionsWindstone Medical Packaging, Inc.
2024-02-28Z-1142-2024Class IIIonoStar PlusVoco GmbH
2024-02-28Z-1143-2024Class IIIonoluxVoco GmbH
2024-02-28Z-1144-2024Class IIPhilips Allura Xper Interventional Fluoroscopic X-ray SystemsPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2024-02-28Z-1145-2024Class IIPhilips Azurion Interventional Fluoroscopic X-ray SystemsPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2024-02-28Z-1146-2024Class IIHENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3AMD Medicom Inc.
2024-02-28Z-1147-2024Class IIHENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3AMD Medicom Inc.
2024-02-28Z-1148-2024Class IIPATTERSON¿ PROCEDURE EARLOOP MASKS- ANTI-FOGAMD Medicom Inc.
2024-02-28Z-1149-2024Class IIEpidural trayB. Braun Medical, Inc.
2024-02-28Z-1150-2024Class IIEpidural trayB. Braun Medical, Inc.
2024-02-28Z-1151-2024Class IIPhilips Allura Xper Interventional Fluoroscopic X-ray SystemsPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2024-02-28Z-1152-2024Class IIPhilips Azurion Interventional Fluoroscopic X-ray SystemsPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2024-02-28Z-1153-2024Class IIEndoVive Replacement Button Kit w/ ENFIT 28F 2Boston Scientific Corporation
2024-02-28Z-1154-2024Class IIThe device is an X-ray system that is capable of radiographic and…Canon Medical System, USA, INC.
2024-02-28Z-1155-2024Class IIThe INFX-8000F is designed to take advantage of the latest…Canon Medical System, USA, INC.
2024-02-28Z-1156-2024Class IIPhilips Allura Xper Interventional Fluoroscopic X-ray SystemsPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2024-02-28Z-1167-2024Class IIESG PK CUTTING FORCEPSOlympus Corporation of the Americas
2024-02-28Z-1168-2024Class IIW&H Surgical handpiece S-12W&H DENTALWERK BUERMOOS GMBH
2024-02-28Z-1169-2024Class II3M Specialty Blade Assembly3M Company - Health Care Business
2024-02-28Z-1170-2024Class II3M Specialty Blade Assembly3M Company - Health Care Business
2024-02-28Z-1171-2024Class IISynapse Cardiology PACS V7FUJIFILM Healthcare Americas Corporation
2024-02-28Z-1172-2024Class IISynapse CV 6FUJIFILM Healthcare Americas Corporation
2024-02-28Z-1173-2024Class IIOPTIMIZER model CCM X11 implantable pulse generatorIMPULSE DYNAMICS (USA) INC
2024-02-28Z-1174-2024Class IIAQUABILITI AQUASTAT 0MRP, LLC dba Aquabiliti
2024-02-28Z-1175-2024Class IIAutomated Impella ControllerAbiomed, Inc.
2024-02-28Z-1176-2024Class IIAzurion 3 with a Certeray generator -To perform image guidance in…PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2024-02-28Z-1177-2024Class IIAzurion 5 with a Certeray generator-To perform image guidance in…PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2024-02-28Z-1178-2024Class IIAzurion 7 with a Certeray generator-To perform image guidance in…PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2024-02-28Z-1179-2024Class IIGORE VIABIL Short Wire Biliary EndoprosthesisW.L. Gore & Associates, Inc.
2024-02-28Z-1180-2024Class IIThese wipes are saturated with 0MEDLINE INDUSTRIES, LP - Northfield
2024-02-28Z-1181-2024Class IISoftware VERIQAPTW-FREIBURG
2024-02-21Z-0957-2024Class IGE Healthcare neonatal incubatorWipro GE Healthcare Private Ltd.
2024-02-21Z-0958-2024Class IGE Healthcare neonatal incubatorWipro GE Healthcare Private Ltd.
2024-02-21Z-0959-2024Class IGE Healthcare Care Plus Hood Field Replacement UnitWipro GE Healthcare Private Ltd.
2024-02-21Z-0960-2024Class IGE Healthcare Care Plus Hood Door FRU kitWipro GE Healthcare Private Ltd.
2024-02-21Z-0961-2024Class IGE Healthcare Lullaby Incubator Model Hood FRU kitWipro GE Healthcare Private Ltd.
2024-02-21Z-0962-2024Class IGE Healthcare Lullaby Incubator Model Hood Door FRU kitWipro GE Healthcare Private Ltd.
2024-02-21Z-0980-2024Class IImpella cathetersAbiomed, Inc.
2024-02-21Z-1056-2024Class IISamsung Digital Diagnostic Mobile X-ray SystemNeuroLogica Corporation
2024-02-21Z-1066-2024Class IIAFTMusculoskeletal Transplant Foundation, Inc.
2024-02-21Z-1067-2024Class IIAFTMusculoskeletal Transplant Foundation, Inc.
2024-02-21Z-1068-2024Class IIAccessory Sets Syringes: 6ml syringe with a female luer with 15cm…OriGen Biomedical, Inc.
2024-02-21Z-1069-2024Class IICaptus 4000e Thyroid Uptake Systems- Intended to be used by trained…Mirion Technologies (Capintec), Inc.
2024-02-21Z-1071-2024Class IISingle Use Distal Cover MAJ-2315 Used with: EVIS EXERA III…Olympus Corporation of the Americas
2024-02-21Z-1072-2024Class IIProxiDiagnost N90- A Multi-functional general Radiography and…Philips North America
2024-02-21Z-1073-2024Class IIProxiDiagnost upgrade- A Multi-functional general Radiography and…Philips North America
2024-02-21Z-1074-2024Class IIImpella cathetersAbiomed, Inc.
2024-02-21Z-1075-2024Class IIMicrobiologics Enteric Pathogens Control PanelMicrobiologics Inc
2024-02-21Z-1076-2024Class IIModel NoMaquet Medical Systems USA
2024-02-21Z-1077-2024Class IIBEQ-HLS 7050 USAMaquet Medical Systems USA
2024-02-21Z-1078-2024Class II3:1 DermacarrierZimmer Surgical Inc
2024-02-21Z-1083-2024Class IIMobileDiagnost wDRSEDECAL SA
2024-02-21Z-1084-2024Class IIStryker NeurovascularStryker, Inc.
2024-02-21Z-1085-2024Class IIStryker NeurovascularStryker, Inc.
2024-02-21Z-1086-2024Class IIThe Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence…Quidel Corporation
2024-02-21Z-1087-2024Class IICombiDiagnost R90 1PHILIPS MEDICAL SYSTEMS
2024-02-21Z-1088-2024Class IICombiDiagnost R90 1PHILIPS MEDICAL SYSTEMS
2024-02-21Z-1089-2024Class IIglobal MediumCooperSurgical, Inc.
2024-02-21Z-1139-2024Class IIBIOFIRE Blood Culture Identification 2BioFire Diagnostics, LLC
2024-02-21Z-1140-2024Class IIFilmArray GastrointestinalBioFire Diagnostics, LLC
2024-02-21Z-1141-2024Class IIHeartSine samaritan PADHeartSine Technologies Ltd
2024-02-14Z-0842-2024Class I1Thoratec Corp.
2024-02-14Z-0847-2024Class ICardinal Health MonojectCardinal Health 200, LLC
2024-02-14Z-0848-2024Class ICardinal Health MonojectCardinal Health 200, LLC
2024-02-14Z-0849-2024Class ICardinal Health MonojectCardinal Health 200, LLC
2024-02-14Z-0850-2024Class ICardinal Health MonojectCardinal Health 200, LLC
2024-02-14Z-0851-2024Class ICardinal Health MonojectCardinal Health 200, LLC
2024-02-14Z-0852-2024Class ICardinal Health MonojectCardinal Health 200, LLC
2024-02-14Z-0853-2024Class ICardinal Health MonojectCardinal Health 200, LLC
2024-02-14Z-0854-2024Class ICardinal Health MonojectCardinal Health 200, LLC
2024-02-14Z-0855-2024Class ICardinal Health MonojectCardinal Health 200, LLC
2024-02-14Z-0856-2024Class ICardinal Health MonojectCardinal Health 200, LLC
2024-02-14Z-0857-2024Class ICardinal Health MonojectCardinal Health 200, LLC
2024-02-14Z-0858-2024Class ICardinal Health MonojectCardinal Health 200, LLC
2024-02-14Z-0859-2024Class ICardinal Health MonojectCardinal Health 200, LLC
2024-02-14Z-0862-2024Class IISenographe PristinaGE Medical Systems, SCS
2024-02-14Z-0929-2024Class IBrightViewPhilips North America
2024-02-14Z-0930-2024Class IBrightView XPhilips North America
2024-02-14Z-0931-2024Class IBrightView XCTPhilips North America
2024-02-14Z-0973-2024Class IIIngenia 1Philips North America
2024-02-14Z-0974-2024Class IIIngenia Elition XPhilips North America
2024-02-14Z-0975-2024Class IIIngenia Ambition XPhilips North America
2024-02-14Z-0976-2024Class IIFLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodonticsG & H Wire Company
2024-02-14Z-0977-2024Class IIBEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE CoatingMaquet Medical Systems USA
2024-02-14Z-0978-2024Class IIBO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE CoatingMaquet Medical Systems USA
2024-02-14Z-0979-2024Class IIBarco MDSC-8527 NXFBarco N.V.
2024-02-14Z-0981-2024Class IIAccess Ultrasensitive Insulin only used on the DxI 9000 Access…Beckman Coulter, Inc.
2024-02-14Z-0982-2024Class IIDxI 9000 Access Immunoassay Analyzer running software version 1Beckman Coulter, Inc.
2024-02-14Z-0983-2024Class IIDual Articulating HeadrestSteris Corporation
2024-02-14Z-0984-2024Class IIDual Articulating HeadrestSteris Corporation
2024-02-14Z-0985-2024Class IIBox as labeled: RegardCooperSurgical, Inc.
2024-02-14Z-0986-2024Class IIAbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5…Covidien LP
2024-02-14Z-0987-2024Class IIFlow-i C20 Anesthesia SystemGetinge Usa Sales Inc
2024-02-14Z-0988-2024Class IIFlow-i C30 Anesthesia SystemGetinge Usa Sales Inc
2024-02-14Z-0989-2024Class IIFlow-i C40 Anesthesia SystemGetinge Usa Sales Inc
2024-02-14Z-0990-2024Class IIFlow-c Anesthesia SystemGetinge Usa Sales Inc
2024-02-14Z-0991-2024Class IIFlow-e Anesthesia SystemGetinge Usa Sales Inc
2024-02-14Z-0992-2024Class IIRX Series CopperRandox Laboratories Ltd.
2024-02-14Z-0993-2024Class IIFilmArray Pneumonia Panel PlusBioFire Diagnostics, LLC
2024-02-14Z-0994-2024Class IIFilmArray Pneumonia PanelBioFire Diagnostics, LLC
2024-02-14Z-0995-2024Class IIGlobus Medical Cranial Drill with StopGlobus Medical, Inc.
2024-02-14Z-0996-2024Class IIGlobus Medical Cranial Drill with StopGlobus Medical, Inc.

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