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Medical device recalls reported in 2025

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ReportedRecallClassProductFirm
2025-04-02Z-1461-2025Class IIMedline procedure kits labeled as: 1) BILLINGS CLINIC SC HEAD & NECKMEDLINE INDUSTRIES, LP - Northfield
2025-04-02Z-1462-2025Class IIMedline procedure kits labeled as: 1) BREAST PACK-LFMEDLINE INDUSTRIES, LP - Northfield
2025-04-02Z-1463-2025Class IIMedline procedure kits labeled as: 1) ANGIOGRAPHY SPECIALSMEDLINE INDUSTRIES, LP - Northfield
2025-04-02Z-1464-2025Class IIMedline procedure kits labeled as: 1) ACOUSTIC NEUROMA PACK-LFMEDLINE INDUSTRIES, LP - Northfield
2025-04-02Z-1465-2025Class IIMedline procedure kits labeled as: 1) ACL ARTHROSCOPY PACKMEDLINE INDUSTRIES, LP - Northfield
2025-04-02Z-1466-2025Class IIBrand Name: Checkpoint Guardian Intraoperative Lead Product Name:…Checkpoint Surgical Inc
2025-04-02Z-1467-2025Class IIBrand Name: Checkpoint Guardian Intraoperative Lead Product Name:…Checkpoint Surgical Inc
2025-04-02Z-1468-2025Class IIProgressa Bed SurfacesBaxter Healthcare Corporation
2025-03-26Z-1277-2025Class Ismiths medical ProPort Plastic Venous Access SystemSmiths Medical ASD, Inc.
2025-03-26Z-1278-2025Class Ismiths medical ProPort Plastic Venous Access SystemSmiths Medical ASD, Inc.
2025-03-26Z-1279-2025Class Ismiths medical ProPort Plastic Venous Access SystemSmiths Medical ASD, Inc.
2025-03-26Z-1280-2025Class Ismiths medical ProPort Plastic Venous Access SystemSmiths Medical ASD, Inc.
2025-03-26Z-1281-2025Class Ismiths medical ProPort Plastic Venous Access SystemSmiths Medical ASD, Inc.
2025-03-26Z-1282-2025Class Ismiths medical ProPort Plastic Venous Access SystemSmiths Medical ASD, Inc.
2025-03-26Z-1283-2025Class Ismiths medical ProPort Plastic Venous Access SystemSmiths Medical ASD, Inc.
2025-03-26Z-1284-2025Class Ismiths medical ProPort Plastic Venous Access SystemSmiths Medical ASD, Inc.
2025-03-26Z-1285-2025Class Ismiths medical ProPort Plastic Venous Access SystemSmiths Medical ASD, Inc.
2025-03-26Z-1286-2025Class Ismiths medical ProPort Plastic Venous Access SystemSmiths Medical ASD, Inc.
2025-03-26Z-1287-2025Class Ismiths medical ProPort Low Profile Plastic Venous Access SystemSmiths Medical ASD, Inc.
2025-03-26Z-1288-2025Class Ismiths medical ProPort Low Profile Plastic Venous Access SystemSmiths Medical ASD, Inc.
2025-03-26Z-1331-2025Class IILAPAROSCOPY PACKAmerican Contract Systems Inc
2025-03-26Z-1332-2025Class IIDR DIULUS INJECTION PACKAmerican Contract Systems Inc
2025-03-26Z-1333-2025Class IIHIP SCOPEAmerican Contract Systems Inc
2025-03-26Z-1334-2025Class IIMAJOR DIEPAmerican Contract Systems Inc
2025-03-26Z-1335-2025Class IICYSTO PACKAmerican Contract Systems Inc
2025-03-26Z-1336-2025Class IIC-SECTION PACKAmerican Contract Systems Inc
2025-03-26Z-1337-2025Class IILAPAROSCOPY PACKAmerican Contract Systems Inc
2025-03-26Z-1338-2025Class IILABOR & DELIVERY PACKAmerican Contract Systems Inc
2025-03-26Z-1339-2025Class IIOPEN HEART ADULTAmerican Contract Systems Inc
2025-03-26Z-1340-2025Class IIGENERAL ANGIO PACKAmerican Contract Systems Inc
2025-03-26Z-1341-2025Class IIBORN ON ARRIVAL KITAmerican Contract Systems Inc
2025-03-26Z-1342-2025Class IIC-SECTION PPSAmerican Contract Systems Inc
2025-03-26Z-1343-2025Class IICENTRAL LINE PICCAmerican Contract Systems Inc
2025-03-26Z-1344-2025Class IILABOR & DELIVERY PPSAmerican Contract Systems Inc
2025-03-26Z-1345-2025Class IIURO ROBOTIC PACKAmerican Contract Systems Inc
2025-03-26Z-1346-2025Class IICYSTOAmerican Contract Systems Inc
2025-03-26Z-1347-2025Class IITOTAL HIP PACKAmerican Contract Systems Inc
2025-03-26Z-1348-2025Class IIDELIVERY PACKAmerican Contract Systems Inc
2025-03-26Z-1349-2025Class IILACERATION TRAYAmerican Contract Systems Inc
2025-03-26Z-1350-2025Class IILACERATION TRAYAmerican Contract Systems Inc
2025-03-26Z-1351-2025Class IIEAR PACKAmerican Contract Systems Inc
2025-03-26Z-1352-2025Class IILAPAROSCOPY PACKAmerican Contract Systems Inc
2025-03-26Z-1353-2025Class IICV BASIC PUMP PACKAmerican Contract Systems Inc
2025-03-26Z-1354-2025Class IIDIAGNOSTIC NEURO IR TRAYAmerican Contract Systems Inc
2025-03-26Z-1355-2025Class IINEURO IR TRAYAmerican Contract Systems Inc
2025-03-26Z-1356-2025Class IIAV FISTULAAmerican Contract Systems Inc
2025-03-26Z-1357-2025Class IIGENERAL LAPAROSCOPIC PACK-LFAmerican Contract Systems Inc
2025-03-26Z-1358-2025Class IIMAJOR VASCULAR PACKAmerican Contract Systems Inc
2025-03-26Z-1359-2025Class IIOPEN HEART A PACKAmerican Contract Systems Inc
2025-03-26Z-1360-2025Class IISPINE LUMBAR PACKAmerican Contract Systems Inc
2025-03-26Z-1361-2025Class IITHORACIC PACKAmerican Contract Systems Inc
2025-03-26Z-1362-2025Class IIVEIN TRAYAmerican Contract Systems Inc
2025-03-26Z-1363-2025Class IIProxima Drape labeled as DRAPE C-SECTION W/ WINDOWMEDLINE INDUSTRIES, LP - Northfield
2025-03-26Z-1364-2025Class IIProxima Drape labeled as PACKMEDLINE INDUSTRIES, LP - Northfield
2025-03-26Z-1365-2025Class IIProxima Drape labeled as ENT-PLASTICS PACKMEDLINE INDUSTRIES, LP - Northfield
2025-03-26Z-1366-2025Class IIProxima Drape labeled as MINOR PACK and LAPAROSCOPYMEDLINE INDUSTRIES, LP - Northfield
2025-03-26Z-1367-2025Class IIProxima Drape labeled as FACE LIFTMEDLINE INDUSTRIES, LP - Northfield
2025-03-26Z-1368-2025Class IIProxima Drape labeled as HEAD AND NECK OSISMEDLINE INDUSTRIES, LP - Northfield
2025-03-26Z-1369-2025Class IIProxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC PMEDLINE INDUSTRIES, LP - Northfield
2025-03-26Z-1370-2025Class IIProxima Drape labeled as ORTHO TRAUMA CDSMEDLINE INDUSTRIES, LP - Northfield
2025-03-26Z-1371-2025Class IIHelix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole VirusMicrobiologics Inc
2025-03-26Z-1372-2025Class IIModular Stem cylindricalWaldemar Link GmbH & Co. KG (Mfg Site)
2025-03-26Z-1373-2025Class IIModular Stem cylindricalWaldemar Link GmbH & Co. KG (Mfg Site)
2025-03-26Z-1374-2025Class IIModular Stem cylindricalWaldemar Link GmbH & Co. KG (Mfg Site)
2025-03-26Z-1375-2025Class IIBD Pyxis: Anesthesia Station ESCareFusion 303, Inc.
2025-03-26Z-1376-2025Class IIMicrostream Instructions for Use and Part Number used withOridion Medical 1987 Ltd.
2025-03-26Z-1377-2025Class IIMicrostream Instructions for Use and Part Number used withOridion Medical 1987 Ltd.
2025-03-26Z-1378-2025Class IIMicrostream Instructions for Use and Part Number used withOridion Medical 1987 Ltd.
2025-03-26Z-1379-2025Class IIMicrostream Instructions for Use and Part Number used withOridion Medical 1987 Ltd.
2025-03-26Z-1380-2025Class IIMicrostream Instructions for Use and Part Number used withOridion Medical 1987 Ltd.
2025-03-26Z-1381-2025Class IIMicrostream Instructions for Use and Part Number used withOridion Medical 1987 Ltd.
2025-03-26Z-1382-2025Class IIMicrostream Instructions for Use and Part Number used withOridion Medical 1987 Ltd.
2025-03-26Z-1383-2025Class IIMicrostream Instructions for Use and Part Number used withOridion Medical 1987 Ltd.
2025-03-26Z-1384-2025Class IIMicrostream Instructions for Use and Part Number used withOridion Medical 1987 Ltd.
2025-03-26Z-1385-2025Class IIMicrostream Instructions for Use and Part Number used withOridion Medical 1987 Ltd.
2025-03-26Z-1386-2025Class IIAccess 2 Immunoassay AnalyzerBeckman Coulter, Inc.
2025-03-26Z-1387-2025Class IIDxI 9000 Access Immunoassay AnalyzerBeckman Coulter, Inc.
2025-03-26Z-1388-2025Class IIDxI 9000 Access Immunoassay AnalyzerBeckman Coulter, Inc.
2025-03-26Z-1389-2025Class IICandida ID AntigenImmuno-Mycologics, Inc
2025-03-26Z-1391-2025Class IIIsoLoc Short Profile Prostate Immobilization Treatment Balloon Device…Angiodynamics, Inc.
2025-03-26Z-1392-2025Class IIOrigin Data Management software versions 3Brainlab AG
2025-03-26Z-1393-2025Class IIMedline procedure kits labeled as: 1) C SECTIONMEDLINE INDUSTRIES, LP - Northfield
2025-03-26Z-1394-2025Class IIMedline procedure kits labeled as: 1) EYE PACKMEDLINE INDUSTRIES, LP - Northfield
2025-03-26Z-1395-2025Class IIZebra Thermal Barcode Printer GX430tRemel, Inc
2025-03-26Z-1397-2025Class IIIntrocan Safety 3 Closed IV Catheter 22 GaB Braun Medical Inc
2025-03-26Z-1398-2025Class IIVERICISMerge Healthcare, Inc.
2025-03-26Z-1399-2025Class IIVERICISMerge Healthcare, Inc.
2025-03-26Z-1400-2025Class IIVERICISMerge Healthcare, Inc.
2025-03-26Z-1401-2025Class IIVERICISMerge Healthcare, Inc.
2025-03-26Z-1402-2025Class IIMerge CardioMerge Healthcare, Inc.
2025-03-26Z-1403-2025Class IIComprehensive Shoulder StemZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY
2025-03-26Z-1404-2025Class IICAPNOCHECK BCI Airway AdapterSmiths Medical ASD, Inc.
2025-03-26Z-1405-2025Class IICAPNOCHECK BCI Airway AdapterSmiths Medical ASD, Inc.
2025-03-26Z-1406-2025Class IICRANI PACKAmerican Contract Systems Inc
2025-03-26Z-1407-2025Class IISynapse PACS Software Version 7FUJIFILM Healthcare Americas Corporation
2025-03-19Z-1289-2025Class IPortex Endotracheal TubeSmiths Medical ASD, Inc.
2025-03-19Z-1297-2025Class IIGE Healthcare Revolution ApexGE Medical Systems, LLC
2025-03-19Z-1298-2025Class IIGE Healthcare Revolution Apex EliteGE Medical Systems, LLC
2025-03-19Z-1299-2025Class IIGE Healthcare Revolution Apex ExpertGE Medical Systems, LLC
2025-03-19Z-1300-2025Class IIGE Healthcare Revolution Apex PlusGE Medical Systems, LLC
2025-03-19Z-1301-2025Class IIGE Healthcare Revolution Apex SelectGE Medical Systems, LLC
2025-03-19Z-1302-2025Class IIGE Healthcare Revolution CTGE Medical Systems, LLC
2025-03-19Z-1303-2025Class IIGE Healthcare Revolution CT ESGE Medical Systems, LLC
2025-03-19Z-1304-2025Class IBD Alaris Systems ManagerCareFusion 303, Inc.
2025-03-19Z-1305-2025Class IBD Care Coordination EngineCareFusion 303, Inc.
2025-03-19Z-1306-2025Class IAortic Root Cannula: 1Medtronic Perfusion Systems
2025-03-19Z-1307-2025Class IICardiFocus Heartlight X3 Catheter- Intended in the treatment of…CardioFocus, Inc.
2025-03-19Z-1308-2025Class IINumerous models of nonsterile hemostatic forceps:Aesculap Inc
2025-03-19Z-1309-2025Class IINumerous models of nonsterile hemostatic forceps:Aesculap Inc
2025-03-19Z-1310-2025Class IINumerous models of nonsterile hemostatic forceps:Aesculap Inc
2025-03-19Z-1311-2025Class IINumerous models of nonsterile hemostatic forceps:Aesculap Inc
2025-03-19Z-1312-2025Class IINumerous models of nonsterile hemostatic forceps:Aesculap Inc
2025-03-19Z-1313-2025Class IIBrand Name: TruScan BodyTruAbutment Inc.
2025-03-19Z-1314-2025Class IICOR Disposable KitDePuy Mitek, Inc., a Johnson & Johnson Co.
2025-03-19Z-1315-2025Class IICOR Disposable KitDePuy Mitek, Inc., a Johnson & Johnson Co.
2025-03-19Z-1316-2025Class IIBrand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number:ZOLL Medical Corporation
2025-03-19Z-1317-2025Class IIBrand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number:ZOLL Medical Corporation
2025-03-19Z-1318-2025Class IIBrand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number:ZOLL Medical Corporation
2025-03-19Z-1319-2025Class IIBrand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number:ZOLL Medical Corporation
2025-03-19Z-1320-2025Class IIBrand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number:ZOLL Medical Corporation
2025-03-19Z-1321-2025Class IIBrand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog…ZOLL Medical Corporation
2025-03-19Z-1322-2025Class IIBrand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number:ZOLL Medical Corporation
2025-03-19Z-1323-2025Class IIBrand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog…ZOLL Medical Corporation
2025-03-19Z-1324-2025Class IISpectral CT on RailsPhilips Medical Systems Nederland B.V.
2025-03-19Z-1325-2025Class IIBrand Name: Da Vinci 5 Product Name: ASSYIntuitive Surgical, Inc.
2025-03-19Z-1326-2025Class IIDxI 9000 Access Immunoassay AnalyzerBeckman Coulter, Inc.
2025-03-19Z-1327-2025Class IIBrand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with…Spectrum Medical Inc
2025-03-19Z-1328-2025Class IIStryker CinchLock Flex Knotless Anchor with Inserter and SutureStryker Corporation
2025-03-19Z-1329-2025Class IIZ1 Femoral Hip SystemZimmer, Inc.
2025-03-19Z-1330-2025Class IIVista Brite TipCordis US Corp
2025-03-12Z-1205-2025Class IVARIPULSE Bi-Directional Ablation Catheter REF D141201Biosense Webster, Inc.
2025-03-12Z-1244-2025Class IRotarex Atherectomy System and Instructions for UseBard Peripheral Vascular Inc
2025-03-12Z-1245-2025Class IMedtronic Pipeline Vantage Embolization Device with Shield TechnologyMicro Therapeutics, Inc.
2025-03-12Z-1246-2025Class IMedtronic Pipeline Vantage Embolization Device with Shield TechnologyMicro Therapeutics, Inc.
2025-03-12Z-1249-2025Class IIAccess ErythropoietinBeckman Coulter, Inc.
2025-03-12Z-1250-2025Class IIBrand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number:…Medimaps Group
2025-03-12Z-1251-2025Class IIhuman med Biofill Infiltration CannulaHUMAN MED AG
2025-03-12Z-1252-2025Class IIPhilips IntelliSpace Cardiovascular softwarePhilips Medical Systems Nederland B.V.
2025-03-12Z-1253-2025Class IBaxter Sigma Spectrum Infusion SystemBaxter Healthcare Corporation
2025-03-12Z-1254-2025Class IBaxter Spectrum IQ Infusion System with Dose IQ Safety SoftwareBaxter Healthcare Corporation
2025-03-12Z-1255-2025Class IIParadigm REF: MMT-712 and MMT-715Medtronic MiniMed, Inc.
2025-03-12Z-1256-2025Class IIParadigm insulin pumpMedtronic MiniMed, Inc.
2025-03-12Z-1257-2025Class IIParadigm insulin pumpMedtronic MiniMed, Inc.
2025-03-12Z-1258-2025Class IIMiniMed insulin pumpMedtronic MiniMed, Inc.
2025-03-12Z-1259-2025Class IIMiniMed insulin pumpMedtronic MiniMed, Inc.
2025-03-12Z-1260-2025Class IIMiniMed insulin pumpMedtronic MiniMed, Inc.
2025-03-12Z-1261-2025Class IIMiniMed insulin pumpMedtronic MiniMed, Inc.
2025-03-12Z-1262-2025Class IIMiniMed insulin pumpMedtronic MiniMed, Inc.
2025-03-12Z-1263-2025Class IIMiniMed insulin pumpMedtronic MiniMed, Inc.
2025-03-12Z-1264-2025Class IIMiniMed insulin pumpMedtronic MiniMed, Inc.
2025-03-12Z-1265-2025Class IIMiniMed insulin pumpMedtronic MiniMed, Inc.
2025-03-12Z-1266-2025Class IIMiniMed insulin pumpMedtronic MiniMed, Inc.
2025-03-12Z-1267-2025Class IIMIM softwareMIM Software Inc
2025-03-12Z-1268-2025Class IICircuitGuard ThermoFlo Filter -Combined Heat and Moisture ExchangerKung Shin Plastics Co. Ltd.
2025-03-12Z-1269-2025Class IICircuitGuard Bacterial/Viral Filter with ElbowKung Shin Plastics Co. Ltd.
2025-03-12Z-1270-2025Class IIPhilips Connected Blood Glucose MeterTelcare, LLC
2025-03-12Z-1271-2025Class IIET Rigid AbutmentHiossen Inc.
2025-03-12Z-1272-2025Class IIET Rigid AbutmentHiossen Inc.
2025-03-12Z-1273-2025Class IIET Rigid AbutmentHiossen Inc.
2025-03-12Z-1274-2025Class IIOsstem Implant SystemHiossen Inc.
2025-03-12Z-1275-2025Class IIET Rigid AbutmentHiossen Inc.
2025-03-12Z-1276-2025Class IIOsstem Implant SystemHiossen Inc.
2025-03-12Z-1290-2025Class II(1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2)…LUMENIS, LTD.
2025-03-12Z-1291-2025Class IIDeRoyal REF 71-C5100NS TubingDeRoyal Industries Inc
2025-03-12Z-1292-2025Class IIVios Monitoring System Bedside Monitor Model BSM2050Murata Vios, Inc.
2025-03-12Z-1293-2025Class IIAlcon Custom Pak with Non-Latex SymbolAlcon Research LLC
2025-03-12Z-1294-2025Class IITISSUE APPROXIMATION SYSTEMTAS Medical Inc
2025-03-12Z-1295-2025Class IIAURORA Surgiscope SystemIntegra LifeSciences Corp.
2025-03-12Z-1296-2025Class IIBD BBL TB Stain Kit KBecton Dickinson & Co.
2025-03-05Z-1196-2025Class IVOCSN Multi-Function Ventilators: VOCSN+ProVentec Life Systems, Inc.
2025-03-05Z-1206-2025Class IIBD Pyxis: MedFlexCareFusion 303, Inc.
2025-03-05Z-1207-2025Class IIBD Pyxis MedFlex 2CareFusion 303, Inc.
2025-03-05Z-1208-2025Class IIIntelePACSINTELERAD MEDICAL SYSTEMS INCORPORATED
2025-03-05Z-1209-2025Class IIATyber Medical
2025-03-05Z-1210-2025Class IIATyber Medical
2025-03-05Z-1211-2025Class IIATyber Medical
2025-03-05Z-1212-2025Class IIATyber Medical
2025-03-05Z-1213-2025Class IIATyber Medical
2025-03-05Z-1214-2025Class IIATyber Medical
2025-03-05Z-1215-2025Class IIATyber Medical
2025-03-05Z-1216-2025Class IIATyber Medical
2025-03-05Z-1217-2025Class IIATyber Medical
2025-03-05Z-1218-2025Class IIATyber Medical
2025-03-05Z-1219-2025Class IIATyber Medical
2025-03-05Z-1220-2025Class IIATyber Medical
2025-03-05Z-1221-2025Class IIATyber Medical
2025-03-05Z-1222-2025Class IIATyber Medical
2025-03-05Z-1223-2025Class IIATyber Medical
2025-03-05Z-1224-2025Class IIATyber Medical
2025-03-05Z-1225-2025Class IIATyber Medical
2025-03-05Z-1226-2025Class IIATyber Medical
2025-03-05Z-1227-2025Class II138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK…CareFusion 303, Inc.
2025-03-05Z-1228-2025Class II155288-01 BD PYXIS MEDBANK MINI 1FH-1FM 169-137 BD PYXIS MEDBANK MINI…CareFusion 303, Inc.
2025-03-05Z-1229-2025Class II139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS…CareFusion 303, Inc.
2025-03-05Z-1230-2025Class II139088-01 BD PYXIS MEDBANK MEDPASS MODULE 169-151 BD PYXIS MEDBANK…CareFusion 303, Inc.
2025-03-05Z-1231-2025Class IIBD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails…CareFusion 303, Inc.
2025-03-05Z-1232-2025Class IILIFEPAK 20e REF 99507-000001 The AED mode is to be used only on…Physio-Control, Inc.
2025-03-05Z-1233-2025Class IIDxC 500 AU Clinical Chemistry AnalyzerBECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.
2025-03-05Z-1234-2025Class IISocrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The…Scientia Vascular, Inc.
2025-03-05Z-1235-2025Class IIPlato 17 Microcatheter REF PL17-160-090 To assist in delivery of…Scientia Vascular, Inc.

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