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Medical device recalls reported in 2024

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ReportedRecallClassProductFirm
2024-04-10Z-1468-2024Class IICovidien Auto Suture" Blunt Tip TrocarCovidien, LP
2024-04-10Z-1469-2024Class IICovidien Auto Suture" Blunt Tip TrocarCovidien, LP
2024-04-10Z-1470-2024Class IICovidien Auto Suture" Blunt Tip TrocarCovidien, LP
2024-04-10Z-1471-2024Class IICovidien Auto Suture" Blunt Tip TrocarCovidien, LP
2024-04-10Z-1472-2024Class IIKarl Storz SE & COKarl Storz Endoscopy
2024-04-10Z-1473-2024Class IIKarl Storz SE & COKarl Storz Endoscopy
2024-04-10Z-1474-2024Class IIKarl Storz SE & COKarl Storz Endoscopy
2024-04-10Z-1475-2024Class II3M Tube Securement Device3M Company - Health Care Business
2024-04-10Z-1476-2024Class IIARCHITECT STAT Myoglobin Reagent KitAbbott Laboratories
2024-04-10Z-1477-2024Class IIstryker Infinity Resection Adjustment BlockWright Medical Technology, Inc.
2024-04-10Z-1478-2024Class IINaviNetics Skull Anchor Key and Drill KitNavinetics Inc
2024-04-10Z-1479-2024Class IIARCHITECT Anti-HCV Reagent KitAbbott GmbH
2024-04-10Z-1480-2024Class IIAlinity i Anti-HCV Reagent KitAbbott GmbH
2024-04-03Z-1285-2024Class INimbus Administration SetInfuTronix LLC
2024-04-03Z-1286-2024Class INimbus II Infusion SystemInfuTronix LLC
2024-04-03Z-1302-2024Class IBoston Scientific POLARSHEATH Steerable Sheath 12FBoston Scientific Corporation
2024-04-03Z-1323-2024Class Istay-safe /Safe Lock Catheter ExtFresenius Medical Care Holdings, Inc.
2024-04-03Z-1324-2024Class Istay-safe /Luer Lock Adapter 4 inFresenius Medical Care Holdings, Inc.
2024-04-03Z-1325-2024Class Istay-safe /Luer Lock Catheter ExtFresenius Medical Care Holdings, Inc.
2024-04-03Z-1326-2024Class Istay-safe /Luer Lock Catheter ExtFresenius Medical Care Holdings, Inc.
2024-04-03Z-1327-2024Class Istay-safe /Luer Catheter ExtFresenius Medical Care Holdings, Inc.
2024-04-03Z-1358-2024Class IIBio-RadBio-Rad Laboratories
2024-04-03Z-1359-2024Class IIThermalon Eye CompressBruder Healthcare Company, LLC
2024-04-03Z-1360-2024Class IIThermalon Sinus CompressBruder Healthcare Company, LLC
2024-04-03Z-1361-2024Class IIThermalon Sinus CompressBruder Healthcare Company, LLC
2024-04-03Z-1362-2024Class IIThermalon Back WrapBruder Healthcare Company, LLC
2024-04-03Z-1363-2024Class IIThermalon Neck WrapBruder Healthcare Company, LLC
2024-04-03Z-1364-2024Class IIThermalon Heating PadBruder Healthcare Company, LLC
2024-04-03Z-1365-2024Class IIThermalon Stye CompressBruder Healthcare Company, LLC
2024-04-03Z-1366-2024Class IIMediBeads Neck WrapBruder Healthcare Company, LLC
2024-04-03Z-1367-2024Class IIMediBeads King PadBruder Healthcare Company, LLC
2024-04-03Z-1368-2024Class IIInstaClear Lens Cleaner-indicated for use during routine diagnostic…Olympus Corporation of the Americas
2024-04-03Z-1369-2024Class IICystatin C CalibratorRandox Laboratories Ltd.
2024-04-03Z-1370-2024Class IISYRINGEAlcon Research, LLC
2024-04-03Z-1371-2024Class IIAptima CMV Quant AssayHologic, Inc.
2024-04-03Z-1372-2024Class IIVITROS Performance Verifier IOrtho-Clinical Diagnostics
2024-04-03Z-1373-2024Class IIVITROS Performance Verifier IIOrtho-Clinical Diagnostics
2024-04-03Z-1374-2024Class IObsidio Conformable EmbolicBoston Scientific Corporation
2024-04-03Z-1375-2024Class IIInsufflation unitOlympus Corporation of the Americas
2024-04-03Z-1376-2024Class IIAccess SubstrateBeckman Coulter, Inc.
2024-04-03Z-1377-2024Class IIBaxter Peri-Guard Repair PatchBaxter Healthcare Corporation
2024-04-03Z-1378-2024Class IIBaxter Supple Peri-Guard Repair PatchBaxter Healthcare Corporation
2024-04-03Z-1379-2024Class IIBaxter Peri-Guard Repair PatchBaxter Healthcare Corporation
2024-04-03Z-1380-2024Class IIBaxter Supple Peri-Guard Repair PatchBaxter Healthcare Corporation
2024-04-03Z-1381-2024Class IIMedivance Neonatal ArcticGel PadsMedivance Inc.
2024-04-03Z-1382-2024Class IGeoMed Custom TracecartsDeRoyal Industries Inc
2024-04-03Z-1383-2024Class IIRELAY PRO Thoracic Stent-Graft SystemBolton Medical Inc.
2024-04-03Z-1384-2024Class IISOLTIVE Pro SuperPulsed LaserOlympus Corporation of the Americas
2024-04-03Z-1385-2024Class IISOLTIVE Premium SuperPulsed LaserOlympus Corporation of the Americas
2024-04-03Z-1386-2024Class IIPatient Information Center iXPhilips North America
2024-04-03Z-1387-2024Class IICareEvent Event Management SystemPhilips North America
2024-04-03Z-1388-2024Class IIEpix Universal Clip ApplierApplied Medical Resources Corp
2024-04-03Z-1389-2024Class IIEpix Universal Clip ApplierApplied Medical Resources Corp
2024-04-03Z-1390-2024Class IIBoston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140Boston Scientific Corporation
2024-04-03Z-1391-2024Class IIHydroFlock Sterile Flocked Collection DevicePuritan Medical Products Company, Llc
2024-04-03Z-1394-2024Class IIIV Start KitMedical Action Industries, Inc. 306
2024-04-03Z-1395-2024Class IIOEmergency Products & Research
2024-04-03Z-1396-2024Class IIOptiCross Coronary Imaging CatheterBoston Scientific Corporation
2024-03-27Z-1267-2024Class IARROW QuickFlash Radial Artery CatherizationARROW INTERNATIONAL Inc.
2024-03-27Z-1274-2024Class Ismiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and…Smiths Medical ASD Inc.
2024-03-27Z-1275-2024Class Ismiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP…Smiths Medical ASD Inc.
2024-03-27Z-1300-2024Class IHeartMate II Left Ventricular Assist SystemThoratec Corp.
2024-03-27Z-1301-2024Class IHeartMate 3 Left Ventricular Assist SystemThoratec Corp.
2024-03-27Z-1303-2024Class IIAccess Total T4Beckman Coulter, Inc.
2024-03-27Z-1304-2024Class IIDCA Systems HbA1c Reagent KitSiemens Healthcare Diagnostics, Inc.
2024-03-27Z-1305-2024Class IITENSIVE Conductive Adhesive GelNatus Neurology Inc
2024-03-27Z-1306-2024Class IInatus neurologyNatus Neurology Inc
2024-03-27Z-1307-2024Class IICuraplex Nasal Intubation Kit with 6mm Endotrol Tube-To perform a…Sarnova HC, Llc
2024-03-27Z-1308-2024Class IICuraplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a…Sarnova HC, Llc
2024-03-27Z-1309-2024Class IINautilusTM ECMO Oxygenator with Balance Biosurface-used in…Mc3 Inc
2024-03-27Z-1310-2024Class IINautilusTM Smart ECMO Module with Balance Biosurface-used in…Mc3 Inc
2024-03-27Z-1311-2024Class IISekisui Diagnostics Control Kit OSOM¿ BVBLUE¿ Bacterial VaginosisMckesson Medical-Surgical Inc. Corporate Office
2024-03-27Z-1312-2024Class IIAbbott Rapid Dx N America LLC Reproductive Endocrinology Control Set…Mckesson Medical-Surgical Inc. Corporate Office
2024-03-27Z-1313-2024Class IISteris Corporation Endo Cleaning Indicator VERIFY" RESITEST"Mckesson Medical-Surgical Inc. Corporate Office
2024-03-27Z-1314-2024Class IIAbbott Point of Care Control Control i-STAT¿ Level 1 10 X 1Mckesson Medical-Surgical Inc. Corporate Office
2024-03-27Z-1315-2024Class IIAbbott Point of Care Control Control i-STAT¿ Level 3 1Mckesson Medical-Surgical Inc. Corporate Office
2024-03-27Z-1316-2024Class IIMedtronic DLP Vessel CannulaMedtronic Perfusion Systems
2024-03-27Z-1317-2024Class IIAbre Venous Self-expanding Stent SystemMedtronic Inc.
2024-03-27Z-1318-2024Class IIAssemblyThink Surgical, Inc.
2024-03-27Z-1319-2024Class IIIIn2Bones, SAS
2024-03-27Z-1320-2024Class IIIIn2Bones, SAS
2024-03-27Z-1321-2024Class IIPreat Nobel Active/Conical-compatible RP Titanium BlankPreat Corp
2024-03-27Z-1322-2024Class IIimpression copingThommen Medical AG
2024-03-27Z-1328-2024Class IILiquid Protein CalibratorsRandox Laboratories Ltd.
2024-03-27Z-1329-2024Class IIHDS Traction Boot IIBaxter Healthcare Corporation
2024-03-27Z-1330-2024Class IISituate Laparotomy SpongeCovidien
2024-03-27Z-1331-2024Class IIDirectional Laser Probe with Alcon / Lumenis connectorD.O.R.C. Dutch Opthalmic Research Center Intl B.V.
2024-03-27Z-1332-2024Class IIDirectional Laser Probe with Alcon / Lumenis connectorD.O.R.C. Dutch Opthalmic Research Center Intl B.V.
2024-03-27Z-1333-2024Class IIDirectional Laser Probe with Alcon / Lumenis connectorD.O.R.C. Dutch Opthalmic Research Center Intl B.V.
2024-03-27Z-1334-2024Class IIMINI STICK MAX 4F X 10 CM STDAngiodynamics, Inc.
2024-03-27Z-1335-2024Class IIMINI STICK MAX 4F X 10 CM STDAngiodynamics, Inc.
2024-03-27Z-1336-2024Class IIMINI STICK MAX 4F X 10 CM STIFFAngiodynamics, Inc.
2024-03-27Z-1337-2024Class IIMINI STICK MAX 4F X 10 CM STIFFAngiodynamics, Inc.
2024-03-27Z-1338-2024Class IIMINI STICK MAX 5F X 10 CM STDAngiodynamics, Inc.
2024-03-27Z-1339-2024Class IIMINI STICK MAX 5F X 10 CM STDAngiodynamics, Inc.
2024-03-27Z-1340-2024Class IIMINI STICK MAX 5F X 10 CM STIFFAngiodynamics, Inc.
2024-03-27Z-1341-2024Class IIMINI STICK MAX 5F X 10 CM STIFFAngiodynamics, Inc.
2024-03-27Z-1342-2024Class IIMINI STICK MAX 4F X 10 CM STIFFAngiodynamics, Inc.
2024-03-27Z-1343-2024Class IIMINI STICK MAX 5F X 10 CM STDAngiodynamics, Inc.
2024-03-27Z-1344-2024Class IIMINI STICK MAX 5F X 10 CM STDAngiodynamics, Inc.
2024-03-27Z-1345-2024Class IIMINI STICK MAX 5F X 10 CM STDAngiodynamics, Inc.
2024-03-27Z-1346-2024Class IIMINI STICK MAX 5F X 10 CM STDAngiodynamics, Inc.
2024-03-27Z-1347-2024Class IIMINI STICK MAX 5F X 15 CM STIFFAngiodynamics, Inc.
2024-03-27Z-1348-2024Class IIMINI STICK MAX 4F X 10CM STIFFAngiodynamics, Inc.
2024-03-27Z-1349-2024Class IImicroStar ReaderLandauer
2024-03-27Z-1350-2024Class IIConvatec EsteemBody Soft ConvexConvaTec, Inc
2024-03-20Z-1277-2024Class IID-Clip Standard/Mini ApplierPeter Lazic Gmbh
2024-03-20Z-1278-2024Class IID-Clip Standard/Mini ApplierPeter Lazic Gmbh
2024-03-20Z-1279-2024Class IID-Clip Standard/Mini ApplierPeter Lazic Gmbh
2024-03-20Z-1280-2024Class IIAtellica IM ErythropoietinSiemens Healthcare Diagnostics, Inc.
2024-03-20Z-1281-2024Class IIADVIA Centaur ErythropoietinSiemens Healthcare Diagnostics, Inc.
2024-03-20Z-1282-2024Class IILVP software of the Ivenix Infusion SystemFresenius Kabi USA, LLC
2024-03-20Z-1283-2024Class IILVP software of the Ivenix Infusion SystemFresenius Kabi USA, LLC
2024-03-20Z-1284-2024Class ICERENOVUS CEREBASE DA Guide SheathMedos International Sarl
2024-03-20Z-1287-2024Class IIL-Aneurysm Clip TITANIUM Paddle-ClipPeter Lazic Gmbh
2024-03-20Z-1288-2024Class IIL-Aneurysm Clip TITANIUM Paddle-ClipPeter Lazic Gmbh
2024-03-20Z-1289-2024Class IISTERIS Boot AssemblyBaxter Healthcare Corporation
2024-03-20Z-1290-2024Class IICARTO VIZIGO Bi-Directional Guiding SheathBiosense Webster, Inc.
2024-03-20Z-1291-2024Class IICLEARLINK Non-DEHP Solution Set Luer Lock AdapterBaxter Healthcare Corporation
2024-03-20Z-1292-2024Class IIShimadzuSHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
2024-03-20Z-1293-2024Class IIEasyPoint NeedleRetractable Technologies, Inc.
2024-03-20Z-1294-2024Class IIBVI Visitec Irrigation HandleBeaver Visitec International, Inc.
2024-03-20Z-1295-2024Class IICVS Health Waterproof Wound Tracking DressingMEDLINE INDUSTRIES, LP - Northfield
2024-03-20Z-1296-2024Class IISPII Model LubinusWaldemar Link GmbH & Co. KG (Mfg Site)
2024-03-20Z-1297-2024Class IISPII Model LubinusWaldemar Link GmbH & Co. KG (Mfg Site)
2024-03-20Z-1298-2024Class IISPII Model LubinusWaldemar Link GmbH & Co. KG (Mfg Site)
2024-03-20Z-1299-2024Class IISPII Model LubinusWaldemar Link GmbH & Co. KG (Mfg Site)
2024-03-13Z-1186-2024Class IMIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC*…Avanos Medical, Inc.
2024-03-13Z-1187-2024Class IMIC* Gastric-Jejunal Feeding TubeAvanos Medical, Inc.
2024-03-13Z-1220-2024Class IIVITROS 3600 Immunodiagnostic SystemOrtho-Clinical Diagnostics, Inc.
2024-03-13Z-1221-2024Class IIVITROS 5600 Integrated SystemOrtho-Clinical Diagnostics, Inc.
2024-03-13Z-1222-2024Class IIVITROS XT7600 Integrated SystemOrtho-Clinical Diagnostics, Inc.
2024-03-13Z-1223-2024Class IIBD Pyxis: MedStation ESCareFusion 303, Inc.
2024-03-13Z-1224-2024Class IIVITROS 3600 Immunodiagnostic System Catalog NosOrtho-Clinical Diagnostics, Inc.
2024-03-13Z-1225-2024Class IIVITROS 4600 Chemistry System Catalog NosOrtho-Clinical Diagnostics, Inc.
2024-03-13Z-1226-2024Class IIVITROS 5600 Integrated System Catalog NosOrtho-Clinical Diagnostics, Inc.
2024-03-13Z-1227-2024Class IIVITROS XT 3400 Chemistry SystemOrtho-Clinical Diagnostics, Inc.
2024-03-13Z-1228-2024Class IIVITROS XT 7600 Integrated SystemOrtho-Clinical Diagnostics, Inc.
2024-03-13Z-1229-2024Class IIVITROS 3600 Immunodiagnostic System Catalog NosOrtho-Clinical Diagnostics, Inc.
2024-03-13Z-1230-2024Class IIVITROS 4600 Chemistry System Catalog NosOrtho-Clinical Diagnostics, Inc.
2024-03-13Z-1231-2024Class IIVITROS 5600 Integrated System Catalog NosOrtho-Clinical Diagnostics, Inc.
2024-03-13Z-1232-2024Class IIVITROS XT 3400 Chemistry SystemOrtho-Clinical Diagnostics, Inc.
2024-03-13Z-1233-2024Class IIVITROS XT 7600 Integrated SystemOrtho-Clinical Diagnostics, Inc.
2024-03-13Z-1234-2024Class II13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EXSynthes (USA) Products LLC
2024-03-13Z-1235-2024Class II1Synthes (USA) Products LLC
2024-03-13Z-1236-2024Class II2Synthes (USA) Products LLC
2024-03-13Z-1237-2024Class IIRIA Tube AssemblySynthes (USA) Products LLC
2024-03-13Z-1238-2024Class IIRAPIDSORB IPS Battery PackSynthes (USA) Products LLC
2024-03-13Z-1239-2024Class IITFNA Femoral Nail 9mmSynthes (USA) Products LLC
2024-03-13Z-1240-2024Class IITFNA Femoral Nail 11mmSynthes (USA) Products LLC
2024-03-13Z-1241-2024Class IIVA-LCP Clavicle Plate 2Synthes (USA) Products LLC
2024-03-13Z-1242-2024Class IIOpalSynthes (USA) Products LLC
2024-03-13Z-1243-2024Class IIDISPAesculap Inc
2024-03-13Z-1244-2024Class IIDISPAesculap Inc
2024-03-13Z-1245-2024Class IIDISPAesculap Inc
2024-03-13Z-1246-2024Class IIDISPAesculap Inc
2024-03-13Z-1247-2024Class IIDISPAesculap Inc
2024-03-13Z-1248-2024Class IIMRI system: Vantage OrianCanon Medical System, USA, INC.
2024-03-13Z-1249-2024Class IIMRI system: Vantage ElanCanon Medical System, USA, INC.
2024-03-13Z-1250-2024Class IIVantage TitanCanon Medical System, USA, INC.
2024-03-13Z-1251-2024Class IIInvacare Homecare Series Bed and Invacare G-Series Beds Containing…Invacare Corporation
2024-03-13Z-1252-2024Class IIThe Apollo Onyx Delivery MicrocatheterMicro Therapeutics, Inc.
2024-03-13Z-1253-2024Class IIThe Apollo Onyx Delivery MicrocatheterMicro Therapeutics, Inc.
2024-03-13Z-1254-2024Class IIPhantom TTC NailParagon 28, Inc.
2024-03-13Z-1255-2024Class IIPhantom TTC NailParagon 28, Inc.
2024-03-13Z-1256-2024Class IIPhantom TTC NailParagon 28, Inc.
2024-03-13Z-1257-2024Class IIEmbrace Drill TowerWaldemar Link GmbH & Co. KG (Mfg Site)
2024-03-13Z-1258-2024Class IIEmbrace Drill TowerWaldemar Link GmbH & Co. KG (Mfg Site)
2024-03-13Z-1259-2024Class IIX3 TRIATHLON CS INSERT NO 3 10 MMHowmedica Osteonics Corp.
2024-03-13Z-1260-2024Class IIX3 TRIATHLON CS INSERT NO 6 10 MMHowmedica Osteonics Corp.
2024-03-13Z-1261-2024Class IIX3 TRIATHLON CS INSERT NO 6 11 MMHowmedica Osteonics Corp.
2024-03-13Z-1262-2024Class IIX3 TRIATHLON CS INSERT NO 7 9 MMHowmedica Osteonics Corp.
2024-03-13Z-1263-2024Class IINO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MMHowmedica Osteonics Corp.
2024-03-13Z-1264-2024Class IINO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MMHowmedica Osteonics Corp.
2024-03-13Z-1265-2024Class IINO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MMHowmedica Osteonics Corp.
2024-03-13Z-1266-2024Class IINO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MMHowmedica Osteonics Corp.
2024-03-13Z-1268-2024Class IISynapse PACSFUJIFILM Healthcare Americas Corporation
2024-03-13Z-1269-2024Class IISynapse PACSFUJIFILM Healthcare Americas Corporation
2024-03-13Z-1270-2024Class IISynapse PACSFUJIFILM Healthcare Americas Corporation
2024-03-13Z-1271-2024Class IISynapse PACSFUJIFILM Healthcare Americas Corporation
2024-03-13Z-1272-2024Class IISynapse PACSFUJIFILM Healthcare Americas Corporation
2024-03-13Z-1273-2024Class IISynapse PACSFUJIFILM Healthcare Americas Corporation
2024-03-13Z-1276-2024Class IIConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy SystemConvaTec, Inc
2024-03-06Z-1057-2024Class IAirLife Adult Manual ResuscitatorVyaire Medical
2024-03-06Z-1058-2024Class IAirLife Adult Manual ResuscitatorVyaire Medical
2024-03-06Z-1059-2024Class IAirLife Adult Manual ResuscitatorVyaire Medical
2024-03-06Z-1060-2024Class IAirLife Adult Manual ResuscitatorVyaire Medical
2024-03-06Z-1061-2024Class IAirLife Adult Manual ResuscitatorVyaire Medical
2024-03-06Z-1062-2024Class IAirLife Adult Manual ResuscitatorVyaire Medical
2024-03-06Z-1063-2024Class IAirLife Adult Manual ResuscitatorVyaire Medical
2024-03-06Z-1064-2024Class IAirLife Adult Manual ResuscitatorVyaire Medical
2024-03-06Z-1065-2024Class IAirLife Adult Manual ResuscitatorVyaire Medical
2024-03-06Z-1070-2024Class IVOCSN Patient Breathing PackageVentec Life Systems, Inc.
2024-03-06Z-1090-2024Class IMEDLINE TRAY TRACH BASIC SOLUTIONMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1091-2024Class IMEDLINE TRAY care and cleaning kits and trays for Tracheostomy and…MEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1092-2024Class IMEDLINE kits and traysMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1093-2024Class IMEDLINE BRONCHOSCOPY TRAYMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1094-2024Class IMEDLINE ARTERIAL BUNDLE NO CATHETERMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1095-2024Class IMEDLINE KitsMEDLINE INDUSTRIES, LP - Northfield
2024-03-06Z-1096-2024Class IMEDLINE KitsMEDLINE INDUSTRIES, LP - Northfield

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