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Medical device recalls reported in 2024

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ReportedRecallClassProductFirm
2024-05-01Z-1631-2024Class IITRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision…Howmedica Osteonics Corp.
2024-05-01Z-1632-2024Class IITRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision…Howmedica Osteonics Corp.
2024-05-01Z-1633-2024Class II3M Durapore Surgical Tape3M Company - Health Care Business
2024-05-01Z-1634-2024Class IIPalindrome Precision HSI Chronic Catheter Sport Pack 14Covidien LP
2024-05-01Z-1635-2024Class IIPalindrome Precision H Chronic Catheter Kit 14Covidien LP
2024-05-01Z-1636-2024Class IIQUIDEL InflammaDry MMP-9 TestQuidel Corporation
2024-05-01Z-1637-2024Class IIQUIDEL InflammaDry MMP-9 TestQuidel Corporation
2024-05-01Z-1686-2024Class IIBrand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog…Electro Medical Systems SA
2024-05-01Z-1687-2024Class IIBrand Name: WATER BOTTLE Product Name: WATER BOTTLE Model/Catalog…Electro Medical Systems SA
2024-05-01Z-1688-2024Class IIBrand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog…Electro Medical Systems SA
2024-05-01Z-1689-2024Class IIBaxter Seprafilm Adhesion Barrier 1 Half SheetBaxter Healthcare Corporation
2024-05-01Z-1690-2024Class IIPhilips Patient Information CenterPhilips North America Llc
2024-04-24Z-1397-2024Class IElekta Disposable Biopsy Needle Kit for Leksell Stereotactic SystemElekta Instrument AB
2024-04-24Z-1485-2024Class ITablo Hemodialysis SystemOutset Medical, Inc.
2024-04-24Z-1499-2024Class IAeris EVOPhilips Respironics, Inc.
2024-04-24Z-1500-2024Class IGarbin EVOPhilips Respironics, Inc.
2024-04-24Z-1501-2024Class ILifeVentEVO2Philips Respironics, Inc.
2024-04-24Z-1502-2024Class ITrilogy EV300Philips Respironics, Inc.
2024-04-24Z-1503-2024Class ITrilogy Evo O2Philips Respironics, Inc.
2024-04-24Z-1504-2024Class ITrilogy EvoPhilips Respironics, Inc.
2024-04-24Z-1505-2024Class ITrilogy Evo Universal VentilatorPhilips Respironics, Inc.
2024-04-24Z-1512-2024Class IDr¿ger Perseus A500 Anesthesia WorkstationDraeger Medical, Inc.
2024-04-24Z-1519-2024Class IAW-S025 NEO SONARMED SENSOR 2SonarMed Inc
2024-04-24Z-1520-2024Class IAW-S030 NEO SONARMED SENSOR 3SonarMed Inc
2024-04-24Z-1521-2024Class IAW-S035 NEO SONARMED SENSOR 3SonarMed Inc
2024-04-24Z-1522-2024Class IISurgical Tools and Cardiovascular Specialty marketing brochuresBaxter Healthcare Corporation
2024-04-24Z-1523-2024Class IISurgical Tools and Cardiovascular Specialty marketing brochuresBaxter Healthcare Corporation
2024-04-24Z-1524-2024Class IISurgical Tools and Cardiovascular Specialty marketing brochuresBaxter Healthcare Corporation
2024-04-24Z-1525-2024Class IIChiba Biopsy NeedleCook Incorporated
2024-04-24Z-1526-2024Class IITrocar NeedleCook Incorporated
2024-04-24Z-1527-2024Class IIYueh Centesis Disposable Catheter NeedleCook Incorporated
2024-04-24Z-1528-2024Class IIPeel-Away IntroducerCook Incorporated
2024-04-24Z-1529-2024Class IIEntuit Secure Adjustable Gastrointestinal Suture Anchor SetCook Incorporated
2024-04-24Z-1530-2024Class IIDilatorCook Incorporated
2024-04-24Z-1531-2024Class IIDilator With AQ Hydrophilic CoatingCook Incorporated
2024-04-24Z-1532-2024Class IIDilatorCook Incorporated
2024-04-24Z-1533-2024Class IISTRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control…Ethicon, Inc.
2024-04-24Z-1534-2024Class IIPOLYSINSURGICAL SPECIALTIES
2024-04-24Z-1535-2024Class IAW-M0001 SONARMED MONITORSonarMed Inc
2024-04-24Z-1536-2024Class IIMasimo Rad-GMasimo Corporation
2024-04-24Z-1537-2024Class IIMasimo Rad-GMasimo Corporation
2024-04-24Z-1538-2024Class IIMasimo Rad-GMasimo Corporation
2024-04-24Z-1539-2024Class IIMasimo Rad-GMasimo Corporation
2024-04-24Z-1540-2024Class IISmiths Medical Medfusion Model 3500 Syringe pumpsSmiths Medical ASD Inc.
2024-04-24Z-1541-2024Class IISmiths Medical Medfusion Model 4000 Syringe pumpSmiths Medical ASD Inc.
2024-04-24Z-1542-2024Class IISmiths Medical Model 3010 Syringe pumps: aSmiths Medical ASD Inc.
2024-04-24Z-1543-2024Class IISmiths Medical Medfusion Guide Barrel ClampSmiths Medical ASD Inc.
2024-04-24Z-1544-2024Class IINeria Soft Infusion SetUnomedical A/S
2024-04-24Z-1545-2024Class IICryoValve SG Cryopreserved Pulmonary Human Heart ValveArtivion, Inc
2024-04-24Z-1549-2024Class IIAtellica CH Iron3Siemens Healthcare Diagnostics, Inc.
2024-04-24Z-1550-2024Class IIAchieva 1Philips North America Llc
2024-04-24Z-1551-2024Class IIAchieva 1Philips North America Llc
2024-04-24Z-1552-2024Class IIAchieva 1Philips North America Llc
2024-04-24Z-1553-2024Class IIAchieva 3Philips North America Llc
2024-04-24Z-1554-2024Class IIAchieva 3Philips North America Llc
2024-04-24Z-1555-2024Class IIAchieva 3Philips North America Llc
2024-04-24Z-1556-2024Class IIAchieva XRPhilips North America Llc
2024-04-24Z-1557-2024Class IIEnterprise 1Philips North America Llc
2024-04-24Z-1558-2024Class IIEvolution Upgrade 3Philips North America Llc
2024-04-24Z-1559-2024Class IIGYROSCAN ACS-NTPhilips North America Llc
2024-04-24Z-1560-2024Class IIGYROSCAN T10-NTPhilips North America Llc
2024-04-24Z-1561-2024Class IIGYROSCAN T5Philips North America Llc
2024-04-24Z-1562-2024Class IIGYROSCAN T5-NTPhilips North America Llc
2024-04-24Z-1563-2024Class IIIngenia 1Philips North America Llc
2024-04-24Z-1564-2024Class IIIngenia 1Philips North America Llc
2024-04-24Z-1565-2024Class IIIngenia 1Philips North America Llc
2024-04-24Z-1566-2024Class IIIngenia 3Philips North America Llc
2024-04-24Z-1567-2024Class IIIngenia 3Philips North America Llc
2024-04-24Z-1568-2024Class IIIngenia Ambition SPhilips North America Llc
2024-04-24Z-1569-2024Class IIIngenia Ambition XPhilips North America Llc
2024-04-24Z-1570-2024Class IIIngenia Elition SPhilips North America Llc
2024-04-24Z-1571-2024Class IIIngenia Elition XPhilips North America Llc
2024-04-24Z-1572-2024Class IIIntera 0Philips North America Llc
2024-04-24Z-1573-2024Class IIIntera 1Philips North America Llc
2024-04-24Z-1574-2024Class IIIntera 1Philips North America Llc
2024-04-24Z-1575-2024Class IIIntera 1Philips North America Llc
2024-04-24Z-1576-2024Class IIIntera 1Philips North America Llc
2024-04-24Z-1577-2024Class IIIntera 1Philips North America Llc
2024-04-24Z-1578-2024Class IIIntera 1Philips North America Llc
2024-04-24Z-1579-2024Class IIIntera 1Philips North America Llc
2024-04-24Z-1580-2024Class IIIntera 1Philips North America Llc
2024-04-24Z-1581-2024Class IIIntera 1Philips North America Llc
2024-04-24Z-1582-2024Class IIIntera 1Philips North America Llc
2024-04-24Z-1583-2024Class IIIntera 1Philips North America Llc
2024-04-24Z-1584-2024Class IIIntera 3Philips North America Llc
2024-04-24Z-1585-2024Class IIIntera Achieva 1Philips North America Llc
2024-04-24Z-1586-2024Class IIIntera CVPhilips North America Llc
2024-04-24Z-1587-2024Class IIMR 5300Philips North America Llc
2024-04-24Z-1588-2024Class IIMR 7700Philips North America Llc
2024-04-24Z-1589-2024Class IISmartPath to dStream for 1Philips North America Llc
2024-04-24Z-1590-2024Class IISmartPath to dStream for XR and 3Philips North America Llc
2024-04-24Z-1591-2024Class IIIdentity Imprint PS Tibial Tray Size 4: Lot 540287Conformis, Inc.
2024-04-24Z-1592-2024Class IIActim PROM dipstikACTIM OY
2024-04-24Z-1593-2024Class IIMicroalbumin Calibrator SeriesRandox Laboratories Ltd.
2024-04-24Z-1594-2024Class IIMicroalbumin Calibrator SeriesRandox Laboratories Ltd.
2024-04-24Z-1595-2024Class IISW Bari Lift & TransferRaye's Inc.
2024-04-24Z-1596-2024Class IIRENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients…Smith & Nephew Medical, Ltd.
2024-04-24Z-1597-2024Class IIRENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients…Smith & Nephew Medical, Ltd.
2024-04-24Z-1598-2024Class IISiemens Artis Models: Interventional Fluoroscopic X-Ray…Siemens Medical Solutions USA, Inc
2024-04-17Z-1481-2024Class IIHemostasis ProbeOlympus Corporation of the Americas
2024-04-17Z-1482-2024Class IIRayStation Software Version Numbers version numbers 8BRAYSEARCH LABORATORIES AB
2024-04-17Z-1483-2024Class IIKWIK-STIK Rhizopus stoloniferMicrobiologics Inc
2024-04-17Z-1484-2024Class ILVP Software of the Ivenix Infusion SystemFresenius Kabi USA, LLC
2024-04-17Z-1486-2024Class IIAltair 330 lbs w/o Hanger BarHuman Care Hc Sweden Ab
2024-04-17Z-1487-2024Class IIBed Assist BarsMEDLINE INDUSTRIES, LP - Northfield
2024-04-17Z-1488-2024Class IIBed Assist BarsMEDLINE INDUSTRIES, LP - Northfield
2024-04-17Z-1495-2024Class IIConvaTec CarboFlexConvaTec, Inc
2024-04-17Z-1496-2024Class IIACETABULAR FIXATION CUPSynovo Production
2024-04-17Z-1497-2024Class IIACETABULAR BEARINGSynovo Production
2024-04-17Z-1498-2024Class IIFemoral Resurfacing CupSynovo Production
2024-04-17Z-1506-2024Class IIChromophare Surgical Light SystemStryker Communications
2024-04-17Z-1507-2024Class IIPHILIPS Incisive Computed tomography X-ray system Incisive CT…Philips North America
2024-04-17Z-1508-2024Class IIEZ2 Connect MDx-IVD Designed to perform automated isolation and…Qiagen Sciences LLC
2024-04-17Z-1509-2024Class IIHillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure DeviceBaxter Healthcare Corporation
2024-04-17Z-1510-2024Class IIHillrom Welch Allyn Spot Vision Screener VS100Baxter Healthcare Corporation
2024-04-17Z-1511-2024Class IIPower CordsBaxter Healthcare Corporation
2024-04-17Z-1513-2024Class IIEndoVive 20Fr Push Safety PEG Kit w/ENFitBoston Scientific Corporation
2024-04-17Z-1514-2024Class IIEndoVive 20Fr Push Standard PEG Kit w/ENFitBoston Scientific Corporation
2024-04-17Z-1515-2024Class IIEndoVive 20Fr Push Safety PEG KitBoston Scientific Corporation
2024-04-17Z-1516-2024Class IIEndoVive 20Fr Push Standard PEG KitBoston Scientific Corporation
2024-04-17Z-1517-2024Class IIEndoVive 20 Fr Safety PEG Push w/ENFit KitBoston Scientific Corporation
2024-04-17Z-1518-2024Class IIPatient CartIntuitive Surgical, Inc.
2024-04-10Z-1351-2024Class IMojo Full Face with HeadgearSleepNet Corporation
2024-04-10Z-1352-2024Class IMojo Non Vented Full Face Mask with HeadgearSleepNet Corporation
2024-04-10Z-1353-2024Class IMojo 2 Full Face Vented MaskSleepNet Corporation
2024-04-10Z-1354-2024Class IMojo 2 Full Face Non Vented MaskSleepNet Corporation
2024-04-10Z-1355-2024Class IMojo 2 Full Face AAV Non Vented MaskSleepNet Corporation
2024-04-10Z-1356-2024Class IiQ 2 Nasal Vented MaskSleepNet Corporation
2024-04-10Z-1357-2024Class IPhantom 2 Nasal Vented MaskSleepNet Corporation
2024-04-10Z-1392-2024Class IIX-Guide Handpiece Adaptor Sleeve 1X-NAV Technologies, LLC
2024-04-10Z-1393-2024Class IIX-Guide Handpiece Adaptor Sleeve 3X-NAV Technologies, LLC
2024-04-10Z-1398-2024Class IIBD Phoenix NMIC-306 Panel is a self-inoculatingBecton Dickinson & Co.
2024-04-10Z-1399-2024Class IIBD Phoenix Yeast ID Panel is a self-inoculatingBecton Dickinson & Co.
2024-04-10Z-1400-2024Class IIHill-Rom PRO+ 36" MRS SurfaceBaxter Healthcare Corporation
2024-04-10Z-1401-2024Class IICardiovascular Procedure Kits that include High Crack Check Valve PN…Terumo Cardiovascular Systems Corporation
2024-04-10Z-1402-2024Class IIExactech Equinoxe GLENOIDExactech, Inc.
2024-04-10Z-1403-2024Class IIExactech Equinoxe GLENOIDExactech, Inc.
2024-04-10Z-1404-2024Class IIExactech Equinoxe GLENOIDExactech, Inc.
2024-04-10Z-1405-2024Class IIExactech Equinoxe GLENOIDExactech, Inc.
2024-04-10Z-1406-2024Class IIExactech Equinoxe GLENOIDExactech, Inc.
2024-04-10Z-1407-2024Class IIExactech Equinoxe GLENOIDExactech, Inc.
2024-04-10Z-1408-2024Class IIExactech Equinoxe GLENOIDExactech, Inc.
2024-04-10Z-1409-2024Class IIExactech Equinoxe GLENOIDExactech, Inc.
2024-04-10Z-1410-2024Class IIExactech Equinoxe GLENOIDExactech, Inc.
2024-04-10Z-1411-2024Class IIExactech Equinoxe GLENOIDExactech, Inc.
2024-04-10Z-1412-2024Class IIExactech Equinoxe CAGE GLENOIDExactech, Inc.
2024-04-10Z-1413-2024Class IIExactech Equinoxe CAGE GLENOIDExactech, Inc.
2024-04-10Z-1414-2024Class IIExactech Equinoxe CAGE GLENOIDExactech, Inc.
2024-04-10Z-1415-2024Class IIExactech Equinoxe CAGE GLENOIDExactech, Inc.
2024-04-10Z-1416-2024Class IIExactech Equinoxe REVERSE SHOULDERExactech, Inc.
2024-04-10Z-1417-2024Class IIExactech Equinoxe REVERSE SHOULDERExactech, Inc.
2024-04-10Z-1418-2024Class IIExactech Equinoxe REVERSE SHOULDERExactech, Inc.
2024-04-10Z-1419-2024Class IIExactech Equinoxe REVERSE SHOULDERExactech, Inc.
2024-04-10Z-1420-2024Class IIExactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00Exactech, Inc.
2024-04-10Z-1421-2024Class IIExactech Equinoxe Constrained Humeral Liner: Item Numbers: a)…Exactech, Inc.
2024-04-10Z-1422-2024Class IIExactech Equinoxe REVERSE SHOULDERExactech, Inc.
2024-04-10Z-1423-2024Class IIExactech Equinoxe REVERSE SHOULDERExactech, Inc.
2024-04-10Z-1424-2024Class IIExactech Equinoxe REVERSE SHOULDERExactech, Inc.
2024-04-10Z-1425-2024Class IIExactech Equinoxe REVERSE SHOULDERExactech, Inc.
2024-04-10Z-1426-2024Class IITorrent Suite Dx Software versions 5Life Technologies Corporation
2024-04-10Z-1427-2024Class IICenturion STERILE TRACH BRUSHMEDLINE INDUSTRIES, LP - Northfield
2024-04-10Z-1428-2024Class IICenturion FCP MAGILL CATH 7MEDLINE INDUSTRIES, LP - Northfield
2024-04-10Z-1429-2024Class IICenturion STERILE COTTON DENTAL ROLLS 6/PKMEDLINE INDUSTRIES, LP - Northfield
2024-04-10Z-1430-2024Class IICenturion STERILE BLOOD COLLECTION TUBEMEDLINE INDUSTRIES, LP - Northfield
2024-04-10Z-1431-2024Class IICenturion kits: a) DENTAL INSTRUMENT KITMEDLINE INDUSTRIES, LP - Northfield
2024-04-10Z-1432-2024Class IICenturion STERILE #5 LARYNGEAL MIRRORMEDLINE INDUSTRIES, LP - Northfield
2024-04-10Z-1433-2024Class IICenturion STERILE ROUND EAR SPECULUM SETMEDLINE INDUSTRIES, LP - Northfield
2024-04-10Z-1434-2024Class IICenturion retractor kits labeled as: a) STERILE 6-1/2" SENN RETRACTORMEDLINE INDUSTRIES, LP - Northfield
2024-04-10Z-1435-2024Class IICenturion hook kits labeled as: a) STERILE SKIN HOOK FINEMEDLINE INDUSTRIES, LP - Northfield
2024-04-10Z-1436-2024Class IICenturion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL…MEDLINE INDUSTRIES, LP - Northfield
2024-04-10Z-1437-2024Class IICenturion Forcep kits labeled as: a) STERILE F/P SPLINTER FORCEPMEDLINE INDUSTRIES, LP - Northfield
2024-04-10Z-1438-2024Class IICenturion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTATMEDLINE INDUSTRIES, LP - Northfield
2024-04-10Z-1439-2024Class IICenturion Curette kits labeled as: a) STERILE BUCK EAR CURETTE "00"MEDLINE INDUSTRIES, LP - Northfield
2024-04-10Z-1440-2024Class IICenturion Clamp kits labeled as: a) STERILE BACKHAUS TOWEL CLAMPMEDLINE INDUSTRIES, LP - Northfield
2024-04-10Z-1441-2024Class IICenturion manual surgical kits labeled as: a) STERILE TUBE OCCLUDING…MEDLINE INDUSTRIES, LP - Northfield
2024-04-10Z-1442-2024Class IICenturion manual surgical kits labeled as: a) STMEDLINE INDUSTRIES, LP - Northfield
2024-04-10Z-1443-2024Class IICenturion manual surgical kits labeled as: a) STERILE ALLIS TISS FCP…MEDLINE INDUSTRIES, LP - Northfield
2024-04-10Z-1444-2024Class IICenturion manual surgical kits labeled as: a) STERILE 4-1/2" S/S…MEDLINE INDUSTRIES, LP - Northfield
2024-04-10Z-1445-2024Class IICenturion manual surgical kits labeled as: a) SUTURE REMOVAL TRAYMEDLINE INDUSTRIES, LP - Northfield
2024-04-10Z-1446-2024Class IICenturion STERILE #16 RUBBER BANDMEDLINE INDUSTRIES, LP - Northfield
2024-04-10Z-1447-2024Class IICenturion PICC LINE SECUREMENT KITMEDLINE INDUSTRIES, LP - Northfield
2024-04-10Z-1448-2024Class IICenturion Manual surgical kits labeled as: a) 15ML SAMPLING TUBE WITH…MEDLINE INDUSTRIES, LP - Northfield
2024-04-10Z-1449-2024Class IICenturion Manual surgical kits labeled as: a) STERILE S/B WIRE SCISSORMEDLINE INDUSTRIES, LP - Northfield
2024-04-10Z-1450-2024Class IICenturion Manual surgical kits labeled as: a) HEGAR UTERINE DILATORMEDLINE INDUSTRIES, LP - Northfield
2024-04-10Z-1451-2024Class IICenturion DISPMEDLINE INDUSTRIES, LP - Northfield
2024-04-10Z-1452-2024Class IIMEDLINE M1S0179 STRL TAPE/PEN PACKMEDLINE INDUSTRIES, LP - Northfield
2024-04-10Z-1453-2024Class IIMEDLINE SWABSTICKS PVP 3 PKMEDLINE INDUSTRIES, LP - Northfield
2024-04-10Z-1454-2024Class IIMEDLINE 4MEDLINE INDUSTRIES, LP - Northfield
2024-04-10Z-1455-2024Class IIMEDLINE SWABSTICKS ALCOHOL 3PKMEDLINE INDUSTRIES, LP - Northfield
2024-04-10Z-1456-2024Class IIATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP TechnologyDePuy Orthopaedics, Inc.
2024-04-10Z-1457-2024Class IISignia" Small Diameter Curved Tip Intelligent ReloadCovidien, LP
2024-04-10Z-1458-2024Class IICovidien Signia" Small Diameter Curved Tip Intelligent ReloadCovidien, LP
2024-04-10Z-1459-2024Class IIBlood Pressure UnitMEDLINE INDUSTRIES, LP - Northfield
2024-04-10Z-1460-2024Class IITrumpetTechnicality Inc.
2024-04-10Z-1461-2024Class IIIHALYARD SURGICAL HOODO&M HALYARD, INC.
2024-04-10Z-1462-2024Class IIAgfa DX-D 100 system-Digital Radiography mobile X-ray SystemAgfa N.V.
2024-04-10Z-1463-2024Class IIUreteral dilatorColoplast Manufacturing US, LLC
2024-04-10Z-1465-2024Class IICovidien Auto Suture" Structural Balloon TrocarCovidien, LP
2024-04-10Z-1466-2024Class IICovidien Auto Suture" Blunt Tip TrocarCovidien, LP
2024-04-10Z-1467-2024Class IICovidien Auto Suture" Blunt Tip TrocarCovidien, LP

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