Data Foundry

All years

Medical device recalls reported in 2022

← Newer · Older →

ReportedRecallClassProductFirm
2022-10-05Z-1809-2022Class IIIaMckesson Medical-Surgical Inc. Corporate Office
2022-10-05Z-1810-2022Class IIAutosoft 90Unomedical A/S
2022-10-05Z-1811-2022Class IIt:slim X2 insulin pumpTandem Diabetes Care Inc
2022-10-05Z-1812-2022Class IIt:slim X2 insulin pumpTandem Diabetes Care Inc
2022-10-05Z-1813-2022Class IIOlympus POWERSEAL 5MMOlympus Corporation of the Americas
2022-10-05Z-1814-2022Class IIOlympus POWERSEAL 5MMOlympus Corporation of the Americas
2022-10-05Z-1815-2022Class IIOlympus POWERSEAL 5MMOlympus Corporation of the Americas
2022-10-05Z-1816-2022Class IIDimension MagnesiumSiemens Healthcare Diagnostics, Inc.
2022-10-05Z-1817-2022Class IIIStarling MonitorBaxter Healthcare Corporation
2022-10-05Z-1818-2022Class IIAmbra PACSDICOM Grid, Inc. d/b/a Ambra Health
2022-10-05Z-1819-2022Class IIVenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM RefAngiodynamics, Inc.
2022-10-05Z-1820-2022Class IIIMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating…Siemens Healthcare Diagnostics, Inc.
2022-10-05Z-1821-2022Class IIOSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR…Ossur Americas
2022-10-05Z-1822-2022Class IIHumidifier bottle and syringe filter kitCooperSurgical, Inc.
2022-10-05Z-1823-2022Class IIHumidifier bottle and syringe filter kitCooperSurgical, Inc.
2022-10-05Z-1824-2022Class IIAmplatz extra Stiff Wire GuideCook Incorporated
2022-10-05Z-1825-2022Class IIBentson Plus Wire GuideCook Incorporated
2022-10-05Z-1826-2022Class IIBentson Wire GuideCook Incorporated
2022-10-05Z-1827-2022Class IIBentson Wire GuideCook Incorporated
2022-10-05Z-1828-2022Class IICoons Interventional Wire GuideCook Incorporated
2022-10-05Z-1829-2022Class IICope Mandril Wire GuideCook Incorporated
2022-10-05Z-1830-2022Class IICope Mandril Wire GuideCook Incorporated
2022-10-05Z-1831-2022Class IIDouble Flexible Tipped Wire GuideCook Incorporated
2022-10-05Z-1832-2022Class IIFixed Core Wire GuideCook Incorporated
2022-10-05Z-1833-2022Class IIFixed Core Wire GuideCook Incorporated
2022-10-05Z-1834-2022Class IIFixed Core Wire GuideCook Incorporated
2022-10-05Z-1835-2022Class IIHeavy Double Flexible Tipped Wire GuideCook Incorporated
2022-10-05Z-1836-2022Class IINewton Wire GuideCook Incorporated
2022-10-05Z-1837-2022Class IIRoadrunner PC Hydrophilic Wire GuideCook Incorporated
2022-10-05Z-1838-2022Class IIRoadrunner PC Wire GuideCook Incorporated
2022-10-05Z-1839-2022Class IIRoadrunner PC Wire GuideCook Incorporated
2022-10-05Z-1840-2022Class IIRoadrunner PC Wire GuideCook Incorporated
2022-10-05Z-1841-2022Class IIRoadrunner PC Wire GuideCook Incorporated
2022-10-05Z-1842-2022Class IIRosen Curved Wire GuideCook Incorporated
2022-10-05Z-1843-2022Class IITorq-Flex Wire Guide Australian ModificationCook Incorporated
2022-10-05Z-1844-2022Class IIVinyl Connecting TubeCook Incorporated
2022-10-05Z-1845-2022Class IILunderquist -Ring Torque Wire GuideCook Incorporated
2022-10-05Z-1846-2022Class IIMovable Core Wire GuideCook Incorporated
2022-10-05Z-1847-2022Class IIMovable Core Wire GuideCook Incorporated
2022-10-05Z-1848-2022Class IILeica Surgical Operating MicroscopesLeica Microsystems, Inc.
2022-10-05Z-1849-2022Class IILeica Surgical Operating MicroscopesLeica Microsystems, Inc.
2022-10-05Z-1850-2022Class IILeica Surgical Operating MicroscopesLeica Microsystems, Inc.
2022-10-05Z-1851-2022Class IILeica Surgical Operating MicroscopesLeica Microsystems, Inc.
2022-10-05Z-1852-2022Class IIProduct/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503Surgical Innovations Ltd
2022-10-05Z-1853-2022Class IIProduct/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001Surgical Innovations Ltd
2022-10-05Z-1854-2022Class IIBarco Medical Network AdapterBARCO NV
2022-10-05Z-1855-2022Class IIMEDLINE CLEARPRO DOUBLE SWIVEL CLOSED SUCTION CATHETERMEDLINE INDUSTRIES, LP - Northfield
2022-10-05Z-1856-2022Class IIMEDLINE CLEARPRO TRACH DOUBLE SWIVEL CLOSED SUCTION CATHETERMEDLINE INDUSTRIES, LP - Northfield
2022-10-05Z-1857-2022Class IIMEDLINE CLEARPRO TRACH T-PIECE CLOSED SUCTION CATHETERMEDLINE INDUSTRIES, LP - Northfield
2022-09-28Z-1752-2022Class IIBD MaxGuard Extension Set with 4-way stopcockCAREFUSION
2022-09-28Z-1753-2022Class IIBD MaxGuard Extension SetCAREFUSION
2022-09-28Z-1754-2022Class IIBD MaxGuard Flow Controller Extension Set with Needleless Y-SiteCAREFUSION
2022-09-28Z-1755-2022Class IIBD MaxGuard Flow Controller Extension Set with Needleless Y-SiteCAREFUSION
2022-09-28Z-1756-2022Class IIBD MaxGuard Drop Administration set with 3 Needleless Y-Sites…CAREFUSION
2022-09-28Z-1757-2022Class IIBD MaxGuard Extension Set with 2 Needleless Y-SiteCAREFUSION
2022-09-28Z-1758-2022Class IIBD MaxGuard Extension Set with 0CAREFUSION
2022-09-28Z-1759-2022Class IIBD MaxGuard Extension Set with 1CAREFUSION
2022-09-28Z-1760-2022Class IIBD MaxGuard 15 Drop Administration Set with 4 Needleless Y-SitesCAREFUSION
2022-09-28Z-1764-2022Class IIBEQ-HLS 7050 USAMaquet Medical Systems USA
2022-09-28Z-1765-2022Class IIBEQ-HLS 5050 USAMaquet Medical Systems USA
2022-09-28Z-1766-2022Class IIBEQ-HLS 5050 USAMaquet Medical Systems USA
2022-09-28Z-1767-2022Class IIBEQ-HLS 7050 USAMaquet Medical Systems USA
2022-09-28Z-1768-2022Class IIORCA FOAM STANDARD CUBE 10x10x10 mmGELITA MEDICAL GMBH
2022-09-28Z-1769-2022Class IIAquaC UNO H [120VFresenius Medical Care Holdings, Inc.
2022-09-28Z-1770-2022Class IIAquaC UNO H [120VFresenius Medical Care Holdings, Inc.
2022-09-28Z-1771-2022Class IIDiversatek HealthDiversatek Healthcare
2022-09-28Z-1772-2022Class IIThe Randox Serology I Positive Control contains the following…Randox Laboratories Ltd.
2022-09-28Z-1773-2022Class IIPDS IIEthicon, Inc.
2022-09-28Z-1774-2022Class IIFungitell STAT- IVD Assay forAssociates of Cape Cod, Inc.
2022-09-28Z-1775-2022Class IIPuritan Bennett 560 VentilatorCovidien Llc
2022-09-28Z-1776-2022Class IIGrappler Suture AnchorParagon 28, Inc.
2022-09-21Z-1653-2022Class IBaxter CLEARLINK SystemBaxter Healthcare Corporation
2022-09-21Z-1706-2022Class IIRoadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBERCook Incorporated
2022-09-21Z-1707-2022Class IIRoadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBERCook Incorporated
2022-09-21Z-1708-2022Class IIRoadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBERCook Incorporated
2022-09-21Z-1709-2022Class IIRoadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBERCook Incorporated
2022-09-21Z-1710-2022Class IIRoadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBERCook Incorporated
2022-09-21Z-1711-2022Class IIRoadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBERCook Incorporated
2022-09-21Z-1712-2022Class IIRoadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBERCook Incorporated
2022-09-21Z-1713-2022Class IIRoadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBERCook Incorporated
2022-09-21Z-1714-2022Class IIRoadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBERCook Incorporated
2022-09-21Z-1715-2022Class IIRoadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBERCook Incorporated
2022-09-21Z-1716-2022Class IIRoadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBERCook Incorporated
2022-09-21Z-1717-2022Class IIRoadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBERCook Incorporated
2022-09-21Z-1718-2022Class IIRoadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBERCook Incorporated
2022-09-21Z-1719-2022Class IIMicroClave Clear Neutral ConnectorICU Medical, Inc.
2022-09-21Z-1720-2022Class II8ICU Medical, Inc.
2022-09-21Z-1721-2022Class II6ICU Medical, Inc.
2022-09-21Z-1722-2022Class IIMicroClave Clear Neutral ConnectorICU Medical, Inc.
2022-09-21Z-1723-2022Class II6ICU Medical, Inc.
2022-09-21Z-1724-2022Class II6"ICU Medical, Inc.
2022-09-21Z-1725-2022Class IIGXL acetabular linersExactech, Inc.
2022-09-21Z-1726-2022Class IIGXL acetabular linersExactech, Inc.
2022-09-21Z-1727-2022Class IIGXL acetabular linersExactech, Inc.
2022-09-21Z-1728-2022Class IIGXL acetabular linersExactech, Inc.
2022-09-21Z-1729-2022Class IIGXL acetabular linersExactech, Inc.
2022-09-21Z-1730-2022Class IIGXL acetabular linersExactech, Inc.
2022-09-21Z-1731-2022Class IIGXL acetabular linersExactech, Inc.
2022-09-21Z-1732-2022Class IIGXL acetabular linersExactech, Inc.
2022-09-21Z-1733-2022Class IIGXL acetabular linersExactech, Inc.
2022-09-21Z-1734-2022Class IIGXL acetabular linersExactech, Inc.
2022-09-21Z-1735-2022Class IIStryker USB ConverterMako Surgical Corporation
2022-09-21Z-1736-2022Class IIIVerify SixCess Challenge PackSteris Corporation Hopkins Facility
2022-09-21Z-1737-2022Class IIDisposable Subdermal Needle ElectrodeTechnomed Europe
2022-09-21Z-1739-2022Class IIAcidified Concentrate Distribution and Storage-The Isopure ACDSIsopure Corp
2022-09-21Z-1740-2022Class IIIHelix Elite Inactivated StandardMicrobiologics Inc
2022-09-21Z-1741-2022Class IIIPTS Panels CHOL+GLU Test StripsPolymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
2022-09-21Z-1742-2022Class IIZAP-X Radiosurgery SystemZap Surgical Systems
2022-09-21Z-1743-2022Class IIIBIOPHEN UFH Control PlasmaAniara Diagnostica LLC
2022-09-21Z-1744-2022Class IIPinnacle3 Radiation Therapy Planning SystemPhilips Medical Systems (Cleveland) Inc
2022-09-21Z-1745-2022Class IIINOmax DSIR -Mallinckrodt, LLC.
2022-09-21Z-1746-2022Class IIQIAcube Connect MDxQiagen Sciences LLC
2022-09-21Z-1747-2022Class IIFABCO ORS DENTAL ROLLSCarwild Corporation
2022-09-21Z-1748-2022Class IISCENARIA View: Software Version V1FUJIFILM Healthcare Americas Corporation
2022-09-21Z-1749-2022Class IISurpria: Software Version V3FUJIFILM Healthcare Americas Corporation
2022-09-21Z-1750-2022Class IISurpria 64: Software Version V3FUJIFILM Healthcare Americas Corporation
2022-09-21Z-1751-2022Class IIiSED Primary Pump Tubing Spare Part Kit-Alcor Scientific, Inc.
2022-09-14Z-1654-2022Class IPhilips BiPAP A30Philips Respironics, Inc.
2022-09-14Z-1655-2022Class IPhilips BiPAP A40Philips Respironics, Inc.
2022-09-14Z-1656-2022Class IPhilips BiPAP V30 AutoPhilips Respironics, Inc.
2022-09-14Z-1657-2022Class IPhilips OmniLab Advanced+Philips Respironics, Inc.
2022-09-14Z-1658-2022Class IPhilips OmniLab Advanced+ IntlPhilips Respironics, Inc.
2022-09-14Z-1659-2022Class IPhilips OmniLab Advanced + with Heated Tube HumidifierPhilips Respironics, Inc.
2022-09-14Z-1661-2022Class IIThe product is a handheld ultraviolet-C germicidal wand and contains…MERCHSOURCE LLC
2022-09-14Z-1675-2022Class IIVITROS XT 3400 Chemistry System with Version 3Ortho-Clinical Diagnostics, Inc.
2022-09-14Z-1676-2022Class IIVITROS XT 7600 Integrated System with Version 3Ortho-Clinical Diagnostics, Inc.
2022-09-14Z-1677-2022Class IICARTO VIZIGO 8Biosense Webster, Inc.
2022-09-14Z-1678-2022Class IIOrthex External Fixation Wire Sharp Bayonet 1OrthoPediatrics Corp
2022-09-14Z-1679-2022Class IIAbbott Alinity m SARS-CoV-2 CTRL KitAbbott Molecular, Inc.
2022-09-14Z-1680-2022Class IIOptima Coil System Model OPTI0520CSF10BALT USA, LLC
2022-09-14Z-1681-2022Class IIProduct Description/Item: ChemoLock Bag SpikeICU Medical, Inc.
2022-09-14Z-1682-2022Class IIProduct Description/Item: ChemoLock Vial SpikeICU Medical, Inc.
2022-09-14Z-1683-2022Class IIMedline CHEST TUBE REORDER NO: DYNJ36762AMedline Industries Inc.
2022-09-14Z-1684-2022Class IIEarly Bird Bleed Monitoring System Introducer Sheath SetSaranas, Inc.
2022-09-14Z-1685-2022Class IIMEGA 8Fr 50cc Intra-Aortic Balloon CatheterDatascope Corporation
2022-09-14Z-1686-2022Class IISensation Plus 8Fr 50cc Intra-Aortic Balloon CatheterDatascope Corporation
2022-09-14Z-1687-2022Class IIInsertion Kit for use with SENSATION PLUS 8FDatascope Corporation
2022-09-14Z-1688-2022Class IIVYGON DRESSING CHANGE W/MAXISWAB kitStradis Healthcare
2022-09-14Z-1689-2022Class IIVarious Angiography packs/traysAmerican Contract Systems, Inc.
2022-09-14Z-1690-2022Class IIVarious Angiography/Cath Lab packs/traysAmerican Contract Systems, Inc.
2022-09-14Z-1691-2022Class IIVarious Pacemaker PacksAmerican Contract Systems, Inc.
2022-09-14Z-1692-2022Class IIVarious PICC LineAmerican Contract Systems, Inc.
2022-09-14Z-1693-2022Class IIVarious ENT PacksAmerican Contract Systems, Inc.
2022-09-14Z-1694-2022Class IIVarious Laparoscopy PacksAmerican Contract Systems, Inc.
2022-09-14Z-1695-2022Class IIVarious Cysto PacksAmerican Contract Systems, Inc.
2022-09-14Z-1696-2022Class IIVarious Port Insertion PacksAmerican Contract Systems, Inc.
2022-09-14Z-1697-2022Class IIBreast Abdominoplasty PackAmerican Contract Systems, Inc.
2022-09-14Z-1698-2022Class IIVarious convenience packsAmerican Contract Systems, Inc.
2022-09-14Z-1699-2022Class IIVarious convenience packsAmerican Contract Systems, Inc.
2022-09-14Z-1700-2022Class IIVarious neurology packsAmerican Contract Systems, Inc.
2022-09-14Z-1701-2022Class IIVarious ob/gyn packsAmerican Contract Systems, Inc.
2022-09-14Z-1702-2022Class IIVarious hysterectomyAmerican Contract Systems, Inc.
2022-09-14Z-1703-2022Class IIVarious C-section packsAmerican Contract Systems, Inc.
2022-09-14Z-1704-2022Class IID&C packAmerican Contract Systems, Inc.
2022-09-14Z-1705-2022Class IIVarious eye packsAmerican Contract Systems, Inc.
2022-09-07Z-1519-2022Class INIM CONTACT EMG Endotracheal TubeMedtronic Xomed, Inc.
2022-09-07Z-1520-2022Class INIM EMG Endotracheal TubeMedtronic Xomed, Inc.
2022-09-07Z-1521-2022Class INIM EMG Endotracheal TubeMedtronic Xomed, Inc.
2022-09-07Z-1563-2022Class IIDigitalDiagnost C50 1Philips North America Llc
2022-09-07Z-1638-2022Class IIAesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal…Aesculap Implant Systems LLC
2022-09-07Z-1639-2022Class IIAggreGuide A-100 InstrumentAggredyne, Inc.
2022-09-07Z-1640-2022Class IIVITEK 2 / MYLA VITEK 2 Software versions 8bioMerieux, Inc.
2022-09-07Z-1641-2022Class IIT-SPOTOXFORD IMMUNOTEC LTD
2022-09-07Z-1642-2022Class IIT-Cell Xtend REF TTKOXFORD IMMUNOTEC LTD
2022-09-07Z-1643-2022Class IIAIM-V Medium REF AVOXFORD IMMUNOTEC LTD
2022-09-07Z-1644-2022Class IIEverFlex Self-Expanding Peripheral Stent with Entrust Delivery SystemMedtronic Inc.
2022-09-07Z-1645-2022Class IIArtis Q floor- Model NoSiemens Medical Solutions USA, Inc
2022-09-07Z-1646-2022Class IIArtis pheno- Model NoSiemens Medical Solutions USA, Inc
2022-09-07Z-1647-2022Class IIArtis icono biplane- Model NoSiemens Medical Solutions USA, Inc
2022-09-07Z-1648-2022Class IIDimension Vista LOCI CA 15-3 Flex reagent cartridgeSiemens Healthcare Diagnostics, Inc.
2022-09-07Z-1649-2022Class IIMetalogix Self-Drill Half-PinNew Standard Device Inc
2022-09-07Z-1650-2022Class IItherascreen FGFR RGQ RT-PCR kitQiagen Sciences LLC
2022-09-07Z-1651-2022Class IItherascreen FGFR RGQ RT-PCR KitQiagen Sciences LLC
2022-09-07Z-1652-2022Class IIFGFR RGQ RT-PCR KitQiagen Sciences LLC
2022-09-07Z-1660-2022Class IIARCHITECT STAT Troponin-I Reagent KitAbbott Laboratories
2022-09-07Z-1666-2022Class IIINFX-8000VCanon Medical System, USA, INC.
2022-09-07Z-1667-2022Class IITaperFit StemCorin Ltd
2022-09-07Z-1668-2022Class IIDeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear…DeRoyal Industries Inc
2022-09-07Z-1669-2022Class IIThe Programmer/Recorder/MonitorBoston Scientific Corporation
2022-09-07Z-1670-2022Class IIThe PRM is intended to be used as part of the ZOOM LATITUDE…Boston Scientific Corporation
2022-09-07Z-1671-2022Class IIThe PRM is intended to be used as part of the ZOOM LATITUDE…Boston Scientific Corporation
2022-09-07Z-1672-2022Class IIPentacam AXL Wave REF 70020Oculus Optikgeraete GMBH
2022-09-07Z-1673-2022Class IIPentacam AXL REF 70100Oculus Optikgeraete GMBH
2022-09-07Z-1674-2022Class IIPentacam HR REF 70900Oculus Optikgeraete GMBH
2022-08-31Z-1522-2022Class IINTERA 3000 Hepatic Artery Infusion PumpIntera Oncology, Inc.
2022-08-31Z-1525-2022Class IHAMILTON-C6 Intensive Care VentilatorHamilton Medical AG
2022-08-31Z-1559-2022Class IIEVIS EXERA III BronchovideoscopeAizu Olympus Co., Ltd.
2022-08-31Z-1560-2022Class IMaquet Critical Care AB/Getinge Servo-u Ventilator SystemGetinge Usa Sales Inc
2022-08-31Z-1561-2022Class INeuRx Diaphragm Pacing SystemSynapse Biomedical Inc
2022-08-31Z-1562-2022Class IIDeRoyal limb holders:DeRoyal Industries Inc
2022-08-31Z-1564-2022Class IINUCLISENS easyMAG Magnetic SilicabioMerieux, Inc.
2022-08-31Z-1565-2022Class IINobel Biocare N1 TiUltra TCC NP 3Nobel Biocare
2022-08-31Z-1566-2022Class II(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE…GE Healthcare, LLC
2022-08-31Z-1567-2022Class IIStryker SWANSON Flexspan Finger Joint Implant W/O Grommets SiliconeWright Medical Technology, Inc.
2022-08-31Z-1568-2022Class IIServo-air Ventilator System-The Servo-air Ventilator System is:…Getinge Usa Sales Inc
2022-08-31Z-1569-2022Class IIProPlan CMF Anatomical ModelMaterialise USA LLC
2022-08-31Z-1570-2022Class IIThe Exacta-Mix 2400 compounding systemBaxter Healthcare Corporation
2022-08-31Z-1571-2022Class IIVanta Clinician Programmer ApplicationMedtronic Neuromodulation
2022-08-31Z-1572-2022Class IISteriSpine PS kit of 2 Multi-Axial Fenestrated ScrewsSAFE ORTHOPAEDICS LLC
2022-08-31Z-1573-2022Class IIHANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144Mizuho OSI

← Newer · Older →