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Medical device recalls reported in 2021

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ReportedRecallClassProductFirm
2021-06-16Z-1801-2021Class IIAtec Insignia Anterior Cervical Plate SystemAlphatec Spine, Inc.
2021-06-16Z-1802-2021Class IIAtec Insignia Anterior Cervical Plate SystemAlphatec Spine, Inc.
2021-06-16Z-1803-2021Class IIAtec Insignia Anterior Cervical Plate SystemAlphatec Spine, Inc.
2021-06-16Z-1804-2021Class IIAtec Insignia Anterior Cervical Plate SystemAlphatec Spine, Inc.
2021-06-16Z-1805-2021Class IIAtec Insignia Anterior Cervical Plate SystemAlphatec Spine, Inc.
2021-06-16Z-1806-2021Class IIAtec Insignia Anterior Cervical Plate SystemAlphatec Spine, Inc.
2021-06-16Z-1807-2021Class IIAtec Insignia Anterior Cervical Plate SystemAlphatec Spine, Inc.
2021-06-16Z-1808-2021Class IIAtec Insignia Anterior Cervical Plate SystemAlphatec Spine, Inc.
2021-06-16Z-1809-2021Class IIAtec Insignia Anterior Cervical Plate SystemAlphatec Spine, Inc.
2021-06-16Z-1810-2021Class IIAtec Insignia Anterior Cervical Plate SystemAlphatec Spine, Inc.
2021-06-16Z-1811-2021Class IIAtec Insignia Anterior Cervical Plate SystemAlphatec Spine, Inc.
2021-06-16Z-1812-2021Class IIAtec Insignia Anterior Cervical Plate SystemAlphatec Spine, Inc.
2021-06-16Z-1813-2021Class IIAtec Insignia Anterior Cervical Plate SystemAlphatec Spine, Inc.
2021-06-16Z-1814-2021Class IIAtec Insignia Anterior Cervical Plate SystemAlphatec Spine, Inc.
2021-06-16Z-1815-2021Class IIAtec Insignia Anterior Cervical Plate SystemAlphatec Spine, Inc.
2021-06-16Z-1816-2021Class IIAtec Insignia Anterior Cervical Plate SystemAlphatec Spine, Inc.
2021-06-16Z-1817-2021Class IIAtec Insignia Anterior Cervical Plate SystemAlphatec Spine, Inc.
2021-06-16Z-1818-2021Class IIAtec Insignia Anterior Cervical Plate SystemAlphatec Spine, Inc.
2021-06-16Z-1819-2021Class IIAtec Insignia Anterior Cervical Plate SystemAlphatec Spine, Inc.
2021-06-16Z-1820-2021Class IIAtec Insignia Anterior Cervical Plate SystemAlphatec Spine, Inc.
2021-06-16Z-1821-2021Class IIAtec Insignia Anterior Cervical Plate SystemAlphatec Spine, Inc.
2021-06-16Z-1822-2021Class IIAtec Insignia Anterior Cervical Plate SystemAlphatec Spine, Inc.
2021-06-16Z-1823-2021Class IIAtec Insignia Anterior Cervical Plate SystemAlphatec Spine, Inc.
2021-06-16Z-1824-2021Class IIAtec Insignia Anterior Cervical Plate SystemAlphatec Spine, Inc.
2021-06-16Z-1825-2021Class IIAtec Insignia Anterior Cervical Plate SystemAlphatec Spine, Inc.
2021-06-16Z-1826-2021Class IIAtec Insignia Anterior Cervical Plate SystemAlphatec Spine, Inc.
2021-06-16Z-1827-2021Class IIAtec Insignia Anterior Cervical Plate SystemAlphatec Spine, Inc.
2021-06-16Z-1828-2021Class IIIVIA Microcatheter VIA 17 REF VIA-17-154-01MICROVENTION INC.
2021-06-16Z-1829-2021Class IIIVIA Microcatheter VIA 21 REF VIA-21-154-01MICROVENTION INC.
2021-06-16Z-1830-2021Class IIIVIA Microcatheter VIA 27 REF VIA-27-154-01MICROVENTION INC.
2021-06-16Z-1831-2021Class IINormand Remisol Advance Data Manager is a software device that…Normand-Info S.A.S.U.
2021-06-16Z-1832-2021Class IDeRoyal Pacemaker Tray PgybkDeRoyal Industries Inc
2021-06-16Z-1833-2021Class IDeRoyal Heart Cath Procedure PackDeRoyal Industries Inc
2021-06-16Z-1834-2021Class IDeRoyal Angio Cath Removal TrayDeRoyal Industries Inc
2021-06-16Z-1835-2021Class IIQuickslide GramPro 1 Automated Gram Stanier is a microscope slide…Hardy Diagnostics
2021-06-16Z-1836-2021Class IIViewRay MRIdian Linac System: Model NoViewray, Inc.
2021-06-16Z-1837-2021Class IISUNSTAR GSunstar Americas, Inc.
2021-06-16Z-1838-2021Class IIRayStationRAYSEARCH LABORATORIES AB
2021-06-16Z-1839-2021Class IINICO Myriad-LX Illumination Pack: REF: NN-1000 Mvriad-LX Illumination…Nico Corp.
2021-06-16Z-1840-2021Class IIMyriad-LX Light Source-for delivery of light to the surgical field to…Nico Corp.
2021-06-16Z-1841-2021Class IIMedline Tissue Recovery Instrument SetMedline Industries Inc
2021-06-16Z-1842-2021Class IIOlympus Sterile Optical Laser FiberQuanta System, S.p.A.
2021-06-16Z-1843-2021Class IIQuanta System Sterile Optical Laser FiberQuanta System, S.p.A.
2021-06-16Z-1844-2021Class IIQuanta System Sterile Optical Laser FiberQuanta System, S.p.A.
2021-06-16Z-1845-2021Class IIDePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer…DePuy Orthopaedics, Inc.
2021-06-16Z-1846-2021Class IIExacTrac Dynamic softwareBrainlab AG
2021-06-16Z-1847-2021Class IICooperSurgical Wallach Loop Electrode 10mm x 10mm Square P/N: 909131CooperSurgical, Inc.
2021-06-09Z-1619-2021Class ILeccurate SARS-CoV-2LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD
2021-06-09Z-1620-2021Class ILeccurate SARS-CoV-2LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD
2021-06-09Z-1651-2021Class IAlaris Infusion Pump ModuleThe Biomed Guys
2021-06-09Z-1685-2021Class IIMultitom RAX with software version VF10Siemens Medical Solutions USA, Inc
2021-06-09Z-1689-2021Class IIVygon Dressing Change w/ MaxiswabVygon U.S.A.
2021-06-09Z-1690-2021Class IICritical Care VentilatorDraeger Medical, Inc.
2021-06-09Z-1691-2021Class IICritical Care VentilatorDraeger Medical, Inc.
2021-06-09Z-1692-2021Class IICritical Care VentilatorDraeger Medical, Inc.
2021-06-09Z-1693-2021Class IICritical Care VentilatorDraeger Medical, Inc.
2021-06-09Z-1694-2021Class IILogical cup linerSignature Orthopedics Pty Limited
2021-06-09Z-1695-2021Class IICascadia AN Interbody Convex 10x22x14mm Catalog Number:…K2M, Inc
2021-06-09Z-1696-2021Class IICascadia AN Interbody Convex 10x22x15mm Catalog Number:…K2M, Inc
2021-06-09Z-1697-2021Class IICascadia AN Interbody Convex 10x28x14mm Catalog Number:…K2M, Inc
2021-06-09Z-1698-2021Class IIT25 Cannulated ScrewdriversFlower Orthopedics Corporation
2021-06-09Z-1699-2021Class IINexSite HDMARVAO MEDICAL DEVICES LTD.
2021-06-09Z-1700-2021Class II10 GAUGE DIRECT UNILATERAL STYLETZavation
2021-06-09Z-1701-2021Class II10 GAUGE CEMENT DELIVERY CANNULAZavation
2021-06-09Z-1702-2021Class IIZVplasty DrillZavation
2021-06-09Z-1703-2021Class IIZVplasty Direct Access Beveled Tip TrocarZavation
2021-06-09Z-1704-2021Class IIZVplasty Direct Access Diamond Tip TrocarZavation
2021-06-09Z-1705-2021Class IIZVplastyZavation
2021-06-09Z-1706-2021Class IIZVplasty Direct Bipedicular Bone Access Kit with DrillZavation
2021-06-09Z-1707-2021Class IIZVplastyZavation
2021-06-09Z-1708-2021Class IIZVplasty Direct Unipedicular Bone Access Kit with DrillZavation
2021-06-09Z-1709-2021Class IIZVplasty Unipedicular Cement Delivery Cannula KitZavation
2021-06-09Z-1710-2021Class IIZVplasty Bipedicular Cement Delivery CannulaZavation
2021-06-09Z-1711-2021Class IIZVplasty Direct Access Bevel Tip TrocarZavation
2021-06-09Z-1712-2021Class IIZVplasty Direct Access Diamond Tip TrocarZavation
2021-06-09Z-1713-2021Class IIZVplasty Direct Bipedicular Bone Access Kit with DrillZavation
2021-06-09Z-1714-2021Class II10 GAUGE DIRECT UNILATERAL STYLETZavation
2021-06-09Z-1715-2021Class II10G DIRECT SINGLEZavation
2021-06-09Z-1716-2021Class II10 GAUGE DIRECT ACCESS DIAMOND TIPZavation
2021-06-09Z-1717-2021Class II11G DIRECT SINGLEZavation
2021-06-09Z-1718-2021Class II10 GAUGE CEMENT DELIVERY CANNULAZavation
2021-06-09Z-1719-2021Class II11G DIRECT WORKING CANNULA DIAMOND TIP MINIZavation
2021-06-09Z-1720-2021Class II10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGESZavation
2021-06-09Z-1721-2021Class IIZVplasty Unipedicular Cement Delivery Cannula KitZavation
2021-06-09Z-1722-2021Class IIZVplasty Biopsy DeviceZavation
2021-06-09Z-1723-2021Class IIZVplasty Biopsy DeviceZavation
2021-06-09Z-1724-2021Class IIZVplasty Direct Access Bevel Tip TrocarZavation
2021-06-09Z-1725-2021Class IIZVplasty Directional Cement Cannula LongZavation
2021-06-09Z-1726-2021Class IIZVplasty Directional Cement CannulaZavation
2021-06-09Z-1727-2021Class II10G DIRECT SINGLEZavation
2021-06-09Z-1728-2021Class IIZVplasty Direct Access Diamond Tip TrocarZavation
2021-06-09Z-1729-2021Class IIZVplasty Direct Bipedicular Bone Access Kit with DrillZavation
2021-06-09Z-1730-2021Class II10 G Coxaxial Cannula with Tuohy ConnectionZavation
2021-06-09Z-1731-2021Class II10 Gauge DrillZavation
2021-06-09Z-1732-2021Class IIZVplasty Cement Delivery CannulaZavation
2021-06-09Z-1733-2021Class II10G BEVELED TROCAR/CANNULAZavation
2021-06-09Z-1734-2021Class II10G DIRECT SINGLE BONE ACCESS KITZavation
2021-06-09Z-1735-2021Class II10G SINGLE CEMENT DELIVERY KITZavation
2021-06-09Z-1736-2021Class II11G BEVELED TROCAR/CANNULAZavation
2021-06-09Z-1737-2021Class II11G DIAMOND TROCAR/CANNULAZavation
2021-06-09Z-1738-2021Class II10G DIRECT DOUBLE BONE ACCESS KITZavation
2021-06-09Z-1739-2021Class II11G DIRECT DOUBLE BONE ACCESS KITZavation
2021-06-09Z-1740-2021Class II10G SINGLE CEMENT DELIVERY KITZavation
2021-06-09Z-1741-2021Class II10G DOUBLE CEMENT DELIVERY KITZavation
2021-06-09Z-1742-2021Class II10G DIRECT DOUBLE BONE ACCESS KITZavation
2021-06-09Z-1743-2021Class II10G DIRECT SINGLE BONE ACCESS KITZavation
2021-06-09Z-1744-2021Class II10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES STERILEZavation
2021-06-09Z-1745-2021Class II10G COAXIAL CANNULA WITH TUOHY CONNECTION STERILEZavation
2021-06-09Z-1746-2021Class II10 GAUGE DRILL STERILEZavation
2021-06-09Z-1747-2021Class II10G CEMENT DELIVERY CANNULAZavation
2021-06-09Z-1748-2021Class II10G BEVELED TROCAR/CANNULAZavation
2021-06-09Z-1749-2021Class II10 GAUGE DIRECT UNILATERAL STYLETZavation
2021-06-09Z-1750-2021Class IICEMIXZavation
2021-06-09Z-1751-2021Class IIInterVZavation
2021-06-09Z-1752-2021Class IIInterVZavation
2021-06-09Z-1753-2021Class IIInterV CurvePlus KitZavation
2021-06-09Z-1754-2021Class IIInterV 10G Bone Access Tools/KitZavation
2021-06-09Z-1755-2021Class IIInterV 11G Kyphoplasty KitZavation
2021-06-09Z-1756-2021Class IIOsteoFlex BONE CEMENTZavation
2021-06-09Z-1757-2021Class IIZVplasty SystemZavation
2021-06-09Z-1758-2021Class IIZVplastyZavation
2021-06-09Z-1759-2021Class IIZVplasty SystemZavation
2021-06-09Z-1760-2021Class IIZVplasty SystemZavation
2021-06-09Z-1761-2021Class IIZVplasty 10GZavation
2021-06-09Z-1762-2021Class IIZVplasty SystemZavation
2021-06-09Z-1763-2021Class IIZVplasty 10GZavation
2021-06-09Z-1764-2021Class IIZVplasty 10GZavation
2021-06-09Z-1765-2021Class IIZVplasty 10GZavation
2021-06-09Z-1766-2021Class IIZVplasty SystemZavation
2021-06-09Z-1767-2021Class IIZVPlastyZavation
2021-06-09Z-1768-2021Class IIOsteoFlex Cement and Mixing SystemZavation
2021-06-09Z-1769-2021Class IIVERTEBREX SINGLE BALLOON KITZavation
2021-06-09Z-1770-2021Class IIVERTEBREX SINGLE BALLOON KITZavation
2021-06-09Z-1771-2021Class IIMiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6Medtronic Minimed
2021-06-09Z-1772-2021Class IIMiniMed 670G Insulin Pump: Models: PUMP MMT-1740KX 670G V6Medtronic Minimed
2021-06-09Z-1773-2021Class IIChange Healthcare Enterprise ViewerCHANGE HEALTHCARE CANADA COMPANY
2021-06-09Z-1774-2021Class IIBRILLIANCE VOLUME systemPhilips North America Llc
2021-06-09Z-1775-2021Class IISynapse CardiovascularFujifilm Medical Systems U.S.A., Inc.
2021-06-09Z-1776-2021Class IIREF 3987Meta C.G.M. Spa
2021-06-09Z-1777-2021Class IIREF 4049 MICROSSMeta C.G.M. Spa
2021-06-09Z-1778-2021Class IIREF: 3598 SAFESCRAPER TWISTMeta C.G.M. Spa
2021-06-09Z-1779-2021Class IIREF 4890 SMARTSCRAPER CE0123Meta C.G.M. Spa
2021-06-09Z-1780-2021Class IITranberg MR CannulaCLINICAL LASERTHERMIA SYSTEMS AB
2021-06-09Z-1781-2021Class IITranberg MR StyletCLINICAL LASERTHERMIA SYSTEMS AB
2021-06-09Z-1782-2021Class IITranberg Laser Applicator Non-cooledCLINICAL LASERTHERMIA SYSTEMS AB
2021-06-09Z-1783-2021Class IIElekta MOSAIC Oncology Information System versions: 2Elekta, Inc.
2021-06-09Z-1788-2021Class IINimbus 4 and Nimbus Professional Alternating-pressure bed mattress…Getinge (Suzhou) Co Ltd
2021-06-09Z-1789-2021Class IIThe Terumo HX2 Temperature Management System provides temperature…Terumo Cardiovascular Systems Corporation
2021-06-09Z-1790-2021Class IIThe Sarns Temperature Control and Monitor unitTerumo Cardiovascular Systems Corporation
2021-06-09Z-1791-2021Class IIThe Sarns TCM IITerumo Cardiovascular Systems Corporation
2021-06-09Z-1792-2021Class IIZimmer Natural Nail -ZNN Cephalomedullary Short Nail 11Zimmer GmbH
2021-06-09Z-1793-2021Class IIZimmer Natural Nail- ZNN Cephalomedullary Short Nail 11Zimmer GmbH
2021-06-02Z-1625-2021Class IIBiPAP V30 AutoPhilips Respironics, Inc.
2021-06-02Z-1626-2021Class IIBiPAP A40Philips Respironics, Inc.
2021-06-02Z-1627-2021Class IIBiPAP A40 System SilverPhilips Respironics, Inc.
2021-06-02Z-1628-2021Class IIBiPAP A40 System SilverPhilips Respironics, Inc.
2021-06-02Z-1629-2021Class IIBiPAP A30Philips Respironics, Inc.
2021-06-02Z-1630-2021Class IIBiPAP A40Philips Respironics, Inc.
2021-06-02Z-1670-2021Class IIAccess SARS-CoV-2 AntigenBeckman Coulter Inc.
2021-06-02Z-1671-2021Class IIIntelliVue MX40 Patient MonitorPhilips North America Llc
2021-06-02Z-1672-2021Class IIGS777 Wall Transformer Model: 77710 Intended Use: The GS777 Wall…Welch Allyn Inc
2021-06-02Z-1673-2021Class IIProBP 3400 Digital Blood Pressure DeviceWelch Allyn Inc
2021-06-02Z-1674-2021Class IICentaur Syphilis Assay-SYP KitSiemens Healthcare Diagnostics, Inc
2021-06-02Z-1675-2021Class IIIRON GEN 2: ROCHE COBAS INTEGRA ANALYZERRoche Diagnostics Operations, Inc.
2021-06-02Z-1676-2021Class IIRubber Dam ClampDentech Corp.
2021-06-02Z-1677-2021Class IINPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s2Nobel Biocare Procera LLC
2021-06-02Z-1678-2021Class IINPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿s3Nobel Biocare Procera LLC
2021-06-02Z-1679-2021Class IINPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s4Nobel Biocare Procera LLC
2021-06-02Z-1680-2021Class IINPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s4Nobel Biocare Procera LLC
2021-06-02Z-1681-2021Class IINPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s6Nobel Biocare Procera LLC
2021-06-02Z-1682-2021Class IIPentax Medical Video DuodenoscopePentax of America Inc
2021-06-02Z-1683-2021Class IIPIC070 Arterial Blood Sampler PICO70Radiometer Medical ApS
2021-06-02Z-1684-2021Class IIGambro Cartridge Blood SetBaxter Healthcare Corporation
2021-06-02Z-1686-2021Class IIThe Ultem Polymeric Resin Koh Cup is a non- sterileCooperSurgical, Inc.
2021-06-02Z-1687-2021Class IIMyWay Walker ChassisJames Leckey Design Ltd
2021-06-02Z-1688-2021Class IIVITROS CoV2 Ag calibratorOrtho-Clinical Diagnostics, INc.
2021-05-26Z-1591-2021Class IVICI VENOUS STENT System Product Usage: is intended for the treatment…Boston Scientific Corporation
2021-05-26Z-1592-2021Class IVICI RDS VENOUS STENT System Product Usage: is indicated for…Boston Scientific Corporation
2021-05-26Z-1593-2021Class IIGORE VIBIL Biliary Endoprosthesis: stentsW.L. Gore & Associates, Inc.
2021-05-26Z-1594-2021Class IIAlpha Interlock Suspension System Lanyard Body: An external…WillowWood Global Llc
2021-05-26Z-1595-2021Class IIElecsys Troponin I STAT Immunoassay: Catalog# 05094798160Roche Diagnostics Operations, Inc.
2021-05-26Z-1596-2021Class IIElecsys Troponin I Immunoassay: Catalog# 05094810160Roche Diagnostics Operations, Inc.
2021-05-26Z-1597-2021Class IIRayStation 4RAYSEARCH LABORATORIES AB
2021-05-26Z-1598-2021Class IIRayStation standalone software radiation therapy treatment planning…RAYSEARCH LABORATORIES AB
2021-05-26Z-1599-2021Class IIMedtronicMedtronic Inc.
2021-05-26Z-1600-2021Class IIMedtronic REF: MMT-7008BMedtronic Inc.
2021-05-26Z-1601-2021Class IIMedtronic REF: MMT-7020AMedtronic Inc.
2021-05-26Z-1602-2021Class IIMedtronic REF: MMT-7020BMedtronic Inc.
2021-05-26Z-1603-2021Class IIMedtronic REF: MMT-7020GAMedtronic Inc.
2021-05-26Z-1604-2021Class IIMedtronic REF: MMT-7020LAMedtronic Inc.
2021-05-26Z-1605-2021Class IIMedtronic REF: MMT-7020LBMedtronic Inc.
2021-05-26Z-1606-2021Class IIMedtronic REF: MMT-7020C Guardian SensorMedtronic Inc.
2021-05-26Z-1607-2021Class IIMedtronic REF: MMT-7020C1 Guardian SensorMedtronic Inc.
2021-05-26Z-1608-2021Class IIMedtronic REF: MMT-7020C2 Guardian SensorMedtronic Inc.
2021-05-26Z-1609-2021Class IIMedtronic REF: MMT-7020C3 Guardian SensorMedtronic Inc.
2021-05-26Z-1610-2021Class IIMedtronic REF: MMT-7020C4 Guardian SensorMedtronic Inc.
2021-05-26Z-1611-2021Class IIMedtronic REF: MMT-7020C5 Guardian SensorMedtronic Inc.
2021-05-26Z-1612-2021Class IIMedtronic REF: MMT-7020D1 Guardian SensorMedtronic Inc.
2021-05-26Z-1613-2021Class IIMedtronic REF: MMT-7020D2 Guardian SensorMedtronic Inc.
2021-05-26Z-1614-2021Class IIMedtronic REF: MMT-7020D3 Guardian SensorMedtronic Inc.

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