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Medical device recalls reported in 2021

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ReportedRecallClassProductFirm
2021-05-26Z-1615-2021Class IIMedtronic REF: MMT-7020D4 Guardian SensorMedtronic Inc.
2021-05-26Z-1616-2021Class IIMedtronic REF: MMT-7020D5 Guardian SensorMedtronic Inc.
2021-05-26Z-1617-2021Class IIMedtronicMedtronic Inc.
2021-05-26Z-1618-2021Class IIMedtronicMedtronic Inc.
2021-05-26Z-1621-2021Class IIELUVIA Drug-Eluting Vascular Stent SystemBoston Scientific Corporation
2021-05-26Z-1622-2021Class IIBiosealBioseal Corporation
2021-05-26Z-1623-2021Class IIBiosealBioseal Corporation
2021-05-26Z-1624-2021Class IIBiosealBioseal Corporation
2021-05-26Z-1631-2021Class IIBPB medica CEMIXBIOPSYBELL S.R.L.
2021-05-26Z-1632-2021Class IIRENOVA SPINE BONE FILLER 10G 12CM CENTIMBIOPSYBELL S.R.L.
2021-05-26Z-1633-2021Class IIBPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIPBIOPSYBELL S.R.L.
2021-05-26Z-1634-2021Class IIBPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANTBIOPSYBELL S.R.L.
2021-05-26Z-1635-2021Class IICEMENT MIXING SYSTEMBIOPSYBELL S.R.L.
2021-05-26Z-1636-2021Class IIEASYNJECTBIOPSYBELL S.R.L.
2021-05-26Z-1637-2021Class II10 GAUGE DIRECT UNILATERAL STYLETBIOPSYBELL S.R.L.
2021-05-26Z-1638-2021Class II10 GAUGE CEMENT DELIVERY CANNULABIOPSYBELL S.R.L.
2021-05-26Z-1639-2021Class II10G DIRECT SINGLEBIOPSYBELL S.R.L.
2021-05-26Z-1640-2021Class II8G DIRECT WORKING CANNULA BEVEL TIPBIOPSYBELL S.R.L.
2021-05-26Z-1641-2021Class II11G DIRECT SINGLEBIOPSYBELL S.R.L.
2021-05-26Z-1642-2021Class IICEMIXBIOPSYBELL S.R.L.
2021-05-26Z-1643-2021Class II11G DIRECT WORKING CANNULA DIAMOND TIP MINIBIOPSYBELL S.R.L.
2021-05-26Z-1644-2021Class II11G DIRECT SINGLEBIOPSYBELL S.R.L.
2021-05-26Z-1645-2021Class II8G DIRECT WORKING CANNULA BEVEL TIPBIOPSYBELL S.R.L.
2021-05-26Z-1646-2021Class II10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGESBIOPSYBELL S.R.L.
2021-05-26Z-1647-2021Class II10G DIRECT WORKING CANNULA BEVEL TIP 15CMBIOPSYBELL S.R.L.
2021-05-26Z-1648-2021Class II10G COAXIAL CANNULA WITH TUOHY CONNECTIONBIOPSYBELL S.R.L.
2021-05-26Z-1649-2021Class II10 GAUGE DRILLBIOPSYBELL S.R.L.
2021-05-26Z-1650-2021Class IICobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators…Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2021-05-26Z-1652-2021Class IIREF 7617400Bard Access Systems Inc.
2021-05-26Z-1653-2021Class IIREF 7617405JBard Access Systems Inc.
2021-05-26Z-1654-2021Class IIREF 7617408Bard Access Systems Inc.
2021-05-26Z-1655-2021Class IIREF 7617408DBard Access Systems Inc.
2021-05-26Z-1656-2021Class IIREF 7655405Bard Access Systems Inc.
2021-05-26Z-1657-2021Class IIREF 7655405JBard Access Systems Inc.
2021-05-26Z-1658-2021Class IIREF 7812400Bard Access Systems Inc.
2021-05-26Z-1659-2021Class IIREF 9617405Bard Access Systems Inc.
2021-05-26Z-1660-2021Class IIREF 9617407Bard Access Systems Inc.
2021-05-26Z-1661-2021Class IIREF 9617408Bard Access Systems Inc.
2021-05-26Z-1662-2021Class IIREF 9617408DBard Access Systems Inc.
2021-05-26Z-1663-2021Class IIREF 9655405Bard Access Systems Inc.
2021-05-26Z-1664-2021Class IIREF 69655405Bard Access Systems Inc.
2021-05-26Z-1665-2021Class IIREF 91660417Bard Access Systems Inc.
2021-05-26Z-1666-2021Class IIREF CK000379Bard Access Systems Inc.
2021-05-26Z-1667-2021Class IIREF CK000516Bard Access Systems Inc.
2021-05-26Z-1668-2021Class IIREF 7617405Bard Access Systems Inc.
2021-05-26Z-1669-2021Class IIREF 7617407Bard Access Systems Inc.
2021-05-19Z-1530-2021Class IASSURITY Pulse Generator REF PM**** SN ********* STSt. Jude Medical, Cardian Rhythm Management Division
2021-05-19Z-1531-2021Class IENDURITY Pulse Generator REF PM**** SN ********* StSt. Jude Medical, Cardian Rhythm Management Division
2021-05-19Z-1536-2021Class IIAquaBplus and AquaBplus B2 Water Purification SystemFresenius Medical Care Holdings, Inc.
2021-05-19Z-1540-2021Class IIRevogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse…Meridian Bioscience Inc
2021-05-19Z-1541-2021Class IIRevogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs…Meridian Bioscience Inc
2021-05-19Z-1542-2021Class IIRegard Dressing Change TrayROi CPS LLC
2021-05-19Z-1543-2021Class IAlaris Pump ModuleSTEP-HAR MEDICAL LLC
2021-05-19Z-1544-2021Class IAlaris Pump ModuleInfusion Pump Repair
2021-05-19Z-1545-2021Class IINM/CT 850 Nuclear Medicine / CT ScannersGE Healthcare, LLC
2021-05-19Z-1546-2021Class IINM/CT 860 Nuclear Medicine / CT ScannersGE Healthcare, LLC
2021-05-19Z-1547-2021Class IINM/CT 870 DR Nuclear Medicine / CT ScannersGE Healthcare, LLC
2021-05-19Z-1548-2021Class IIProvox Life Night HMEAtos Medical AB
2021-05-19Z-1549-2021Class IINeuroTherm NT2000iX RadiofrequencyAbbott Laboratories Inc. (St Jude Medical)
2021-05-19Z-1550-2021Class IIPowerPort duo MBard Peripheral Vascular Inc
2021-05-19Z-1551-2021Class IIPowerPort duo MBard Peripheral Vascular Inc
2021-05-19Z-1552-2021Class IIPowerPort duo MBard Peripheral Vascular Inc
2021-05-19Z-1553-2021Class IIReWalk Personal 6Argo Medical Technologies Ltd
2021-05-19Z-1554-2021Class IKit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420Medical Action Industries, Inc. 306
2021-05-19Z-1555-2021Class IKit: Injection REVIEW MAI Kit Part Number: 74736Medical Action Industries, Inc. 306
2021-05-19Z-1556-2021Class IKit: Midline Insertion DAMedical Action Industries, Inc. 306
2021-05-19Z-1557-2021Class IKit: LVAD Dres ChgMedical Action Industries, Inc. 306
2021-05-19Z-1558-2021Class IKit: Blood CultureMedical Action Industries, Inc. 306
2021-05-19Z-1559-2021Class IKit: Blood Culture MAI Kit Part Number: 80076Medical Action Industries, Inc. 306
2021-05-19Z-1560-2021Class IIEyesuite 9Haag-Streit USA Inc
2021-05-19Z-1561-2021Class IIRemel Bile Esculin Azide Agar w/ 6mcg/ml VancomycinRemel Inc
2021-05-19Z-1562-2021Class IIAFT Straight TubeMusculoskeletal Transplant Foundation, Inc.
2021-05-19Z-1563-2021Class IICalibration Serum Level 3Randox Laboratories Ltd.
2021-05-19Z-1564-2021Class IIIVenaSeal Closure SystemMedtronic Inc.
2021-05-19Z-1565-2021Class IIREF CH3397 Oncology Kit w/Spiros¿ICU Medical, Inc.
2021-05-19Z-1566-2021Class IIREF CH3582 5 INICU Medical, Inc.
2021-05-19Z-1567-2021Class IIREF 20124-01 30"ICU Medical, Inc.
2021-05-19Z-1568-2021Class IIREF 20130-01 Spinning Spiros Closed Male LuerICU Medical, Inc.
2021-05-19Z-1569-2021Class IIREF Spinning Spiros Closed Male LuerICU Medical, Inc.
2021-05-19Z-1570-2021Class IIREF CL3011 30"ICU Medical, Inc.
2021-05-19Z-1571-2021Class IIREF CL3028T 30"ICU Medical, Inc.
2021-05-19Z-1572-2021Class IIREF CL3538 Oncology Kit w/5"ICU Medical, Inc.
2021-05-19Z-1573-2021Class IIREF CL3946 Oncology Kit w/5"ICU Medical, Inc.
2021-05-19Z-1574-2021Class IIREF CL3960 Oncology Kit w/60"ICU Medical, Inc.
2021-05-19Z-1575-2021Class IIREF CL4151 45"ICU Medical, Inc.
2021-05-19Z-1576-2021Class IIREF CH2020 20mL Syringe w/Spinning SpirosICU Medical, Inc.
2021-05-19Z-1577-2021Class IIREF CH2060 60mL Syringe w/Spinning SpirosICU Medical, Inc.
2021-05-19Z-1578-2021Class IIREF CH3011 30"ICU Medical, Inc.
2021-05-19Z-1579-2021Class IIREF CH3020 40"ICU Medical, Inc.
2021-05-19Z-1580-2021Class IIREF CH3625 5"ICU Medical, Inc.
2021-05-19Z-1581-2021Class IIREF 011-CH3967 Admin Set w/ClaveTMICU Medical, Inc.
2021-05-19Z-1582-2021Class IIREF 011-H2864-HSR 180 cmICU Medical, Inc.
2021-05-19Z-1583-2021Class IIREF 011-H3597 42 cmICU Medical, Inc.
2021-05-19Z-1584-2021Class IIREF 034-H2629 Appx 1ICU Medical, Inc.
2021-05-19Z-1585-2021Class IIREF 20120-01 Spiros" Closed Male LuerICU Medical, Inc.
2021-05-19Z-1586-2021Class IIREF 20130-01 Spinning Spiros¿ Closed Male LuerICU Medical, Inc.
2021-05-19Z-1587-2021Class IIREF CH3034 5"ICU Medical, Inc.
2021-05-19Z-1588-2021Class IIREF CH3235 30"ICU Medical, Inc.
2021-05-19Z-1589-2021Class IIREF CH3762 35"ICU Medical, Inc.
2021-05-19Z-1590-2021Class IIREF K7040-001 Spinning Spiros Closed Male LuerICU Medical, Inc.
2021-05-12Z-1519-2021Class IIGrace Medical REF S-2500 *** SHEEHY BONE DUST COLLECTOR *** Stainless…Oto Med Inc
2021-05-12Z-1520-2021Class IIGrace Medical REF S-3500 *** COX BONE DUST COLLECTOR *** 2 stainless…Oto Med Inc
2021-05-12Z-1521-2021Class IIGrace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2…Oto Med Inc
2021-05-12Z-1522-2021Class IICareLink SmartSync Device ManagerMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2021-05-12Z-1523-2021Class IICRT-P Quad ModelsMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2021-05-12Z-1524-2021Class IIDJO EMPOWR KNEE Femoral SizerEncore Medical, LP
2021-05-12Z-1525-2021Class IIImplantable Pulse GeneratorsMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2021-05-12Z-1526-2021Class IIImplantable cardiac resynchronization therapy pacemakersMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2021-05-12Z-1527-2021Class IIProgrammersMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2021-05-12Z-1528-2021Class IICareLink SmartSync Device ManagerMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2021-05-12Z-1529-2021Class IILeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer…LeMaitre Vascular, Inc.
2021-05-12Z-1532-2021Class IIMedtronic Abre Venous Self-expanding Sent SystemMedtronic Inc.
2021-05-12Z-1533-2021Class IICentricity Universal ViewerGE Healthcare, LLC
2021-05-12Z-1534-2021Class IIVACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3Greiner Bio-One North America, Inc.
2021-05-12Z-1535-2021Class IIIntellis Model 97755 RechargerMedtronic Neuromodulation
2021-05-05Z-1486-2021Class IIProtek Solo Venous Dilator Set: dilatorCardiac Assist, Inc
2021-05-05Z-1487-2021Class IISpectrum IQBaxter Healthcare Corporation
2021-05-05Z-1488-2021Class IIVERIGENE Processor SPLuminex Corporation
2021-05-05Z-1489-2021Class IIVITROS¿ Black Reference Slides CATALOG #: J02316Ortho-Clinical Diagnostics, INc.
2021-05-05Z-1490-2021Class IIColpassist Vaginal Positioning DeviceBoston Scientific Corporation
2021-05-05Z-1491-2021Class IIUpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning DeviceBoston Scientific Corporation
2021-05-05Z-1492-2021Class IIIEXALT ControllerBoston Scientific Corporation
2021-05-05Z-1493-2021Class IIChromosome X Alpha-Satellite in FITC SpectrumCytocell Ltd.
2021-05-05Z-1494-2021Class IIDental pinsColtene Whaledent Inc
2021-05-05Z-1495-2021Class IIArtis zee ceiling-interventional Fluoroscopic X-Ray System Model…Siemens Medical Solutions USA, Inc
2021-05-05Z-1496-2021Class IIArtis systemsSiemens Medical Solutions USA, Inc
2021-05-05Z-1497-2021Class IIInterventional Fluoroscopic X-Ray System ARTIS icono biplane-…Siemens Medical Solutions USA, Inc
2021-05-05Z-1498-2021Class IIINFINITY_TRAY Custom Procedural KitConMed Corporation
2021-05-05Z-1499-2021Class IIKIT_INFINITY_BASE Custom Procedural KitConMed Corporation
2021-05-05Z-1500-2021Class IIInCore Lapidus Disposable Kit 28mm LeftNextremity Solutions
2021-05-05Z-1501-2021Class IIInCore Lapidus Disposable Kit 28mm RightNextremity Solutions
2021-05-05Z-1502-2021Class IIStryker Medela REF 077Medela AG Medical Technology
2021-05-05Z-1503-2021Class IITrinity Biotech Captia Measles IgM KitClark Laboratories, Inc.
2021-05-05Z-1504-2021Class IIPower WheelchairMerits Holdings Co. dba Merits Health Products, Inc.
2021-05-05Z-1505-2021Class IIScooterMerits Holdings Co. dba Merits Health Products, Inc.
2021-05-05Z-1506-2021Class IIICardiosave Hybrid IABPDatascope Corp.
2021-05-05Z-1507-2021Class IIICardiosave Rescue IABPDatascope Corp.
2021-05-05Z-1508-2021Class IIChange Healthcare Enterprise ViewerCHANGE HEALTHCARE CANADA COMPANY
2021-05-05Z-1509-2021Class IIFiltered Triple-Leg Extension SetB. Braun Medical, Inc.
2021-05-05Z-1510-2021Class IICANNU-Flex SILK Interference Screws 6 mmx 30 mmSmith & Nephew, Inc.
2021-05-05Z-1511-2021Class IIDONJOY REF:11-0447-9-ULTRASLING PRODJ Orthopedics de Mexico S.A. de C.V.
2021-05-05Z-1512-2021Class IIDONJOY REF:11-0471-9 ULTRASLING PRO ER/IR 15DJ Orthopedics de Mexico S.A. de C.V.
2021-05-05Z-1513-2021Class IIDONJOY REF:11-0472-9 ULTRASLING PRO ER/IR 30DJ Orthopedics de Mexico S.A. de C.V.
2021-05-05Z-1514-2021Class IIDONJOY REF:11-0473-9 ULTRASLING PRO ABDJ Orthopedics de Mexico S.A. de C.V.
2021-05-05Z-1515-2021Class IIPalm CupsSmiths Medical ASD Inc.
2021-05-05Z-1516-2021Class IIACE MDI Spacer with Small MaskSmiths Medical ASD Inc.
2021-05-05Z-1517-2021Class IIPhilips Xper Flex CardioPhilips North America Llc
2021-05-05Z-1518-2021Class IIOmnia Soft Tissue Punch is a dental instrument designed to remove…Omnia SRL
2021-04-28Z-1375-2021Class IAftermarket Alaris Infusion Pump Module Model 8100 Front BezelPacific Medical Group Inc.
2021-04-28Z-1426-2021Class IInstructions for Use and Patient Manual for HeartWare HVAD SystemHeartware, Inc.
2021-04-28Z-1431-2021Class IIBard Clean-Cath Intermittent CatheterC.R. Bard, Inc.
2021-04-28Z-1432-2021Class IIAssure COVID-19 IgG/IgM Rapid Test Device that include: 1) Pouch LabelAZURE BIOTECH INC
2021-04-28Z-1433-2021Class IIThe AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled…Boston Scientific Corporation
2021-04-28Z-1434-2021Class IISensis/ Sensis Vibe Hemo systems with VD12A software as follows:…Siemens Medical Solutions USA, Inc
2021-04-28Z-1435-2021Class IIBCS XP System: Multipurpose system for in vitro coagulation studiesSiemens Healthcare Diagnostics, Inc.
2021-04-28Z-1436-2021Class IIDirectInject consists of a sterile dual paste system which is calcium…Stryker Leibinger GmbH & Co. KG
2021-04-28Z-1437-2021Class IITritanium X TL InstrumentsStryker Spine
2021-04-28Z-1438-2021Class IIInstructions for Use and Patient Manual for HeartWare HVAD SystemHeartware, Inc.
2021-04-28Z-1439-2021Class IIEndoskeleton TC Interbody System with Titan nanoLOCK Surface…Medtronic Sofamor Danek USA, Inc
2021-04-28Z-1440-2021Class IIEndoskeleton TC Interbody System with Titan nanoLOCK Surface…Medtronic Sofamor Danek USA, Inc
2021-04-28Z-1441-2021Class IIBIOTRONIK Ilestro 7 DR-TBIOTRONIK Inc
2021-04-28Z-1442-2021Class IIBIOTRONIK Ilestro 7 DR-TBIOTRONIK Inc
2021-04-28Z-1443-2021Class IIBIOTRONIK Ilestro 7 VR-TBIOTRONIK Inc
2021-04-28Z-1444-2021Class IIBIOTRONIK Ilestro 7 VR-TBIOTRONIK Inc
2021-04-28Z-1445-2021Class IIBIOTRONIK Ilestro 7 VR-T DXBIOTRONIK Inc
2021-04-28Z-1446-2021Class IIBIOTRONIK Iperia 7BIOTRONIK Inc
2021-04-28Z-1447-2021Class IIBIOTRONIK Iforia 7BIOTRONIK Inc
2021-04-28Z-1448-2021Class IIBIOTRONIK Iforia 7BIOTRONIK Inc
2021-04-28Z-1449-2021Class IIBIOTRONIK IPERIA 7BIOTRONIK Inc
2021-04-28Z-1450-2021Class IIBIOTRONIK ITREVIA 7BIOTRONIK Inc
2021-04-28Z-1451-2021Class IIBIOTRONIK ITREVIA 7BIOTRONIK Inc
2021-04-28Z-1452-2021Class IIBIOTRONIK ITREVIA 7BIOTRONIK Inc
2021-04-28Z-1453-2021Class IIBIOTRONIK IPERIA 7BIOTRONIK Inc
2021-04-28Z-1454-2021Class IIBIOTRONIK INVENTRA 7BIOTRONIK Inc
2021-04-28Z-1455-2021Class IIBIOTRONIK ITREVIA 7BIOTRONIK Inc
2021-04-28Z-1456-2021Class IIBIOTRONIK ILIVIA 7BIOTRONIK Inc
2021-04-28Z-1457-2021Class IIBIOTRONIK ILIVIA 7BIOTRONIK Inc
2021-04-28Z-1458-2021Class IIBIOTRONIK ILIVIA 7BIOTRONIK Inc
2021-04-28Z-1459-2021Class IIBIOTRONIK INVENTRA 7BIOTRONIK Inc
2021-04-28Z-1460-2021Class IIBIOTRONIK INVENTRA 7BIOTRONIK Inc
2021-04-28Z-1461-2021Class IIBIOTRONIK ILIVIA 7BIOTRONIK Inc
2021-04-28Z-1462-2021Class IIBIOTRONIK ILIVIA NEO 7 VR-T DF-1 ProMRIBIOTRONIK Inc
2021-04-28Z-1463-2021Class IIBIOTRONIK INTICA NEO 7 VR-T DX DF-1 ProMRIBIOTRONIK Inc
2021-04-28Z-1464-2021Class IIBIOTRONIK ILIVIA NEO 7 DR-T DF-1 ProMRIBIOTRONIK Inc
2021-04-28Z-1465-2021Class IIBIOTRONIK INTICA NEO 7 HF-T DF-1 IS-1 ProMRIBIOTRONIK Inc
2021-04-28Z-1466-2021Class IISmart Port CT-Implantable Port Catalogue #: CT96STSD-VIAngiodynamics Inc. (Navilyst Medical Inc.)
2021-04-28Z-1467-2021Class IIAngioDynamics Safe Sheath UltraliteAngiodynamics Inc. (Navilyst Medical Inc.)
2021-04-28Z-1468-2021Class IIMidline Catheter Dressing Change Kit with StatlockTrinity Sterile, Inc.
2021-04-28Z-1469-2021Class IIInstructions for Use and Patient Manual for HeartWare HVAD SystemHeartware, Inc.
2021-04-28Z-1470-2021Class IILogiCal Monitoring SetSmiths Medical ASD Inc.
2021-04-28Z-1471-2021Class IIMark 910 LogiCalSmiths Medical ASD Inc.
2021-04-28Z-1472-2021Class IILeft Heart KitSmiths Medical ASD Inc.
2021-04-28Z-1473-2021Class IILogiCal Left Heart KitSmiths Medical ASD Inc.
2021-04-28Z-1474-2021Class IIGang Cath Lab SetSmiths Medical ASD Inc.
2021-04-28Z-1475-2021Class IIANGIOGRAPHIC KIT W/MX123-3MR MANIFOLDSmiths Medical ASD Inc.
2021-04-28Z-1476-2021Class IIManifold rotatorSmiths Medical ASD Inc.
2021-04-28Z-1477-2021Class IIStopcock rotatorSmiths Medical ASD Inc.
2021-04-28Z-1478-2021Class IIHIGH PRESSURE TUBINGSmiths Medical ASD Inc.
2021-04-28Z-1479-2021Class IIHIGH PRESSURE ROTATORSmiths Medical ASD Inc.
2021-04-28Z-1480-2021Class IITubing with male luer lock adapterSmiths Medical ASD Inc.

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