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Medical device recalls reported in 2019

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ReportedRecallClassProductFirm
2019-08-21Z-2246-2019Class IIGo-EZ Screw 6BioPro, Inc.
2019-08-21Z-2247-2019Class IIGo-EZ Screw 6BioPro, Inc.
2019-08-21Z-2248-2019Class IIGo-EZ Screw 6BioPro, Inc.
2019-08-21Z-2249-2019Class IIGo-EZ Screw 6BioPro, Inc.
2019-08-21Z-2250-2019Class IIGo-EZ Screw 6BioPro, Inc.
2019-08-21Z-2251-2019Class IIGo-EZ Screw 6BioPro, Inc.
2019-08-21Z-2252-2019Class IIGo-EZ Screw 6BioPro, Inc.
2019-08-21Z-2253-2019Class IIGo-EZ Screw 6BioPro, Inc.
2019-08-21Z-2254-2019Class IIGo-EZ Screw 6BioPro, Inc.
2019-08-21Z-2255-2019Class IIGo-EZ Screw 6BioPro, Inc.
2019-08-21Z-2256-2019Class IIGo-EZ Screw 6BioPro, Inc.
2019-08-21Z-2257-2019Class IIGo-EZ Screw 6BioPro, Inc.
2019-08-21Z-2258-2019Class IIGo-EZ Screw 6BioPro, Inc.
2019-08-21Z-2259-2019Class IIK-Wire HBS Sterile LotBioPro, Inc.
2019-08-21Z-2260-2019Class IICardinal Health Jackson-Pratt Channel Drain 15FR Cardinal PN:JP-2223…Degania Silicone, Ltd.
2019-08-21Z-2261-2019Class IICardinal Health Jackson-Pratt Channel Drain 15FRDegania Silicone, Ltd.
2019-08-21Z-2262-2019Class IICardinal Health Jackson-Pratt Channel Drain 15FRDegania Silicone, Ltd.
2019-08-21Z-2263-2019Class IICardinal Health Jackson-Pratt Channel Drain 19FRDegania Silicone, Ltd.
2019-08-21Z-2264-2019Class IICardinal Health Jackson-Pratt Channel Drain 19FRDegania Silicone, Ltd.
2019-08-21Z-2265-2019Class IICardinal Health Jackson-Pratt Channel Drain 19FRDegania Silicone, Ltd.
2019-08-21Z-2266-2019Class IIMedline Silicone Drain 15Fr 3/16" Full Fluted PN: DYNJWE2188HB An…Degania Silicone, Ltd.
2019-08-21Z-2267-2019Class IISmith & Nephew Negative Pressure Wound Therapy 15FR Channel Wound…Degania Silicone, Ltd.
2019-08-21Z-2268-2019Class IISOMATOM Definition ASSiemens Medical Solutions USA, Inc
2019-08-21Z-2269-2019Class IISOMATOM Definition EdgeSiemens Medical Solutions USA, Inc
2019-08-21Z-2270-2019Class IISOMATOM Definition FlashSiemens Medical Solutions USA, Inc
2019-08-21Z-2271-2019Class IISOMATOM DriveSiemens Medical Solutions USA, Inc
2019-08-21Z-2272-2019Class IISOMATOM ConfidenceSiemens Medical Solutions USA, Inc
2019-08-21Z-2273-2019Class IISOMATOM Edge PlusSiemens Medical Solutions USA, Inc
2019-08-21Z-2274-2019Class IISOMATOM ForceSiemens Medical Solutions USA, Inc
2019-08-21Z-2275-2019Class IIHS70A Diagnostic Ultrasound System Version 2NeuroLogica Corporation
2019-08-21Z-2276-2019Class IIWS80A Diagnostic Ultrasound System Version 1NeuroLogica Corporation
2019-08-21Z-2277-2019Class IISunTech Medical DisposableSuntech Medical, Inc.
2019-08-21Z-2278-2019Class IISLIM HandlePega Medical Inc.
2019-08-21Z-2279-2019Class IIBD Vacutainer Fluoride Tubes for Blood Alcohol determinations Part…Becton Dickinson & Company
2019-08-21Z-2280-2019Class IIGALAXY G3 Mini Microcoil Delivery System Product No: GLM915030Codman & Shurtleff Inc
2019-08-21Z-2281-2019Class IIMED-RX POLYURETHANE FEEDING TUBES: a) 5Fr X 16"Canadian Hospital Specialties
2019-08-21Z-2282-2019Class IIAries Bordetella AssayLuminex Corporation
2019-08-21Z-2283-2019Class IIARIES HSV 1&2 AssayLuminex Corporation
2019-08-21Z-2284-2019Class IIARIES Flu A/B & RSV AssayLuminex Corporation
2019-08-21Z-2285-2019Class IIARIES GBS AssayLuminex Corporation
2019-08-21Z-2286-2019Class IIARIES Group A Strep AssayLuminex Corporation
2019-08-21Z-2287-2019Class IIARIES CLuminex Corporation
2019-08-21Z-2288-2019Class IIARIES Extraction KitLuminex Corporation
2019-08-14Z-2070-2019Class IELLIPSE VRSt Jude Medical Inc.
2019-08-14Z-2071-2019Class IELLIPSE VRSt Jude Medical Inc.
2019-08-14Z-2072-2019Class IELLIPSE VRSt Jude Medical Inc.
2019-08-14Z-2073-2019Class IELLIPSE DRSt Jude Medical Inc.
2019-08-14Z-2074-2019Class IELLIPSE DRSt Jude Medical Inc.
2019-08-14Z-2075-2019Class IELLIPSE DRSt Jude Medical Inc.
2019-08-14Z-2092-2019Class IIClubMax Laser Projection SeriesGk Photonics Inc
2019-08-14Z-2093-2019Class IIAtom Laser Projection SeriesGk Photonics Inc
2019-08-14Z-2094-2019Class IISpectrum Laser Projection SeriesGk Photonics Inc
2019-08-14Z-2095-2019Class IIMaxim Laser Projection SeriesGk Photonics Inc
2019-08-14Z-2096-2019Class IILogolas Laser Projection SeriesGk Photonics Inc
2019-08-14Z-2097-2019Class IIBurstberry Laser Projection SeriesGk Photonics Inc
2019-08-14Z-2100-2019Class IILidar System for Erosion Flume Application Class 1 Laser Product…ASTRA, LLC
2019-08-14Z-2105-2019Class IIYXLON Cheetah cabinet X-Ray System Product Usage: The products are…Comet Technologies Usa Inc
2019-08-14Z-2106-2019Class IIYXLON Cougar Cabinet X-Ray System Product Usage: The products are…Comet Technologies Usa Inc
2019-08-14Z-2136-2019Class IIMED EL Cochlear Implant SystemMED-EL Elektromedizinische Gereate, Gmbh
2019-08-14Z-2137-2019Class IIMED EL Cochlear Implant SystemMED-EL Elektromedizinische Gereate, Gmbh
2019-08-14Z-2138-2019Class IIMED EL Cochlear Implant SystemMED-EL Elektromedizinische Gereate, Gmbh
2019-08-14Z-2139-2019Class IIToothete Oral Care Sodium Bicarbonate MouthpasteSage Products Inc
2019-08-14Z-2140-2019Class IICERTAINBiomet 3i, LLC
2019-08-14Z-2141-2019Class IICERTAINBiomet 3i, LLC
2019-08-14Z-2142-2019Class IICERTAINBiomet 3i, LLC
2019-08-14Z-2143-2019Class IICERTAINBiomet 3i, LLC
2019-08-14Z-2144-2019Class IICERTAINBiomet 3i, LLC
2019-08-14Z-2145-2019Class IIGeistlich Bio-Oss PenGeistlich Pharma North America, Inc.
2019-08-14Z-2146-2019Class IIGeistlich Bio-Oss PenGeistlich Pharma North America, Inc.
2019-08-14Z-2147-2019Class IIGeistlich Bio-Oss PenGeistlich Pharma North America, Inc.
2019-08-14Z-2148-2019Class IIOlympus MAJ-209 Single Use Suction ValvesOlympus Corporation of the Americas
2019-08-14Z-2150-2019Class IIHuman Assayed Multi-Sera Level 2Randox Laboratories, Limited
2019-08-14Z-2151-2019Class IILiberty Cycler CassettesFresenius Medical Care Renal Therapies Group, LLC
2019-08-14Z-2152-2019Class IISenTec Membrane ChangerSenTec AG
2019-08-14Z-2153-2019Class IISenTec Standard Starter Set with and without Service GasSenTec AG
2019-08-14Z-2154-2019Class IISenTec Neonatal Starter Set with and without Service GasSenTec AG
2019-08-14Z-2155-2019Class IISenTec Membrane Changer SetSenTec AG
2019-08-14Z-2156-2019Class IISenTec Membrane Changer Insert [5 pcsSenTec AG
2019-08-14Z-2157-2019Class IIIPTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref…Polymer Technology Systems, Inc.
2019-08-14Z-2158-2019Class IIIHenry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test…Polymer Technology Systems, Inc.
2019-08-14Z-2159-2019Class IIDRG Salivary Testosterone ELISA- IVD for the detection of Testerone…DRG Instruments GmbH
2019-08-14Z-2160-2019Class IISerrato 9Howmedica Osteonics Corp.
2019-08-14Z-2161-2019Class IISTERILE GRAVES VAGINAL SPECULUM MEDIUM Kit Code # GVS10MSTCenturion Medical Products Corporation
2019-08-14Z-2162-2019Class IISTERILE FLUORO SSP TRAY Kit Code: MNS11605Centurion Medical Products Corporation
2019-08-14Z-2163-2019Class IICIRCUMCISION TRAY Kit Code: CIT2245Centurion Medical Products Corporation
2019-08-14Z-2164-2019Class IICIRCUMCISION TRAY Kit Code: CIT2650HCenturion Medical Products Corporation
2019-08-14Z-2165-2019Class IINEONATAL PICC INSERTION TRAY Kit Code: CVI2310Centurion Medical Products Corporation
2019-08-14Z-2166-2019Class IILVAD DRESSING SYSTEM W/BIOPATCHKit Code: DM700Centurion Medical Products Corporation
2019-08-14Z-2167-2019Class IIDAILY DRIVELINE KIT Kit Code: DM940Centurion Medical Products Corporation
2019-08-14Z-2168-2019Class IIHIGH DRAINAGE LVAD TRAY Kit Code: DM950Centurion Medical Products Corporation
2019-08-14Z-2169-2019Class IIDRIVELINE MANAGEMENT TRAY Kit Code: DT17780BCenturion Medical Products Corporation
2019-08-14Z-2170-2019Class IIDRIVELINE MANAGEMENT SYSTEM 1 DAILY Kit Code: DT18440ACenturion Medical Products Corporation
2019-08-14Z-2171-2019Class IIUNIVERSAL BLOCK TRAY Kit Code: MNS6645Centurion Medical Products Corporation
2019-08-14Z-2172-2019Class IILACERATION TRAY Kit Code: SUT18370Centurion Medical Products Corporation
2019-08-14Z-2173-2019Class IISNAG FREE SUTURE TRAY Kit Code: SUT14355Centurion Medical Products Corporation
2019-08-14Z-2174-2019Class IIVITROS 250 Chemistry SystemOrtho Clinical Diagnostics
2019-08-14Z-2175-2019Class IIVITROS 250 Chemistry SystemOrtho Clinical Diagnostics
2019-08-14Z-2176-2019Class IIVITROS 250AT Chemistry SystemOrtho Clinical Diagnostics
2019-08-14Z-2177-2019Class IIVITROS 350 Chemistry SystemOrtho Clinical Diagnostics
2019-08-14Z-2178-2019Class IIVITROS Chemistry Products Calibrator Kit 32Ortho Clinical Diagnostics
2019-08-14Z-2179-2019Class IIVITROS 5600 Integrated SystemOrtho Clinical Diagnostics
2019-08-14Z-2180-2019Class IIVITROS 5600 Integrated SystemOrtho Clinical Diagnostics
2019-08-14Z-2181-2019Class IIVITROS 4600 Chemistry SystemOrtho Clinical Diagnostics
2019-08-14Z-2182-2019Class IIVITROS 4600 Chemistry SystemOrtho Clinical Diagnostics
2019-08-14Z-2183-2019Class IIVITROS 5Ortho Clinical Diagnostics
2019-08-14Z-2184-2019Class IIVITROS 5Ortho Clinical Diagnostics
2019-08-14Z-2185-2019Class IIVITROS Chemistry Products Calibrator Kit 32Ortho Clinical Diagnostics
2019-08-14Z-2186-2019Class IIIngenuity CTPhilips Medical Systems (Cleveland) Inc
2019-08-14Z-2187-2019Class IIIngenuity Core128 Model # 728323Philips Medical Systems (Cleveland) Inc
2019-08-14Z-2188-2019Class IIIngenuity Core Model # 728321Philips Medical Systems (Cleveland) Inc
2019-08-14Z-2189-2019Class IIiCTPhilips Medical Systems (Cleveland) Inc
2019-08-14Z-2190-2019Class IIiCT SP Model # 728311Philips Medical Systems (Cleveland) Inc
2019-08-14Z-2191-2019Class IIBrilliance 64 Model # 728231Philips Medical Systems (Cleveland) Inc
2019-08-14Z-2192-2019Class IIIQon Spectral CT Model # 728332Philips Medical Systems (Cleveland) Inc
2019-08-14Z-2193-2019Class IIIngenuity TF PET/CT Model # 882456Philips Medical Systems (Cleveland) Inc
2019-08-14Z-2194-2019Class IIVereos PET/CT Model # 882446Philips Medical Systems (Cleveland) Inc
2019-08-14Z-2195-2019Class IILantis 6Siemens Medical Solutions USA, Inc
2019-08-14Z-2196-2019Class IILantis 8Siemens Medical Solutions USA, Inc
2019-08-14Z-2197-2019Class IILantis CommanderSiemens Medical Solutions USA, Inc
2019-08-14Z-2198-2019Class IILantis systemSiemens Medical Solutions USA, Inc
2019-08-14Z-2199-2019Class IIPhilips EPIQ and Affiniti Ultrasound Systems with software version 4Philips Ultrasound Inc
2019-08-14Z-2200-2019Class IIHYTEC 288 SystemHycor Biomedical Inc
2019-08-14Z-2201-2019Class IIThe Alinity ci-series System Control Modules which are configured…Abbott Gmbh & Co. KG
2019-08-14Z-2202-2019Class IIVITROS Chemistry Products GLU Slides-Product Code:1707801Ortho-Clinical Diagnostics
2019-08-14Z-2203-2019Class IIEndoscopic Cleaning Brushes sold in various Endoscopy KitsMedline Industries Inc
2019-08-14Z-2204-2019Class IILSB Style Anchor BoltAd-Tech Medical Instrument Corporation
2019-08-14Z-2205-2019Class IIPhilips Azurion systems with software version R1Philips North America, LLC
2019-08-14Z-2206-2019Class IICodman ISOCOOL Bipolar Forceps-are indicated for cauterizingIntegra LifeSciences Corp.
2019-08-14Z-2207-2019Class IIIAssayed Bovine Multi-Sera Level 1Randox Laboratories, Limited
2019-08-14Z-2208-2019Class IIAlinity i Ferritin Reagent KitAbbott Ireland Diagnostics Division
2019-08-14Z-2209-2019Class IIEnCor Breast Biopsy ProbesBard Peripheral Vascular Inc
2019-08-14Z-2210-2019Class IIEnCor Breast Biopsy ProbesBard Peripheral Vascular Inc
2019-08-14Z-2211-2019Class IIEnCor Breast Biopsy ProbesBard Peripheral Vascular Inc
2019-08-14Z-2212-2019Class IIEnCor Breast Biopsy ProbesBard Peripheral Vascular Inc
2019-08-14Z-2213-2019Class IIEnCor Breast Biopsy ProbesBard Peripheral Vascular Inc
2019-08-14Z-2214-2019Class IIEnCor Breast Biopsy ProbesBard Peripheral Vascular Inc
2019-08-14Z-2215-2019Class II14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion…Medical Components, Inc dba MedComp
2019-08-14Z-2216-2019Class II14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion…Medical Components, Inc dba MedComp
2019-08-14Z-2217-2019Class II14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion…Medical Components, Inc dba MedComp
2019-08-14Z-2218-2019Class IIThe DABRA LaserRa Medical Systems Inc
2019-08-14Z-2219-2019Class IIIDEAL IMPLANT Structured Breast ImplantIdeal Implant Incorporated
2019-08-14Z-2220-2019Class IIRegard ¿ custom surgical pack labeled as "LAPROi Consolidated Service Center (CSC)
2019-08-14Z-2221-2019Class IIRegard ¿ custom surgical pack labeled as "LAPAROSCOPICROi Consolidated Service Center (CSC)
2019-08-14Z-2222-2019Class IISmartRelease Endoscopic Carpal Tunnel Release HandpieceMicroAire Surgical Instruments, LLC
2019-08-14Z-2223-2019Class IIThe Visibly Online Refractive Vision Test which is part of the…Opternative Inc
2019-08-14Z-2228-2019Class IIWorkstationIntellijoint Surgical, Inc.
2019-08-14Z-2229-2019Class IIDimension¿ FerritinSiemens Healthcare Diagnostics, Inc.
2019-08-07Z-1956-2019Class ISheridan Endotracheal Tube contained inside Centurion kit code TC7855Centurion Medical Products Corporation
2019-08-07Z-1997-2019Class IIAzurion lnterventional Fluoroscopic X-ray SystemPhilips Medical Systems Nederlands
2019-08-07Z-2056-2019Class IIAGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic…Agfa N.V.
2019-08-07Z-2086-2019Class IIRusch EasyCath KitTeleflex Medical
2019-08-07Z-2087-2019Class IIMaximum Pelvic TrainerRalston Group
2019-08-07Z-2088-2019Class IFilter-TipsQiagen Sciences LLC
2019-08-07Z-2089-2019Class IIAcuject Variable Injection NeedleWilson-Cook Medical Inc.
2019-08-07Z-2090-2019Class IIFlexible Drill ShaftEncore Medical, Lp
2019-08-07Z-2091-2019Class IIMonaco RTP SystemElekta Inc
2019-08-07Z-2098-2019Class IIA&E Medical CorpAlto Development Corp
2019-08-07Z-2099-2019Class IIInovo Single Luman Conserver Product Usage: This device is intended…Inovo, Inc
2019-08-07Z-2101-2019Class IITerumo Capiox NX19 Oxygenator With ReservoirTerumo Cardiovascular Systems Corporation
2019-08-07Z-2102-2019Class IITerumo Capiox NX19 Oxygenator With ReservoirTerumo Cardiovascular Systems Corporation
2019-08-07Z-2103-2019Class IITerumo Capiox NX19 OxygenatorTerumo Cardiovascular Systems Corporation
2019-08-07Z-2104-2019Class IITerumo Capiox NX19 OxygenatorTerumo Cardiovascular Systems Corporation
2019-08-07Z-2107-2019Class IIFrontal Stretch Buckle Closure ApronBurlington Medical, LLC
2019-08-07Z-2108-2019Class IIFrontal Apron Velcro ClosureBurlington Medical, LLC
2019-08-07Z-2109-2019Class IIFrontal Support Belt ApronBurlington Medical, LLC
2019-08-07Z-2110-2019Class IIFrontal Quick Drop OR ApronBurlington Medical, LLC
2019-08-07Z-2111-2019Class II1 pc Full Wrap Support Belt ApronBurlington Medical, LLC
2019-08-07Z-2112-2019Class II2 pc Full Wrap Vest & KiltBurlington Medical, LLC
2019-08-07Z-2113-2019Class IIVestBurlington Medical, LLC
2019-08-07Z-2114-2019Class II2 pc Full Overlap Vest & KiltBurlington Medical, LLC
2019-08-07Z-2115-2019Class IIOverlap VestBurlington Medical, LLC
2019-08-07Z-2116-2019Class II2 pc Full Wrap Vest & Kilt Back-SaverBurlington Medical, LLC
2019-08-07Z-2117-2019Class IIPeak VestBurlington Medical, LLC
2019-08-07Z-2118-2019Class IIKiltBurlington Medical, LLC
2019-08-07Z-2119-2019Class IIThyroid CollarBurlington Medical, LLC
2019-08-07Z-2120-2019Class II1 pc Full Wrap Back Relief ApronBurlington Medical, LLC
2019-08-07Z-2121-2019Class IIThyroid CollarBurlington Medical, LLC
2019-08-07Z-2122-2019Class IIThyroid CollarBurlington Medical, LLC
2019-08-07Z-2123-2019Class IISleeveBurlington Medical, LLC
2019-08-07Z-2124-2019Class IIFrontal Apron with Quick Drop Velcro ClosureBurlington Medical, LLC
2019-08-07Z-2125-2019Class IIFront/Back Apron with Stretch Velcro ClosureBurlington Medical, LLC
2019-08-07Z-2126-2019Class IIHalf ApronBurlington Medical, LLC
2019-08-07Z-2127-2019Class IICapBurlington Medical, LLC
2019-08-07Z-2128-2019Class IIHoodBurlington Medical, LLC
2019-08-07Z-2129-2019Class IIPorta ShieldBurlington Medical, LLC
2019-08-07Z-2130-2019Class IIThyroid Collar OversizeBurlington Medical, LLC
2019-08-07Z-2131-2019Class IIGE Senographe PristinaGE Healthcare, LLC
2019-08-07Z-2132-2019Class IIGE Pristina SerenaGE Healthcare, LLC
2019-08-07Z-2133-2019Class IINasal Alar SpO2 SensorXhale Assurance, Inc.
2019-08-07Z-2134-2019Class IIAUTOSTAT II IgM Rheumatoid FactorHycor Biomedical Inc
2019-08-07Z-2135-2019Class IIStratus CS Acute Care cTNI TestPakSiemens Healthcare Diagnostics Inc
2019-07-31Z-1987-2019Class IIC3 is an in vitro diagnostic assay for the quantitative determination…Abbott Laboratories, Inc
2019-07-31Z-1988-2019Class IIImmunoglobulin A is an in vitro diagnostic assay for the quantitative…Abbott Laboratories, Inc
2019-07-31Z-1989-2019Class IIImmunoglobulin G is an in vitro diagnostic assay for the quantitative…Abbott Laboratories, Inc
2019-07-31Z-1990-2019Class IIImmunoglobulin M is an in vitro diagnostic assay for the quantitative…Abbott Laboratories, Inc
2019-07-31Z-1991-2019Class IIApolipoprotein A1 is an in vitro diagnostic assay for the…Abbott Laboratories, Inc
2019-07-31Z-1992-2019Class IIC4 is an in vitro diagnostic assay for the quantitative determination…Abbott Laboratories, Inc
2019-07-31Z-1993-2019Class IITheAbbott Laboratories, Inc
2019-07-31Z-1994-2019Class IIApolipoprotein B is an in vitro diagnostic assay for the quantitative…Abbott Laboratories, Inc
2019-07-31Z-1995-2019Class IITransferrin is an in vitro diagnostic assay for the quantitative…Abbott Laboratories, Inc

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