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Medical device recalls reported in 2020

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ReportedRecallClassProductFirm
2020-06-24Z-2388-2020Class IIMAMMOMAT RevelationSiemens Medical Solutions USA, Inc
2020-06-24Z-2389-2020Class IIExtremitiesMedtronic Sofamor Danek USA Inc
2020-06-24Z-2390-2020Class IIMedtronic Bone Void FillerMedtronic Sofamor Danek USA Inc
2020-06-24Z-2391-2020Class IIMedtronic Bone Void FillerMedtronic Sofamor Danek USA Inc
2020-06-24Z-2392-2020Class IIDDU-2300 Lifeline/ReviveR ViewDefibtech, LLC
2020-06-24Z-2393-2020Class IIDDU-2400EN Lifeline PRODefibtech, LLC
2020-06-24Z-2394-2020Class IIDDU-2450 Lifeline ECG Model Numbers DDU-A2450EN DDU-E2450DE…Defibtech, LLC
2020-06-24Z-2395-2020Class IIBioFlo Midline Catheter and BioFlo Maximal Barrier KitsAngiodynamics, Inc.
2020-06-24Z-2396-2020Class IIBioFlo Midline Convenience KitsAngiodynamics, Inc.
2020-06-24Z-2397-2020Class IIBioFlo PICC and Xcela PICC Convenience KitsAngiodynamics, Inc.
2020-06-24Z-2398-2020Class IIBioFlo PICC and Xcela PICC Maximal Barrier Nursing KitsAngiodynamics, Inc.
2020-06-24Z-2399-2020Class IILeica ARveo and M530 OH6 microscope systemsLeica Microsystems, Inc.
2020-06-24Z-2400-2020Class IIMueller Knife HandleCarefusion 2200 Inc
2020-06-24Z-2401-2020Class IIAlinity CAbbott Gmbh & Co. KG
2020-06-24Z-2402-2020Class IIDIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE…Diasol, Inc
2020-06-17Z-2262-2020Class IIModel Number: 06917259001 UDI: 04015630976010Ventana Medical Systems Inc
2020-06-17Z-2263-2020Class IOvation iX Abdominal Stent Graft SystemsEndologix, Inc.
2020-06-17Z-2265-2020Class IIRegardROi CPS LLC
2020-06-17Z-2266-2020Class IIGenicon GENILook Model 200-005-151Genicon, Inc.
2020-06-17Z-2267-2020Class IIGenicon GENILook Model 200-005-152Genicon, Inc.
2020-06-17Z-2268-2020Class IIGenicon GENILook Model 200-005-153Genicon, Inc.
2020-06-17Z-2269-2020Class IIGenicon GENILook Model 200-005-251Genicon, Inc.
2020-06-17Z-2270-2020Class IIGenicon GENILook Model 200-105-151Genicon, Inc.
2020-06-17Z-2271-2020Class IIGenicon GENILook Model 200-105-152Genicon, Inc.
2020-06-17Z-2272-2020Class IIGenicon GENILook Model 200-105-251Genicon, Inc.
2020-06-17Z-2273-2020Class IIGenicon Natura Model 210-005-051Genicon, Inc.
2020-06-17Z-2274-2020Class IIGenicon Natura Model 210-005-151Genicon, Inc.
2020-06-17Z-2275-2020Class IIGenicon Natura Model 210-005-152Genicon, Inc.
2020-06-17Z-2276-2020Class IIGenicon Natura Model 210-005-251Genicon, Inc.
2020-06-17Z-2277-2020Class IIGenicon Natura Model 210-105-251Genicon, Inc.
2020-06-17Z-2278-2020Class IIGenicon GENILook Model 200-105-252Genicon, Inc.
2020-06-17Z-2279-2020Class IIGenicon Natura Model 210-005-052Genicon, Inc.
2020-06-17Z-2280-2020Class IIADVIA Chemistry Fructosamine ReagentSiemens Healthcare Diagnostics, Inc.
2020-06-17Z-2281-2020Class IIAtellica CH Fructosamine ReagentSiemens Healthcare Diagnostics, Inc.
2020-06-17Z-2282-2020Class IIADVIA Chemistry Enzymatic Creatinine_2Siemens Healthcare Diagnostics, Inc.
2020-06-17Z-2283-2020Class IIAtellica CH Enzymatic Creatinine_2Siemens Healthcare Diagnostics, Inc.
2020-06-17Z-2284-2020Class IIDimension Enzymatic CreatinineSiemens Healthcare Diagnostics, Inc.
2020-06-17Z-2285-2020Class IIDimension Vista Enzymatic CreatinineSiemens Healthcare Diagnostics, Inc.
2020-06-17Z-2286-2020Class IIOrmco Damon Q2 Orthodontic Metal BracketOrmco/Sybronendo
2020-06-17Z-2287-2020Class IIAcrysofAlcon Research LLC
2020-06-17Z-2288-2020Class IIArrow FlexTip Plus Epidural Kit with NRFit ConnectorArrow International Inc
2020-06-17Z-2289-2020Class IIElekta UnityElekta, Inc.
2020-06-17Z-2290-2020Class IItherascreen EGFR RGQ PCR KitQiagen Sciences LLC
2020-06-17Z-2291-2020Class II4plus Streptavidin HRP LabelBiocare Medical, LLC
2020-06-17Z-2292-2020Class IIENF-GP2 Rhino-Laryngo FiberscopeOlympus Corporation of the Americas
2020-06-17Z-2293-2020Class IIRadiForce GX560 monochrome LCD monitorEizo Corporation
2020-06-17Z-2294-2020Class IIRadiForce RX360Eizo Corporation
2020-06-17Z-2295-2020Class IIFilmArray BCID PanelBioFire Diagnostics, LLC
2020-06-17Z-2296-2020Class IIFilmArray BCID PanelBioFire Diagnostics, LLC
2020-06-17Z-2297-2020Class IIElekta UnityElekta Limited
2020-06-17Z-2298-2020Class IIHardyCHROM MRSAHardy Diagnostics
2020-06-17Z-2299-2020Class IITriever20 Aspiration Guide Catheter a component of FlowTriever…INARI MEDICAL
2020-06-17Z-2300-2020Class IIComprehensive VRS InserterBiomet, Inc.
2020-06-17Z-2301-2020Class IIHistoplasma ImmunodiffusionImmuno-Mycologics, Inc
2020-06-17Z-2302-2020Class IIMulti Display Manager in the Artis SystemsSiemens Medical Solutions USA, Inc
2020-06-17Z-2303-2020Class IIBiomet 6Biomet
2020-06-17Z-2304-2020Class IIBiomet 8Biomet
2020-06-17Z-2305-2020Class IIABiomet
2020-06-17Z-2306-2020Class IIABiomet
2020-06-17Z-2307-2020Class IIABiomet
2020-06-17Z-2308-2020Class IIABiomet
2020-06-17Z-2309-2020Class IIABiomet
2020-06-17Z-2310-2020Class IIABiomet
2020-06-17Z-2311-2020Class IIABiomet
2020-06-17Z-2312-2020Class IIABiomet
2020-06-17Z-2313-2020Class IIABiomet
2020-06-17Z-2314-2020Class IIABiomet
2020-06-17Z-2315-2020Class IIABiomet
2020-06-17Z-2316-2020Class IIABiomet
2020-06-17Z-2317-2020Class IIABiomet
2020-06-17Z-2318-2020Class IIABiomet
2020-06-17Z-2319-2020Class IIABiomet
2020-06-17Z-2320-2020Class IIABiomet
2020-06-17Z-2321-2020Class IIABiomet
2020-06-17Z-2322-2020Class IIABiomet
2020-06-17Z-2323-2020Class IIABiomet
2020-06-17Z-2324-2020Class IIABiomet
2020-06-17Z-2325-2020Class IIInfinix-8000V with Catheterization Table CAT-850B or CAT-860BCanon Medical System, USA, INC.
2020-06-17Z-2326-2020Class IIInfinix-8000C with Catheterization Table CAT-850B or CAT-860BCanon Medical System, USA, INC.
2020-06-17Z-2327-2020Class IIInfinix-8000F with Catheterization Table CAT-850B or CAT-860BCanon Medical System, USA, INC.
2020-06-17Z-2328-2020Class IISTAINLESS STEEL REPROCESSING TRAYIntuitive Surgical, Inc.
2020-06-17Z-2329-2020Class IISTAINLESS STEEL REPROCESSING TRAYIntuitive Surgical, Inc.
2020-06-17Z-2330-2020Class IIMazor X Surgical System Positioner Type IIMedtronic Navigation, Inc.
2020-06-17Z-2331-2020Class IIsmith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELLSmith & Nephew, Inc.
2020-06-17Z-2332-2020Class IIsmith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED…Smith & Nephew, Inc.
2020-06-17Z-2333-2020Class IIsmith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELLSmith & Nephew, Inc.
2020-06-17Z-2334-2020Class IIsmith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED…Smith & Nephew, Inc.
2020-06-17Z-2335-2020Class IIsmith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELLSmith & Nephew, Inc.
2020-06-17Z-2336-2020Class IIsmith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED…Smith & Nephew, Inc.
2020-06-17Z-2337-2020Class IIPhilips SureSigns VM1SpO2Philips North America, LLC
2020-06-17Z-2338-2020Class IIIntelliSpace PACS 4Philips Healthcare Informatics, Inc.
2020-06-17Z-2339-2020Class IIRayStation 4RAYSEARCH LABORATORIES AB
2020-06-17Z-2340-2020Class IIRayStation 5 Service Pack 3RAYSEARCH LABORATORIES AB
2020-06-17Z-2341-2020Class IIRayStation 6RAYSEARCH LABORATORIES AB
2020-06-17Z-2342-2020Class IIRayStation 6 Service Pack 2RAYSEARCH LABORATORIES AB
2020-06-17Z-2343-2020Class IIRayStation 6 Service Pack 3RAYSEARCH LABORATORIES AB
2020-06-17Z-2344-2020Class IIRayStation 8ARAYSEARCH LABORATORIES AB
2020-06-17Z-2345-2020Class IIRayStation 8A Service Pack 1RAYSEARCH LABORATORIES AB
2020-06-17Z-2346-2020Class IIRayStation 8BRAYSEARCH LABORATORIES AB
2020-06-17Z-2347-2020Class IIRayStation 8B Service Pack 1RAYSEARCH LABORATORIES AB
2020-06-17Z-2348-2020Class IIRayStation 8B Service Pack 2RAYSEARCH LABORATORIES AB
2020-06-17Z-2349-2020Class IIRayStation 9ARAYSEARCH LABORATORIES AB
2020-06-17Z-2350-2020Class IIRayStation 9BRAYSEARCH LABORATORIES AB
2020-06-17Z-2351-2020Class IIRayStation 9B Service Pack 1RAYSEARCH LABORATORIES AB
2020-06-17Z-2352-2020Class IIRayStation 6 Service Pack 1RAYSEARCH LABORATORIES AB
2020-06-17Z-2353-2020Class IIRayStation 7RAYSEARCH LABORATORIES AB
2020-06-17Z-2354-2020Class IIA LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A…Acuity Surgical Devices, LLC
2020-06-17Z-2355-2020Class IIA LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A…Acuity Surgical Devices, LLC
2020-06-17Z-2356-2020Class IIBD FACS Sample Prep AssistantBecton, Dickinson and Company, BD Biosciences
2020-06-17Z-2357-2020Class IIBD FACS Sample Prep AssistantBecton, Dickinson and Company, BD Biosciences
2020-06-17Z-2358-2020Class IIBD FACS Sample Prep AssistantBecton, Dickinson and Company, BD Biosciences
2020-06-17Z-2359-2020Class IIInfant/Child Reduced Energy Defibrillation ElectrodesPhysio-Control, Inc.
2020-06-17Z-2360-2020Class IIInfant Child Starter KitsPhysio-Control, Inc.
2020-06-10Z-2164-2020Class IIOmnipod DASH Insulin Management SystemInsulet Corporation
2020-06-10Z-2165-2020Class IIOmnipod DASH Insulin Management SystemInsulet Corporation
2020-06-10Z-2166-2020Class IISterile Custom Packs to be used in surgical proceduresAmerican Contract Systems
2020-06-10Z-2167-2020Class IISterile Custom Packs to be used in surgical proceduresAmerican Contract Systems
2020-06-10Z-2168-2020Class IICustom Packs to be used in surgical proceduresAmerican Contract Systems
2020-06-10Z-2169-2020Class IISterile Custom Packs to be used in surgical proceduresAmerican Contract Systems
2020-06-10Z-2170-2020Class IISterile Custom Packs to be used in surgical proceduresAmerican Contract Systems
2020-06-10Z-2171-2020Class IISterile Custom Packs to be used in surgical proceduresAmerican Contract Systems
2020-06-10Z-2172-2020Class IISterile Custom Packs to be used in surgical proceduresAmerican Contract Systems
2020-06-10Z-2173-2020Class IISterile Custom Packs to be used in surgical proceduresAmerican Contract Systems
2020-06-10Z-2174-2020Class IISterile Custom Packs to be used in surgical proceduresAmerican Contract Systems
2020-06-10Z-2175-2020Class IISterile Custom Packs to be used in surgical proceduresAmerican Contract Systems
2020-06-10Z-2176-2020Class IISterile Custom Packs to be used in surgical proceduresAmerican Contract Systems
2020-06-10Z-2177-2020Class IISterile Custom Packs to be used in surgical proceduresAmerican Contract Systems
2020-06-10Z-2178-2020Class IISterile Custom Packs to be used in surgical proceduresAmerican Contract Systems
2020-06-10Z-2179-2020Class IISterile Custom Packs to be used in surgical proceduresAmerican Contract Systems
2020-06-10Z-2180-2020Class IIOSTEOVATIONEX 2CC INJECT FORMULAOsteomed, LLC
2020-06-10Z-2181-2020Class IIOSTEOVATIONEX 3CC INJECT FORMULAOsteomed, LLC
2020-06-10Z-2182-2020Class IIOSTEOVATIONEX 5CC INJECT FORMULAOsteomed, LLC
2020-06-10Z-2183-2020Class IIOSTEOVATION 5CC INJECT FORMULAOsteomed, LLC
2020-06-10Z-2184-2020Class IIOSTEOVATION 10CC INJECT FORMULAOsteomed, LLC
2020-06-10Z-2185-2020Class IIOSTEOVATIONEX 5CC IMPACTFORMULAOsteomed, LLC
2020-06-10Z-2186-2020Class IIOSTEOVATIONEX 3CC IMPACTFORMULAOsteomed, LLC
2020-06-10Z-2187-2020Class IIOSTEOVATION 3CC IMPACTFORMULAOsteomed, LLC
2020-06-10Z-2188-2020Class IIOSTEOVATION 5CC IMPACTFORMULAOsteomed, LLC
2020-06-10Z-2189-2020Class IIOSTEOVATION RMX Injectable BVF 5CCOsteomed, LLC
2020-06-10Z-2190-2020Class IIOSTEOVATION 10 CC IMPACT FORMULAOsteomed, LLC
2020-06-10Z-2191-2020Class IIOSTEOVATION RMX 10 CC InjectableOsteomed, LLC
2020-06-10Z-2192-2020Class IIPower supply provided with Afinion 2Abbott Diagnostics Technologies AS
2020-06-10Z-2193-2020Class IIGambro Cartridge Blood Set Prime LineBaxter Healthcare Corporation
2020-06-10Z-2194-2020Class IIGambro Cartridge Blood Transport System for Hemodialysis Blood SetBaxter Healthcare Corporation
2020-06-10Z-2195-2020Class IIGambro Cartridge Low Volume Blood Transport System for Hemodialysis…Baxter Healthcare Corporation
2020-06-10Z-2196-2020Class IIGambro Cartridge Low Weight-Low Volume Blood Transport System for…Baxter Healthcare Corporation
2020-06-10Z-2197-2020Class IIOLYMPUS ShockPulse-SE Lithotripsy SystemOlympus Corporation of the Americas
2020-06-10Z-2198-2020Class IIFlexLab Augomation System using the Aliquoter ModuleInpeco S.A.
2020-06-10Z-2199-2020Class IIAccelerator a3600 Automation System using the Aliquoter ModuleInpeco S.A.
2020-06-10Z-2200-2020Class IIAptio Automation System using the Aliquoter ModuleInpeco S.A.
2020-06-10Z-2201-2020Class IITRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEMTrividia Health, Inc.
2020-06-10Z-2202-2020Class IIAGFA Digital Radiography X- Ray system DR 800 with MUSICA DynamicAgfa N.V.
2020-06-10Z-2203-2020Class IIPressure Monitoring SetCook Inc.
2020-06-10Z-2204-2020Class IIPressure Monitoring TrayCook Inc.
2020-06-10Z-2205-2020Class IIAC Powered hospital adjustable bedUmano Medical, Inc.
2020-06-10Z-2206-2020Class IIMedtronic Implantable Insulin Pump SystemMedtronic Inc.
2020-06-10Z-2207-2020Class IINobelActive Internal NP 3Nobel Biocare Usa Llc
2020-06-10Z-2208-2020Class IIEQUISTREAM¿ XK Long-Term Hemodialysis CatheterBard Peripheral Vascular Inc
2020-06-10Z-2209-2020Class IIEQUISTREAM¿ XK Long-Term Hemodialysis CatheterBard Peripheral Vascular Inc
2020-06-10Z-2210-2020Class IIVital MIS Spinal Fixation system implants CANN POLY EXT TAB 4Zimmer Biomet, Inc.
2020-06-10Z-2211-2020Class IIVital MIS Spinal Fixation system implants CANN POLY EXT TAB 4Zimmer Biomet, Inc.
2020-06-10Z-2212-2020Class IIVital MIS Spinal Fixation system implants CANN POLY EXT TAB 4Zimmer Biomet, Inc.
2020-06-10Z-2213-2020Class IIVital MIS Spinal Fixation system implants CANN POLY EXT TAB 4Zimmer Biomet, Inc.
2020-06-10Z-2214-2020Class IIVital MIS Spinal Fixation system implants CANN POLY EXT TAB 5Zimmer Biomet, Inc.
2020-06-10Z-2215-2020Class IIVital MIS Spinal Fixation system implants CANN POLY EXT TAB 5Zimmer Biomet, Inc.
2020-06-10Z-2216-2020Class IIVital MIS Spinal Fixation system implants CANN POLY EXT TAB 5Zimmer Biomet, Inc.
2020-06-10Z-2217-2020Class IIVital MIS Spinal Fixation system implants CANN POLY EXT TAB 5Zimmer Biomet, Inc.
2020-06-10Z-2218-2020Class IIVital MIS Spinal Fixation system implants CANN POLY EXT TAB 5Zimmer Biomet, Inc.
2020-06-10Z-2219-2020Class IIVital MIS Spinal Fixation system implants CANN POLY EXT TAB 6Zimmer Biomet, Inc.
2020-06-10Z-2220-2020Class IIVital MIS Spinal Fixation system implants CANN POLY EXT TAB 6Zimmer Biomet, Inc.
2020-06-10Z-2221-2020Class IIVital MIS Spinal Fixation system implants CANN POLY EXT TAB 6Zimmer Biomet, Inc.
2020-06-10Z-2222-2020Class IIVital MIS Spinal Fixation system implants CANN POLY EXT TAB 6Zimmer Biomet, Inc.
2020-06-10Z-2223-2020Class IIVital MIS Spinal Fixation system implants CANN POLY EXT TAB 7Zimmer Biomet, Inc.
2020-06-10Z-2224-2020Class IIVital MIS Spinal Fixation system implants CANN POLY EXT TAB 6Zimmer Biomet, Inc.
2020-06-10Z-2225-2020Class IIVital MIS Spinal Fixation system implants CANN POLY EXT TAB 7Zimmer Biomet, Inc.
2020-06-10Z-2226-2020Class IIVital MIS Spinal Fixation system implants CANN POLY EXT TAB 7Zimmer Biomet, Inc.
2020-06-10Z-2227-2020Class IIVital MIS Spinal Fixation system implants CANN POLY EXT TAB 7Zimmer Biomet, Inc.
2020-06-10Z-2228-2020Class IIVital MIS Spinal Fixation system implants CANN BL POLY EXT 8Zimmer Biomet, Inc.
2020-06-10Z-2229-2020Class IIVital MIS Spinal Fixation system implants CANN BL POLY EXT 8Zimmer Biomet, Inc.
2020-06-10Z-2230-2020Class IIVital MIS Spinal Fixation system implants CANN BL POLY EXT 8Zimmer Biomet, Inc.
2020-06-10Z-2231-2020Class IIVital MIS Spinal Fixation system implants CANN BL POLY EXT 8Zimmer Biomet, Inc.
2020-06-10Z-2232-2020Class IIVital MIS Spinal Fixation system implants CANN BL POLY EXT 8Zimmer Biomet, Inc.
2020-06-10Z-2233-2020Class IIVital MIS Spinal Fixation system implants VITAL MIS TAB BREAKERZimmer Biomet, Inc.
2020-06-10Z-2234-2020Class IIVital MIS Spinal Fixation system implants CANN POLY EXT TAB 7Zimmer Biomet, Inc.
2020-06-10Z-2237-2020Class IIBeckman Coulter Access Immunoassay SystemsBeckman Coulter Inc.
2020-06-10Z-2238-2020Class IIBeckman Coulter Access Immunoassay SystemsBeckman Coulter Inc.
2020-06-10Z-2239-2020Class IIBeckman Coulter ACCESS Immunoassay SystemsBeckman Coulter Inc.
2020-06-10Z-2240-2020Class IIBeckman Coulter ACCESS Immunoassay SystemsBeckman Coulter Inc.
2020-06-10Z-2241-2020Class IIBeckman Coulter ACCESS Immunoassay SystemsBeckman Coulter Inc.
2020-06-10Z-2242-2020Class IIBeckman Coulter ACCESS Immunoassay SystemsBeckman Coulter Inc.
2020-06-10Z-2243-2020Class IIType S Extension For use with VarianMed Tec Inc
2020-06-10Z-2244-2020Class IICardiovascular Monitoring Device accessoryPhilips North America, LLC
2020-06-10Z-2245-2020Class IIMagnetic Resonance Imaging Diagnostic Device accessoryPhilips North America, LLC
2020-06-10Z-2246-2020Class IICentrella Smart+ BedHill-Rom, Inc.
2020-06-10Z-2247-2020Class IIsafeCLINITUBES Blood SamplerRadiometer Medical ApS
2020-06-10Z-2248-2020Class IIsafeCLINITUBES Blood SamplerRadiometer Medical ApS
2020-06-10Z-2249-2020Class IIsafeCLINITUBES Blood SamplerRadiometer Medical ApS
2020-06-10Z-2250-2020Class IIHealing Abutment Conical Connection RP 0 3Nobel Biocare Usa Llc
2020-06-10Z-2251-2020Class IIAccelerator APS Aliquoter ModuleAbbott Laboratories
2020-06-10Z-2252-2020Class IIMultifire VersaTrack Auto Suture Hernia StaplerCovidien Llc

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