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Medical device recalls reported in 2020

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ReportedRecallClassProductFirm
2020-08-19Z-2801-2020Class IIArrow Single Shot Epidural Anesthesia KitArrow International Inc
2020-08-19Z-2802-2020Class IICannon II Plus Replacement Hub SetArrow International Inc
2020-08-19Z-2803-2020Class IIArrow TheraCath Epidural CatheterArrow International Inc
2020-08-19Z-2804-2020Class IINextStep Retrograde Replacement Hub SetArrow International Inc
2020-08-12Z-2716-2020Class IAlaris System PC Unit Model 8000CareFusion 303, Inc.
2020-08-12Z-2717-2020Class IAlaris System PC Unit Model 8015CareFusion 303, Inc.
2020-08-12Z-2718-2020Class IAlaris Pump Module Model 8100CareFusion 303, Inc.
2020-08-12Z-2719-2020Class IAlaris Syringe Module Model 8110CareFusion 303, Inc.
2020-08-12Z-2720-2020Class IAlaris PCA Module Model 8120CareFusion 303, Inc.
2020-08-12Z-2721-2020Class IAlaris EtCO2 Module Model 8300CareFusion 303, Inc.
2020-08-12Z-2722-2020Class IAlaris SpO2 Module Model 8210 and Model 8220CareFusion 303, Inc.
2020-08-12Z-2723-2020Class IAlaris Auto ID Module Model 8600CareFusion 303, Inc.
2020-08-12Z-2734-2020Class IMedfusion Syringe Pump Model 4000Smiths Medical ASD Inc.
2020-08-12Z-2735-2020Class IMedfusion Syringe Pump Model 3500Smiths Medical ASD Inc.
2020-08-12Z-2736-2020Class IAlaris Pump Module Model 8100CareFusion 303, Inc.
2020-08-12Z-2740-2020Class IAlaris System PC Unit Model 8000 modular infusion pump and monitoring…CareFusion 303, Inc.
2020-08-12Z-2741-2020Class IAlaris System PC Unit Model 8015CareFusion 303, Inc.
2020-08-12Z-2743-2020Class IIRemisol Advance running Software Version 1Normand-Info S.A.S.U.
2020-08-12Z-2744-2020Class IISutter Swyng non-stick bipolar forcepsSutter Medizintechnik GmbH
2020-08-12Z-2745-2020Class IIMako Hip End EffectorMako Surgical Corporation
2020-08-12Z-2746-2020Class IISUTUREFIX ULTRA SutureSmith & Nephew, Inc.
2020-08-12Z-2747-2020Class IIDCA Vantage Handheld Barcode ScannerSiemens Healthcare Diagnostics, Inc.
2020-08-12Z-2748-2020Class IIPleur-Evac Adult-Ped WetTELEFLEX MEDICAL INC
2020-08-12Z-2749-2020Class IIPleur-Evac Adult-Ped WetTELEFLEX MEDICAL INC
2020-08-12Z-2750-2020Class IICARESCAPE ONEGE Healthcare, LLC
2020-08-12Z-2751-2020Class IIRandox Lipase Assay: Lipase Colorimetric ReagentRANDOX LABORATORIES, LTD.
2020-08-12Z-2752-2020Class IIRandox Lipase Assay: Lipase Colorimetric R1 BufferRANDOX LABORATORIES, LTD.
2020-08-12Z-2753-2020Class IIRandox Lipase Assay: Lipase Colorimetric R2 SubstrateRANDOX LABORATORIES, LTD.
2020-08-12Z-2754-2020Class IIBD MAX SARS-CoV-2 ReagentsBecton Dickinson & Co.
2020-08-12Z-2755-2020Class IISIEMENS Healthineers Luminos dRF Max Model: 10762471- Product Usage:…Siemens Medical Solutions USA, Inc
2020-08-12Z-2756-2020Class IISIEMENS Healthineers Luminos Agile Max Model: 10762472Siemens Medical Solutions USA, Inc
2020-08-12Z-2757-2020Class IISIEMENS Healthineers Uroskop Omnia max Model: 10762473Siemens Medical Solutions USA, Inc
2020-08-12Z-2758-2020Class IISIEMENS Healthineers Ysio MaxSiemens Medical Solutions USA, Inc
2020-08-12Z-2759-2020Class IICaptivator Polypectomy SnareBoston Scientific Corporation
2020-08-12Z-2760-2020Class IICaptivator Polypectomy SnareBoston Scientific Corporation
2020-08-12Z-2761-2020Class IICaptivator Polypectomy SnareBoston Scientific Corporation
2020-08-12Z-2762-2020Class IICaptivator Polypectomy SnareBoston Scientific Corporation
2020-08-12Z-2763-2020Class IICaptivator Polypectomy SnareBoston Scientific Corporation
2020-08-12Z-2764-2020Class IICaptiflex SnaresBoston Scientific Corporation
2020-08-12Z-2765-2020Class IICaptivator Polypectomy SnareBoston Scientific Corporation
2020-08-12Z-2766-2020Class IIEndoscopic Cleaning BrushMedline Industries Inc
2020-08-12Z-2767-2020Class IIBOSS DeBakey "Gator-Grip" Needle Holder 2 mm tipBoss Instruments, Ltd.
2020-08-12Z-2768-2020Class IIBeacon EUS Access System Preloaded Access 90degree Needle sterileCovidien Llc
2020-08-12Z-2769-2020Class IIBeacon EUS Access System Preloaded Access 135degree Needle sterileCovidien Llc
2020-08-05Z-2698-2020Class IIMatrixNEURO ScrewsSynthes, Inc.
2020-08-05Z-2699-2020Class IIregard Migrating IndicatorResource Optimization & Innovation LLC
2020-08-05Z-2700-2020Class IIInnoWave Sonic IrrigatorSteris Corporation
2020-08-05Z-2701-2020Class IIAlinity ci series System Control ModuleAbbott Gmbh & Co. KG
2020-08-05Z-2702-2020Class IISmith & Nephew T-F1X0 RCG Drill PacSmith & Nephew, Inc.
2020-08-05Z-2703-2020Class IIComputed Tomography X-ray SystemShanghai United Imaging Healthcare Co., Ltd.
2020-08-05Z-2704-2020Class IIComputed Tomography X-ray SystemShanghai United Imaging Healthcare Co., Ltd.
2020-08-05Z-2705-2020Class IIComputed Tomography X-ray SystemShanghai United Imaging Healthcare Co., Ltd.
2020-08-05Z-2706-2020Class IITube Set for TEMRichard Wolf GmbH
2020-08-05Z-2707-2020Class IIStealthStation" S7 System with Polaris Spectra Camera part number PSU…Medtronic Navigation, Inc.
2020-08-05Z-2708-2020Class IITTDEYEChengdu Ai Qin E-commerce Co., Ltd
2020-08-05Z-2709-2020Class IITTDEYEChengdu Ai Qin E-commerce Co., Ltd
2020-08-05Z-2710-2020Class IITTDEYEChengdu Ai Qin E-commerce Co., Ltd
2020-08-05Z-2711-2020Class IITTDEYEChengdu Ai Qin E-commerce Co., Ltd
2020-08-05Z-2712-2020Class IITTDEYEChengdu Ai Qin E-commerce Co., Ltd
2020-08-05Z-2713-2020Class IITTDEYEChengdu Ai Qin E-commerce Co., Ltd
2020-08-05Z-2714-2020Class IITTDEYEChengdu Ai Qin E-commerce Co., Ltd
2020-08-05Z-2715-2020Class IIProteus 235 The Proton Therapy SystemIon Beam Applications S.A.
2020-08-05Z-2724-2020Class IIClearPro T-Piece Closed Suction CatheterMedline Industries Inc
2020-08-05Z-2725-2020Class IIClearPro Trach T-Piece Closed Suction CatheterMedline Industries Inc
2020-08-05Z-2726-2020Class IIRusch Greenlite Product Code: 004550002 GTIN: 14026704663061TELEFLEX MEDICAL INC
2020-08-05Z-2727-2020Class IIRusch Greenlite Product Code: 0004550003 GTIN: 14026704663078TELEFLEX MEDICAL INC
2020-08-05Z-2728-2020Class IIRusch Greenlite Product Code: 004550004 GTIN: 14026704663085TELEFLEX MEDICAL INC
2020-08-05Z-2729-2020Class IIRusch Greenlite Product Code: 004551002 GTIN: 14026704663115TELEFLEX MEDICAL INC
2020-08-05Z-2730-2020Class IIRusch Greenlite Product Code: 004551003 GTIN: 14026704663122TELEFLEX MEDICAL INC
2020-08-05Z-2731-2020Class IIRusch Greenlite Product Code: 004551004 GTIN: 24026704553796TELEFLEX MEDICAL INC
2020-08-05Z-2732-2020Class IIRusch Greenlite Product Code: 004551035 GTIN:7290102156443TELEFLEX MEDICAL INC
2020-08-05Z-2733-2020Class IISterile Low Profile ScrewArthrex, Inc.
2020-08-05Z-2737-2020Class IIProgressa BedHill-Rom, Inc.
2020-08-05Z-2738-2020Class IICentrella Smart+ BedHill-Rom, Inc.
2020-08-05Z-2739-2020Class IIMatrixMIDFACE ScrewsSynthes Produktions GmbH
2020-08-05Z-2742-2020Class IIOrthopedics 6OrthoPediatrics Corp
2020-07-29Z-2640-2020Class IIExpansion Control OverlayEHOB, Inc.
2020-07-29Z-2641-2020Class IIComputed Tomography X-ray SystemShanghai United Imaging Healthcare Co., Ltd.
2020-07-29Z-2642-2020Class IIILivaNova USA Sterile Disposable ConnectorLivaNova USA Inc.
2020-07-29Z-2643-2020Class IILoFric OrigoWellspect HealthCare (Division of DENTSPLY IH AB)
2020-07-29Z-2644-2020Class IILoFric OrigoWellspect HealthCare (Division of DENTSPLY IH AB)
2020-07-29Z-2645-2020Class IILoFric OrigoWellspect HealthCare (Division of DENTSPLY IH AB)
2020-07-29Z-2646-2020Class IIThora-Para 5 Fr Non-Valved Catheter Drainage TrayCarefusion 2200 Inc
2020-07-29Z-2647-2020Class IISafe-T PLUS Thora-Para 5 Fr Non-Valved Catheter Drainage TrayCarefusion 2200 Inc
2020-07-29Z-2648-2020Class IISafe-T-Centesis 6 Fr Catheter Drainage TrayCarefusion 2200 Inc
2020-07-29Z-2649-2020Class IISafe-T-Centesis 6 Fr Catheter Drainage Tray w/o LidocaineCarefusion 2200 Inc
2020-07-29Z-2650-2020Class IISafe-T-Centesis PLUS 6 Fr Catheter Drainage TrayCarefusion 2200 Inc
2020-07-29Z-2651-2020Class IISafe-T-Centesis 8 Fr Catheter Drainage TrayCarefusion 2200 Inc
2020-07-29Z-2652-2020Class IISafe-T-Centesis PLUS 8 Fr Catheter Drainage TrayCarefusion 2200 Inc
2020-07-29Z-2653-2020Class IIThora-Para 8 Fr Catheter Drainage TrayCarefusion 2200 Inc
2020-07-29Z-2654-2020Class IIThora-Para 8 Fr Catheter Drainage Tray w/o LidocaineCarefusion 2200 Inc
2020-07-29Z-2655-2020Class IISafe-T 8 Fr Thora-Para Tray With 8 FrCarefusion 2200 Inc
2020-07-29Z-2656-2020Class IISafe-T PLUS Thora-Para 8 Fr Catheter Drainage TrayCarefusion 2200 Inc
2020-07-29Z-2657-2020Class IIThora-Para 5 Fr Catheter Drainage TrayCarefusion 2200 Inc
2020-07-29Z-2658-2020Class IISafe-T 5 Fr Thora-Para Tray With 5 FrCarefusion 2200 Inc
2020-07-29Z-2659-2020Class IISafe-T PLUS Thora-Para 5 Fr Catheter Drainage TrayCarefusion 2200 Inc
2020-07-29Z-2660-2020Class IIPowerLoc MAX Power Injectable Infusion Set AllPoints Port Access…Becton Dickinson & Company
2020-07-29Z-2661-2020Class IIPowerLoc MAX Power-Injectable Infusion Set myPICK Port Access KitBecton Dickinson & Company
2020-07-29Z-2662-2020Class IIPowerLoc MAX Power Injectable Infusion Port Access KitBecton Dickinson & Company
2020-07-29Z-2663-2020Class IIPowerLoc MAX Power Injectable Infusion Set with GuardIVa…Becton Dickinson & Company
2020-07-29Z-2664-2020Class IISafeStep Huber Needle Set AllPoints Port Access SystemBecton Dickinson & Company
2020-07-29Z-2665-2020Class IISafeStep Huber Needle Set myPICK Port Access KitBecton Dickinson & Company
2020-07-29Z-2666-2020Class IISafeStep Huber Needle Set Port Access KitBecton Dickinson & Company
2020-07-29Z-2667-2020Class IISafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic…Becton Dickinson & Company
2020-07-29Z-2668-2020Class IISafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic…Becton Dickinson & Company
2020-07-29Z-2669-2020Class IISafeStep Huber Needle Set with Y Injection Site and Medegen…Becton Dickinson & Company
2020-07-29Z-2670-2020Class IIPowerLoc MAX Power Injectable Infusion SetBecton Dickinson & Company
2020-07-29Z-2671-2020Class IISafeStep Huber Needle SetBecton Dickinson & Company
2020-07-29Z-2672-2020Class IIANAX 5U&I CORP.
2020-07-29Z-2673-2020Class IISoftware 1898072 IPC upgrade v 2Medtronic Xomed, Inc.
2020-07-29Z-2674-2020Class IIAblation Galil TechnologyBoston Scientific Corporation
2020-07-29Z-2675-2020Class IIAblation Galil TechnologyBoston Scientific Corporation
2020-07-29Z-2676-2020Class IIAblation Galil TechnologyBoston Scientific Corporation
2020-07-29Z-2677-2020Class IIAblation Galil TechnologyBoston Scientific Corporation
2020-07-29Z-2678-2020Class IIAblation Galil TechnologyBoston Scientific Corporation
2020-07-29Z-2679-2020Class IIAblation Galil TechnologyBoston Scientific Corporation
2020-07-29Z-2680-2020Class IIAblation Galil TechnologyBoston Scientific Corporation
2020-07-29Z-2681-2020Class IIAblation Galil TechnologyBoston Scientific Corporation
2020-07-29Z-2682-2020Class IIAblation Galil TechnologyBoston Scientific Corporation
2020-07-29Z-2683-2020Class IIAblation Galil TechnologyBoston Scientific Corporation
2020-07-29Z-2684-2020Class IINuvasive NVM5 EMG ModuleNuVasive Inc
2020-07-29Z-2685-2020Class IITRIGENSmith & Nephew, Inc.
2020-07-29Z-2686-2020Class IIMEVION S250 Proton Radiation Treatment SystemMevion Medical Systems, Inc.
2020-07-29Z-2687-2020Class IISysmex PS-10 Sample Preparation System Catalog number:BQ716341Sysmex America, Inc.
2020-07-29Z-2688-2020Class IIsyngoSiemens Medical Solutions USA, Inc
2020-07-29Z-2689-2020Class IIIntelliVue G7m Anesthesia Gas ModulePhilips North America, LLC
2020-07-29Z-2690-2020Class IIAccurian RF AblationMedtronic Sofamor Danek USA Inc
2020-07-29Z-2691-2020Class IIAccurian RF AblationMedtronic Sofamor Danek USA Inc
2020-07-29Z-2692-2020Class IIAccurian RF AblationMedtronic Sofamor Danek USA Inc
2020-07-29Z-2693-2020Class IIAccurian RF AblationMedtronic Sofamor Danek USA Inc
2020-07-29Z-2694-2020Class IIAccurian RF AblationMedtronic Sofamor Danek USA Inc
2020-07-29Z-2695-2020Class IIAccurian RF AblationMedtronic Sofamor Danek USA Inc
2020-07-29Z-2696-2020Class IIIntelliVue MX800 patient monitorPhilips North America, LLC
2020-07-29Z-2697-2020Class IIIntelliVue MX700 patient monitorPhilips North America, LLC
2020-07-22Z-2547-2020Class IIMOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous /…DiaSorin Molecular LLC
2020-07-22Z-2548-2020Class IIMOL3650 Simplexa VZV DirectDiaSorin Molecular LLC
2020-07-22Z-2549-2020Class IIMOL3655 Simplexa VZV Swab DirectDiaSorin Molecular LLC
2020-07-22Z-2550-2020Class IIIPOWERWAND XL 4Fr 8cm Maximum Barrier KitAccess Scientific LLC
2020-07-22Z-2551-2020Class IIMagNA Pure 96 InstrumentRoche Molecular Systems, Inc.
2020-07-22Z-2552-2020Class IIenVista one-piece hydrophobic acrylic toric intraocular lensBausch & Lomb Surgical, Inc.
2020-07-22Z-2553-2020Class IBodyGuard BodySetCME America, LLC
2020-07-22Z-2554-2020Class IBodyGuard MicrosetCME America, LLC
2020-07-22Z-2555-2020Class IBodyGuard MicrosetCME America, LLC
2020-07-22Z-2556-2020Class IBodyGuard MicrosetCME America, LLC
2020-07-22Z-2557-2020Class IBodyGuard MicrosetCME America, LLC
2020-07-22Z-2558-2020Class IBodyGuard MicrosetCME America, LLC
2020-07-22Z-2559-2020Class IBodyGuard MicrosetCME America, LLC
2020-07-22Z-2560-2020Class IBodyGuard MicrosetCME America, LLC
2020-07-22Z-2561-2020Class IBodyGuard MicrosetCME America, LLC
2020-07-22Z-2562-2020Class IBodyGuard MicrosetCME America, LLC
2020-07-22Z-2563-2020Class IBodyGuard MicrosetCME America, LLC
2020-07-22Z-2564-2020Class IBodyGuard Microset with FilterCME America, LLC
2020-07-22Z-2565-2020Class IBodyGuard MicrosetCME America, LLC
2020-07-22Z-2566-2020Class IBodyGuard MicrosetCME America, LLC
2020-07-22Z-2567-2020Class IBodyGuard Microset with Needleless AdaptorCME America, LLC
2020-07-22Z-2568-2020Class ICMExpress Microbore SetCME America, LLC
2020-07-22Z-2569-2020Class ICMExpress Microbore SetCME America, LLC
2020-07-22Z-2570-2020Class IBodyGuard Microset w/ Non-Vented Spike ConnectorCME America, LLC
2020-07-22Z-2571-2020Class IBodyGuard Microset with FilterCME America, LLC
2020-07-22Z-2572-2020Class IBodyGuard Microset with FilterCME America, LLC
2020-07-22Z-2573-2020Class IBodyGuard MicrosetCME America, LLC
2020-07-22Z-2574-2020Class IBodyGuard MicrosetCME America, LLC
2020-07-22Z-2575-2020Class IBodyGuard MicrosetCME America, LLC
2020-07-22Z-2576-2020Class IBodyGuard MicrosetCME America, LLC
2020-07-22Z-2577-2020Class IBodyGuard MicrosetCME America, LLC
2020-07-22Z-2578-2020Class ICMExpress Microbore SetsCME America, LLC
2020-07-22Z-2579-2020Class ICMExpress Microbore SetsCME America, LLC
2020-07-22Z-2580-2020Class ICMExpress Microbore SetsCME America, LLC
2020-07-22Z-2581-2020Class IBodyGuard Microset with Male Luer ConnectorsCME America, LLC
2020-07-22Z-2582-2020Class IBodyGuard set with Female LuerCME America, LLC
2020-07-22Z-2583-2020Class IBodyGuard Microset with Filter and Manual Priming ValveCME America, LLC
2020-07-22Z-2584-2020Class IBodyGuard Microset w/ 0CME America, LLC
2020-07-22Z-2585-2020Class IStandard BodySet with Needleless ConnectorsCME America, LLC
2020-07-22Z-2586-2020Class ICMExpress Microbore SetCME America, LLC
2020-07-22Z-2587-2020Class ICMExpress Needleless Y Site Microbore SetCME America, LLC
2020-07-22Z-2588-2020Class IBodyGuard Microset With Female LuerCME America, LLC
2020-07-22Z-2589-2020Class IBodyGuard Microset w/ 0CME America, LLC
2020-07-22Z-2590-2020Class IIThis is an accessory to Intelect AdvancedDJO, LLC
2020-07-22Z-2591-2020Class IITrinias DAP MeterShimadzu Medical Systems
2020-07-22Z-2592-2020Class IIACUMED CALLOS INJECT 10CCSkeletal Kinetics, Llc
2020-07-22Z-2593-2020Class IIACUMED CALLOS INJECT 3CCSkeletal Kinetics, Llc
2020-07-22Z-2594-2020Class IIACUMED CALLOS INJECT 5CCSkeletal Kinetics, Llc
2020-07-22Z-2595-2020Class IIACUMED IMPACT 10CCSkeletal Kinetics, Llc
2020-07-22Z-2596-2020Class IIACUMED IMPACT 5CCSkeletal Kinetics, Llc
2020-07-22Z-2597-2020Class IICRANIOSCULPT CSkeletal Kinetics, Llc
2020-07-22Z-2598-2020Class IICRANIOSCULPT CSkeletal Kinetics, Llc
2020-07-22Z-2599-2020Class IICRANIOSCULPT CSkeletal Kinetics, Llc
2020-07-22Z-2600-2020Class IICRANIOSCULPT FLOWSkeletal Kinetics, Llc
2020-07-22Z-2601-2020Class IICRANIOSCULPT FLOWSkeletal Kinetics, Llc
2020-07-22Z-2602-2020Class IICRANIOSCULPT FLOWSkeletal Kinetics, Llc
2020-07-22Z-2603-2020Class IICRANIOSCULPT FLOWSkeletal Kinetics, Llc
2020-07-22Z-2604-2020Class IICRANIOSCULPT FLOWSkeletal Kinetics, Llc
2020-07-22Z-2605-2020Class IICRANIOSCULPTSkeletal Kinetics, Llc
2020-07-22Z-2606-2020Class IIEXACTECH OSSILIX FILSkeletal Kinetics, Llc
2020-07-22Z-2607-2020Class IIEXACTECH OSSILIX FILSkeletal Kinetics, Llc
2020-07-22Z-2608-2020Class IIEXACTECH OSSILIX FORMSkeletal Kinetics, Llc
2020-07-22Z-2609-2020Class IIEXACTECH OSSILIX FORMSkeletal Kinetics, Llc
2020-07-22Z-2610-2020Class IIMEDTRONIC BONE VOID FILLERSkeletal Kinetics, Llc
2020-07-22Z-2611-2020Class IIMEDTRONIC BONE VOID FILLERSkeletal Kinetics, Llc
2020-07-22Z-2612-2020Class IIOSTEOVATION EXSkeletal Kinetics, Llc

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