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Medical device recalls reported in 2021

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ReportedRecallClassProductFirm
2021-10-13Z-0058-2022Class IIZollZOLL Circulation, Inc.
2021-10-13Z-0059-2022Class IIZollZOLL Circulation, Inc.
2021-10-13Z-0060-2022Class IIZollZOLL Circulation, Inc.
2021-10-13Z-0061-2022Class IIZollZOLL Circulation, Inc.
2021-10-13Z-0062-2022Class IIZollZOLL Circulation, Inc.
2021-10-13Z-0063-2022Class IIZollZOLL Circulation, Inc.
2021-10-13Z-0064-2022Class IIZollZOLL Circulation, Inc.
2021-10-13Z-0065-2022Class IIZollZOLL Circulation, Inc.
2021-10-13Z-0066-2022Class IIZollZOLL Circulation, Inc.
2021-10-13Z-0069-2022Class IICardioQuipCardioQuip, LLC
2021-10-13Z-0070-2022Class IIPhilips UltrasoundPhilips Ultrasound Inc
2021-10-13Z-0071-2022Class IIPhilips UltrasoundPhilips Ultrasound Inc
2021-10-13Z-0072-2022Class IIARCH Leg Positioning SystemInnovative Orthopedic Technologies, LLC
2021-10-13Z-0073-2022Class IIAngioDynamics NanoKnife Disposable Single Electrode ProbesAngiodynamics, Inc.
2021-10-13Z-0074-2022Class IIATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint…DePuy Orthopaedics, Inc.
2021-10-13Z-0075-2022Class IICardiosave Hybrid Intra-Aortic Balloon PumpDatascope Corp.
2021-10-13Z-0076-2022Class IICardiosave Rescue Intra-Aortic Balloon PumpDatascope Corp.
2021-10-06Z-2485-2021Class IIVACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ringGreiner Bio-One North America, Inc.
2021-10-06Z-2499-2021Class IDeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation…Deroyal Industries, Inc. Lafollette
2021-10-06Z-2518-2021Class IOmnisound GelAccelerated Care Plus Corporation
2021-10-06Z-2542-2021Class IIThe Instructions for UseVascutek, Ltd.
2021-10-06Z-2543-2021Class IIThe Instructions for UseVascutek, Ltd.
2021-10-06Z-2544-2021Class II15 drops/mlB. Braun Medical, Inc.
2021-10-06Z-2545-2021Class IIOutlook Pump Sets w/3 CARESITE Needle-Free Injection Sites:…B. Braun Medical, Inc.
2021-10-06Z-2546-2021Class IIOutlook¿ Pump 15 Drop 0B. Braun Medical, Inc.
2021-10-06Z-2547-2021Class II60 drops/mlB. Braun Medical, Inc.
2021-10-06Z-2548-2021Class II10 drops/mlB. Braun Medical, Inc.
2021-10-06Z-2549-2021Class IIOutlook Pump Measured Volume Solution Set/ w/ Auto Shut-OffB. Braun Medical, Inc.
2021-10-06Z-2550-2021Class IIET82HP OUTLOOK PUMP EXTENSION SET-single-use for use with the Outlook…B. Braun Medical, Inc.
2021-10-06Z-2551-2021Class IIV1500HP OUTLOOK PUMP SET 118-single-use for use with the Outlook…B. Braun Medical, Inc.
2021-10-06Z-2552-2021Class IIOUTLOOK PUMP IV SET W/UNIVERSAL SPIKE-single-use for use with the…B. Braun Medical, Inc.
2021-10-06Z-2553-2021Class IIY-Type BloodB. Braun Medical, Inc.
2021-10-06Z-2554-2021Class IIOUTLOOK PUMP IV SETB. Braun Medical, Inc.
2021-10-06Z-2555-2021Class IIPUMP SETB. Braun Medical, Inc.
2021-10-06Z-2556-2021Class IIOUTLOOK PUMP SETB. Braun Medical, Inc.
2021-10-06Z-2557-2021Class IIOUTLOOK PUMP SET 3 CARESITE LADS 133 INB. Braun Medical, Inc.
2021-10-06Z-2558-2021Class IIOutlook Pump Add-On Set-single useB. Braun Medical, Inc.
2021-10-06Z-2559-2021Class IIOutlook Pump Primary Administration Set w/ micro Tubing for Epidural…B. Braun Medical, Inc.
2021-10-06Z-2560-2021Class IIOutlook Pump Blood Administration Set with SAFELINE Injection…B. Braun Medical, Inc.
2021-10-06Z-2561-2021Class IICovidien HysteroLux Fluid Management System Control UnitWOM World of Medicine AG
2021-10-06Z-2562-2021Class IILYMOL Medical Elite X Class Rigid Bronchoscope SystemLymol Medical Corporation
2021-10-06Z-2563-2021Class IIElekta MonacoElekta Inc
2021-10-06Z-2564-2021Class IIBF-N20 OES BronchofiberscopeOlympus Corporation of the Americas
2021-10-06Z-2565-2021Class IIBF-3C40 OES BronchofiberscopeOlympus Corporation of the Americas
2021-10-06Z-2566-2021Class IIBF-XP60 OES BronchofiberscopeOlympus Corporation of the Americas
2021-10-06Z-2567-2021Class IIBF-1T60 OES BronchofiberscopeOlympus Corporation of the Americas
2021-10-06Z-2568-2021Class IIBF-P60 OES BronchofiberscopeOlympus Corporation of the Americas
2021-10-06Z-2569-2021Class IIBF-XP160F EVIS EXERA BronchovideoscopeOlympus Corporation of the Americas
2021-10-06Z-2570-2021Class IIBF-XT160 EVIS EXERA BronchovideoscopeOlympus Corporation of the Americas
2021-10-06Z-2571-2021Class IIBF-P180 EVIS EXERA II BronchovideoscopeOlympus Corporation of the Americas
2021-10-06Z-2572-2021Class IIBF-1T180 EVIS EXERA II BronchovideoscopeOlympus Corporation of the Americas
2021-10-06Z-2573-2021Class IIBF-Q180-AC EVIS EXERA II BronchovideoscopeOlympus Corporation of the Americas
2021-10-06Z-2574-2021Class IINAMIC ManifoldsMedline Industries Inc
2021-10-06Z-2575-2021Class IINAMIC Stopcocks:Medline Industries Inc
2021-10-06Z-2576-2021Class IIVysis CLL FISH Probe Kit with the following components: Vysis LSI p53…Abbott Molecular, Inc.
2021-10-06Z-2577-2021Class IImperative CareIMPERATIVE CARE INC
2021-10-06Z-2578-2021Class IIPAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SUAesculap Implant Systems LLC
2021-10-06Z-2579-2021Class IIPAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13Aesculap Implant Systems LLC
2021-10-06Z-2580-2021Class IIAtomlab 500 Dose Calibrator Software 2Biodex Medical Systems, Inc.
2021-10-06Z-2581-2021Class IIAtomLab 500Plus Dose CalibratorSoftware 2Biodex Medical Systems, Inc.
2021-10-06Z-2582-2021Class INorco Ultrasound GelNorth Coast Medical Inc
2021-10-06Z-2583-2021Class IEcoLotion Transmission LotionNorth Coast Medical Inc
2021-10-06Z-2584-2021Class IIOperating room tableDeerfield Imaging, Inc.
2021-10-06Z-2585-2021Class IIOperating room tableDeerfield Imaging, Inc.
2021-10-06Z-2586-2021Class IIOperating room tableDeerfield Imaging, Inc.
2021-10-06Z-2587-2021Class IGENOSYL DSVero Biotech, LLC
2021-10-06Z-2588-2021Class IIArjo Citadel beds originally assembled with the IndiGo modules during…ARJOHUNTLEIGH POLSKA Sp. z.o.o.
2021-10-06Z-2589-2021Class IIAtrium ADVANTA VXT Vascular GraftAtrium Medical Corporation
2021-10-06Z-2590-2021Class IIAMX Navigate Mobile X-Ray SystemGE Healthcare, LLC
2021-10-06Z-2591-2021Class IIMOSAIQ Oncology Information SystemElekta, Inc.
2021-10-06Z-2592-2021Class IIAtrium Pneumostat Chest Drain ValveAtrium Medical Corporation
2021-10-06Z-2593-2021Class IIuMI 550 SystemShanghai United Imaging Healthcare Co., Ltd.
2021-10-06Z-2594-2021Class IIuEXPLORER PET/CT SystemShanghai United Imaging Healthcare Co., Ltd.
2021-10-06Z-2595-2021Class IIFlow sensors kept as stand-alone user replaceable spare parts for the…GE Healthcare, LLC
2021-10-06Z-2596-2021Class IIFlow sensors that may be installed in the following GEHC anesthesia…GE Healthcare, LLC
2021-10-06Z-2597-2021Class IIOctoStretch with Stretch LevellerHill-Rom, Inc.
2021-10-06Z-2598-2021Class IIFlexoStretch Model Number: 3156057Hill-Rom, Inc.
2021-10-06Z-2599-2021Class IIStretch Leveller Model Number: 3156200Hill-Rom, Inc.
2021-10-06Z-2600-2021Class IILikoStretch 1900 Model Number: 3156051Hill-Rom, Inc.
2021-10-06Z-2601-2021Class IILikoStretch Mod 600 IC Model Number: 3156065 LikoStretch Mod 600 ICHill-Rom, Inc.
2021-10-06Z-2602-2021Class IIDxA 5000Beckman Coulter Inc.
2021-10-06Z-2603-2021Class IICorin TriFit TSCorin Ltd
2021-10-06Z-2604-2021Class IICorin Trinity ScrewCorin Ltd
2021-10-06Z-2605-2021Class IICorin Trinity-iCorin Ltd
2021-10-06Z-2606-2021Class IICorin Trinity Liner ECIMACorin Ltd
2021-10-06Z-2607-2021Class IICorin BIOLOX Delta Mod HeadCorin Ltd
2021-10-06Z-2608-2021Class IICorin Trinity Dual MobilityCorin Ltd
2021-10-06Z-2609-2021Class IICorin MetaFix Hip StemCorin Ltd
2021-10-06Z-2610-2021Class IICorin Unity Knee AugmentsCorin Ltd
2021-10-06Z-2611-2021Class IICorin Unity Knee CS InsertCorin Ltd
2021-10-06Z-2612-2021Class IICorin Unity Knee PatellaCorin Ltd
2021-10-06Z-2614-2021Class IIDuoDERM Control Gel Formula Border Dressings 15x15cmConvaTec, Inc
2021-10-06Z-2615-2021Class IICardiosave Hybrid Intra-Aortic Balloon PumpDatascope Corp.
2021-10-06Z-2616-2021Class IICardiosave Rescue Intra-Aortic Balloon PumpDatascope Corp.
2021-10-06Z-2617-2021Class IIXcela PICC with PASV Valve Technology/Kit 5 F-55cmAngiodynamics Inc. (Navilyst Medical Inc.)
2021-09-29Z-2469-2021Class IUltrasound Gel labeled under the following brand names: MediChoice…Mac Medical Supply Co Inc
2021-09-29Z-2480-2021Class IEcoGel 100 Imaging GelAMTEC SALES Inc
2021-09-29Z-2483-2021Class IIEPIQ Diagnostic Ultrasound Systems: Software Versions 5Philips Ultrasound Inc
2021-09-29Z-2484-2021Class IIAffiniti Diagnostic Ultrasound Systems: Software Versions 5Philips Ultrasound Inc
2021-09-29Z-2486-2021Class IISARS-CoV-2 Process ControlMicrobiologics Inc
2021-09-29Z-2487-2021Class IISARS-CoV-2 Process ControlMicrobiologics Inc
2021-09-29Z-2488-2021Class IIPhantom Nail SystemParagon 28, Inc.
2021-09-29Z-2489-2021Class IIBone Marrow Transplantation biopsy needleM.D.L. S.r.l.
2021-09-29Z-2490-2021Class IIAspirated Cyto-Histological Biopsy needleM.D.L. S.r.l.
2021-09-29Z-2491-2021Class IIMammary Nodules LocalizationM.D.L. S.r.l.
2021-09-29Z-2492-2021Class IISoft Tissue Biopsy NeedlesM.D.L. S.r.l.
2021-09-29Z-2493-2021Class IIGeneral Manual surgical instrumentM.D.L. S.r.l.
2021-09-29Z-2494-2021Class IIAd-Tech Lightweight CABRIO CableAd-Tech Medical Instrument Corporation
2021-09-29Z-2495-2021Class IIAd-Tech Lightweight TECH ATTACH CableAd-Tech Medical Instrument Corporation
2021-09-29Z-2496-2021Class IIAd-Tech TECH ATTACH Cable- Product Usage: Designed for the purpose of…Ad-Tech Medical Instrument Corporation
2021-09-29Z-2497-2021Class IIEVIS EXERA BF-XT160 BronchofibervideoscopeOlympus Corporation of the Americas
2021-09-29Z-2498-2021Class IIcobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat SystemRoche Molecular Systems, Inc.
2021-09-29Z-2500-2021Class IIComputed tomography x-ray systems with software syngoSiemens Medical Solutions USA, Inc
2021-09-29Z-2501-2021Class IIScorpion Portal Vein Access SetArgon Medical Devices, Inc
2021-09-29Z-2502-2021Class IICentricity PACS-IW with Universal ViewerGE Healthcare, LLC
2021-09-29Z-2503-2021Class IICentricity Universal Viewer and Viewer 6GE Healthcare, LLC
2021-09-29Z-2504-2021Class IIDLP Left Heart Vent CathetersMedtronic Perfusion Systems
2021-09-29Z-2505-2021Class IIDLP Left Heart Vent CathetersMedtronic Perfusion Systems
2021-09-29Z-2506-2021Class IICoLink Bone Graft HarvesterIn2bones USA, LLC
2021-09-29Z-2507-2021Class IIGreiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3Greiner Bio-One North America, Inc.
2021-09-29Z-2508-2021Class IIAccess SARS CoV-2 IgGBeckman Coulter Inc.
2021-09-29Z-2509-2021Class IIUnivation X System knee implant devices as follows: Catalog/Product:…Aesculap Implant Systems LLC
2021-09-29Z-2510-2021Class IIUnivation X System knee implant devices as follows: Catalog/Product:…Aesculap Implant Systems LLC
2021-09-29Z-2511-2021Class IIUnivation X System knee implant devices as follows: Catalog/Product:…Aesculap Implant Systems LLC
2021-09-29Z-2512-2021Class IIUnivation X System knee implant devices as follows: Catalog/Product:…Aesculap Implant Systems LLC
2021-09-29Z-2513-2021Class IIUnivation X System knee implant devices as follows: Catalog/Product:…Aesculap Implant Systems LLC
2021-09-29Z-2514-2021Class IIUnivation X System knee implant devices as follows: Catalog/Product:…Aesculap Implant Systems LLC
2021-09-29Z-2515-2021Class IIUnivation X System knee implant devices as follows: Catalog/Product:…Aesculap Implant Systems LLC
2021-09-29Z-2516-2021Class IIUnivation X System Tray Sysem knee implant devices as follows: Tray…Aesculap Implant Systems LLC
2021-09-29Z-2517-2021Class IISight OLO-E1/U1 Software and Operators Manual Software v2SIGHT DIAGNOSTICS LTD
2021-09-29Z-2519-2021Class IIDuoDERM CGF Dressing 10x10CMConvaTec, Inc
2021-09-29Z-2520-2021Class II10 ga ARS Decompression NeedleNorth American Rescue LLC.
2021-09-29Z-2521-2021Class IICatalog A119216MC.R. Bard Inc
2021-09-29Z-2522-2021Class IICatalog A300314AC.R. Bard Inc
2021-09-29Z-2523-2021Class IICatalog A300316AC.R. Bard Inc
2021-09-29Z-2524-2021Class IICatalog A300318AC.R. Bard Inc
2021-09-29Z-2525-2021Class IICatalog A303316AC.R. Bard Inc
2021-09-29Z-2526-2021Class IICatalog A303318AC.R. Bard Inc
2021-09-29Z-2527-2021Class IICatalog A319416AMC.R. Bard Inc
2021-09-29Z-2528-2021Class IICatalog A399400AC.R. Bard Inc
2021-09-29Z-2529-2021Class IICatalog A800061C.R. Bard Inc
2021-09-29Z-2530-2021Class IICatalog A800360C.R. Bard Inc
2021-09-29Z-2531-2021Class IICatalog A800361C.R. Bard Inc
2021-09-29Z-2532-2021Class IICatalog A800365C.R. Bard Inc
2021-09-29Z-2533-2021Class IICatalog A897514C.R. Bard Inc
2021-09-29Z-2534-2021Class IICatalog A899916C.R. Bard Inc
2021-09-29Z-2535-2021Class IICatalog A902616C.R. Bard Inc
2021-09-29Z-2536-2021Class IICatalog A902916C.R. Bard Inc
2021-09-29Z-2537-2021Class IICatalog A943216C.R. Bard Inc
2021-09-29Z-2538-2021Class IICatalog A319516AMC.R. Bard Inc
2021-09-29Z-2539-2021Class IICatalog A902416C.R. Bard Inc
2021-09-29Z-2540-2021Class IICatalog A303416AC.R. Bard Inc
2021-09-29Z-2541-2021Class IICatalog A942216C.R. Bard Inc
2021-09-22Z-2428-2021Class ICordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MBCordis Corporation
2021-09-22Z-2429-2021Class ICordis 5F SUPER TORQUE PIG PIGTAIL SPECIALCordis Corporation
2021-09-22Z-2430-2021Class ICordis SUPER TORQUE MB 5F PIGCordis Corporation
2021-09-22Z-2431-2021Class ICordis SUPER TORQUE MB 5F PIGCordis Corporation
2021-09-22Z-2432-2021Class ICordis SUPER TORQUE MB 5F PIGCordis Corporation
2021-09-22Z-2433-2021Class IAMSORB PLUS PREFILLED G-CAN 1Armstrong Medical Services Limited
2021-09-22Z-2443-2021Class IIThe Hero Model 100Hero Health
2021-09-22Z-2444-2021Class IIcobas infinity central lab running software version 3Roche Diagnostics Operations, Inc.
2021-09-22Z-2445-2021Class IIsyngoSiemens Medical Solutions USA, Inc
2021-09-22Z-2446-2021Class IIsyngoSiemens Medical Solutions USA, Inc
2021-09-22Z-2447-2021Class IIMR MAGNETOM Systems with RT Image Suite with syngo MR VA20ASiemens Medical Solutions USA, Inc
2021-09-22Z-2448-2021Class IIColonoscope Family # 1-Pentax Video ColonoscopesPentax of America Inc
2021-09-22Z-2449-2021Class IIGastroscope Family # 1-Gastroscopes without a Water Jet Channel…Pentax of America Inc
2021-09-22Z-2450-2021Class IIPotassium Hydroxide 10%Gibson Bioscience
2021-09-22Z-2451-2021Class IIVerigene EP Amplification Reagent Kit TestLuminex Corporation
2021-09-22Z-2452-2021Class IICellex qSARS-Cov-2 Antigen Rapid TestCellex
2021-09-22Z-2453-2021Class IIConfigura Advance ChairAccora Inc
2021-09-22Z-2454-2021Class IIBD Extension Set SMALLBORE Tubing with 2 SmartSite VALVESCAREFUSION
2021-09-22Z-2455-2021Class IIBD SmartSite 'Y' Extension Set 2 Needle-Free ValvesCAREFUSION
2021-09-22Z-2456-2021Class IIBD Gravity Burette Set 60 DROP 1CAREFUSION
2021-09-22Z-2457-2021Class IIBD Syringe Set 20 DP MIC TBG 0CAREFUSION
2021-09-22Z-2458-2021Class IIBD BURETTE GRAVITY SET 60 DROP 2 Smartsite VALVES VENTED/NONVENTEDCAREFUSION
2021-09-22Z-2459-2021Class IIBD Alaris Pump Infusion Buerette Set 0CAREFUSION
2021-09-22Z-2460-2021Class IIBD Extension Set SMALLBORE Tubing SmartSite VALVECAREFUSION
2021-09-22Z-2461-2021Class IIBD SmartSite Bag Access DeviceCAREFUSION
2021-09-22Z-2462-2021Class IIBD Gravity Burette Set 60 DP 3 SmartSite VALVES BALL VALVE DRIP…CAREFUSION
2021-09-22Z-2463-2021Class IIBD Gravity IV Set 3-port Closed Manifold Back Check Valve 3…CAREFUSION
2021-09-22Z-2464-2021Class IIBD ADD-ON Burette Set V/NV Needle-Free ValveCAREFUSION
2021-09-22Z-2465-2021Class IIBD SE Burette Set 20 Drops 2 Injection Ports Vented/NonVentedCAREFUSION
2021-09-22Z-2466-2021Class IIBD Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite PortCAREFUSION
2021-09-22Z-2467-2021Class IIBD SmartSiteCAREFUSION
2021-09-22Z-2468-2021Class IIBD SmartSite Bag Access Device Needle-Free ValveCAREFUSION
2021-09-22Z-2470-2021Class IIArjo Disposable Repositioning SlingGetinge Dominican Republic SA
2021-09-22Z-2471-2021Class IIACUSON Juniper Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.
2021-09-22Z-2472-2021Class IIAlinity ci-series System Control Module clinical chemistry and…Abbott Laboratories
2021-09-22Z-2473-2021Class IIMcKesson Lap SpongeCypress Medical Products LLC
2021-09-22Z-2474-2021Class IIThe Allura Xper series is intended for use on human patients to…Philips North America Llc
2021-09-22Z-2475-2021Class IIThe Allura Xper series is intended for use on human patients to…Philips North America Llc
2021-09-22Z-2476-2021Class IIThe Azurion seriesPhilips North America Llc
2021-09-22Z-2477-2021Class IILyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124Quidel Corporation
2021-09-22Z-2478-2021Class IIMedtronic HVAD Pump Implant KitsHeartware, Inc.
2021-09-22Z-2479-2021Class IIMaxi Sky 1000Arjohuntleigh Magog, Inc.
2021-09-22Z-2481-2021Class IIBOND Ready-To-Use Primary Antibody CDX2Leica Microsystems, Inc.
2021-09-22Z-2482-2021Class IIBraun ThermoScan PRO 6000 Ear Thermometer-indicated for the…Welch Allyn Inc
2021-09-15Z-2376-2021Class INORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129Smiths Medical ASD Inc.
2021-09-15Z-2377-2021Class INORMOFLO Irrigation Warming administration setSmiths Medical ASD Inc.
2021-09-15Z-2391-2021Class ILiquaSonic Ultrasound Gel 250mLAthena Medical Products Inc

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