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Medical device recalls reported in 2021

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ReportedRecallClassProductFirm
2021-11-24Z-0265-2022Class IISmith and Nephew EVOS Self-Tapping Locking Screw SST:Smith & Nephew, Inc.
2021-11-24Z-0266-2022Class IICobas u 601 urinalysis test systemRoche Diagnostics Operations, Inc.
2021-11-17Z-0183-2022Class IEllume COVID-19 Home TestELLUME LTD
2021-11-17Z-0204-2022Class IIMcKesson PREVENT HT Safety Blood Collection NeedlesZhejiang Kindly Medical Devices Co., Ltd.
2021-11-17Z-0205-2022Class IIMcKesson PREVENT HT Safety Blood Collection NeedlesZhejiang Kindly Medical Devices Co., Ltd.
2021-11-17Z-0206-2022Class IIMcKesson PREVENT HT Safety Winged Blood Collection Needle with Tube…Zhejiang Kindly Medical Devices Co., Ltd.
2021-11-17Z-0207-2022Class IIMcKesson PREVENT HT Safety Winged Blood Collection Needle with Tube…Zhejiang Kindly Medical Devices Co., Ltd.
2021-11-17Z-0208-2022Class IIHENRY SCHEIN Safety Blood Collection Needle 21Gx 1 1/4 InchZhejiang Kindly Medical Devices Co., Ltd.
2021-11-17Z-0209-2022Class IIHENRY SCHEIN Safety Blood Collection Needle 22Gx 1 1/4 InchZhejiang Kindly Medical Devices Co., Ltd.
2021-11-17Z-0210-2022Class IICovidien Emprint Ablation Catheter with Thermosphere Technology…Covidien Llc
2021-11-17Z-0211-2022Class IIQuikClot Combat Gauze-For Temporary External Use To Control Traumatic…Z-Medica, LLC
2021-11-17Z-0212-2022Class IITHERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSATherakos, Inc.
2021-11-17Z-0213-2022Class IIPhilips Azurion Interventional Fluoroscopic X-Ray SystemPhilips North America Llc
2021-11-17Z-0214-2022Class IIT4 EIA KitBioCheck, Inc.
2021-11-17Z-0215-2022Class IIHemodialysis Delivery SystemBaxter Healthcare Corporation
2021-11-10Z-0119-2022Class IMonoject 0Windstone Medical Packaging, Inc.
2021-11-10Z-0184-2022Class IIFIVE S 3Karl Storz Endoscopy
2021-11-10Z-0185-2022Class IIFlexor Check-Flo IntroducerCook Inc.
2021-11-10Z-0186-2022Class IIFlexor Check-Flo IntroducerCook Inc.
2021-11-10Z-0187-2022Class IICOVENA PICC SleeveQueen Comfort Products lLC
2021-11-10Z-0188-2022Class II3M Red Dot Electrodes3M Company - Health Care Business
2021-11-10Z-0189-2022Class IIArietta 750 Ultrasound Software Version: V1FujiFilm Healthcare Americas Corporation
2021-11-10Z-0190-2022Class IIArietta 850 Ultrasound- Software Version: V1FujiFilm Healthcare Americas Corporation
2021-11-10Z-0191-2022Class IILisendo 880 Ultrasound Software Version: V1FujiFilm Healthcare Americas Corporation
2021-11-10Z-0192-2022Class IIArietta 65 Ultrasound Software Versions: V1FujiFilm Healthcare Americas Corporation
2021-11-10Z-0193-2022Class IIAptio Automation Interface Module to ADVIA Centaur XP/XPTSiemens Healthcare Diagnostics, Inc.
2021-11-10Z-0194-2022Class IIPL Coupling GelLumenis, Inc.
2021-11-10Z-0195-2022Class IIAtellica IM SARS-CoV-2 Antigen AssaySiemens Healthcare Diagnostics, Inc
2021-11-10Z-0196-2022Class IIADVIA Centaur SARS-CoV-2 Antigen AssaySiemens Healthcare Diagnostics, Inc
2021-11-10Z-0197-2022Class IIImplantDirectImplant Direct Sybron Manufacturing LLC
2021-11-10Z-0198-2022Class IIImplantDirectImplant Direct Sybron Manufacturing LLC
2021-11-10Z-0199-2022Class IIThe MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube…Bayer Medical Care, Inc.
2021-11-10Z-0200-2022Class IIArtis zeegoSiemens Medical Solutions USA, Inc
2021-11-10Z-0201-2022Class IIClinician Programmer ApplicationMedtronic Neuromodulation
2021-11-10Z-0202-2022Class IIAspiration Syringe KitMICROVENTION INC.
2021-11-10Z-0203-2022Class IIGM Helix Acqua Implant 3Jjgc Industria E Comercio De Materials Dentarios Sa
2021-11-03Z-0001-2022Class IIRAPTAR Laser Range FindersPotomac River Group, Corp.
2021-11-03Z-0118-2022Class IROSA One 3MEDTECH SAS
2021-11-03Z-0163-2022Class IIIPneupac paraPac plus 300 ventilator kitSmiths Medical ASD Inc.
2021-11-03Z-0164-2022Class IIREF/Catalogue Number GSX0030AW L Gore & Associates, Inc.
2021-11-03Z-0165-2022Class IIREF/Catalogue Number GSX0020AW L Gore & Associates, Inc.
2021-11-03Z-0166-2022Class IIREF/Catalogue Number GSX0025AW L Gore & Associates, Inc.
2021-11-03Z-0167-2022Class IIREF/Catalogue Number GSXE0020W L Gore & Associates, Inc.
2021-11-03Z-0168-2022Class IIREF/Catalogue Number GSXE0025W L Gore & Associates, Inc.
2021-11-03Z-0169-2022Class IIREF/Catalogue Number GSXE0030W L Gore & Associates, Inc.
2021-11-03Z-0170-2022Class IIREF/Catalogue Number GSXE0025BW L Gore & Associates, Inc.
2021-11-03Z-0171-2022Class IIREF/Catalogue Number GSXE0030BW L Gore & Associates, Inc.
2021-11-03Z-0172-2022Class IIREF/Catalogue Number GSX0030HW L Gore & Associates, Inc.
2021-11-03Z-0173-2022Class IIC315-HIS Delivery CatheterMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2021-11-03Z-0174-2022Class IIConcerto User Interface Software provided with the following systems:Xstrahl Limited
2021-11-03Z-0175-2022Class IICliquid MD version 3AB SCIEX
2021-11-03Z-0176-2022Class IIASC PneumoLiner deviceOlympus Corporation of the Americas
2021-11-03Z-0177-2022Class IIBivona Aire-Cuf Endotracheal TubeSmiths Medical ASD Inc.
2021-11-03Z-0178-2022Class IIBivona Uncuffed Wire Endotracheal TubesSmiths Medical ASD Inc.
2021-11-03Z-0179-2022Class IIBD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf…Becton Dickinson & Company
2021-11-03Z-0180-2022Class IIAtellica CH Urinary/Cerebrospinal Fluid ProteinSiemens Healthcare Diagnostics, Inc.
2021-11-03Z-0181-2022Class IIAdvia Chemistry Urinary/Cerebrospinal Fluid ProteinSiemens Healthcare Diagnostics, Inc.
2021-11-03Z-0182-2022Class IIOncentra Brachy users using version 4Elekta, Inc.
2021-10-27Z-0091-2022Class ICardiosave Li-Ion Battery PackDatascope Corp.
2021-10-27Z-0107-2022Class ICADD-Solis VIP ambulatory infusion pumpSmiths Medical ASD Inc.
2021-10-27Z-0120-2022Class IIVITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative…Ortho Clinical Diagnostics Inc
2021-10-27Z-0121-2022Class IIP2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641Fort Defiance Industries, LLC
2021-10-27Z-0122-2022Class IIMPR Slotted MalletImplant Resource Inc
2021-10-27Z-0123-2022Class IIEPIQ CVxi Diagnostic Ultrasound SystemsPhilips Ultrasound Inc
2021-10-27Z-0124-2022Class IIAtellica IM 1300 AnalyzerSiemens Healthcare Diagnostics, Inc
2021-10-27Z-0125-2022Class IIAtellica IM 1600 AnalyzerSiemens Healthcare Diagnostics, Inc
2021-10-27Z-0126-2022Class IITenaculumStradis Medical, LLC dba Stradis Healthcare
2021-10-27Z-0127-2022Class IIIUD Insertion PackStradis Medical, LLC dba Stradis Healthcare
2021-10-27Z-0128-2022Class IIIUD Insertion KitStradis Medical, LLC dba Stradis Healthcare
2021-10-27Z-0129-2022Class IIEndometrial Biopsy KitStradis Medical, LLC dba Stradis Healthcare
2021-10-27Z-0130-2022Class IIFoundation KitStradis Medical, LLC dba Stradis Healthcare
2021-10-27Z-0131-2022Class IIStandard IUD Insertion KitStradis Medical, LLC dba Stradis Healthcare
2021-10-27Z-0132-2022Class IISIGNA Premier nuclear magnetic resonance imaging systemGE Healthcare, LLC
2021-10-27Z-0133-2022Class IISIGNA Architect nuclear magnetic resonance imaging systemGE Healthcare, LLC
2021-10-27Z-0134-2022Class IISIGNA Pioneer nuclear magnetic resonance imaging systemGE Healthcare, LLC
2021-10-27Z-0135-2022Class IIDiscovery MR750w 3GE Healthcare, LLC
2021-10-27Z-0136-2022Class IIDiscovery MR750 3GE Healthcare, LLC
2021-10-27Z-0137-2022Class IISIGNA CreatorGE Healthcare, LLC
2021-10-27Z-0138-2022Class IISIGNA Voyager nuclear magnetic resonance imaging systemGE Healthcare, LLC
2021-10-27Z-0139-2022Class IISIGNA Artist nuclear magnetic resonance imaging systemGE Healthcare, LLC
2021-10-27Z-0140-2022Class IIOptima MR450w 1GE Healthcare, LLC
2021-10-27Z-0141-2022Class II1GE Healthcare, LLC
2021-10-27Z-0142-2022Class IICanon PET-CT SCANNERCanon Medical System, USA, INC.
2021-10-27Z-0143-2022Class II6Smith & Nephew, Inc.
2021-10-27Z-0144-2022Class IIHerniatomeADRIA SRL
2021-10-27Z-0145-2022Class IIHerniatomeADRIA SRL
2021-10-27Z-0146-2022Class IIHerniatomeADRIA SRL
2021-10-27Z-0147-2022Class IIKit: Central Line Dres Change 20/CsMedical Action Industries, Inc. 306
2021-10-27Z-0148-2022Class IICADD Administration SetsSmiths Medical ASD Inc.
2021-10-27Z-0149-2022Class IIHemosIL Liquid Anti-Xa- Automated chromogenic assay for the…Instrumentation Laboratory
2021-10-27Z-0150-2022Class IIHemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro…Instrumentation Laboratory
2021-10-27Z-0151-2022Class IIHemosIL Liquid Anti-Xa- Automated chromogenic assay for the…Instrumentation Laboratory
2021-10-27Z-0152-2022Class IIsmiths medical portex Loss of Resistance DeviceSmiths Medical ASD Inc.
2021-10-27Z-0153-2022Class IICatalog # BEK4511Bard Peripheral Vascular Inc
2021-10-27Z-0154-2022Class IICatalog # BEK3411Bard Peripheral Vascular Inc
2021-10-27Z-0155-2022Class IImedfusion StopcockSmiths Medical ASD Inc.
2021-10-27Z-0156-2022Class IIMedtronic sterile single-use blades that are components of the…Medtronic Xomed, Inc.
2021-10-27Z-0157-2022Class IIMedtronic sterile single-use blades that are components of the…Medtronic Xomed, Inc.
2021-10-27Z-0158-2022Class IIMedtronic Sterile single-use blades that are components of the…Medtronic Xomed, Inc.
2021-10-27Z-0159-2022Class IIREF 8420Limacorporate S.p.A
2021-10-27Z-0160-2022Class IIREF 8420Limacorporate S.p.A
2021-10-27Z-0161-2022Class IIEasi-Care Gait Belt Metal BuckleKinsman Enterprises Inc
2021-10-27Z-0162-2022Class IISIMPLEXA COVID-19 Positive Control PackDiaSorin Molecular LLC
2021-10-20Z-0004-2022Class IAlinity m SARS-CoV-2 Amp KitAbbott Molecular, Inc.
2021-10-20Z-0005-2022Class IAlinity m Resp-4-Plex AMP KitAbbott Molecular, Inc.
2021-10-20Z-0006-2022Class IAlinity m SARS-CoV-2 Amp KitAbbott Molecular, Inc.
2021-10-20Z-0007-2022Class IAlinity m SARS-CoV-2 Amp KitAbbott Molecular, Inc.
2021-10-20Z-0008-2022Class IAlinity m Resp-4-Plex AMP KitAbbott Molecular, Inc.
2021-10-20Z-0067-2022Class IECO 85CB Lotion Ultrasound 8National Distribution & Contracting Inc
2021-10-20Z-0068-2022Class IECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser BtlNational Distribution & Contracting Inc
2021-10-20Z-0077-2022Class IIHeparinW L Gore & Associates, Inc.
2021-10-20Z-0078-2022Class IIPhilipsPhilips North America LLC
2021-10-20Z-0079-2022Class IIPhilipsPhilips North America LLC
2021-10-20Z-0080-2022Class IIPhilipsPhilips North America LLC
2021-10-20Z-0081-2022Class IIPhilipsPhilips North America LLC
2021-10-20Z-0082-2022Class IIBioPlex 2200 ANA Screen Control SetBio-Rad Laboratories, Inc.
2021-10-20Z-0083-2022Class IIcobas EGFR Mutation Test v2-Somatic gene mutation detection system…Roche Molecular Systems, Inc.
2021-10-20Z-0084-2022Class IIMYLA Versions: 4BioMerieux SA
2021-10-20Z-0085-2022Class IIEndoskeleton" TAS Interbody System with Titan nanoLOCK" Surface…Medtronic Sofamor Danek USA Inc
2021-10-20Z-0086-2022Class IIEndoskeleton" TCS Interbody System with Titan nanoLOCK" Surface…Medtronic Sofamor Danek USA Inc
2021-10-20Z-0087-2022Class IIFlexLabInpeco S.A.
2021-10-20Z-0088-2022Class IEcoGel 200Red Medical Supplies
2021-10-20Z-0089-2022Class IEcoGel 200Red Medical Supplies
2021-10-20Z-0090-2022Class IEcoGel 100Red Medical Supplies
2021-10-20Z-0092-2022Class IImedex LogiCal 5mL Closed Blood Sampling SystemSmiths Medical ASD Inc.
2021-10-20Z-0093-2022Class IIsmiths medical medex HemoDraw Plus Closed Blood Sampling Set with…Smiths Medical ASD Inc.
2021-10-20Z-0094-2022Class IIsmiths medical medex CBSS 2-fach Druckmesset mit OptionSmiths Medical ASD Inc.
2021-10-20Z-0095-2022Class IIsmiths medical medex CBSS 5 mlSmiths Medical ASD Inc.
2021-10-20Z-0096-2022Class IIsmiths medical medex CBSS 5 mlSmiths Medical ASD Inc.
2021-10-20Z-0097-2022Class IIsmiths medical medex CBSS 5 mlSmiths Medical ASD Inc.
2021-10-20Z-0098-2022Class IIsmiths medical medex CBSS 5 mlSmiths Medical ASD Inc.
2021-10-20Z-0099-2022Class IIsmiths medical medex CBSS-5ML Zweifach setSmiths Medical ASD Inc.
2021-10-20Z-0100-2022Class IIsmiths medical medex CBSS-5ML Antishunt setSmiths Medical ASD Inc.
2021-10-20Z-0101-2022Class IIsmiths medical medex CBSS-5MLSmiths Medical ASD Inc.
2021-10-20Z-0102-2022Class IIsmiths medical medex CBSS-5MLSmiths Medical ASD Inc.
2021-10-20Z-0103-2022Class IIsmiths medical medex CBSS-5MLSmiths Medical ASD Inc.
2021-10-20Z-0104-2022Class IIChesapeake Anterior LumbarK2M, Inc
2021-10-20Z-0105-2022Class IIThoraguard Chest Tube KitCentese Inc.
2021-10-20Z-0106-2022Class IIIon Flexison Biopsy NeedleIntuitive Surgical, Inc.
2021-10-20Z-0108-2022Class IIEvita V500 Ventilator with Installed CO2 Measurement Option-Intended…Draeger Medical, Inc.
2021-10-20Z-0109-2022Class IIBabylog VN500 Ventilator with Installed CO2 Measurement…Draeger Medical, Inc.
2021-10-20Z-0110-2022Class IIUnited Orthopedics USTAR II Knee System USTAR II Knee System Segment…Uoc Usa Inc
2021-10-20Z-0111-2022Class IIFlower Drill Bit Kit 2Flower Orthopedics Corporation
2021-10-20Z-0112-2022Class IIFlower Drill Bit Kit 2Flower Orthopedics Corporation
2021-10-20Z-0113-2022Class IIFlower Drill Bit Kit 2Flower Orthopedics Corporation
2021-10-20Z-0114-2022Class IIFlower Lag Screw Kit 2Flower Orthopedics Corporation
2021-10-20Z-0115-2022Class IIElekta Medical Linear AcceleratorELEKTA SOLUTIONS AB
2021-10-20Z-0116-2022Class IIElekta Medical Linear AcceleratorElekta, Inc.
2021-10-20Z-0117-2022Class IIPower Processor 3KBeckman Coulter Inc.
2021-10-13Z-0002-2022Class IIREF TIN3015Bard Peripheral Vascular Inc
2021-10-13Z-0003-2022Class IIMedtronic Bio-Medicus Insertion KitsMedtronic Perfusion Systems
2021-10-13Z-0009-2022Class IGEL CONDUCTORDJO, LLC
2021-10-13Z-0010-2022Class IUltra-Myossage Lotion 1-gallon bottleDJO, LLC
2021-10-13Z-0011-2022Class IIELIWelch Allyn Inc Mortara
2021-10-13Z-0012-2022Class IICentricity Universal Viewer 7GE Healthcare, LLC
2021-10-13Z-0013-2022Class IIScan Abutment SPPaltop Advanced Dental Solutions Ltd
2021-10-13Z-0014-2022Class IIScan Abutment NPPaltop Advanced Dental Solutions Ltd
2021-10-13Z-0015-2022Class IIScan Abutment MUPaltop Advanced Dental Solutions Ltd
2021-10-13Z-0016-2022Class IIScan Abutment SUPaltop Advanced Dental Solutions Ltd
2021-10-13Z-0017-2022Class IIScan Abutment PCAPaltop Advanced Dental Solutions Ltd
2021-10-13Z-0018-2022Class IIScan Abutment WPPaltop Advanced Dental Solutions Ltd
2021-10-13Z-0019-2022Class IIOPTETRAK Comprehensive Knee SystemExactech, Inc.
2021-10-13Z-0020-2022Class IIOPTETRAK Comprehensive Knee System including OPTETRAK…Exactech, Inc.
2021-10-13Z-0021-2022Class IIOPTETRAK LOGIC Polyethylene Tibial InsertsExactech, Inc.
2021-10-13Z-0022-2022Class IIOPTETRAK Comprehensive Knee System custom devices labeled as the…Exactech, Inc.
2021-10-13Z-0023-2022Class IITRULIANT Knee System including TRULIANT Tibial InsertsExactech, Inc.
2021-10-13Z-0024-2022Class IIVantage Total Ankle System including aExactech, Inc.
2021-10-13Z-0025-2022Class IIOPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial…Exactech, Inc.
2021-10-13Z-0026-2022Class IIOPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS…Exactech, Inc.
2021-10-13Z-0027-2022Class IIARTHROFOCUS Polyethylene Tibial InsertsExactech, Inc.
2021-10-13Z-0028-2022Class IITECNIS Eyhance IOLs are permanent intraocular implants intended for…Johnson & Johnson Surgical Vision Inc
2021-10-13Z-0029-2022Class IAction De GalaAesthetics Systems Usa Inc
2021-10-13Z-0030-2022Class IINutrifill ScleralContamac Solutions, Inc.
2021-10-13Z-0031-2022Class IINox T3s RecorderNOX MEDICAL
2021-10-13Z-0032-2022Class IIAccess hsTnI High Sensitivity Troponin IBeckman Coulter Inc.
2021-10-13Z-0033-2022Class IIIAlinity c CRP Vario Cardiac High Sensitivity Calibrator KitSentinel CH SpA
2021-10-13Z-0034-2022Class IIFlower E-KitFlower Orthopedics Corporation
2021-10-13Z-0035-2022Class IICardioQuipCardioQuip, LLC
2021-10-13Z-0036-2022Class IICardioQuipCardioQuip, LLC
2021-10-13Z-0037-2022Class IICardioQuipCardioQuip, LLC
2021-10-13Z-0038-2022Class IICardioQuipCardioQuip, LLC
2021-10-13Z-0039-2022Class IIZoll REF: 8700-0782-01ZOLL Circulation, Inc.
2021-10-13Z-0040-2022Class IIZollZOLL Circulation, Inc.
2021-10-13Z-0041-2022Class IIZOLLZOLL Circulation, Inc.
2021-10-13Z-0042-2022Class IIZOLLZOLL Circulation, Inc.
2021-10-13Z-0043-2022Class IIZOLLZOLL Circulation, Inc.
2021-10-13Z-0044-2022Class IIZOLLZOLL Circulation, Inc.
2021-10-13Z-0045-2022Class IIZOLLZOLL Circulation, Inc.
2021-10-13Z-0046-2022Class IIZOLLZOLL Circulation, Inc.
2021-10-13Z-0047-2022Class IIZoll REF: 8700-0782-40ZOLL Circulation, Inc.
2021-10-13Z-0048-2022Class IIZoll REF: 8700-0783-01ZOLL Circulation, Inc.
2021-10-13Z-0049-2022Class IIZoll REF: 8700-0783-40ZOLL Circulation, Inc.
2021-10-13Z-0050-2022Class IIZoll REF: 8700-0782-14ZOLL Circulation, Inc.
2021-10-13Z-0051-2022Class IIZoll REF: 8700-0783-14ZOLL Circulation, Inc.
2021-10-13Z-0052-2022Class IIZoll REF: 8700-0793-14ZOLL Circulation, Inc.
2021-10-13Z-0053-2022Class IIZollZOLL Circulation, Inc.
2021-10-13Z-0054-2022Class IIZollZOLL Circulation, Inc.
2021-10-13Z-0055-2022Class IIZollZOLL Circulation, Inc.
2021-10-13Z-0056-2022Class IIZollZOLL Circulation, Inc.
2021-10-13Z-0057-2022Class IIZollZOLL Circulation, Inc.

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