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Medical device recalls reported in 2018

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ReportedRecallClassProductFirm
2018-02-28Z-0680-2018Class IICVC Tray PediatricsVygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
2018-02-28Z-0681-2018Class II19Ga x 1 Huber Needle SetVygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
2018-02-28Z-0682-2018Class II3-Way Standardbore StopcockVygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
2018-02-28Z-0683-2018Class IIPhilips QCPR MeterPhilips Electronics North America Corporation
2018-02-28Z-0684-2018Class IIPhilips QCPR MeterPhilips Electronics North America Corporation
2018-02-28Z-0685-2018Class IIInnova Self-Expanding Stent SystemBoston Scientific Corporation
2018-02-28Z-0686-2018Class IIInnova Self-Expanding Stent SystemBoston Scientific Corporation
2018-02-28Z-0687-2018Class IINitinol TC Reusable ElectrodesCosman Medical, LLC
2018-02-28Z-0688-2018Class IIPreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath…Merit Medical Systems, Inc.
2018-02-28Z-0689-2018Class IIPhilips Avent Smart Ear ThermometerPhilips Consumer Lifestyle
2018-02-28Z-0690-2018Class IIARROW¿ PICC powered by ARROW¿ VPS¿ StyletArrow International Inc
2018-02-21Z-0486-2018Class IIRadial Artery Catheterization SetArrow International Inc
2018-02-21Z-0562-2018Class IIIngenuity TF PET/CTPhilips Medical Systems (Cleveland) Inc
2018-02-21Z-0563-2018Class IIVado Steerable Sheath 8Kalila Medical
2018-02-21Z-0564-2018Class IIVado Bi-Directional Steerable Sheath 8Kalila Medical
2018-02-21Z-0565-2018Class IIBARDC.R. Bard, Inc.
2018-02-21Z-0566-2018Class IIMedtronic ANGLED DRILLMedtronic Sofamor Danek USA Inc
2018-02-21Z-0567-2018Class IIPerifix Continuous Epidural Anesthesia TrayB. Braun Medical, Inc.
2018-02-21Z-0568-2018Class IIPerifix Single Dose Epidural Anesthesia TrayB. Braun Medical, Inc.
2018-02-21Z-0569-2018Class IIPencan Spinal Needle TrayB. Braun Medical, Inc.
2018-02-21Z-0570-2018Class IIPerifix Epidural AnesthesiaTrayB. Braun Medical, Inc.
2018-02-21Z-0571-2018Class IIPerifix FX Epidural Anesthesia TrayB. Braun Medical, Inc.
2018-02-21Z-0572-2018Class IIPENCAN Spinal Anesthesia TrayB. Braun Medical, Inc.
2018-02-21Z-0573-2018Class IISpinal & Epidural Anesthesia TrayB. Braun Medical, Inc.
2018-02-21Z-0574-2018Class IICustomer Epidural Anesthesia TrayB. Braun Medical, Inc.
2018-02-21Z-0575-2018Class IIPain Management TrayB. Braun Medical, Inc.
2018-02-21Z-0576-2018Class IIContiplex Nerve Block TrayB. Braun Medical, Inc.
2018-02-21Z-0577-2018Class IICustom Made Tracheostomy Device The CADD Administration Sets with…Smiths Medical ASD, Inc.
2018-02-21Z-0578-2018Class IIEMS products from Graham MedicalLITTLE RAPIDS CORPORATION
2018-02-21Z-0579-2018Class IICarestation 620 A1GE Medical Systems China Co., Ltd.
2018-02-21Z-0580-2018Class IICarestation 620 A2GE Medical Systems China Co., Ltd.
2018-02-21Z-0581-2018Class IIAVID Medical QA Pack AV10654-10Avid Medical, Inc.
2018-02-21Z-0591-2018Class IINS357R Vega PS Tibia Trial/Preparation Plateau size T4Aesculap Implant Systems LLC
2018-02-21Z-0592-2018Class IIXpert CT/NG Catalog GXCT/NG-120 Batch 1000049568Cepheid
2018-02-21Z-0593-2018Class IICORAIL COXA VARA HIGH OFFSET STEM Collared Size 9DePuy Orthopaedics, Inc.
2018-02-21Z-0594-2018Class IICORAIL HIGH OFFSET STEM Collarless SIZE 14DePuy Orthopaedics, Inc.
2018-02-21Z-0595-2018Class IIHologic PantherHologic, Inc
2018-02-21Z-0596-2018Class IIPersona Partial Knee System Product Usage: The Persona Partial Knee…Zimmer Biomet, Inc.
2018-02-21Z-0597-2018Class IIResponse 5OrthoPediatrics Corp
2018-02-21Z-0598-2018Class II3M Bair Hugger3M Company - Health Care Business
2018-02-21Z-0599-2018Class II3M Bair Hugger3M Company - Health Care Business
2018-02-21Z-0600-2018Class IITotal Knee ReplacementConforMIS, Inc.
2018-02-21Z-0601-2018Class IIARROW PICC powered by ARROW VPS StyletArrow International Inc
2018-02-21Z-0602-2018Class IIArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central…Arrow International Inc
2018-02-21Z-0603-2018Class IIExactech GPS Total Shoulder Application 3Exactech, Inc.
2018-02-21Z-0604-2018Class II11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/RightSynthes (USA) Products LLC
2018-02-21Z-0605-2018Class IILyophilized Chemistry Calibrator Level 1 Product Usage: Beckman…Beckman Coulter Inc.
2018-02-21Z-0606-2018Class IIBlastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCEGibson Laboratories LLC
2018-02-21Z-0607-2018Class IISynvisc-One ¿Sanofi Genzyme
2018-02-21Z-0608-2018Class IIMulti-Unit Abutment AngledKeystone Dental Inc
2018-02-21Z-0609-2018Class IIBlockAid Cut Resistant Surgical Glove LinersZimmer Biomet, Inc.
2018-02-21Z-0612-2018Class IIAZimmer Surgical Inc
2018-02-21Z-0613-2018Class IIAZimmer Surgical Inc
2018-02-21Z-0614-2018Class IIArtis oneFloor-mounted system for uncompromised imagingSiemens Medical Solutions USA, INC
2018-02-21Z-0615-2018Class IIVideo Cystoscope models ECY-1570 and ECY-1570KPentax of America Inc
2018-02-21Z-0616-2018Class IIIPurely Yours Breast PumpAMEDA, INC.
2018-02-21Z-0617-2018Class IINorian Drillable InjectSynthes USA
2018-02-21Z-0618-2018Class IINorian Drillable InjectSynthes USA
2018-02-21Z-0619-2018Class IIELAN 4 Burr: ELAN 4 1-RING ROSEN BURR+ D0Aesculap Implant Systems LLC
2018-02-21Z-0620-2018Class IIELAN 4 Drill: ELAN 4 1-RING TWIST DRILL D1Aesculap Implant Systems LLC
2018-02-21Z-0621-2018Class IIELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1Aesculap Implant Systems LLC
2018-02-21Z-0622-2018Class IIModel #: CG8900Medtronic Neurosurgery
2018-02-21Z-0623-2018Class IIThe ELAN 4 Air System is intended for high speed cuttingAesculap Implant Systems LLC
2018-02-21Z-0624-2018Class IIJS Series SterilContainer S2 SystemAesculap Implant Systems LLC
2018-02-21Z-0625-2018Class IIAccu-Chek Connect Diabetes Management AppRoche Diabetes Care, Inc.
2018-02-21Z-0626-2018Class IIG7 DUAL MOBILITY LINER 44MM F Product Usage: Intended for use in hip…Zimmer Biomet, Inc.
2018-02-21Z-0627-2018Class IIAGC 2000 LP PatellaZimmer Biomet, Inc.
2018-02-21Z-0628-2018Class IIAGC 2000 LP PatellaZimmer Biomet, Inc.
2018-02-21Z-0629-2018Class IIHemotherm¿ Dual Reservoir Cooler/Heater System Models 400CE and 400MR…Cincinnati Sub-Zero Products LLC
2018-02-21Z-0630-2018Class IICentral Venous Catheter Set Triple Lumen PolyurethaneCook Inc.
2018-02-21Z-0631-2018Class IICentral Venous Catheter Tray Triple Lumen PolyurethaneCook Inc.
2018-02-21Z-0632-2018Class IICentral Venous Catheter Set Heparin Coated Triple Lumen PolyurethaneCook Inc.
2018-02-21Z-0633-2018Class IICentral Venous Tray Triple Lumen Polyurethane CatheterCook Inc.
2018-02-21Z-0634-2018Class IISpectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic…Cook Inc.
2018-02-14Z-0489-2018Class IMRx Defibrillator Model # M3535A & M3536APhilips North America, LLC
2018-02-14Z-0505-2018Class IIPeripheral Diamondback 1Cardiovascular Systems Inc
2018-02-14Z-0506-2018Class IIPeripheral Diamondback 1Cardiovascular Systems Inc
2018-02-14Z-0507-2018Class IIThe ReNew Reusable Grasper and Dissector Tips are to be used with the…Microline Surgical, Inc.
2018-02-14Z-0508-2018Class IIAArtis Q/ QSiemens Medical Solutions USA, Inc
2018-02-14Z-0509-2018Class IIAIRO Mobile CT SystemBrainlab AG
2018-02-14Z-0510-2018Class IIBrightView XPhilips Medical Systems (Cleveland) Inc
2018-02-14Z-0511-2018Class IIBrightView XCT Model 882482 Product Usage: BrightView XCT is a gamma…Philips Medical Systems (Cleveland) Inc
2018-02-14Z-0512-2018Class IIBrightView Model 882480 Product Usage: BrightView and BrightView X…Philips Medical Systems (Cleveland) Inc
2018-02-14Z-0513-2018Class IIPrecedence 6 Model # 882351 Product Usage: PrecedencePhilips Medical Systems (Cleveland) Inc
2018-02-14Z-0514-2018Class IIPrecedence 16 Model # 882350 Product Usage: PrecedencePhilips Medical Systems (Cleveland) Inc
2018-02-14Z-0515-2018Class IIADVIA Centaur Calibrator 30Siemens Healthcare Diagnostics, Inc
2018-02-14Z-0516-2018Class IIDRILL BIT MINI QUICK CONNECT 1Zimmer Biomet, Inc.
2018-02-14Z-0517-2018Class IIPC-1000Panoramic Rental Corp.
2018-02-14Z-0518-2018Class IIPhilips Brilliance 64 computed tomography x-ray systemPhilips Medical Systems (Cleveland) Inc
2018-02-14Z-0519-2018Class IIPhilips Ingenuity Core computed tomography x-ray systemPhilips Medical Systems (Cleveland) Inc
2018-02-14Z-0520-2018Class IIPhilips Ingenuity Core 128 computed tomography x-ray systemPhilips Medical Systems (Cleveland) Inc
2018-02-14Z-0521-2018Class IIPhilips Ingenuity CT computed tomography x-ray systemPhilips Medical Systems (Cleveland) Inc
2018-02-14Z-0522-2018Class IIIngenuity TF PET/CTPhilips Medical Systems (Cleveland) Inc
2018-02-14Z-0523-2018Class IIDisposable Light Handle CoverEcolab, Inc.
2018-02-14Z-0524-2018Class IISyngoSiemens Medical Solutions USA, Inc
2018-02-14Z-0525-2018Class IISUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid…ConvaTec, Inc
2018-02-14Z-0526-2018Class IIAccu2i pMTA ApplicatorAngiodynamics, Inc.
2018-02-14Z-0527-2018Class IIAccu2i pMTA ApplicatorAngiodynamics, Inc.
2018-02-14Z-0528-2018Class IIAccu2i pMTA ApplicatorAngiodynamics, Inc.
2018-02-14Z-0529-2018Class IIAccu2i pMTA ApplicatorAngiodynamics, Inc.
2018-02-14Z-0530-2018Class IIAccu2i pMTA ApplicatorAngiodynamics, Inc.
2018-02-14Z-0531-2018Class IIAccu2i pMTA ApplicatorAngiodynamics, Inc.
2018-02-14Z-0532-2018Class IISpacelabs Healthcare Xhibit Telemetry ReceiverSpacelabs Healthcare Inc
2018-02-14Z-0533-2018Class II6Medical Components, Inc dba MedComp
2018-02-14Z-0534-2018Class IICovidien Vistec" X-Ray Detectable SpongesCovidien LP
2018-02-14Z-0535-2018Class IIMedtronic Custom Perfusion SystemsMedtronic Perfusion Systems
2018-02-14Z-0536-2018Class IIPowerPICC Provena CathetersBard Access Systems Inc.
2018-02-14Z-0537-2018Class IIIMedtronic AscendaMedtronic Neuromodulation
2018-02-14Z-0538-2018Class IIAlteon HA Femoral StemExactech, Inc.
2018-02-14Z-0539-2018Class IIImplant DirectImplant Direct Sybron Manufacturing, LLC
2018-02-14Z-0540-2018Class IISafety-Deluxe Lumbar Puncture TrayRobert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
2018-02-14Z-0541-2018Class IISafety-Deluxe Basic Soft Tissue Biopsy Tray without Biopsy NeedleRobert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
2018-02-14Z-0542-2018Class IISafety-Deluxe Lumbar Puncture TrayRobert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
2018-02-14Z-0543-2018Class IISafety Deluxe Bone Marrow Biopsy/ Aspiration Tray with Biopsy Needle…Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
2018-02-14Z-0544-2018Class IILaceration TrayRobert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
2018-02-14Z-0545-2018Class IILumbar Puncture TrayRobert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
2018-02-14Z-0546-2018Class IISafety Deluxe Bone Marrow Biopsy/Aspiration TrayRobert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
2018-02-14Z-0547-2018Class IIM/DN Intramedullary Fixation Humeral Guide WireZimmer Biomet, Inc.
2018-02-14Z-0548-2018Class IIM/DN Intramedullary Fixation Humeral Guide WireZimmer Biomet, Inc.
2018-02-14Z-0549-2018Class IIHumeral Guide Wire Ball Tip 2Zimmer Biomet, Inc.
2018-02-14Z-0550-2018Class IIZimmer Natural Nail System Tear Drop Guide Wire 3Zimmer Biomet, Inc.
2018-02-14Z-0551-2018Class IIZimmer Natural Nail System Tear Drop Guide Wire 2Zimmer Biomet, Inc.
2018-02-14Z-0552-2018Class IIACE3M Company - Health Care Business
2018-02-14Z-0553-2018Class IIRheumatoid FactorThe Binding Site Group, Ltd.
2018-02-14Z-0554-2018Class IITD60 Transmitter battery charger used with the BeneVision Central…Mindray DS USA, Inc. dba Mindray North America
2018-02-14Z-0555-2018Class IIVNSCyberonics, Inc
2018-02-14Z-0556-2018Class IICovidien Emprint Percutaneous Antenna with Thermosphere TechnologyCovidien LLC
2018-02-14Z-0557-2018Class IICovidien Emprint Percutaneous Antenna with Thermosphere TechnologyCovidien LLC
2018-02-14Z-0558-2018Class IICovidien Emprint Percutaneous Antenna with Thermosphere TechnologyCovidien LLC
2018-02-14Z-0559-2018Class IICovidien Emprint Percutaneous Antenna with Thermosphere TechnologyCovidien LLC
2018-02-14Z-0560-2018Class IICovidien Emprint Percutaneous Antenna with Thermosphere TechnologyCovidien LLC
2018-02-14Z-0561-2018Class IICovidien Emprint Percutaneous Antenna with Thermosphere TechnologyCovidien LLC
2018-02-07Z-0379-2018Class IIMetrotom 800Carl Zeiss Metrology Inc
2018-02-07Z-0412-2018Class IISST TWIST DRILLMicroAire Surgical Instruments, LLC
2018-02-07Z-0413-2018Class IIElements Obturation UnitOrmco/Sybronendo
2018-02-07Z-0414-2018Class IIEquinoxe CageExactech, Inc.
2018-02-07Z-0415-2018Class IIEquinoxe CageExactech, Inc.
2018-02-07Z-0416-2018Class II7x10" Small Utility Positioner with CoverMolnlycke Health Care, Inc
2018-02-07Z-0417-2018Class II9x15" Medium Utility Positioner with CoverMolnlycke Health Care, Inc
2018-02-07Z-0418-2018Class IITriage Drugs of Abuse Plus TCA 25 Test KitAlere San Diego, Inc.
2018-02-07Z-0419-2018Class IIMA3320-PM Premium AdultStryker Medical Division of Stryker Corporation
2018-02-07Z-0420-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0421-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0422-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0423-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0424-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0425-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0426-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0427-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0428-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0429-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0430-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0431-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0432-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0433-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0434-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0435-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0436-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0437-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0438-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0439-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0440-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0441-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0442-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0443-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0444-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0445-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0446-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0447-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0448-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0449-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0450-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0451-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0452-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0453-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0454-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0455-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0456-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0457-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0458-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0459-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0460-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0461-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0462-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0463-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0464-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0465-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0466-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0467-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0468-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0469-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0470-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0471-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0472-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0473-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0474-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0475-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0476-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0477-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.
2018-02-07Z-0478-2018Class IIAffixus Hip Fracture NailZimmer Biomet, Inc.

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