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Medical device recalls reported in 2016

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ReportedRecallClassProductFirm
2016-09-21Z-2801-2016Class IIRAPIDLab 1245 Blood Gas Analyzer Siemens Material NumberSiemens Healthcare Diagnostics Inc
2016-09-21Z-2802-2016Class IIRAPIDLab 1260 Blood Gas Analyzer Siemens Material NumberSiemens Healthcare Diagnostics Inc
2016-09-21Z-2803-2016Class IIRAPIDLab 1265 Blood Gas Analyzer Siemens Material NumberSiemens Healthcare Diagnostics Inc
2016-09-21Z-2804-2016Class IIIThe VITROS¿ Chemistry Products Calibrator Kit 31Ortho-Clinical Diagnostics
2016-09-21Z-2805-2016Class IITranspac IV Monitoring Kit with SafeSet 84inch Arterial Pressure…ICU Medical, Inc.
2016-09-21Z-2806-2016Class IITranspac IV Trifurcated Kit With Safeset Reservoir And 2 Blood…ICU Medical, Inc.
2016-09-21Z-2807-2016Class IITranspac IV Bifurcated Kit with SafeSet ReservoirICU Medical, Inc.
2016-09-21Z-2808-2016Class IITranspac IV Monitoring Kit with 2 SafeSet Blood Sampling PortsICU Medical, Inc.
2016-09-21Z-2809-2016Class IITranspac IV Monitoring Kit with 2 SafeSet Reservoir and 2 Blood…ICU Medical, Inc.
2016-09-21Z-2810-2016Class IITranspac IV Monitoring Kit with 2 SafeSet 84" Arterial Pressure TubingICU Medical, Inc.
2016-09-21Z-2811-2016Class IITranspac IV Monitoring Kit with SafeSet Reservoir and Blood Sampling…ICU Medical, Inc.
2016-09-21Z-2812-2016Class IITranspac IV Trifurcated Monitoring Kit with SafeSet Reservoir and 2…ICU Medical, Inc.
2016-09-21Z-2813-2016Class IITranspac IV Trifurcated Monitoring Kit with 84" SafeSet ReservoirICU Medical, Inc.
2016-09-21Z-2814-2016Class IISingle Monitoring Kit with 30mL Flush DeviceICU Medical, Inc.
2016-09-21Z-2815-2016Class IIMonitoring Kit with 30mL Flush DeviceICU Medical, Inc.
2016-09-21Z-2816-2016Class IITriple Line SafeSet Kit with 03mL Flush DeviceICU Medical, Inc.
2016-09-21Z-2817-2016Class IIDouble Kit with SafeSet and 03mL Flush DeviceICU Medical, Inc.
2016-09-21Z-2818-2016Class IIMonitoring Kit with 03mL Flush DeviceICU Medical, Inc.
2016-09-21Z-2819-2016Class IISafeSet Kit with 30 mL Flush DeviceICU Medical, Inc.
2016-09-21Z-2820-2016Class IIBifurcated SafeSet Kit with 03mL Flush DeviceICU Medical, Inc.
2016-09-21Z-2821-2016Class IIPediatric Kit with 30mL Flush DeviceICU Medical, Inc.
2016-09-21Z-2822-2016Class II5 Port OFF Manifold with Transpac IVICU Medical, Inc.
2016-09-21Z-2823-2016Class IIMonitoring Kit with TP4ICU Medical, Inc.
2016-09-21Z-2824-2016Class IITranspac IV Monitoring Kit with SafeSet 84" Arterial Pressure TubingICU Medical, Inc.
2016-09-21Z-2825-2016Class IITP4 Kit with 10cc SafeSet ReservoirICU Medical, Inc.
2016-09-21Z-2826-2016Class IITranspac IV Monitoring Kit with 03 ml Squeeze FlushICU Medical, Inc.
2016-09-21Z-2827-2016Class IITranspac IV Trifurcated Monitoring Kit with SafeSet ReservoirICU Medical, Inc.
2016-09-21Z-2828-2016Class IIMonitoring Kit with TP4ICU Medical, Inc.
2016-09-21Z-2829-2016Class IIAirStrip Sense4Baby Model C Fetal Monitor The Sense4Baby System…AirStrip Technologies, Inc.
2016-09-21Z-2830-2016Class IIOption-vf Urinary CatheterC.R. Bard, Inc.
2016-09-21Z-2831-2016Class IIOption-vm Urinary CatheterC.R. Bard, Inc.
2016-09-21Z-2832-2016Class IIThe Bigger-Better-BladderCirculatory Technology Inc
2016-09-21Z-2834-2016Class IILAUREATE World Phaco SystemAlcon Research, Ltd.
2016-09-14Z-2693-2016Class IADVANCEMicroPort Orthopedics Inc.
2016-09-14Z-2694-2016Class IADVANCEMicroPort Orthopedics Inc.
2016-09-14Z-2695-2016Class IADVANCEMicroPort Orthopedics Inc.
2016-09-14Z-2696-2016Class IADVANCEMicroPort Orthopedics Inc.
2016-09-14Z-2697-2016Class IADVANCEMicroPort Orthopedics Inc.
2016-09-14Z-2698-2016Class IADVANCEMicroPort Orthopedics Inc.
2016-09-14Z-2699-2016Class IADVANCEMicroPort Orthopedics Inc.
2016-09-14Z-2700-2016Class IADVANCEMicroPort Orthopedics Inc.
2016-09-14Z-2701-2016Class IADVANCEMicroPort Orthopedics Inc.
2016-09-14Z-2702-2016Class IADVANCEMicroPort Orthopedics Inc.
2016-09-14Z-2703-2016Class IADVANCEMicroPort Orthopedics Inc.
2016-09-14Z-2714-2016Class IIAcecide-C High Level Disinfectant & Sterilant 875 mLBest Sanitizers Inc
2016-09-14Z-2715-2016Class IIMerge RadSuite softwareMerge Healthcare, Inc.
2016-09-14Z-2716-2016Class IINOMAD Pro Packaged X-Ray SystemAribex Inc
2016-09-14Z-2717-2016Class IINOMAD Pro2 Packaged X-Ray SystemAribex Inc
2016-09-14Z-2718-2016Class IIArjoHuntleigh Sara CombilizerARJOHUNTLEIGH POLSKA Sp. z.o.o.
2016-09-14Z-2719-2016Class IIReliaMed¿ Silver Alginate/CMCAdvanced Medical Solutions Ltd.
2016-09-14Z-2720-2016Class IIReliaMed¿ Alginate/CMCAdvanced Medical Solutions Ltd.
2016-09-14Z-2721-2016Class IIMedical Linear AcceleratorElekta, Inc.
2016-09-14Z-2722-2016Class IIPlum A+ Hyperbaric Infusion PumpHospira Inc.
2016-09-14Z-2723-2016Class IIPlum A+ Infusion PumpHospira Inc.
2016-09-14Z-2724-2016Class IIPlum A+ Infusion PumpHospira Inc.
2016-09-14Z-2725-2016Class IIPlum A+3 Infusion PumpHospira Inc.
2016-09-14Z-2726-2016Class IIPlum A+ Infusion Pump with Hospira MedNet SoftwareHospira Inc.
2016-09-14Z-2727-2016Class IIPlum A+ Infusion Pump with Hospira MedNet SoftwareHospira Inc.
2016-09-14Z-2728-2016Class IIPlum A+3 Infusion Pump SystemHospira Inc.
2016-09-14Z-2729-2016Class IIPlum A+3 Infusion PumpHospira Inc.
2016-09-14Z-2730-2016Class IIPlum A+3 Infusion Pump with Hospira MedNet SoftwareHospira Inc.
2016-09-14Z-2731-2016Class IIGE Healthcare SIGNA CreatorGE Healthcare, LLC
2016-09-14Z-2732-2016Class IIUniCel DxH 800 and DxH 600 Coulter Cellular Analysis SystemBeckman Coulter Inc.
2016-09-14Z-2733-2016Class IIIntegra Cranial Access KitsIntegra LifeSciences Corp. d.b.a. Integra Pain Management
2016-09-14Z-2734-2016Class II2 over 2 Elevating Monitor SuspensionOmega Medical Imaging, Inc.
2016-09-14Z-2735-2016Class IIBrightView XPhilips Medical Systems (Cleveland) Inc
2016-09-14Z-2736-2016Class IIBrightView XCT Model 882482Philips Medical Systems (Cleveland) Inc
2016-09-14Z-2737-2016Class IIBrightView XCT Upgrade Model 882454Philips Medical Systems (Cleveland) Inc
2016-09-14Z-2738-2016Class IIPINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath…Terumo Medical Corporation
2016-09-14Z-2739-2016Class IICentricity Enterprise Archive is a software product for receivingGe Healthcare It
2016-09-14Z-2740-2016Class IIArterial Line Catheterization Kit with Sharps Safety Features Permits…Arrow International Inc
2016-09-14Z-2741-2016Class IIRadial Artery Catheterization Kit with Sharps Safety Features Permits…Arrow International Inc
2016-09-14Z-2742-2016Class IIADVIA Centaur¿ PSA AssaySiemens Healthcare Diagnostics, Inc
2016-09-14Z-2743-2016Class IIAchillon Minimally Invasive Device for Achilles Tendon Rupture…Integra LifeSciences Corp.
2016-09-14Z-2744-2016Class IIMicrotek Franz Angiography Drape with Radiation ShieldEcolab Inc
2016-09-14Z-2745-2016Class IISmith & Nephew Whipknot Soft Tissue CinchSmith & Nephew, Inc.
2016-09-14Z-2746-2016Class IIThe Connecting BracketMaquet Cardiovascular Us Sales, Llc
2016-09-14Z-2747-2016Class IIMENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR…Mentor Texas, LP.
2016-09-14Z-2748-2016Class IIMENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 The MENTOR…Mentor Texas, LP.
2016-09-14Z-2749-2016Class IIPacemakers: Accolade MRI DR Model L311Boston Scientific Corporation
2016-09-14Z-2750-2016Class IIAffinity Four Birthing Bed Model P3700 The primary packaging is…Hill-Rom, Inc.
2016-09-14Z-2751-2016Class IIHard Tissue ReplacementBiomet Microfixation, LLC
2016-09-14Z-2752-2016Class IICoonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra SmallZimmer Biomet, Inc.
2016-09-14Z-2753-2016Class IIAxiom REG implants Sterile The Axiom REG implants are used as…Anthogyr
2016-09-14Z-2754-2016Class IIAxiom 2Anthogyr
2016-09-14Z-2755-2016Class IIIntermediate carton label reads in part as: "Bard-Parker***Stainless…Aspen Surgical Puerto Rico Corp.
2016-09-14Z-2756-2016Class IIAortic Arch Cannula and Coronary Artery Perfusion Cannula with BallonSorin Group USA, Inc.
2016-09-14Z-2757-2016Class IICoronary Artery Perfusion Cannula with BalloonSorin Group USA, Inc.
2016-09-14Z-2758-2016Class IIeSiemens Medical Solutions USA, Inc.
2016-09-14Z-2759-2016Class IIWECK¿ Horizon" Manual-Load Ligating Clip ApplierTeleflex Medical
2016-09-14Z-2760-2016Class IIThe system provides the ability to transmit patient data files for…Invivo Corporation
2016-09-14Z-2761-2016Class IINylon Surgical Suture for human use and vet useRiverpoint Medical, LLC
2016-09-14Z-2762-2016Class IIPolypropylene Surgical SuturesRiverpoint Medical, LLC
2016-09-14Z-2763-2016Class IINeural Signal AmplifierBlackrock Microsystems, LLC
2016-09-14Z-2764-2016Class IIPatient CableBlackrock Microsystems, LLC
2016-09-14Z-2765-2016Class IISureSight Obturator Introducer Localization SystemsHologic, Inc
2016-09-14Z-2766-2016Class IISureSight Obturator Introducer Localization SystemsHologic, Inc
2016-09-14Z-2767-2016Class IISterile DrapeNOVADAQ TECHNOLOGIES INC.
2016-09-14Z-2768-2016Class IICertegra Workstation used in conjunction with Medrad Stellant CT…Bayer Healthcare
2016-09-14Z-2769-2016Class IIInnocor Cardiopulmonary Exercise and Lung Function Testing System…Innovision A/S
2016-09-07Z-2669-2016Class IIAllura Xper with release R8Philips Electronics North America Corporation
2016-09-07Z-2670-2016Class IIUNIQ 1Philips Electronics North America Corporation
2016-09-07Z-2671-2016Class IICentricity Laboratory Core Lab System 4GE Healthcare It
2016-09-07Z-2672-2016Class IIDiamond Coated Tips and Burs are accessories to the Ultrasonic ScalerNakanishi Inc.
2016-09-07Z-2673-2016Class IIDiamond Coated Tips and Burs are accessories to the air powered Bone…Nakanishi Inc.
2016-09-07Z-2674-2016Class IIDiamond Coated Tips and Burs are accessories to the air powered…Nakanishi Inc.
2016-09-07Z-2675-2016Class IISTAPLERIntuitive Surgical, Inc.
2016-09-07Z-2676-2016Class IISTAPLER 30Intuitive Surgical, Inc.
2016-09-07Z-2677-2016Class IICURVED-TIP STAPLER 30Intuitive Surgical, Inc.
2016-09-07Z-2678-2016Class IIGeo-MedDeRoyal Industries Inc
2016-09-07Z-2679-2016Class IIDeRoyalDeRoyal Industries Inc
2016-09-07Z-2680-2016Class IINIO-A / NIO-P is an instant IO access device comprises housing with…Waismed Ltd
2016-09-07Z-2681-2016Class IIPCR Compano Basic Reader using 100-127V as mains voltagePhilips Electronics North America Corporation
2016-09-07Z-2682-2016Class IIPhilips DuraDiagnost stationary X-ray systemPhilips Electronics North America Corporation
2016-09-07Z-2683-2016Class IIMAQUET Servo Humidifier 163Teleflex Medical
2016-09-07Z-2684-2016Class IIINTEGRA Spinal TrayIntegra LifeSciences Corp. d.b.a. Integra Pain Management
2016-09-07Z-2685-2016Class IIRadSuite softwareMerge Healthcare, Inc.
2016-09-07Z-2686-2016Class IIiConnect Enterprise ArchiveMerge Healthcare, Inc.
2016-09-07Z-2687-2016Class IIBaxter Non-DEHP Micro-Volume Extension SetBaxter Healthcare Corp.
2016-09-07Z-2688-2016Class IIInvivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with…Invivo Corporation
2016-09-07Z-2689-2016Class IIA7 Anesthesia Delivery SystemMindray DS USA, Inc. dba Mindray North America
2016-09-07Z-2690-2016Class IIFUJIFILM Digital Mammography System Aspire HDFujifilm Medical Systems U.S.A., Inc.
2016-09-07Z-2691-2016Class IIHexaPOD evo RT System Product Usage: The intended use of the device…Elekta, Inc.
2016-09-07Z-2692-2016Class IIUniCel DxH Slidemaker Stainer Coulter Cellular Analysis SystemBeckman Coulter Inc.
2016-09-07Z-2704-2016Class IIADVIA Chemistry XPTSiemens Healthcare Diagnostics, Inc.
2016-09-07Z-2705-2016Class IIDouble Pump RF Patient CassetteMedical Vision Ab
2016-09-07Z-2706-2016Class IITerumo Custom Cardiovascular System Cardiovascular Procedure Kits…Terumo Cardiovascular Systems Corp
2016-09-07Z-2707-2016Class IISMR allen wrench 5 mmLimacorporate S.p.A
2016-09-07Z-2708-2016Class IIAlcon AcrySof IQ IOL with ULTRASERT Delivery System Product Usage:…Alcon Research, Ltd.
2016-09-07Z-2709-2016Class IIMerge Cardio softwareMerge Healthcare, Inc.
2016-09-07Z-2710-2016Class IIBD Vacutainer Push Button Blood Collection SetBecton Dickinson & Company
2016-09-07Z-2711-2016Class IISPECULAR MICROSCOPE CEM-530Nidek Inc
2016-09-07Z-2712-2016Class IIMonaco RTP System Used to make treatment plans for patients with…Elekta, Inc.
2016-09-07Z-2713-2016Class IIThe 9025TRU Arterial Blood GasCardinal Health
2016-08-31Z-2354-2016Class IAlere INRatio PT/INR System Professional Model Numbers: 0100004…Alere San Diego, Inc.
2016-08-31Z-2355-2016Class IINRatio Prothrombin TimeAlere San Diego, Inc.
2016-08-31Z-2356-2016Class IAlere INRatio Replacement Monitor Model Number: 0100137 Usage: The…Alere San Diego, Inc.
2016-08-31Z-2357-2016Class IAlere INRatio2 PT/INR Professional Testing System Model Number:…Alere San Diego, Inc.
2016-08-31Z-2358-2016Class IAlere INRatio2 PT/INR Home Monitoring System Model Number: 0200432Alere San Diego, Inc.
2016-08-31Z-2359-2016Class IAlere INRatio2 Replacement MonitorAlere San Diego, Inc.
2016-08-31Z-2360-2016Class IAlere INRatio2 PT/INR Professional Monitoring System Model Number:…Alere San Diego, Inc.
2016-08-31Z-2361-2016Class IAlere INRatio PT/INR Test Strips Model Number: 0100071Alere San Diego, Inc.
2016-08-31Z-2362-2016Class IAlere INRatio/ INRatio2 PT/INR Test Strips Model Number: 99007EUAlere San Diego, Inc.
2016-08-31Z-2537-2016Class IRoadrunner Uniglide Hydrophilic Wire GuideCook Inc.
2016-08-31Z-2595-2016Class IIAdult ThermoGard¿ Dual Dispersive ElectrodesConmed Corporation
2016-08-31Z-2596-2016Class IIAdult ThermoGard¿ Dual Dispersive ElectrodesConmed Corporation
2016-08-31Z-2597-2016Class IIPediatric ThermoGard¿ Dual Dispersive ElectrodesConmed Corporation
2016-08-31Z-2598-2016Class IIAdult Dual Dispersive ElectrodesConmed Corporation
2016-08-31Z-2599-2016Class IIPediatric Dual Dispersive ElectrodesConmed Corporation
2016-08-31Z-2600-2016Class IILarge QWIX Compression screwIntegra LifeSciences Corp.
2016-08-31Z-2601-2016Class IIISiemens RAPIDPoint¿ 500 v2Siemens Healthcare Diagnostics Inc
2016-08-31Z-2602-2016Class IIMedtronicMedtronic Neuromodulation
2016-08-31Z-2603-2016Class IITIGR Matrix Surgical MeshNovus Scientific Ab
2016-08-31Z-2604-2016Class IICARESCAPE VC150 Vital Signs MonitorINNOKAS MEDICAL OY
2016-08-31Z-2605-2016Class IIPanacea Air Pro Mattress Control UnitAmerican National Mfg Inc
2016-08-31Z-2606-2016Class IICobalt HV Bone Cement Product Usage: Cobalt HV Bone Cement provides…Encore Medical, Lp
2016-08-31Z-2607-2016Class IIRadiesseMerz North America, Inc.
2016-08-31Z-2608-2016Class IIConical portio adapterRichard Wolf Medical Instruments Corp.
2016-08-31Z-2609-2016Class II1) The HomeChoice automated peritoneal dialysis systemBaxter Healthcare Corp.
2016-08-31Z-2610-2016Class IIBeacon Tip Torcon NB Advantage Catheter CatheterCook Inc.
2016-08-31Z-2611-2016Class IIBeacon Tip Royal Flush Plus High-Flow Catheter CatheterCook Inc.
2016-08-31Z-2612-2016Class IIBeacon Tip Centimeter Sizing Catheter Beacon Tip White Vessel Sizing…Cook Inc.
2016-08-31Z-2613-2016Class IIShuttle Select Slip-Cath CatheterCook Inc.
2016-08-31Z-2614-2016Class IISlip-Cath Beacon Tip Catheter CatheterCook Inc.
2016-08-31Z-2615-2016Class IIFluoroSet Radiographic Tubal Assessment Set CannulaCook Inc.
2016-08-31Z-2616-2016Class IIHaskal Transjugular Intrahepatic Portal Access Set IntroducerCook Inc.
2016-08-31Z-2617-2016Class IIKumpe Access Catheter CathetherCook Inc.
2016-08-31Z-2618-2016Class IILiver Access and Biopsy Needle Set Biopsy needle kit Intended for use…Cook Inc.
2016-08-31Z-2619-2016Class IINeff DAgostino Percutaneous Access Set AccessoriesCook Inc.
2016-08-31Z-2620-2016Class IIAprima Access Nonvascular Introducer Set AccessoriesCook Inc.
2016-08-31Z-2621-2016Class IISelective Salpingography Catheter with Beacon Tip CannulaCook Inc.
2016-08-31Z-2622-2016Class IITransluminal Biliary Biopsy Forceps Set ForcepsCook Inc.
2016-08-31Z-2623-2016Class IIWhite Lumax Guiding Coaxial Catheter CatheterCook Inc.
2016-08-31Z-2624-2016Class IISOMATOM Definition AS with software version VA48A-SP2Siemens Medical Solutions USA, Inc
2016-08-31Z-2625-2016Class IISOMATOM Definition Flash with software version VA48A-SP2Siemens Medical Solutions USA, Inc
2016-08-31Z-2626-2016Class IISOMATOM Definition Edge with software version VA48A-SP2Siemens Medical Solutions USA, Inc
2016-08-31Z-2627-2016Class IIRadSuite softwareMerge Healthcare, Inc.
2016-08-31Z-2628-2016Class IIOEC UroView 2800GE OEC Medical Systems, Inc
2016-08-31Z-2629-2016Class IIOEC 9800GE OEC Medical Systems, Inc
2016-08-31Z-2630-2016Class II120 V Neptune 3 RoverStryker Instruments Div. of Stryker Corporation
2016-08-31Z-2631-2016Class IIRESPONSIVEMedtronic Sofamor Danek USA Inc
2016-08-31Z-2632-2016Class IIRESPONSIVEMedtronic Sofamor Danek USA Inc
2016-08-31Z-2633-2016Class IIRESPONSIVEMedtronic Sofamor Danek USA Inc
2016-08-31Z-2634-2016Class IIRESPONSIVEMedtronic Sofamor Danek USA Inc
2016-08-31Z-2635-2016Class IITIBIAL TRAYMedtronic Sofamor Danek USA Inc
2016-08-31Z-2636-2016Class IITIBIAL TRAYMedtronic Sofamor Danek USA Inc
2016-08-31Z-2637-2016Class IITIBIAL TRAYMedtronic Sofamor Danek USA Inc
2016-08-31Z-2638-2016Class IITIBIAL TRAYMedtronic Sofamor Danek USA Inc
2016-08-31Z-2639-2016Class IIZiehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic ImagingZiehm Imaging Inc
2016-08-31Z-2640-2016Class IIZiehm Vision RFD MotZiehm Imaging Inc
2016-08-31Z-2641-2016Class IIZiehm Vision RFDZiehm Imaging Inc
2016-08-31Z-2642-2016Class IIZiehm Vision RZiehm Imaging Inc
2016-08-31Z-2643-2016Class IIZiehm SoloZiehm Imaging Inc
2016-08-31Z-2644-2016Class IIZiehm Vision2Ziehm Imaging Inc
2016-08-31Z-2645-2016Class IIDBS Pocket AdaptorMedtronic Neuromodulation
2016-08-31Z-2646-2016Class IIBVX-330BR Bovie Precise 360 Handpiece 33cmBovie Medical Corporation
2016-08-31Z-2647-2016Class IIBVX-330NR Bovie Precise 360 Handpiece 33cmBovie Medical Corporation
2016-08-31Z-2648-2016Class IIBVX-450BR Bovie Precise 360 Handpiece 45cmBovie Medical Corporation
2016-08-31Z-2649-2016Class IIBVX-450NR Bovie Precise 360 Handpiece 45cmBovie Medical Corporation
2016-08-31Z-2650-2016Class IIMedtronicMedtronic Inc., Cardiac Rhythm and Heart Failure

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