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Medical device recalls reported in 2016

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ReportedRecallClassProductFirm
2016-02-24Z-0819-2016Class IICovidien Endo GIA Ultra Universal 12 mm Short Stapler Handle Ref:…Medtronic
2016-02-24Z-0820-2016Class IICovidien Endo GIA Ultra Universal Standard Stapler Handle Ref:…Medtronic
2016-02-24Z-0821-2016Class IICovidien Endo GIA Ultra Universal 12 mm XL Stapler Handle Ref:…Medtronic
2016-02-24Z-0822-2016Class IIBest Practice Kits containing certain production lots of Endo GIA…Medtronic
2016-02-17Z-0688-2016Class IIMoog Curlin InfusionMOOG Medical Devices Group
2016-02-17Z-0752-2016Class IIINFX-8000V Bi-Plane X-Ray Interventional System X-ray systemsToshiba American Medical Systems Inc
2016-02-17Z-0758-2016Class II2Spectranetics Corp.
2016-02-17Z-0759-2016Class IIPatient transport Shuttle with Trendelenburg quick adjustment functionTrumpf Medical Systems, Inc.
2016-02-17Z-0760-2016Class IIArctic Sun 5000 and Arctic Sun 2000C.R. Bard, Inc.
2016-02-17Z-0761-2016Class IIVS200 radiographic Cassette Holder or Wall StandDel Medical, Inc.
2016-02-17Z-0762-2016Class IIVS300 radiographic Cassette Holder or Wall StandDel Medical, Inc.
2016-02-17Z-0763-2016Class IIMavig Monitor Suspension SystemGE Medical Systems, LLC
2016-02-17Z-0764-2016Class IIPhilips Allura Xper FD20 Ceiling version onlyPhilips Electronics North America Corporation
2016-02-17Z-0765-2016Class IIAllura Xper FD OR TablePhilips Electronics North America Corporation
2016-02-17Z-0766-2016Class IIPhilips Healthcare TraumaDiagnostPhilips Electronics North America Corporation
2016-02-17Z-0767-2016Class IIMEVION S250 Radiation therapy systemMevion Medical Systems, Inc.
2016-02-17Z-0768-2016Class IIGE HealthcareGE Medical Systems, LLC
2016-02-17Z-0769-2016Class IIGE HealthcareGE Medical Systems, LLC
2016-02-17Z-0770-2016Class IIGE HealthcareGE Medical Systems, LLC
2016-02-17Z-0771-2016Class IICyberKnife RoboticAccuray Incorporated
2016-02-17Z-0772-2016Class IIIMPLANTZimmer Dental Inc
2016-02-17Z-0773-2016Class IIIMPLANTZimmer Dental Inc
2016-02-17Z-0774-2016Class IIIMPLANTZimmer Dental Inc
2016-02-17Z-0775-2016Class IIIMPLANTZimmer Dental Inc
2016-02-17Z-0776-2016Class IIIMPLANTZimmer Dental Inc
2016-02-17Z-0777-2016Class IIIMPLANTZimmer Dental Inc
2016-02-17Z-0778-2016Class IIIMPLANTZimmer Dental Inc
2016-02-17Z-0779-2016Class IIIMPLANTZimmer Dental Inc
2016-02-17Z-0780-2016Class IIIMPLANTZimmer Dental Inc
2016-02-17Z-0781-2016Class IIIMPLANTZimmer Dental Inc
2016-02-17Z-0782-2016Class IIIMPLANTZimmer Dental Inc
2016-02-17Z-0783-2016Class IIIMPLANTZimmer Dental Inc
2016-02-17Z-0784-2016Class IIIMPLANTZimmer Dental Inc
2016-02-17Z-0785-2016Class IIBard Distaflo Vascular Bypass GraftBard Peripheral Vascular Inc
2016-02-17Z-0786-2016Class IIBard Distaflo Vascular Bypass GraftBard Peripheral Vascular Inc
2016-02-17Z-0787-2016Class IISIGMA HP MBT Non-Keel Punch Knee InstrumentDePuy Orthopaedics, Inc.
2016-02-17Z-0788-2016Class IIEndobon-Xenograft GranulesBiomet France SARL
2016-02-17Z-0789-2016Class IIReuseable rotary blade/abraderRichard Wolf Medical Instruments Corp.
2016-02-17Z-0790-2016Class IIReuseable rotary blade/abraderRichard Wolf Medical Instruments Corp.
2016-02-17Z-0791-2016Class IIReuseable rotary blade/abraderRichard Wolf Medical Instruments Corp.
2016-02-17Z-0792-2016Class IIMizuho OSI TriosMizuho OSI
2016-02-17Z-0793-2016Class IISmith & Nephew BEAVER Blade 4Smith & Nephew, Inc.
2016-02-17Z-0794-2016Class IIRadSuiteMerge Healthcare, Inc.
2016-02-17Z-0795-2016Class IIPharmaCaribe PulmoSal 7% Sodium chloridePharmacaribe llc
2016-02-17Z-0796-2016Class IIT-piece Nebulizer with in-line connectorsSalter Labs
2016-02-17Z-0797-2016Class IIFirebird Spinal Fixation System Torque Limiting HandleOrthofix, Inc
2016-02-10Z-0691-2016Class IEmergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog…Draeger Medical, Inc.
2016-02-10Z-0692-2016Class IEmergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000…Draeger Medical, Inc.
2016-02-10Z-0696-2016Class IIET-20 Anesthesia Extension TubesGlobal Healthcare Inc
2016-02-10Z-0699-2016Class IIBiosure DriverSmith & Nephew, Inc., Endoscopy Div.
2016-02-10Z-0700-2016Class IIBiosure Ratchet DriverSmith & Nephew, Inc., Endoscopy Div.
2016-02-10Z-0701-2016Class IIPanorama Patient Monitoring NetworkMindray DS USA, Inc. dba Mindray North America
2016-02-10Z-0702-2016Class IIAllura Xper FD10Philips Electronics North America Corporation
2016-02-10Z-0703-2016Class IIAllura Xper FD10/10Philips Electronics North America Corporation
2016-02-10Z-0704-2016Class IIAllura Xper FD10 OR TablePhilips Electronics North America Corporation
2016-02-10Z-0705-2016Class IIAllura Xper FD20/10Philips Electronics North America Corporation
2016-02-10Z-0706-2016Class IIAllura Xper FD20/15Philips Electronics North America Corporation
2016-02-10Z-0707-2016Class IIAllura Xper FD20Philips Electronics North America Corporation
2016-02-10Z-0708-2016Class IIUNIQ FDPhilips Electronics North America Corporation
2016-02-10Z-0709-2016Class IIUNIQ FD OR tablePhilips Electronics North America Corporation
2016-02-10Z-0710-2016Class IIAllura Xper FD20 OR TablePhilips Electronics North America Corporation
2016-02-10Z-0711-2016Class IIAllura Xper FD20 BiplanePhilips Electronics North America Corporation
2016-02-10Z-0712-2016Class IIAllura Xper FD20 Biplane OR TablePhilips Electronics North America Corporation
2016-02-10Z-0713-2016Class IIAllura Xper FD20/20Philips Electronics North America Corporation
2016-02-10Z-0714-2016Class IIAllura Xper FD20/20 OR TablePhilips Electronics North America Corporation
2016-02-10Z-0715-2016Class IIAllura CV20Philips Electronics North America Corporation
2016-02-10Z-0716-2016Class IICardiovascular Allura CentronPhilips Electronics North America Corporation
2016-02-10Z-0717-2016Class IIINTEGRIS H3000Philips Electronics North America Corporation
2016-02-10Z-0718-2016Class IIINTEGRIS HM3000Philips Electronics North America Corporation
2016-02-10Z-0719-2016Class IIINTEGRIS BN/BV3000Philips Electronics North America Corporation
2016-02-10Z-0720-2016Class IIINTEGRIS BH3000Philips Electronics North America Corporation
2016-02-10Z-0721-2016Class IIINTEGRIS V3000Philips Electronics North America Corporation
2016-02-10Z-0722-2016Class IIINTEGRIS H5000Philips Electronics North America Corporation
2016-02-10Z-0723-2016Class IIINTEGRIS BH5000Philips Electronics North America Corporation
2016-02-10Z-0724-2016Class IIINTEGRIS V5000: Model Number: 72248 The Philips INTEGRIS 3000 I 5000…Philips Electronics North America Corporation
2016-02-10Z-0725-2016Class IIINTEGRIS BV5000: Model Number: 72249 The Philips INTEGRIS 3000 I 5000…Philips Electronics North America Corporation
2016-02-10Z-0726-2016Class IIINTEGRIS Allura 9Philips Electronics North America Corporation
2016-02-10Z-0727-2016Class IIINTEGRIS Allura 15-12Philips Electronics North America Corporation
2016-02-10Z-0728-2016Class IIINTEGRIS Allura 15-12Philips Electronics North America Corporation
2016-02-10Z-0729-2016Class IIINTEGRIS CVPhilips Electronics North America Corporation
2016-02-10Z-0730-2016Class IIINTEGRIS BV3000 MONOPhilips Electronics North America Corporation
2016-02-10Z-0731-2016Class IIBaxterBaxter Corporation Englewood
2016-02-10Z-0732-2016Class IIPS-500 Scope WarmerJosNoe Medical, Inc.
2016-02-10Z-0733-2016Class IIMediChoice Cohesive BandagesOwens & Minor Distribution, Inc.
2016-02-10Z-0734-2016Class IIMediChoice Cohesive BandagesOwens & Minor Distribution, Inc.
2016-02-10Z-0735-2016Class IIMediChoice Cohesive BandagesOwens & Minor Distribution, Inc.
2016-02-10Z-0736-2016Class IIHemosIL PlasminogenInstrumentation Laboratory Co.
2016-02-10Z-0737-2016Class IIDenali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral…Bard Peripheral Vascular Inc
2016-02-10Z-0738-2016Class IIThe ABX PENTRA Cholesterol CP refHoriba Instruments Inc
2016-02-10Z-0739-2016Class IIABX PENTRA Enzymatic Creatinine CP refHoriba Instruments Inc
2016-02-10Z-0740-2016Class IIABX PENTRA Glucose PAP CP refHoriba Instruments Inc
2016-02-10Z-0741-2016Class IIABX PENTRA Lactic Acid CP refHoriba Instruments Inc
2016-02-10Z-0742-2016Class IIABX PENTRA Triglycerides CP refHoriba Instruments Inc
2016-02-10Z-0743-2016Class IIABX PENTRA Uric Acid CP refHoriba Instruments Inc
2016-02-10Z-0744-2016Class IIACIST Medical SystemsAcist Medical Systems
2016-02-10Z-0745-2016Class IIDS/US Proton Feature with Pinnacle3 Software Version 10Philips Medical Systems
2016-02-10Z-0746-2016Class IIAstral 100Resmed Corporation
2016-02-10Z-0747-2016Class IISynthes Small Electric DriveThe Anspach Effort, Inc.
2016-02-10Z-0748-2016Class IIAQURE SystemRadiometer America Inc
2016-02-10Z-0749-2016Class IIBacT/ALERT¿ SNbioMerieux, Inc.
2016-02-10Z-0750-2016Class IIBacT/ALERT¿ FAbioMerieux, Inc.
2016-02-10Z-0754-2016Class IIADVIA Centaur PSA AssaySiemens Healthcare Diagnostics, Inc
2016-02-10Z-0755-2016Class IIADVIA Chemistry XPT SystemsSiemens Healthcare Diagnostics, Inc.
2016-02-10Z-0756-2016Class IIAPI ZYM Bx2BioMerieux SA
2016-02-10Z-0757-2016Class IIOlympus TJF-Q180V flexible gastrointestinal Duodenoscope Product…Olympus Corporation of the Americas
2016-02-03Z-0651-2016Class IIVantage Panoramic X-Ray System used to perform dental and orthodontic…Midmark Corp dba Progeny Inc
2016-02-03Z-0689-2016Class IIZilver¿ 518RX Vascular Stent with Rapid Exchange Delivery SystemCook Medical Incorporated
2016-02-03Z-0690-2016Class IILipogems SPA Aspiration CannulaeGlobalmed Logistix
2016-02-03Z-0693-2016Class IIFresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and…Fresenius Medical Care Renal Therapies Group, LLC
2016-02-03Z-0694-2016Class IIFuse 1C ColonoscopeEndoChoice, Inc.
2016-02-03Z-0695-2016Class IID-10 Rack LoaderBio-Rad Laboratories, Inc.
2016-02-03Z-0697-2016Class IIEliA SmDP WellPhadia Ab
2016-01-27Z-0598-2016Class IBrainlab Cranial Navigation System: An Image Guided Surgery System /…Brainlab AG
2016-01-27Z-0630-2016Class Iarkray SPOTCHEM II Glucose Reagent test stripsArkray Factory USA, Inc.
2016-01-27Z-0631-2016Class Iarkray SPOTCHEM II Basic PanelArkray Factory USA, Inc.
2016-01-27Z-0645-2016Class IICyberonics Vagus Nerve Stimulator VNS Therapy AspireSR GeneratorCyberonics, Inc
2016-01-27Z-0656-2016Class IIFMS neXtra¿ 3DePuy Mitek, Inc., a Johnson & Johnson Co.
2016-01-27Z-0657-2016Class IIFMS neXtra¿ 3DePuy Mitek, Inc., a Johnson & Johnson Co.
2016-01-27Z-0658-2016Class IIFMS 3DePuy Mitek, Inc., a Johnson & Johnson Co.
2016-01-27Z-0659-2016Class IIVNS Therapy AspireSR Generator Model 106Cyberonics, Inc
2016-01-27Z-0660-2016Class IOptisure Dual Coil Defibrillation LeadsSt Jude Medical Cardiac Rhythm Management Division
2016-01-27Z-0661-2016Class IIFukuda Denshi patient monitor model DS-8100M and DS-8100NFukuda Denshi USA, Inc.
2016-01-27Z-0662-2016Class IIExcella II Rod CatInnovasis, Inc
2016-01-27Z-0663-2016Class IIAccusorb MRI MAC7001 Part Number: MRI-01 MRI-Large Blanket Various…MWT Materials, Inc.
2016-01-27Z-0664-2016Class IIAccusorb MRI MAC7002 Part Number: MRI-02 MRI-Arm Sleeve Various Sizes…MWT Materials, Inc.
2016-01-27Z-0665-2016Class IIAccusorb MRI MAC7004 Part Number: MRI-04 MRI-Poncho Product Usage:…MWT Materials, Inc.
2016-01-27Z-0666-2016Class IIAccusorb MRI MAC7007 Part Number: MRI-07 MRI-Breast Shield Product…MWT Materials, Inc.
2016-01-27Z-0667-2016Class IIAccusorb MRI MAC7008 Part Number: MRI-08 MRI-Boot Product Usage:…MWT Materials, Inc.
2016-01-27Z-0668-2016Class IIAccusorb MRI MAC7003 Part Number: MRI-03 UMWT Materials, Inc.
2016-01-27Z-0669-2016Class IIAccusorb MRI MAC7005 Part Number: MRI-05 Leg Wrap Product Usage:…MWT Materials, Inc.
2016-01-27Z-0670-2016Class IIAccusorb MRI MAC7006 Part Number: MRI-06 MRI-Large Torso Wrap Product…MWT Materials, Inc.
2016-01-27Z-0671-2016Class IIAccusorb MRI MAC7009 Part Number: MRI-09 MRI- Leg Wrap Blanket…MWT Materials, Inc.
2016-01-27Z-0672-2016Class IIAccusorb MRI MAC7010 Product Usage: Radio frequency shielding…MWT Materials, Inc.
2016-01-27Z-0673-2016Class IIAccusorb MRI MAC7030 Product Usage: Radio frequency shielding…MWT Materials, Inc.
2016-01-27Z-0674-2016Class IIValeant Pharmaceuticals North AmericaValeant Pharmacueticals International
2016-01-27Z-0675-2016Class IIInVision-Plus and InVision-Plus Junior Needleless IV ConnectorRymed Technologies, LLC
2016-01-27Z-0676-2016Class IIInVision-Plus CS Needleless IV ConnectorRymed Technologies, LLC
2016-01-27Z-0677-2016Class IIGE HealthcareGE Medical Systems, LLC
2016-01-27Z-0678-2016Class IIGE HealthcareGE Medical Systems, LLC
2016-01-27Z-0679-2016Class IIGE HealthcareGE Medical Systems, LLC
2016-01-27Z-0680-2016Class IIGE HealthcareGE Medical Systems, LLC
2016-01-27Z-0681-2016Class IIGE HealthcareGE Medical Systems, LLC
2016-01-27Z-0682-2016Class IIAnesthesia device service kitsGE Medical Systems, LLC
2016-01-27Z-0683-2016Class IIIBA Dosimetry GmbH Lift Table Type 4320Iba Dosimetry Gmbh
2016-01-27Z-0684-2016Class IITLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME…Abeon Medical Corporation
2016-01-27Z-0685-2016Class IITLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLYAbeon Medical Corporation
2016-01-27Z-0686-2016Class IIWilson Penile Implantation System Retractor FrameAbeon Medical Corporation
2016-01-27Z-0687-2016Class IIThe eSiemens Medical Solutions USA, Inc.
2016-01-20Z-0586-2016Class IMOVES SystemThornhill Research Inc
2016-01-20Z-0587-2016Class IMOVES System Lithium Polymer Batteries The MOVES System is a portable…Thornhill Research Inc
2016-01-20Z-0620-2016Class IIBoston ScientificBoston Scientific Corporation
2016-01-20Z-0621-2016Class IIBoston ScientificBoston Scientific Corporation
2016-01-20Z-0622-2016Class IIUniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The…OrthoPediatrics Corp
2016-01-20Z-0623-2016Class IICavity 8 Gauge Spine Wand indicated for resectionArthroCare Corporation
2016-01-20Z-0624-2016Class IINIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with…Nipro Medical Corporation
2016-01-20Z-0625-2016Class IIZimmerZimmer Biomet, Inc.
2016-01-20Z-0626-2016Class IIAltiVate Reverse Humeral BroachEncore Medical, Lp
2016-01-20Z-0627-2016Class IIMedrad Source Administration SetsBayer Healthcare
2016-01-20Z-0628-2016Class IIIFMC7 FITCBecton, Dickinson and Company, BD Biosciences
2016-01-20Z-0629-2016Class IIReprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet…Stryker Sustainability Solutions
2016-01-20Z-0632-2016Class IIPerkin Elmer WIZARD2 1-detectorPerkinelmer
2016-01-20Z-0633-2016Class IIPerkin Elmer WIZARD2 2-detectorPerkinelmer
2016-01-20Z-0634-2016Class IIPerkin Elmer ClWIZARD2 5-detectorPerkinelmer
2016-01-20Z-0635-2016Class IIPerkin Elmer WIZARD2 10-detectorPerkinelmer
2016-01-20Z-0636-2016Class IIPerkin Elmer WIZARD2 5-detectorPerkinelmer
2016-01-20Z-0637-2016Class IIPerkin Elmer WIZARD2 10-detectorPerkinelmer
2016-01-20Z-0638-2016Class IIPerkin Elmer WIZARD2 1-detectorPerkinelmer
2016-01-20Z-0639-2016Class IIMercury Medical Neo-Tee T-Piece Resuscitator and T-Piece CircuitMercury Enterprises, Inc. dba Mercury Medical
2016-01-20Z-0640-2016Class IIVITROS 3600 Chemistry SystemOrtho-Clinical Diagnostics
2016-01-20Z-0641-2016Class IIVITROS 5600 Chemistry SystemOrtho-Clinical Diagnostics
2016-01-20Z-0642-2016Class IIVITROS 4600 Chemistry SystemOrtho-Clinical Diagnostics
2016-01-20Z-0643-2016Class IIVITROS 5Ortho-Clinical Diagnostics
2016-01-20Z-0644-2016Class IIModel NuCARTGNCompView Medical, LLC
2016-01-20Z-0646-2016Class IIZimmer Periarticular Locking Plate System 3Zimmer Biomet, Inc.
2016-01-20Z-0647-2016Class IIRT Elements are applications for radiation treatment planning for use…Brainlab AG
2016-01-20Z-0648-2016Class IIRT Elements are applications for radiation treatment planning for use…Brainlab AG
2016-01-20Z-0649-2016Class IIiChem 10 SG Urine Chemistry StripsBeckman Coulter Inc.
2016-01-20Z-0650-2016Class IIBiomet Integral Centralizer Hip SystemBiomet, Inc.
2016-01-20Z-0652-2016Class II0 degIntuitive Surgical, Inc.
2016-01-20Z-0653-2016Class II30 degIntuitive Surgical, Inc.
2016-01-20Z-0654-2016Class IIZimmer Universal Locking System 3Zimmer Biomet, Inc.
2016-01-20Z-0655-2016Class IIErgon 2 Articulating Equipment Boom Monitor Brackets mounting point…Skytron, Div. The KMW Group, Inc
2016-01-13Z-0478-2016Class IThe Fuhrman Pleural/Pneumopericardial Drainage Set The Fuhrman…Stryker Sustainability Solutions
2016-01-13Z-0572-2016Class IICNSystems TASK FORCE MONITOR 3040iPartners In Medicine Llc
2016-01-13Z-0573-2016Class IISmith & Nephew GENESISSmith & Nephew, Inc.
2016-01-13Z-0574-2016Class IICorflex Contender Post-Op Knee Brace Lite Model: 75-7500-000…Corflex
2016-01-13Z-0575-2016Class IICT ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-011…Corflex
2016-01-13Z-0576-2016Class IIHAILEY ORTHO CONTENDER POST-OP-KNEE BRACE Model : 75-7500-038…Corflex
2016-01-13Z-0577-2016Class IIORTHO SPEC GRP CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-075…Corflex
2016-01-13Z-0578-2016Class IIBRIELLE ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-087…Corflex
2016-01-13Z-0579-2016Class IIADV ORTHO CONTENDER POST-OP-KNEE BRACE LITE Model: 75-7500-231…Corflex
2016-01-13Z-0580-2016Class IICONTENDER POST-OP-KNEE BRACE FULL FOAM Model: 75-7550-000…Corflex
2016-01-13Z-0581-2016Class IINatus Quantum System with NeuroWorks SoftwareNatus Neurology DBA Excel Tech., Ltd. (XLTEK)
2016-01-13Z-0582-2016Class IIRemote Patient Monitoring SystemVidco, Inc.
2016-01-13Z-0583-2016Class IIInterGuard 5Ultradent Products, Inc.
2016-01-13Z-0584-2016Class IIBIRMINGHAM HIP RESURFACING MODULAR HEADSmith & Nephew, Inc.
2016-01-13Z-0585-2016Class IISYNTHESSynthes (USA) Products LLC
2016-01-13Z-0588-2016Class IIBoston Scientific ACUITY Pro Coronary Sinus Guide CatheterBoston Scientific Corporation
2016-01-13Z-0589-2016Class IIMaquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz…Maquet Cardiovascular Us Sales, Llc
2016-01-13Z-0590-2016Class IINexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 PrecoatZimmer Manufacturing B.V.

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