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Medical device recalls reported in 2016

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ReportedRecallClassProductFirm
2016-08-24Z-2589-2016Class IIConvenience KitsAvid Medical, Inc.
2016-08-24Z-2590-2016Class IIConvenience KitsAvid Medical, Inc.
2016-08-24Z-2591-2016Class IIPEDIATRIC KIDNEY BIOPSY TRAYAvid Medical, Inc.
2016-08-24Z-2592-2016Class IIMAMMOGRAPHYAvid Medical, Inc.
2016-08-24Z-2593-2016Class IIHospira RECEPTAL CANISTERS: 1LHospira Inc.
2016-08-24Z-2594-2016Class IIHospira RECEPTAL LINERS: 1LHospira Inc.
2016-08-17Z-2342-2016Class INucliSENS easyMAG Magnetic Silica The NucliSENS easyMAG accessory…BioMerieux SA
2016-08-17Z-2344-2016Class IIArtis zee/ zeegoSiemens Medical Solutions USA, Inc
2016-08-17Z-2345-2016Class IIIMedivance ArcticGel Neonatal Pad The pad is designed to fit into an…C.R. Bard, Inc.
2016-08-17Z-2346-2016Class IIMX 16-slice whole body computed tomography X-ray systemPhilips Medical Systems (Cleveland) Inc
2016-08-17Z-2347-2016Class IIMX 16-slice SKD whole body computed tomography X-ray systemPhilips Medical Systems (Cleveland) Inc
2016-08-17Z-2348-2016Class IISTAPLER 45Intuitive Surgical, Inc.
2016-08-17Z-2349-2016Class IISTAPLER 30Intuitive Surgical, Inc.
2016-08-17Z-2350-2016Class IICURVED-TIP STAPLER 30Intuitive Surgical, Inc.
2016-08-17Z-2351-2016Class IIRichard Allan Scientific 10% Neutral Buffered FormalinRichard-Allan Scientific Company
2016-08-17Z-2352-2016Class IIVITROS Immunodiagnostic Products Estradiol Reagent PackORTHO-CLINICAL DIAGNOSTICS
2016-08-17Z-2353-2016Class IIS3 MedSurg BedStryker Medical Division of Stryker Corporation
2016-08-17Z-2363-2016Class IIMerge PACS softwareMerge Healthcare, Inc.
2016-08-17Z-2364-2016Class IIlnvacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16Invacare Corporation
2016-08-17Z-2365-2016Class IIInvacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16 AWInvacare Corporation
2016-08-17Z-2366-2016Class IIBrilliance 64 Computed Tomography X-ray systems is intended to…Philips Medical Systems (Cleveland) Inc
2016-08-17Z-2367-2016Class IIBrilliance BigBore Oncology Computed Tomography X-ray systemsPhilips Medical Systems (Cleveland) Inc
2016-08-17Z-2368-2016Class IIBrilliance BigBore Radiology Computed Tomography X-ray systemsPhilips Medical Systems (Cleveland) Inc
2016-08-17Z-2369-2016Class IIBrilliance 16 Computed Tomography X-ray systems is intended to…Philips Medical Systems (Cleveland) Inc
2016-08-17Z-2370-2016Class IIBrilliance CT 16 Power Computed Tomography X-ray systems is intended…Philips Medical Systems (Cleveland) Inc
2016-08-17Z-2371-2016Class IIIngenuity Core Computed Tomography X-ray systems is intended to…Philips Medical Systems (Cleveland) Inc
2016-08-17Z-2372-2016Class IIIngenuity Core 128 Computed Tomography X-ray systems is intended to…Philips Medical Systems (Cleveland) Inc
2016-08-17Z-2373-2016Class IIOptraPol Polishing DiscsIvoclar Vivadent, Inc.
2016-08-17Z-2374-2016Class IIServo Humidifier 163Teleflex Medical
2016-08-17Z-2375-2016Class IIInstructions for UseNobel Biocare Usa Llc
2016-08-17Z-2376-2016Class IIVolker 2080Hill-Rom, Inc.
2016-08-17Z-2377-2016Class IIStryker Orthopaedics Modular Handle Triathlon InstrumentsStryker Howmedica Osteonics Corp.
2016-08-17Z-2378-2016Class IIIBD Tritest CD3 FITC/CD4 PE/CD45 PerCPBecton, Dickinson and Company, BD Biosciences
2016-08-17Z-2379-2016Class IIMerge PACS softwareMerge Healthcare, Inc.
2016-08-17Z-2380-2016Class IIBrilliance 64 CT Model 728231Philips Medical Systems (Cleveland) Inc
2016-08-17Z-2381-2016Class IIBrilliance iCTPhilips Medical Systems (Cleveland) Inc
2016-08-17Z-2382-2016Class IIBrilliance iCT SP Model NoPhilips Medical Systems (Cleveland) Inc
2016-08-17Z-2383-2016Class IIIngenuity Core Model NoPhilips Medical Systems (Cleveland) Inc
2016-08-17Z-2384-2016Class IIIngenuity Core128 Model NoPhilips Medical Systems (Cleveland) Inc
2016-08-17Z-2385-2016Class IIIngenuity CT Model NoPhilips Medical Systems (Cleveland) Inc
2016-08-17Z-2386-2016Class IIIntegra External Fixation System Universal Wire Fixation BoltIntegra LifeSciences Corp.
2016-08-17Z-2387-2016Class IIIntegra External Fixation System Slotted PostIntegra LifeSciences Corp.
2016-08-17Z-2388-2016Class IIEtCO2 Module -Part Number: 02Edan Diagnostics
2016-08-17Z-2389-2016Class IISynthes 2Synthes (USA) Products LLC
2016-08-17Z-2390-2016Class IIStryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with…Stryker Howmedica Osteonics Corp.
2016-08-17Z-2391-2016Class IICoolife Sinergy Radiofrequency KitHalyard Health, Inc
2016-08-17Z-2392-2016Class IIHitachi Scenaria Computed Tomography System Hitachi Medical Systems…Hitachi Medical Systems America Inc
2016-08-17Z-2393-2016Class IIAXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEMSiemens Medical Solutions USA, Inc
2016-08-17Z-2394-2016Class IIARTIS ZEE AND ZEEGOSiemens Medical Solutions USA, Inc
2016-08-17Z-2395-2016Class IIARTIS Q AND QSiemens Medical Solutions USA, Inc
2016-08-17Z-2396-2016Class IIOrthopedic manual surgical instrument Usage: Exeter Rasp Handle is a…Stryker Howmedica Osteonics Corp.
2016-08-17Z-2397-2016Class IIZyston¿ Transform Instrument CaseZimmer Biomet Spine, Inc
2016-08-17Z-2398-2016Class IIZyston¿ Transform Implant KitZimmer Biomet Spine, Inc
2016-08-17Z-2399-2016Class IIInvacare¿ Bariatric Bed w/o mattress & railsInvacare Corporation
2016-08-17Z-2400-2016Class IIInvacare¿ Bariatric Bed with mattress and railsInvacare Corporation
2016-08-17Z-2401-2016Class IIInvacare¿ Foot Section for Semi & Full Electric BedsInvacare Corporation
2016-08-17Z-2402-2016Class IIJunction BoxesInvacare Corporation
2016-08-17Z-2404-2016Class IIMedicine CupMedline Industries Inc
2016-08-17Z-2405-2016Class IIOpthalmic: PASCAL Synthesis is an ophthalmic scanning laser systemTopcon Medical Laser Systems, Inc
2016-08-17Z-2525-2016Class IIStratus¿ CS STAT Fluorometric Analyzer-microprocessor-controlled…Siemens Healthcare Diagnostics Inc
2016-08-10Z-2215-2016Class IOxylog 3000Draeger Medical, Inc.
2016-08-10Z-2255-2016Class IIOlympus Scientific Solutions Americas CorporationOlympus Scientific Solutions Americas
2016-08-10Z-2301-2016Class IIMerge PACS softwareMerge Healthcare, Inc.
2016-08-10Z-2302-2016Class IIVITROS Immunodiagnostic Products Total T4 Reagent PackORTHO-CLINICAL DIAGNOSTICS
2016-08-10Z-2303-2016Class IIMerge PACS softwareMerge Healthcare, Inc.
2016-08-10Z-2304-2016Class IIONLINE TDM Vancomycin 100 testsRoche Diagnostics Operations, Inc.
2016-08-10Z-2305-2016Class IIMultiDiagnost Eleva with Flat DetectorPhilips Electronics North America Corporation
2016-08-10Z-2306-2016Class IIUroDiagnostPhilips Electronics North America Corporation
2016-08-10Z-2307-2016Class IIMultiDiagnost ElevaPhilips Electronics North America Corporation
2016-08-10Z-2308-2016Class IIAU480 Chemistry AnalyzersBeckman Coulter Inc.
2016-08-10Z-2309-2016Class IIAU680 Chemistry AnalyzersBeckman Coulter Inc.
2016-08-10Z-2310-2016Class IIAU5800 Chemistry AnalyzersBeckman Coulter Inc.
2016-08-10Z-2311-2016Class IIIAmediCheck Instant Test CupBranan Medical Corporation
2016-08-10Z-2312-2016Class II3T 16ch Flex SPEEDER CoilNeoCoil, LLC
2016-08-10Z-2313-2016Class IISynergy Cranial S7Medtronic Navigation, Inc.
2016-08-10Z-2314-2016Class IIFrameLinkMedtronic Navigation, Inc.
2016-08-10Z-2315-2016Class IIS7 MACH FrameLinkMedtronic Navigation, Inc.
2016-08-10Z-2316-2016Class IISynergy SpineMedtronic Navigation, Inc.
2016-08-10Z-2317-2016Class IIFusion ENT ApplicationMedtronic Navigation, Inc.
2016-08-10Z-2318-2016Class IIMACH Cranial TreonMedtronic Navigation, Inc.
2016-08-10Z-2319-2016Class IIMACH AxiEM Cranial TreonMedtronic Navigation, Inc.
2016-08-10Z-2320-2016Class IIRePlant¿ Angled Abutment Part Number 6050-52-60Implant Direct Sybron Manufacturing, LLC
2016-08-10Z-2321-2016Class IITWIST DR 25X95MM Cann 12MM Thd 30MM AOZimmer Gmbh
2016-08-10Z-2322-2016Class IITWIST D 28X150MM CBS 45 Cann 14 MM AOZimmer Gmbh
2016-08-10Z-2323-2016Class IIV-TEK TWIST D 3Zimmer Gmbh
2016-08-10Z-2324-2016Class IIV-TEK TWIST D 40X90MM 30MM Cann 12MM RndZimmer Gmbh
2016-08-10Z-2325-2016Class IIBK Medical ApS Ultrasound System Scanner bk2300B-K Medical A/S
2016-08-10Z-2326-2016Class IIMentor MemoryGel Breast ImplantMentor Texas, LP.
2016-08-10Z-2327-2016Class IIHorizon 24 Large Titanium Clips with Adhesive BackingTeleflex Medical
2016-08-10Z-2328-2016Class IIIntelliVue Patient Monitor Product Usage: The monitors are indicated…Philips Electronics North America Corporation
2016-08-10Z-2329-2016Class II6F/7F MynxGrip Vascular Closure DeviceAccessClosure, Inc., A Cardinal Health Company
2016-08-10Z-2330-2016Class IIEnVision FLEX+Dako Denmark A/S
2016-08-10Z-2331-2016Class IISpirit Plus BedCHG Hospital Beds Inc
2016-08-10Z-2332-2016Class IISpirit Select BedCHG Hospital Beds Inc
2016-08-10Z-2333-2016Class IIISureStep TrayC.R. Bard, Inc.
2016-08-10Z-2334-2016Class IIZimmer¿ Air Dermatome II HandpieceZimmer Surgical Inc
2016-08-10Z-2335-2016Class IIZimmer¿ Air Dermatome II Handpiece w/o HoseZimmer Surgical Inc
2016-08-10Z-2336-2016Class IIZimmer¿ Air Dermatome II Width PlateZimmer Surgical Inc
2016-08-10Z-2337-2016Class IIZimmer¿ Air Dermatome II Width PlateZimmer Surgical Inc
2016-08-10Z-2338-2016Class IIZimmer¿ Air Dermatome II Width PlateZimmer Surgical Inc
2016-08-10Z-2339-2016Class IIZimmer¿ Air Dermatome II Width PlateZimmer Surgical Inc
2016-08-10Z-2340-2016Class IIZimmer¿ Air Dermatome II Width PlateZimmer Surgical Inc
2016-08-10Z-2341-2016Class IIMerge HEMO softwareMerge Healthcare, Inc.
2016-08-10Z-2343-2016Class II91496 Ultraview SL Command ModuleSpacelabs Healthcare Inc
2016-08-03Z-2212-2016Class IDIAMOND-FLEX CIRCULAR RETRACTORCarefusion 2200 Inc
2016-08-03Z-2236-2016Class IIGE Inspection TechnologiesGE Inspection Technologies, LP
2016-08-03Z-2251-2016Class IIBest Theratronics cabinet x-ray systems intended for use in the…BEST THERATRONICS LTD.
2016-08-03Z-2257-2016Class IIAUTOCOMP6 XPS High Speed Compounder REF 58810The Metrix Company
2016-08-03Z-2258-2016Class IIAUTOCOMP6 XP High Speed Compounder REF 58810The Metrix Company
2016-08-03Z-2259-2016Class IIAUTOCOMP6 High Speed CompounderThe Metrix Company
2016-08-03Z-2260-2016Class IIContainer fill and transfer setsThe Metrix Company
2016-08-03Z-2261-2016Class IIContainer fill and transfer setsThe Metrix Company
2016-08-03Z-2262-2016Class IIDual Chamber Container fill and transfer setsThe Metrix Company
2016-08-03Z-2263-2016Class IIDual Chamber Container fill with gravity/attached transfer setsThe Metrix Company
2016-08-03Z-2264-2016Class IIContainer fill and transfer setsThe Metrix Company
2016-08-03Z-2265-2016Class IIIAcceava Mono II Rapid Test StripAlere San Diego, Inc.
2016-08-03Z-2266-2016Class IIICardinal Health Mono Rapid TestAlere San Diego, Inc.
2016-08-03Z-2267-2016Class IIIClearview MONOAlere San Diego, Inc.
2016-08-03Z-2268-2016Class IIIHenry Schein One Step + Mono Rapid Test DeviceAlere San Diego, Inc.
2016-08-03Z-2269-2016Class IIIProadvantage Mono Rapid Test CassetteAlere San Diego, Inc.
2016-08-03Z-2270-2016Class IIIStanbio Rely Mono Rapid TestAlere San Diego, Inc.
2016-08-03Z-2271-2016Class IIISignify MonoAlere San Diego, Inc.
2016-08-03Z-2272-2016Class IIUniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access…Beckman Coulter Inc.
2016-08-03Z-2273-2016Class IIVITROS Chemistry Products Ca SlidesOrtho-Clinical Diagnostics
2016-08-03Z-2274-2016Class IIAllegra X-5 rotor yokeBeckman Coulter Inc.
2016-08-03Z-2275-2016Class IIColonoscope Product Usage: Intended to provide optical visualization…Pentax Medical Company
2016-08-03Z-2276-2016Class IIConfocal GI Scope Product Usage: Intended to provide optical…Pentax Medical Company
2016-08-03Z-2277-2016Class IIDuodenoscope Product Usage: Intended to provide optical visualization…Pentax Medical Company
2016-08-03Z-2278-2016Class IIGastroscope Product Usage: Intended to provide optical visualization…Pentax Medical Company
2016-08-03Z-2279-2016Class IIUltrasound Gastroscope Product Usage: Intended to provide optical…Pentax Medical Company
2016-08-03Z-2280-2016Class IISignmoidoscope Product Usage: Intended to provide optical…Pentax Medical Company
2016-08-03Z-2281-2016Class IIStryker Orthopaedics Trident Constrained Liner Inserter/Impactor TipStryker Howmedica Osteonics Corp.
2016-08-03Z-2282-2016Class IIIInstructions for UseTosoh Bioscience, Inc.
2016-08-03Z-2283-2016Class IIAnastoclip AC 8cm 35 ClipsLeMaitre Vascular, Inc.
2016-08-03Z-2284-2016Class IIAnastoClip AC 8cm 35 ClipsLeMaitre Vascular, Inc.
2016-08-03Z-2285-2016Class IIAnasto AC Closure System and Anasto Universal Clip Remover- Anasto AC…LeMaitre Vascular, Inc.
2016-08-03Z-2286-2016Class IIAnastoCiip Universal Clip RemoverLeMaitre Vascular, Inc.
2016-08-03Z-2287-2016Class IIAnastoCiip Universal Clip RemoverLeMaitre Vascular, Inc.
2016-08-03Z-2288-2016Class IIAnastoCiip Universal Clip RemoverLeMaitre Vascular, Inc.
2016-08-03Z-2289-2016Class IIAnastoCiip Universal Clip RemoverLeMaitre Vascular, Inc.
2016-08-03Z-2290-2016Class IIQuickie Q7 wheelchairSunrise Medical (US) LLC
2016-08-03Z-2291-2016Class IIMolift Air 205Moller Vital
2016-08-03Z-2292-2016Class IIAvenir M¿ller Stem 4 Standard Avenir M¿ller Stem 6 Lateral Hip joint…Zimmer Gmbh
2016-08-03Z-2293-2016Class IIMOSAIQ Oncology Information SystemElekta, Inc.
2016-08-03Z-2294-2016Class IIEndotine Transbleph 3MicroAire Surgical Instruments, LLC
2016-08-03Z-2295-2016Class IIBabytherm 8004/8010Draeger Medical, Inc.
2016-08-03Z-2296-2016Class IIIntegra External Fixation System Rocker Bottom Model # 12225400Integra LifeSciences Corp.
2016-08-03Z-2297-2016Class IISPHERICAL HEAD REFLECTIONSmith & Nephew, Inc.
2016-08-03Z-2298-2016Class IISyva¿ EMIT¿ 2000 TheophyllineSiemens Healthcare Diagnostics, Inc.
2016-08-03Z-2299-2016Class IIADVIA¿ ChemistrySiemens Healthcare Diagnostics, Inc.
2016-08-03Z-2300-2016Class IIImagecast PACS with Centricity RIS-IC versions prior to 10Ge Healthcare It
2016-07-27Z-2096-2016Class IAngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number:…Stryker Sustainability Solutions
2016-07-27Z-2188-2016Class IIToshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6Toshiba American Medical Systems Inc
2016-07-27Z-2206-2016Class IIRayStation 3RAYSEARCH LABORATORIES AB
2016-07-27Z-2207-2016Class IIHX2" Temperature Management SystemsTerumo Cardiovascular Systems Corporation
2016-07-27Z-2208-2016Class IISarns TCMTerumo Cardiovascular Systems Corporation
2016-07-27Z-2209-2016Class IISarns TCM IITerumo Cardiovascular Systems Corporation
2016-07-27Z-2210-2016Class IIPreamendments device-Sarns Dual Cooler-HeaterTerumo Cardiovascular Systems Corporation
2016-07-27Z-2213-2016Class IIAMD-RITMED brand Conforming Stretch Gauze BandagesAmd-Ritmed, Inc.
2016-07-27Z-2214-2016Class IIDepuy Synthes Trauma- Trochanteric Fixation Nail AdvancedSynthes (USA) Products LLC
2016-07-27Z-2216-2016Class IIcobas¿ Liat¿ AnalyzerRoche Molecular Systems, Inc.
2016-07-27Z-2217-2016Class IICarestream Touch PrimeCarestream Health Inc
2016-07-27Z-2218-2016Class IISmith and Nephew TWINFIX QUICK-T Knot Pusher Suture CutterSmith & Nephew, Inc.
2016-07-27Z-2219-2016Class IIThe pumpWalkMed Infusion, LLC
2016-07-27Z-2220-2016Class IIThe pumpWalkMed Infusion, LLC
2016-07-27Z-2221-2016Class IISpike SetWalkMed Infusion, LLC
2016-07-27Z-2222-2016Class IIT030-000 -30" 20 Drop IV Admin Secondary SetWalkMed Infusion, LLC
2016-07-27Z-2223-2016Class IIT090-000 90" 20 Drop IV Admin SetWalkMed Infusion, LLC
2016-07-27Z-2224-2016Class IIT090-000V 90" 20 Drop IV Admin Set w/ Needlefree Y-SiteWalkMed Infusion, LLC
2016-07-27Z-2225-2016Class IIT090-000W 90" 20 Drop IV Admin Set w/2 Needlefree Y-Sites Back Check…WalkMed Infusion, LLC
2016-07-27Z-2226-2016Class IIT090-022V 90" 20 Drop IV Admin Set Needle free Y-Site & 0WalkMed Infusion, LLC
2016-07-27Z-2227-2016Class IIT095-022WalkMed Infusion, LLC
2016-07-27Z-2228-2016Class IIT095-120 IV Set with 1WalkMed Infusion, LLC
2016-07-27Z-2229-2016Class IIT100-000FWalkMed Infusion, LLC
2016-07-27Z-2230-2016Class IIT100-000VFWalkMed Infusion, LLC
2016-07-27Z-2231-2016Class IIT100-000WFWalkMed Infusion, LLC
2016-07-27Z-2232-2016Class IIT100-022F with 0WalkMed Infusion, LLC
2016-07-27Z-2233-2016Class IIT100-120F with 1WalkMed Infusion, LLC
2016-07-27Z-2234-2016Class IIT105-000WC IV Set w/2 Y-SitesWalkMed Infusion, LLC
2016-07-27Z-2235-2016Class IIT100-022WFWalkMed Infusion, LLC
2016-07-27Z-2237-2016Class IIReplace Select Tapered TiU NP 3Nobel Biocare Usa Llc
2016-07-27Z-2238-2016Class II2Stryker Instruments Div. of Stryker Corporation
2016-07-27Z-2239-2016Class IIATEC CANISTERHologic, Inc
2016-07-27Z-2240-2016Class IITSP Hip Fracture Plating System deviceBiomet, Inc.
2016-07-27Z-2241-2016Class IIDimension Vista¿ Homocysteine Flex Reagent CartridgeCSL Behring GmbH
2016-07-27Z-2242-2016Class IIMODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF…Encore Medical, Lp
2016-07-27Z-2243-2016Class IIParker Trach-Vac Endotracheal TubesParker Medical
2016-07-27Z-2244-2016Class IIAngiographic Injector and SyringeBayer Healthcare
2016-07-27Z-2245-2016Class IISyngoSiemens Medical Solutions USA, Inc
2016-07-27Z-2246-2016Class IIDeVilbiss Model 7305P-D Powered Suction UnitDeVilbiss Healthcare LLC
2016-07-27Z-2247-2016Class IIThe Synchron Systems No Foam DxCBeckman Coulter Inc.
2016-07-27Z-2248-2016Class IIOT1000 Series Orthopedic Surgical TablesSteris Corporation
2016-07-27Z-2249-2016Class IIAmerigel Hydrogel Wound Dressing Advanced Formula for wound…Amerx Health Care Corp.
2016-07-27Z-2250-2016Class IIConvenience Kits from Centurion that contain a Medtronic/Covidien…Centurion Medical Products Corporation
2016-07-27Z-2252-2016Class IIBD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount…Becton, Dickinson and Company, BD Biosciences
2016-07-27Z-2253-2016Class IIAnspach G1 High Speed Electric Handpiece Air CooledThe Anspach Effort, Inc.
2016-07-27Z-2254-2016Class IIcobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2:…Roche Molecular Systems, Inc.
2016-07-27Z-2256-2016Class IIADVIA¿ Centaur XPT system software versions V1Siemens Healthcare Diagnostics, Inc.
2016-07-20Z-1887-2016Class IHeartWare Ventricular Assist System: HeartWare BatteryHeartware, Inc.
2016-07-20Z-2139-2016Class IIThe LifeCare PCA Plus II infusion pump system is designed for safeHospira Inc.

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