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Medical device recalls reported in 2017

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ReportedRecallClassProductFirm
2017-06-21Z-2586-2017Class IIPointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage:…Medtest Holdings, Inc.
2017-06-21Z-2587-2017Class IISheridan SHER-I-SLIP and SOFT-TIP Intubating Stylets are intubating…Teleflex Medical
2017-06-21Z-2588-2017Class IIMonica Novii Wireless Patch System product Usage: Novii InterfaceMONICA HEALTHCARE LTD
2017-06-21Z-2589-2017Class IICADD¿ High Volume Administration Set with FlowStopSmiths Medical ASD Inc.
2017-06-21Z-2590-2017Class IIMerge PACS softwareMerge Healthcare, Inc.
2017-06-21Z-2591-2017Class IIMerge PACS softwareMerge Healthcare, Inc.
2017-06-21Z-2593-2017Class IIVERSA-FXII SC TUBE PLT 90DX16HZimmer Biomet, Inc.
2017-06-21Z-2594-2017Class IIVERSA-FX II STD TUBE 130DX16HZimmer Biomet, Inc.
2017-06-21Z-2595-2017Class IIR-F IM NAIL 10MMDX48CM LGZimmer Biomet, Inc.
2017-06-21Z-2596-2017Class IIFEM IM NAIL 15MMDX30CMZimmer Biomet, Inc.
2017-06-21Z-2597-2017Class IITIBIAL I/M NAIL 15MMDX26CMZimmer Biomet, Inc.
2017-06-21Z-2598-2017Class IIFEM IM NAIL 14MMDX30CM LEFTZimmer Biomet, Inc.
2017-06-21Z-2599-2017Class IIZ NAIL PF 14MM X 46CM UNIV Z NAIL GT 14MM X 46CM R Z NAIL GT 14MM X…Zimmer Biomet, Inc.
2017-06-21Z-2600-2017Class II4Zimmer Biomet, Inc.
2017-06-14Z-2172-2017Class IIEllex Tango Reflex with slit lamp Laser Ophthalmic In the SLT modeLaserex Systems Inc.
2017-06-14Z-2220-2017Class IILarge Stealth ChamberIba Dosimetry
2017-06-14Z-2221-2017Class IIIUrea Base AgarAcumedia Manufacturers, Inc.
2017-06-14Z-2223-2017Class IICobas connection moduleRoche Diagnostics Corporation
2017-06-14Z-2225-2017Class IMagellan Diagnostics LeadCare and LeadCare II test KitsMagellan Diagnostics, Inc.
2017-06-14Z-2226-2017Class IMagellan Diagnostics LeadCare Ultra and LeadCare Plus test KitsMagellan Diagnostics, Inc.
2017-06-14Z-2227-2017Class IISesamoid PlastyOrthosoft, Inc. dba Zimmer CAS
2017-06-14Z-2228-2017Class IIOxygen MasksConvaTec, Inc
2017-06-14Z-2229-2017Class IIRebreathing MaskConvaTec, Inc
2017-06-14Z-2230-2017Class IINon-Rebreathing MaskConvaTec, Inc
2017-06-14Z-2231-2017Class IIOxygen MaskConvaTec, Inc
2017-06-14Z-2232-2017Class IIOxygen MasksConvaTec, Inc
2017-06-14Z-2233-2017Class IINon-Rebreather Oxygen MaskConvaTec, Inc
2017-06-14Z-2234-2017Class IINon-Rebreather MaskConvaTec, Inc
2017-06-14Z-2235-2017Class IIOxygen MasksConvaTec, Inc
2017-06-14Z-2236-2017Class IIRebreather Oxygen MaskConvaTec, Inc
2017-06-14Z-2237-2017Class IIOxygen MasksConvaTec, Inc
2017-06-14Z-2238-2017Class IINon-RebreatherConvaTec, Inc
2017-06-14Z-2239-2017Class IIOxygen MaskConvaTec, Inc
2017-06-14Z-2240-2017Class IIOxygen MaskConvaTec, Inc
2017-06-14Z-2241-2017Class IINon-Rebreathing MaskConvaTec, Inc
2017-06-14Z-2242-2017Class IIOxygen MaskConvaTec, Inc
2017-06-14Z-2243-2017Class IINon-Rebreather Oxygen MaskConvaTec, Inc
2017-06-14Z-2244-2017Class IINon-Rebreather Mask w 7ConvaTec, Inc
2017-06-14Z-2245-2017Class IIPediatricConvaTec, Inc
2017-06-14Z-2246-2017Class IIBaxter MiniCap Extended Life PD Transfer Set with Twist ClampBaxter Healthcare Corporation
2017-06-14Z-2247-2017Class IIKYPHONMedtronic Sofamor Danek USA Inc
2017-06-14Z-2248-2017Class IIBerchtold Chromophare F300 Exam Light CHROMOPHARE examination lights…Stryker Communications
2017-06-14Z-2249-2017Class IIArsenal Spinal Fixation SystemAlphatec Spine, Inc.
2017-06-14Z-2250-2017Class IISmartMonitor 2 PS/PSLCircadiance LLC
2017-06-14Z-2251-2017Class IIHudson RCITeleflex Medical
2017-06-14Z-2252-2017Class IIClear Flashback Needle 7cm x 18G AMC/4Argon Medical Devices, Inc
2017-06-14Z-2253-2017Class IIMACArrow International Inc
2017-06-14Z-2254-2017Class IIARROWg+ard BlueArrow International Inc
2017-06-14Z-2255-2017Class IIARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit The MACArrow International Inc
2017-06-14Z-2256-2017Class IIArrow Pressure Injectable PICC Kit The Arrow International Pressure…Arrow International Inc
2017-06-14Z-2257-2017Class IIArrow VPS Access Kit with Maximal Barrier Precautions for use with 5…Arrow International Inc
2017-06-14Z-2258-2017Class IIPressure Injectable Multi-Lumen Central Venous Catheterization Kit…Arrow International Inc
2017-06-14Z-2259-2017Class IIMACArrow International Inc
2017-06-14Z-2260-2017Class IITwo-Lumen Hemodialysis Catheterization Kit with Blue Flex TipArrow International Inc
2017-06-14Z-2261-2017Class IIPercutaneous Sheath Introducer Kit with ARROWg+ard BlueArrow International Inc
2017-06-14Z-2262-2017Class IIPressure Injectable ARROWArrow International Inc
2017-06-14Z-2263-2017Class IIARROWg+ard Blue PLUSArrow International Inc
2017-06-14Z-2264-2017Class IIARROWg+ard Blue MAC Two-Lumen Central Venous Access KitArrow International Inc
2017-06-14Z-2265-2017Class IIARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit The large-bore…Arrow International Inc
2017-06-14Z-2266-2017Class IIArrow PICC with Chlorag+ard Technology A PICC permits venous access…Arrow International Inc
2017-06-14Z-2267-2017Class IIPressure injectable Jugular Axillo-Subclavian Central CThe CG+Arrow…Arrow International Inc
2017-06-14Z-2268-2017Class IIArrow Pressure Injectable PICC Kit The Arrow International Pressure…Arrow International Inc
2017-06-14Z-2269-2017Class IIArrow Pressure Injectable PICC Kit The Arrow International Pressure…Arrow International Inc
2017-06-14Z-2270-2017Class IIARROWg+ard Blue Large-Bore Multi-Lumen CVC KitArrow International Inc
2017-06-14Z-2271-2017Class IIPressure Injectable Multi-Lumen Central Venous Catheterization Kit…Arrow International Inc
2017-06-14Z-2272-2017Class IIPressure Injectable Multi-Lumen Central Venous Catheterization Kit…Arrow International Inc
2017-06-14Z-2273-2017Class IIPressure Injectable Two-Lumen Central Venous Catheterization Kit with…Arrow International Inc
2017-06-14Z-2274-2017Class IIPressure Injectable ARROWg+ard Blue PLUSArrow International Inc
2017-06-14Z-2275-2017Class IIPressure Injectable Two-Lumen Central Venous Catheterization Kit with…Arrow International Inc
2017-06-14Z-2276-2017Class IIPressure Injectable Multi-Lumen Central Venous Catheterization Kit…Arrow International Inc
2017-06-14Z-2277-2017Class IIPressure Injectable Quad-Lumen Central Venous Catheterization Kit…Arrow International Inc
2017-06-14Z-2278-2017Class IIAGB+ Pressure Injectable Multi-Lumen CVC Kit intended to permit…Arrow International Inc
2017-06-14Z-2279-2017Class IIAGB+ Pressure Injectable Multi-Lumen CVC Kit The Arrow Central Venous…Arrow International Inc
2017-06-14Z-2280-2017Class IIArrow Pressure Injectable PICC Kit The Arrow International Pressure…Arrow International Inc
2017-06-14Z-2281-2017Class IIArrowArrow International Inc
2017-06-14Z-2282-2017Class IIArrow¿ VPS¿ Access Kit with Maximal Barrier Precautions for use with…Arrow International Inc
2017-06-14Z-2283-2017Class IIArrow¿ VPS¿ Access Kit with Maximal Barrier Precautions for use with…Arrow International Inc
2017-06-14Z-2284-2017Class IIArrowArrow International Inc
2017-06-14Z-2285-2017Class IIPressure Injectable ARROWArrow International Inc
2017-06-14Z-2286-2017Class IIArrow PICC with Chlorag+ard Technology The ArrowEVOLUTION Pressure…Arrow International Inc
2017-06-14Z-2287-2017Class IIArrow¿ Access Kit with Maximal Barrier Precautions for use with 4 FrArrow International Inc
2017-06-14Z-2288-2017Class IIArrowArrow International Inc
2017-06-14Z-2289-2017Class IIArrow¿ Access Kit with Maximal Barrier Precautions for use with 5 FrArrow International Inc
2017-06-14Z-2290-2017Class IIArrow¿ Access Kit with Maximal Barrier Precautions for use with 5 FrArrow International Inc
2017-06-14Z-2291-2017Class IIArrow PICC with Chlorag+ard Technology A PICC permits venous access…Arrow International Inc
2017-06-14Z-2292-2017Class II"Pressure Injectable Jugular Axillo-Subclavian Central CatheterArrow International Inc
2017-06-14Z-2293-2017Class IIPercutaneous Sheath Introducer Kit with Integral Hemostasis…Arrow International Inc
2017-06-14Z-2294-2017Class IIFemoral Arterial Line Catheterization Kit The Arrow¿ Arterial…Arrow International Inc
2017-06-14Z-2295-2017Class IIFemoral Arterial Line Catheterization Kit The Arrow¿ Arterial…Arrow International Inc
2017-06-14Z-2296-2017Class IIRadial Artery Catheterization Kit with Sharps Safety Features The…Arrow International Inc
2017-06-14Z-2297-2017Class IIRadial Artery Catheterization Kit with Sharps Safety Features The…Arrow International Inc
2017-06-14Z-2298-2017Class IIQuickFlash Radial Artery/Arterial Line Catheterization Kit The Arrow¿…Arrow International Inc
2017-06-14Z-2299-2017Class IIArterial Catheterization Kit with Maximal Barrier Precautions The…Arrow International Inc
2017-06-14Z-2300-2017Class IIArterial Catheterization Kit The Arrow¿ Arterial Catheterization…Arrow International Inc
2017-06-14Z-2301-2017Class IIQuickFlashArrow International Inc
2017-06-14Z-2302-2017Class IIArterial Line Kit with Sharps Safety Features and Maximal Barrier…Arrow International Inc
2017-06-14Z-2303-2017Class IIARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit The large-bore…Arrow International Inc
2017-06-14Z-2304-2017Class IIPercutaneous Sheath Introducer Kit with ARROWg+ard BlueArrow International Inc
2017-06-14Z-2305-2017Class IIARROWg+ard Blue PLUSArrow International Inc
2017-06-14Z-2306-2017Class IITwo-Lumen Hemodialysis Catheterization Kit with Blue FlexTipArrow International Inc
2017-06-14Z-2307-2017Class IIARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit…Arrow International Inc
2017-06-14Z-2308-2017Class IIARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit…Arrow International Inc
2017-06-14Z-2309-2017Class IIIBeekley Medical 0-SPOT Mammography Skin Markers REF 652Beekley Corporation
2017-06-14Z-2310-2017Class IIWillscher Vas Reapproximator SetCook Inc.
2017-06-14Z-2311-2017Class IIWillscher Vas SkewersCook Inc.
2017-06-14Z-2312-2017Class IIWillscher Vas Reapproximator PlateCook Inc.
2017-06-14Z-2313-2017Class IIEndoscopic Curved NeedleCook Inc.
2017-06-14Z-2314-2017Class IILapSac IntroducerCook Inc.
2017-06-14Z-2315-2017Class IILapSac Introducer SetCook Inc.
2017-06-14Z-2316-2017Class IIIMedTest DX Assayed Human Multi Sera Control Level 1Medtest Holdings, Inc.
2017-06-14Z-2317-2017Class IIDePuy Synthes various orthopedic instruments modified by UDePuy Orthopaedics, Inc.
2017-06-14Z-2318-2017Class IIVitality Spinal Fixation SystemZimmer Biomet Spine Inc.
2017-06-14Z-2319-2017Class IINexstim eXima NBS System Software version 2Nexstim PLC
2017-06-14Z-2320-2017Class IINBS System 4Nexstim PLC
2017-06-14Z-2321-2017Class IIResponse BandLoc 5OrthoPediatrics Corp
2017-06-07Z-2109-2017Class IIAngio WorkStationToshiba American Medical Systems Inc
2017-06-07Z-2151-2017Class IAbsorb Bioresorbable Vascular ScaffoldAbbott Vascular
2017-06-07Z-2152-2017Class IIPausch Uroview FD fluoroscopic X-ray system UDI numberHans Pausch Rontgengeratebau Gmbh
2017-06-07Z-2165-2017Class IIPointe Scientific Lactate DehydrogenaseMedtest Holdings, Inc.
2017-06-07Z-2166-2017Class IISHBG IMMULITE 2000/IMMULITE 2000 XPi For the in vitro diagnostic use…Siemens Healthcare Diagnostics, Inc.
2017-06-07Z-2167-2017Class IIILiquid Urine Control Level 3 For Professional Use in the quality…Randox Laboratories
2017-06-07Z-2168-2017Class IIIAIA-PACK TPOAb CONTROL SETTosoh Bioscience, Inc.
2017-06-07Z-2169-2017Class IIIAIA-PACK TgAb CONTROL SETTosoh Bioscience, Inc.
2017-06-07Z-2170-2017Class IIArrowArrow International Inc
2017-06-07Z-2171-2017Class II1000 ml CanisterKCI USA, INC.
2017-06-07Z-2173-2017Class IIElecsys PreciControl Varia 3Roche Diagnostics Corporation
2017-06-07Z-2174-2017Class IIEndopath ETS-FLEX Endoscopic Articulating Linear CutterEthicon Endo-Surgery Inc
2017-06-07Z-2175-2017Class IINMT Patient CablePhilips Electronics North America Corporation
2017-06-07Z-2176-2017Class IIAbbVie PEGAbbVie Inc.
2017-06-07Z-2177-2017Class IIAbbVie PEGAbbVie Inc.
2017-06-07Z-2178-2017Class IIAbbVie PEGAbbVie Inc.
2017-06-07Z-2179-2017Class IITable Patient Step on RFX/SFXGE Healthcare, LLC
2017-06-07Z-2180-2017Class IIDolphin Inflation DeviceVascular Solutions, Inc.
2017-06-07Z-2197-2017Class IIThe Acumed Slide-Loc Anatomic Radial Head System is intended for use…Acumed LLC
2017-06-07Z-2198-2017Class IIReusable instruments in the KneeZimmer Biomet, Inc.
2017-06-07Z-2199-2017Class IIAdenovirusCell Marque Corporation
2017-06-07Z-2200-2017Class IIEstrogen ReceptorCell Marque Corporation
2017-06-07Z-2201-2017Class IIEstrogen ReceptorCell Marque Corporation
2017-06-07Z-2202-2017Class IIHCell Marque Corporation
2017-06-07Z-2203-2017Class IIHer2/NeuCell Marque Corporation
2017-06-07Z-2204-2017Class IIHer2/NeuCell Marque Corporation
2017-06-07Z-2205-2017Class IIHerpes Simplex Virus ICell Marque Corporation
2017-06-07Z-2206-2017Class IIHerpes Simplex Virus II 0Cell Marque Corporation
2017-06-07Z-2207-2017Class IISV40Cell Marque Corporation
2017-06-07Z-2208-2017Class IIVaricella Zoster Virus 7Cell Marque Corporation
2017-06-07Z-2209-2017Class IICD117Cell Marque Corporation
2017-06-07Z-2210-2017Class IIHHV-8Cell Marque Corporation
2017-06-07Z-2211-2017Class IIDraco Enzymatic Deep-Cleaning Pad with Enzymatic Detergent Catalogue…Madison Polymeric Engineering
2017-06-07Z-2212-2017Class IIISabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081…Acumedia Manufacturers, Inc.
2017-06-07Z-2213-2017Class IIINutrient GelatinAcumedia Manufacturers, Inc.
2017-06-07Z-2214-2017Class IIIBeef Extract PowderAcumedia Manufacturers, Inc.
2017-06-07Z-2215-2017Class IIAFFIXUS Hip Fracture Nail Product Usage: The Hip Fracture Nail System…Zimmer Biomet, Inc.
2017-06-07Z-2216-2017Class IIModular Hybrid Glenoid Base Large for the Comprehensive Shoulder…Zimmer Biomet, Inc.
2017-06-07Z-2217-2017Class IICardinalCardinal Scale Mfg Co
2017-06-07Z-2218-2017Class IIAssist Bed RailInvacare Corporation
2017-06-07Z-2219-2017Class IIExact Sciences Sample Mixer 2Exact Sciences Corporation
2017-05-31Z-2051-2017Class IHeartMate¿ II LVAS with Pocket ControllerThoratec Corporation
2017-05-31Z-2052-2017Class IHeartMate¿ II LVAS with Pocket ControllerThoratec Corporation
2017-05-31Z-2053-2017Class IHeartMate¿ II LVAS with Pocket ControllerThoratec Corporation
2017-05-31Z-2117-2017Class IIAmplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia…Medtronic Inc., Cardiac Rhythm and Heart Failure
2017-05-31Z-2118-2017Class I10-1335MEBI Patient Care, Inc.
2017-05-31Z-2119-2017Class I10-1398MEBI Patient Care, Inc.
2017-05-31Z-2120-2017Class IIStatLock¿ IV Premium Catheter Stabilization DeviceBard Access Systems Inc.
2017-05-31Z-2121-2017Class IIIPointe Scientific Chemistry Controls Level I and II LEVl: Amber glass…Medtest Holdings, Inc.
2017-05-31Z-2122-2017Class IICSICardiovascular Systems Inc
2017-05-31Z-2123-2017Class IIMerge Cardio softwareMerge Healthcare, Inc.
2017-05-31Z-2124-2017Class IIMicroalbumin ReagentBeckman Coulter Inc.
2017-05-31Z-2125-2017Class IILegacy Full Contour Laboratory Abutment: 3Implant Direct Sybron Manufacturing, LLC
2017-05-31Z-2126-2017Class IICeftriaxone TX 32 US S30BioMerieux SA
2017-05-31Z-2127-2017Class IIPE CONNECTOR 3/8 STRAIGHT 20/BXTeleflex Medical
2017-05-31Z-2128-2017Class IIPE CONNECTOR 3/8 Y 20/BXTeleflex Medical
2017-05-31Z-2129-2017Class IIPE CONNECTOR 5 IN 1 20/BXTeleflex Medical
2017-05-31Z-2130-2017Class IIINFANT 20/BXTeleflex Medical
2017-05-31Z-2131-2017Class IIJackson-Pratt Hemaduct Cardiothoracic Silicone Round DrainCardinal Health 200, LLC
2017-05-31Z-2132-2017Class IIJackson-Pratt Hemaduct Silicone Flat DrainCardinal Health 200, LLC
2017-05-31Z-2133-2017Class IIJackson-Pratt Hemaduct Silicone Flat DrainCardinal Health 200, LLC
2017-05-31Z-2134-2017Class IIJackson-Pratt Hemaduct Silicone Round DrainCardinal Health 200, LLC
2017-05-31Z-2135-2017Class IIJackson-Pratt Hemaduct Silicone Round DrainCardinal Health 200, LLC
2017-05-31Z-2136-2017Class IIJackson-Pratt Hemaduct Silicone Round DrainCardinal Health 200, LLC
2017-05-31Z-2137-2017Class IIJackson-Pratt Hemaduct Silicone Round DrainCardinal Health 200, LLC
2017-05-31Z-2138-2017Class IIJackson-Pratt Hemaduct Silicone Round DrainCardinal Health 200, LLC
2017-05-31Z-2139-2017Class IIJackson-Pratt Hemaduct Silicone Round DrainCardinal Health 200, LLC
2017-05-31Z-2140-2017Class IIJackson-Pratt PVC Round DrainCardinal Health 200, LLC
2017-05-31Z-2141-2017Class IIJackson-Pratt Silicone Flat DrainCardinal Health 200, LLC
2017-05-31Z-2142-2017Class IIJackson-Pratt Silicone Flat DrainCardinal Health 200, LLC
2017-05-31Z-2143-2017Class IIJackson-Pratt Silicone Flat DrainCardinal Health 200, LLC
2017-05-31Z-2144-2017Class IIJackson-Pratt Silicone Flat DrainCardinal Health 200, LLC
2017-05-31Z-2145-2017Class IIJackson-Pratt Silicone Round DrainCardinal Health 200, LLC
2017-05-31Z-2146-2017Class IIJackson-Pratt Silicone Round DrainCardinal Health 200, LLC
2017-05-31Z-2147-2017Class IIJackson-Pratt Silicone Round DrainCardinal Health 200, LLC
2017-05-31Z-2148-2017Class IIJackson-Pratt Silicone Round DrainCardinal Health 200, LLC
2017-05-31Z-2149-2017Class IIJackson-Pratt Silicone Flat DrainCardinal Health 200, LLC
2017-05-31Z-2150-2017Class IIJackson-Pratt Silicone Flat DrainCardinal Health 200, LLC
2017-05-31Z-2153-2017Class IIOpteryx Variable Rescue ScrewInnovasis, Inc
2017-05-31Z-2155-2017Class IICytoGuard Closed Luer ConnectorB Braun Medical Inc
2017-05-31Z-2156-2017Class IIAXIOM SensisSiemens Medical Solutions USA, Inc
2017-05-31Z-2157-2017Class IIUniCel DxH 800 Coulter Cellular Analysis SystemBeckman Coulter Inc.
2017-05-31Z-2158-2017Class IIUniCel DxH 600 Coulter Cellular Analysis SystemBeckman Coulter Inc.
2017-05-31Z-2159-2017Class IIMesaLabs Conductivity Standard SolutionMesa Laboratories, Inc.
2017-05-31Z-2160-2017Class IIHoffmann LRF Safety ClipStryker Howmedica Osteonics Corp.

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