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Medical device recalls reported in 2016

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ReportedRecallClassProductFirm
2016-07-20Z-2140-2016Class IIThe PCA 3 system cam be used in a wide range of clinical settingsHospira Inc.
2016-07-20Z-2141-2016Class IILifeCare PCA infusion system with Hospira MedNet software allows…Hospira Inc.
2016-07-20Z-2142-2016Class IIThe LifeCare Pump Model 4200 PCA Infuser makes possible the practical…Hospira Inc.
2016-07-20Z-2143-2016Class IIIenGen Laboratory Automation SystemOrtho-Clinical Diagnostics
2016-07-20Z-2144-2016Class IIMerge OfficePACS softwareMerge Healthcare, Inc.
2016-07-20Z-2145-2016Class IIIVITROS Immunodiagnostic Products AFP Reagent PackORTHO-CLINICAL DIAGNOSTICS
2016-07-20Z-2146-2016Class IIQuickSlide MGS-80Hardy Diagnostics
2016-07-20Z-2147-2016Class IIAORTIC ARCH CANNULASorin Group USA, Inc.
2016-07-20Z-2148-2016Class IIIBreathe Right ClearGSK Consumer Healthcare
2016-07-20Z-2149-2016Class IIOptical Surface Monitoring System{OSMSVarian Medical Systems, Inc.
2016-07-20Z-2150-2016Class IIOptical Surface Monitoring System{Align RT Plus} This is used on…Varian Medical Systems, Inc.
2016-07-20Z-2151-2016Class IINovaPACS  versions 7Novarad Corporation
2016-07-20Z-2152-2016Class II6Synthes (USA) Products LLC
2016-07-20Z-2153-2016Class II6Synthes (USA) Products LLC
2016-07-20Z-2154-2016Class II7Synthes (USA) Products LLC
2016-07-20Z-2155-2016Class II4Synthes (USA) Products LLC
2016-07-20Z-2156-2016Class II4Synthes (USA) Products LLC
2016-07-20Z-2157-2016Class II4Synthes (USA) Products LLC
2016-07-20Z-2158-2016Class II3Synthes (USA) Products LLC
2016-07-20Z-2159-2016Class IIMerge OfficePACS softwareMerge Healthcare, Inc.
2016-07-20Z-2160-2016Class IITarget Detachable Coils: TARGET 360 NANO 1 MM X 2 CM MODEL Number:…Stryker Neurovascular
2016-07-20Z-2161-2016Class IITarget Detachable Coils: TARGET 360 NANO 1 MM X 3 CM MODEL Number:…Stryker Neurovascular
2016-07-20Z-2162-2016Class IITarget Detachable Coils: TARGET 360 NANO 1Stryker Neurovascular
2016-07-20Z-2163-2016Class IITarget Detachable Coils: TARGET 360 NANO 1Stryker Neurovascular
2016-07-20Z-2164-2016Class IITarget Detachable Coils: TARGET 360 NANO 1Stryker Neurovascular
2016-07-20Z-2165-2016Class IITarget Detachable Coils: TARGET HELICAL NANO 1 MM X 1 CM MODEL…Stryker Neurovascular
2016-07-20Z-2166-2016Class IITarget Detachable Coils: TARGET HELICAL NANO 1 MM X 2 CM MODEL…Stryker Neurovascular
2016-07-20Z-2167-2016Class IITarget Detachable Coils: TARGET HELICAL NANO 1 MM X 3 CM MODEL…Stryker Neurovascular
2016-07-20Z-2168-2016Class IITarget Detachable Coils: TARGET HELICAL NANO 1Stryker Neurovascular
2016-07-20Z-2169-2016Class IITarget Detachable Coils: TARGET HELICAL NANO 1Stryker Neurovascular
2016-07-20Z-2170-2016Class IITarget Detachable Coils: TARGET HELICAL NANO 1Stryker Neurovascular
2016-07-20Z-2171-2016Class IITarget Detachable Coils: TARGET HELICAL NANO 1Stryker Neurovascular
2016-07-20Z-2172-2016Class IITarget Detachable Coils: TARGET 360 NANO 2MM X 3CM MODEL…Stryker Neurovascular
2016-07-20Z-2173-2016Class IITarget Detachable Coils: TARGET 360 NANO 2MM X 4CM MODEL…Stryker Neurovascular
2016-07-20Z-2174-2016Class IITarget Detachable Coils: TARGET 360 NANO 2Stryker Neurovascular
2016-07-20Z-2175-2016Class IITarget Detachable Coils: TARGET 360 NANO 3MM X 4CM MODEL…Stryker Neurovascular
2016-07-20Z-2176-2016Class IITarget Detachable Coils: TARGET 360 NANO 3MM X 6CM MODEL…Stryker Neurovascular
2016-07-20Z-2177-2016Class IITarget Detachable Coils: TARGET 360 NANO 3Stryker Neurovascular
2016-07-20Z-2178-2016Class IITarget Detachable Coils: TARGET HELICAL NANO 2MM X 2CM MODEL…Stryker Neurovascular
2016-07-20Z-2179-2016Class IITarget Detachable Coils: TARGET HELICAL NANO 2MM X 3CM MODEL…Stryker Neurovascular
2016-07-20Z-2180-2016Class IITarget Detachable Coils: TARGET HELICAL NANO 2MM X 4CM MODEL…Stryker Neurovascular
2016-07-20Z-2181-2016Class IITarget Detachable Coils: TARGET HELICAL NANO 2MM X 6CM MODEL…Stryker Neurovascular
2016-07-20Z-2182-2016Class IITarget Detachable Coils: TARGET HELICAL NANO 2Stryker Neurovascular
2016-07-20Z-2183-2016Class IITarget Detachable Coils: TARGET HELICAL NANO 2Stryker Neurovascular
2016-07-20Z-2184-2016Class IITarget Detachable Coils: TARGET HELICAL NANO 3MM X 4CM MODEL…Stryker Neurovascular
2016-07-20Z-2185-2016Class IITarget Detachable Coils: TARGET HELICAL NANO 3MM X 4CM MODEL…Stryker Neurovascular
2016-07-20Z-2186-2016Class IITarget Detachable Coils: TARGET HELICAL NANO 3MM X 6CM MODEL…Stryker Neurovascular
2016-07-20Z-2187-2016Class IITarget Detachable Coils: TARGET HELICAL NANO 3MM X 8CM MODEL…Stryker Neurovascular
2016-07-20Z-2189-2016Class IIScrewdriver BladeSynthes (USA) Products LLC
2016-07-20Z-2190-2016Class IIPart # 313Synthes (USA) Products LLC
2016-07-20Z-2191-2016Class IIPart # SD313Synthes (USA) Products LLC
2016-07-20Z-2192-2016Class IIPart # SD313Synthes (USA) Products LLC
2016-07-20Z-2193-2016Class IIPart #311Synthes (USA) Products LLC
2016-07-20Z-2194-2016Class IIPart # 313Synthes (USA) Products LLC
2016-07-20Z-2195-2016Class IIPart # 313Synthes (USA) Products LLC
2016-07-20Z-2196-2016Class IIPart #313Synthes (USA) Products LLC
2016-07-20Z-2197-2016Class IIPart #313Synthes (USA) Products LLC
2016-07-20Z-2198-2016Class IIPart # 313Synthes (USA) Products LLC
2016-07-20Z-2199-2016Class IIPart # 313Synthes (USA) Products LLC
2016-07-20Z-2200-2016Class IIMedtronicMedtronic Inc., Cardiac Rhythm and Heart Failure
2016-07-20Z-2201-2016Class IIFemoral Arterial Line Catheterization Kit with Sharps Safety Features…Arrow International Inc
2016-07-20Z-2202-2016Class IIFemoral Arterial Line Catheterization Kit with Sharps Safety Features…Arrow International Inc
2016-07-20Z-2203-2016Class IIIcobas¿ Liat Influenza A/B Quality Control KitRoche Molecular Systems, Inc.
2016-07-20Z-2204-2016Class II5Stryker Instruments Div. of Stryker Corporation
2016-07-20Z-2205-2016Class II6Stryker Instruments Div. of Stryker Corporation
2016-07-20Z-2211-2016Class IIMammotome Revolve Dual Vacuum Assist Biopsy System Model number:…Devicor Medical Products Inc
2016-07-13Z-1908-2016Class IABG-HM-1 Hummi Micro Draw Blood Transfer DeviceHummingbird Med
2016-07-13Z-2004-2016Class IIMusculoskeletal Transplant FoundationMusculoskeletal Transplant Foundation, Inc.
2016-07-13Z-2082-2016Class IIMedtronic 0-arm Imaging mobile x-ray systemMedtronic Navigation, Inc.-Littleton
2016-07-13Z-2083-2016Class IIMedtronic Navigation O-arm 02 surgical x-ray imaging systemMedtronic Navigation, Inc.-Littleton
2016-07-13Z-2119-2016Class IIIVITROS Chemistry Products Calibrator Kit 29Ortho-Clinical Diagnostics
2016-07-13Z-2120-2016Class IIThe ZYTO Tower is the input device to program the software with…ZYTO Technologies, Inc.
2016-07-13Z-2121-2016Class IIThe ZYTO Select and ZYTO Elite software programs are used to rank…ZYTO Technologies, Inc.
2016-07-13Z-2122-2016Class IICovidien Cytosponge Cell Collection KitCovidien, LLC
2016-07-13Z-2123-2016Class IICovidien Cytosponge Cell Collection DeviceCovidien, LLC
2016-07-13Z-2124-2016Class IIMagnetic Resonance System G-scan BrioEsaote S.p.A.
2016-07-13Z-2125-2016Class IIMedtronicMedtronic Inc., Cardiac Rhythm and Heart Failure
2016-07-13Z-2126-2016Class IIBattery Power Line II Battery OscillatorThe Anspach Effort, Inc.
2016-07-13Z-2127-2016Class IINovation Press-Fit Splined RDDExactech, Inc.
2016-07-13Z-2128-2016Class IINovation Press-Fit Splined RDDExactech, Inc.
2016-07-13Z-2129-2016Class IIPoleStar systemMedtronic Navigation
2016-07-13Z-2130-2016Class IIThe System 83 PlusCustom Ultrasonics, Inc.
2016-07-13Z-2131-2016Class IIGE HealthcareGE Healthcare, LLC
2016-07-13Z-2132-2016Class IIItem # 4042-CPR Rescue KitLifeline First Aid LLC
2016-07-13Z-2133-2016Class II5195GMLifeline First Aid LLC
2016-07-13Z-2134-2016Class IIImage1 SPIES X-LINK Camera Control UnitKarl Storz Endoscopy
2016-07-13Z-2135-2016Class IIMEXL-3010/A5- Vantage Titan 3T Magnetic Resonance Imaging System…Toshiba American Medical Systems Inc
2016-07-13Z-2136-2016Class IIARROWArrow International Inc
2016-07-13Z-2137-2016Class IIHeaterBaum Foot & Ankle Heating PadErgoactives, Llc
2016-07-13Z-2138-2016Class IISynthes Ti Button Plate 7 HolesSynthes (USA) Products LLC
2016-07-06Z-2049-2016Class IIPrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement…Baxter Healthcare Corp.
2016-07-06Z-2050-2016Class IIBigger-Better-Bladder With 3/8" ID tubingCirculatory Technology Inc
2016-07-06Z-2051-2016Class IIViperWire Advance Peripheral Guide WireCardiovascular Systems Inc
2016-07-06Z-2052-2016Class IIMOSAIQ Oncology Information SystemElekta, Inc.
2016-07-06Z-2053-2016Class IISodium Chloride Inhalation SolutionNephron Pharmaceuticals Corp.
2016-07-06Z-2054-2016Class IISodium Chloride Inhalation SolutionNephron Pharmaceuticals Corp.
2016-07-06Z-2055-2016Class IISymbiq One Channel InfuserHospira Inc.
2016-07-06Z-2056-2016Class IISymbiq Two Channel InfuserHospira Inc.
2016-07-06Z-2057-2016Class IIdynarex Specimen ContainersDynarex Corporation
2016-07-06Z-2058-2016Class II*** 1) Product labeled in part: List NoHospira Inc.
2016-07-06Z-2059-2016Class II*** 1) Product labeled in part: 14951-48Hospira Inc.
2016-07-06Z-2060-2016Class II*** 1) Product labeled in part: List NoHospira Inc.
2016-07-06Z-2061-2016Class II*** 1) Product labeled in part: 19734-28Hospira Inc.
2016-07-06Z-2062-2016Class II*** 1) Product labeled in part: 19683-28Hospira Inc.
2016-07-06Z-2063-2016Class IILiquid stable 2 part Homocysteine ReagentMedtest Holdings, Inc.
2016-07-06Z-2064-2016Class IIAlaris System PC Unit Model 8015 with software versions 9CareFusion 303, Inc.
2016-07-06Z-2065-2016Class IIBronchoscope Intended to provide optical visualization of and…Pentax Medical Company
2016-07-06Z-2066-2016Class IICholedocho-Nephroscope Intended to provide optical visualization of…Pentax Medical Company
2016-07-06Z-2067-2016Class IICholedochoscope Intended to provide optical visualization of and…Pentax Medical Company
2016-07-06Z-2068-2016Class IIColonoscope Intended to provide optical visualization of and…Pentax Medical Company
2016-07-06Z-2069-2016Class IIConfocal GI Scope Intended to provide optical visualization of an…Pentax Medical Company
2016-07-06Z-2070-2016Class IICystoscope Intended to provide optical visualization of and…Pentax Medical Company
2016-07-06Z-2071-2016Class IIGastroscope Intended to provide optical visualization of and…Pentax Medical Company
2016-07-06Z-2072-2016Class IIIntubation Scope Intended to provide optical visualization ofPentax Medical Company
2016-07-06Z-2073-2016Class IILaryngo Stroboscope Product Usage Intended to provide optical…Pentax Medical Company
2016-07-06Z-2074-2016Class IINaso-Pharyngo-Laryngoscope Intended to provide optical visualization…Pentax Medical Company
2016-07-06Z-2075-2016Class IISignmoidoscope Intended to provide optical visualization ofPentax Medical Company
2016-07-06Z-2076-2016Class IIUltrasound Bronchoscope Intended to provide optical visualization ofPentax Medical Company
2016-07-06Z-2077-2016Class IIUltrasound Gastroscope Intended to provide optical visualization ofPentax Medical Company
2016-07-06Z-2078-2016Class IIUreteroscope Intended to provide optical visualization of and…Pentax Medical Company
2016-07-06Z-2079-2016Class IIEsophagoscope Gastrointestinal TractPentax Medical Company
2016-07-06Z-2080-2016Class IISmall Bowel Scope Gastrointestinal TractPentax Medical Company
2016-07-06Z-2081-2016Class IICENTURION Vision SystemAlcon Research, Ltd.
2016-07-06Z-2084-2016Class IIK-wireIntegra LifeSciences Corp.
2016-07-06Z-2085-2016Class IISaw Sagittal Catalog Number: ES 300Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
2016-07-06Z-2086-2016Class IICadence Size 5 Left Tibial Tray ImplantIntegra LifeSciences Corp.
2016-07-06Z-2087-2016Class IIHettich Centrifuge Modules: StreamLAB Centrifuge ModuleSiemens Healthcare Diagnostics Inc.
2016-07-06Z-2088-2016Class IISyngoSiemens Medical Solutions USA, Inc
2016-07-06Z-2089-2016Class IIIMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK…CMP Industries, Llc
2016-07-06Z-2090-2016Class IILEGIONSmith & Nephew, Inc.
2016-07-06Z-2091-2016Class IILEGIONSmith & Nephew, Inc.
2016-07-06Z-2092-2016Class IILEGIONSmith & Nephew, Inc.
2016-07-06Z-2093-2016Class IILEGIONSmith & Nephew, Inc.
2016-07-06Z-2094-2016Class IILEGIONSmith & Nephew, Inc.
2016-07-06Z-2095-2016Class IILEGIONSmith & Nephew, Inc.
2016-07-06Z-2097-2016Class IIIMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK…CMP Industries, Llc
2016-07-06Z-2098-2016Class IIIMPAK ELASTIC ACRYLIC RESIN POWDER & LIQUIDCMP Industries, Llc
2016-07-06Z-2099-2016Class IIDako HER2 CISH pharmDx KitDako North America Inc.
2016-07-06Z-2100-2016Class IILIFEPAK CR Plus and/or LIFEPAK EXPRESS are Automatic External…Physio-Control, Inc.
2016-07-06Z-2101-2016Class IIAluminum crutch under the following labels: 1) Aluminum crutchMedical Depot Inc.
2016-07-06Z-2102-2016Class IIEZ adjust aluminum crutch under the following labels: 1) EZ adjust…Medical Depot Inc.
2016-07-06Z-2103-2016Class IIUniversal aluminum crutchMedical Depot Inc.
2016-07-06Z-2104-2016Class IIUniversal Quick Adjust under the following labels: 1) Aluminum crutchMedical Depot Inc.
2016-07-06Z-2105-2016Class IIUniversal Quick Adjust under the following labels: 1) Aluminum crutchMedical Depot Inc.
2016-07-06Z-2106-2016Class IIDirect Supply aluminum crutchMedical Depot Inc.
2016-07-06Z-2107-2016Class IISYNGO Breast CareSiemens Medical Solutions USA, Inc
2016-07-06Z-2108-2016Class IIAccess Free T3 AssayBeckman Coulter Inc.
2016-07-06Z-2109-2016Class IIBig Bore Oncology tomography X-ray system scannerPhilips Medical Systems (Cleveland) Inc
2016-07-06Z-2110-2016Class IIBig Bore Radiology tomography X-ray system scannerPhilips Medical Systems (Cleveland) Inc
2016-07-06Z-2111-2016Class IIBrilliance CT Big Bore OncologyPhilips Medical Systems (Cleveland) Inc
2016-07-06Z-2112-2016Class IIBrilliance iCT model #728306Philips Medical Systems (Cleveland) Inc
2016-07-06Z-2113-2016Class IIIngenuity FlexPhilips Medical Systems (Cleveland) Inc
2016-07-06Z-2114-2016Class IIIngenuity Core 128Philips Medical Systems (Cleveland) Inc
2016-07-06Z-2115-2016Class IIIngenuity CorePhilips Medical Systems (Cleveland) Inc
2016-07-06Z-2116-2016Class IIBrilliance 64Philips Medical Systems (Cleveland) Inc
2016-07-06Z-2117-2016Class IIIngenuity Core-Computed Tomography X-ray system Product Usage: The…Philips Medical Systems (Cleveland) Inc
2016-07-06Z-2118-2016Class IIIngenuity Core 128-Computed Tomography X-ray system Product Usage:…Philips Medical Systems (Cleveland) Inc
2016-06-29Z-2005-2016Class IIBiograph mCT-X 4RSiemens Medical Solutions USA Inc.
2016-06-29Z-2006-2016Class IIBiograph 16 TruePoint TVSiemens Medical Solutions USA Inc.
2016-06-29Z-2007-2016Class IIBIOGRAPH 40Siemens Medical Solutions USA Inc.
2016-06-29Z-2008-2016Class IIBIOGRAPH 40 TruePointSiemens Medical Solutions USA Inc.
2016-06-29Z-2009-2016Class IIBIOGRAPH 40 TruePoint w/TrueVSiemens Medical Solutions USA Inc.
2016-06-29Z-2010-2016Class IIBIOGRAPH 40-3R to 64-3R UpgradeSiemens Medical Solutions USA Inc.
2016-06-29Z-2011-2016Class IIBiograph 6 TP 3R to 4R UpgradeSiemens Medical Solutions USA Inc.
2016-06-29Z-2012-2016Class IIBIOGRAPH 6 TruePointSiemens Medical Solutions USA Inc.
2016-06-29Z-2013-2016Class IIBIOGRAPH 64Siemens Medical Solutions USA Inc.
2016-06-29Z-2014-2016Class IIBIOGRAPH 64-3R TruePointSiemens Medical Solutions USA Inc.
2016-06-29Z-2015-2016Class IIBIOGRAPH 64-4R TruePoint w/TrueVSiemens Medical Solutions USA Inc.
2016-06-29Z-2016-2016Class IIBIOGRAPH 6-4R TruePoint w/TrueVSiemens Medical Solutions USA Inc.
2016-06-29Z-2017-2016Class IIBiograph Sys 16-3R to 16-4R upgradeSiemens Medical Solutions USA Inc.
2016-06-29Z-2018-2016Class IIBIOGRAPH Sys 40-3R to 40-4RSiemens Medical Solutions USA Inc.
2016-06-29Z-2019-2016Class IIBIOGRAPH SYS 64-3R to 64-4RSiemens Medical Solutions USA Inc.
2016-06-29Z-2020-2016Class IIBIOGRAPH mCT Flow 20-3RSiemens Medical Solutions USA Inc.
2016-06-29Z-2021-2016Class IIBIOGRAPH mCT Flow 20-4RSiemens Medical Solutions USA Inc.
2016-06-29Z-2022-2016Class IIBIOGRAPH mCT Flow 40-3RSiemens Medical Solutions USA Inc.
2016-06-29Z-2023-2016Class IIBIOGRAPH mCT Flow 40-4RSiemens Medical Solutions USA Inc.
2016-06-29Z-2024-2016Class IIBIOGRAPH mCT Flow 64-3RSiemens Medical Solutions USA Inc.
2016-06-29Z-2025-2016Class IIBIOGRAPH mCT Flow 64-4RSiemens Medical Solutions USA Inc.
2016-06-29Z-2026-2016Class IIBIOGRAPH mCT Flow Edge-3RSiemens Medical Solutions USA Inc.
2016-06-29Z-2027-2016Class IIBIOGRAPH mCT Flow Edge-4RSiemens Medical Solutions USA Inc.
2016-06-29Z-2028-2016Class IIBIOGRAPH mCT SSiemens Medical Solutions USA Inc.
2016-06-29Z-2029-2016Class IIBIOGRAPH mCT SSiemens Medical Solutions USA Inc.
2016-06-29Z-2030-2016Class IIBiograph mCT-SSiemens Medical Solutions USA Inc.
2016-06-29Z-2031-2016Class IIBiograph mCT-SSiemens Medical Solutions USA Inc.
2016-06-29Z-2032-2016Class IIBiograph mCT-SSiemens Medical Solutions USA Inc.
2016-06-29Z-2033-2016Class IIBiograph mCT-SSiemens Medical Solutions USA Inc.
2016-06-29Z-2034-2016Class IIBiograph mCT-X 3RSiemens Medical Solutions USA Inc.
2016-06-29Z-2035-2016Class IISYS IVKSiemens Medical Solutions USA Inc.
2016-06-29Z-2036-2016Class IISYS IVKSiemens Medical Solutions USA Inc.
2016-06-29Z-2037-2016Class IIBiograph 16 TruePointSiemens Medical Solutions USA Inc.
2016-06-29Z-2038-2016Class IISIOOA ICell Marque Corporation
2016-06-29Z-2039-2016Class IIICytoVision Image Analysis and Capture SystemLeica Biosystems Richmond Inc.
2016-06-29Z-2040-2016Class IIHistoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The…Immuno-Mycologics, Inc
2016-06-29Z-2041-2016Class IISiemens Healthcare ADVIA Centaur Tnl-Ultra AssaySiemens Healthcare Diagnostics, Inc
2016-06-29Z-2042-2016Class IISharpoint Polypropylene Blue Monofilament 6"/15cm 9-0 USPSSC- Surgical Specialties Corporation
2016-06-29Z-2043-2016Class IIFujifilm Synapse PACS software version 4Fujifilm Medical Systems U.S.A., Inc.
2016-06-29Z-2044-2016Class IICrit Line in a ClipFresenius Medical Care Renal Therapies Group, LLC
2016-06-29Z-2045-2016Class IIMyriad handpiece Tissue morcellatorNico Corp.
2016-06-29Z-2046-2016Class II6534-08N InterActive¿ Implant Open-Tray Transfer Narrow Part Number:…Implant Direct Sybron Manufacturing, LLC
2016-06-29Z-2047-2016Class IIGerm TerminatorCeg Enterprises Llc

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