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Medical device recalls reported in 2014

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ReportedRecallClassProductFirm
2014-08-20Z-2167-2014Class IIEsaote PA230E Transducer A portable and cart base ultrasound system…Biosound Esaote, Inc.
2014-08-20Z-2168-2014Class IIINanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic…Nanosphere, Inc.
2014-08-20Z-2169-2014Class II5 mL Reaction VesselsAbbott Molecular
2014-08-20Z-2170-2014Class IIVerigene Gram-Negative Blood Culture Nucleic Acid TestNanosphere, Inc.
2014-08-20Z-2171-2014Class IIEndoWrist Stapler System User Manual Addendum and Wall ChartIntuitive Surgical, Inc.
2014-08-20Z-2172-2014Class IIMedtronic Ascenda Intrathecal Catheter models 8780 and 8781Medtronic Neuromodulation
2014-08-20Z-2173-2014Class IIMedtronic MiniMed Implantable Insulin PumpMedtronic MiniMed Inc.
2014-08-20Z-2174-2014Class IISiemens Linear Accelerators of type ARTISTESiemens Medical Solutions USA, Inc
2014-08-20Z-2175-2014Class IIDX-D 600AGFA Healthcare Corp.
2014-08-20Z-2176-2014Class IIIAgfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is…AGFA Healthcare Corp.
2014-08-20Z-2177-2014Class IIKodak DirectView DR 7500 Diagnostic X-Ray System Product Usage: The…Carestream Health, Inc.
2014-08-20Z-2178-2014Class IIIRadiomat M+ NIF 14 x 17AGFA Healthcare Corp.
2014-08-20Z-2179-2014Class IIMedtronic MiniMed Guardian MonitorMedtronic MiniMed Inc.
2014-08-20Z-2180-2014Class IISiemens Syngo RT Therapist and Syngo RT Oncologist intended use of…Siemens Medical Solutions USA, Inc
2014-08-20Z-2181-2014Class IILuma Wrap Phototherapy Swaddler is designed to provide centered and…Beevers Manufacturing & Supply, Inc.
2014-08-20Z-2182-2014Class IIIntegra NewPort MIS System Model NoIntegra LifeSciences Corp.
2014-08-20Z-2183-2014Class IIVITROS¿ Immunodiagnostic Products CA 19-9 Calibrators and Reagent…ORTHO-CLINICAL DIAGNOSTICS
2014-08-20Z-2184-2014Class IICodman CertasCodman & Shurtleff, Inc.
2014-08-20Z-2185-2014Class IICodman CertasCodman & Shurtleff, Inc.
2014-08-20Z-2186-2014Class IICodman CertasCodman & Shurtleff, Inc.
2014-08-20Z-2187-2014Class IICodman CertasCodman & Shurtleff, Inc.
2014-08-20Z-2188-2014Class IICodman CertasCodman & Shurtleff, Inc.
2014-08-20Z-2189-2014Class IICodman CertasCodman & Shurtleff, Inc.
2014-08-20Z-2190-2014Class IICodman CertasCodman & Shurtleff, Inc.
2014-08-20Z-2191-2014Class IICodman CertasCodman & Shurtleff, Inc.
2014-08-20Z-2193-2014Class IIPrismaflex TPE 2000 setGambro Renal Products, Incorporated
2014-08-20Z-2194-2014Class IIPrisma TPE 2000 setGambro Renal Products, Incorporated
2014-08-20Z-2195-2014Class IIPrisma M 60 PRE setGambro Renal Products, Incorporated
2014-08-20Z-2196-2014Class IIPrisma M60 POSTDILUTION setGambro Renal Products, Incorporated
2014-08-20Z-2197-2014Class IIPrisma M 100 PRE setGambro Renal Products, Incorporated
2014-08-20Z-2198-2014Class IIPrisma M100 setGambro Renal Products, Incorporated
2014-08-20Z-2199-2014Class IIPrisma M100 PRE pump infusion setGambro Renal Products, Incorporated
2014-08-20Z-2200-2014Class IIPrisma HF1000 presetGambro Renal Products, Incorporated
2014-08-20Z-2201-2014Class IIPrismaflex M60 setGambro Renal Products, Incorporated
2014-08-20Z-2202-2014Class IIPrismaflex M100Gambro Renal Products, Incorporated
2014-08-20Z-2203-2014Class IIPrismaflex M150Gambro Renal Products, Incorporated
2014-08-20Z-2204-2014Class IIPrismaflex HF 1000Gambro Renal Products, Incorporated
2014-08-20Z-2205-2014Class IIPrismaflex HF 1400Gambro Renal Products, Incorporated
2014-08-20Z-2206-2014Class IIPrisMARS KitGambro Renal Products, Incorporated
2014-08-20Z-2207-2014Class IIX-MARS SetGambro Renal Products, Incorporated
2014-08-20Z-2208-2014Class IIMedical Positioning Rapid Response HUT tableMedical Positioning Inc
2014-08-20Z-2209-2014Class IIMedical Positioning Rapid Response HUT tableMedical Positioning Inc
2014-08-20Z-2210-2014Class IIMedical Positioning Rapid Response HUT table with Dual 2 Way Drop…Medical Positioning Inc
2014-08-20Z-2211-2014Class IIMedical Positioning Rapid Response HUT tableMedical Positioning Inc
2014-08-20Z-2212-2014Class IIDevice Brand Name: Distal Radius Fracture Repair System Device…Biomet, Inc.
2014-08-20Z-2213-2014Class IINavigation Spine & Trauma 3D Version 2Brainlab AG
2014-08-20Z-2214-2014Class IIVITROS¿ Chemistry Products CDM PROM Calibration Data Module RevOrtho-Clinical Diagnostics
2014-08-20Z-2215-2014Class IIMoore Hip Prosthesis Long Fenestrated Stem 38 mmZimmer, Inc.
2014-08-20Z-2216-2014Class IIDouble Offset Rasp HandleZimmer, Inc.
2014-08-20Z-2217-2014Class IIDouble Offset Rasp HandleZimmer, Inc.
2014-08-20Z-2218-2014Class IIDouble Offset Rasp HandleZimmer, Inc.
2014-08-20Z-2219-2014Class IIVI DBL OFFST W/ LRG STPLZimmer, Inc.
2014-08-20Z-2220-2014Class IIDouble Offset Rasp HandleZimmer, Inc.
2014-08-20Z-2221-2014Class IIDouble Offset Rasp HandleZimmer, Inc.
2014-08-20Z-2222-2014Class IIDouble Offset Rasp HandleZimmer, Inc.
2014-08-20Z-2223-2014Class IIVl DBL OFFST WI LRG STPLZimmer, Inc.
2014-08-20Z-2224-2014Class IIVER2 DBL OFFSET RASP HANDLEZimmer, Inc.
2014-08-20Z-2225-2014Class IIVER2 D8L OFFSET RASP HANDLEZimmer, Inc.
2014-08-20Z-2226-2014Class IIDouble Offset Rasp HandleZimmer, Inc.
2014-08-20Z-2227-2014Class IIDouble Offset Rasp HandleZimmer, Inc.
2014-08-20Z-2228-2014Class IIVER2 HANDLEZimmer, Inc.
2014-08-20Z-2229-2014Class IIVER2 HANDLEZimmer, Inc.
2014-08-20Z-2230-2014Class II23Zimmer, Inc.
2014-08-20Z-2231-2014Class II23Zimmer, Inc.
2014-08-20Z-2232-2014Class IIVIDAS D-Dimer Exclusion IIBioMerieux SA
2014-08-20Z-2233-2014Class IIIBD Multi Check CD4 Low Control Catalog NoBD Biosciences, Systems & Reagents
2014-08-20Z-2234-2014Class IIVital Sync" VPMP & IMNellcor Puritan Bennett Inc. (dba Covidien LP)
2014-08-20Z-2235-2014Class IIVital Sync RMS 1Nellcor Puritan Bennett Inc. (dba Covidien LP)
2014-08-20Z-2236-2014Class IIVerigene BC-GN Test KitNanosphere, Inc.
2014-08-20Z-2237-2014Class IIIntelliSpace PortalPhilips Medical Systems (Cleveland) Inc
2014-08-13Z-2136-2014Class IISerrated Soft Tissue ShieldsX Spine Systems Inc
2014-08-13Z-2137-2014Class IIKODAK DirectView DR 9000 SystemCarestream Health Inc.
2014-08-13Z-2138-2014Class IIAdvanDx Quick FISH Fixation Kit for BCAdvandx Inc
2014-08-13Z-2139-2014Class IIVITROS 3600 Immunodiagnostic System --- For use in the in vitro…Ortho-Clinical Diagnostics
2014-08-13Z-2140-2014Class IIVITROS 4600 Chemistry SystemOrtho-Clinical Diagnostics
2014-08-13Z-2141-2014Class IIVITROS 5600 Integrated System --- For use in the in vitro quantitativeOrtho-Clinical Diagnostics
2014-08-13Z-2142-2014Class IIIINSIGHT Dental FilmCarestream Health Inc.
2014-08-13Z-2143-2014Class IIIUltra-speed Dental FilmCarestream Health Inc.
2014-08-13Z-2144-2014Class IITapered-Screw Vent ImplantZimmer, Inc.
2014-08-13Z-2146-2014Class IIExacTrac is intended to be used to place patients at an accurately…Brainlab AG
2014-08-13Z-2147-2014Class IIBoston Scientific ENDOTAK RELIANCE¿ SGBoston Scientific CRM Corp
2014-08-13Z-2149-2014Class IISIEMENS ADVIA Centaur CP Immunoassay System BNP kitSiemens Healthcare Diagnostics, Inc
2014-08-13Z-2150-2014Class IISIEMENS ADVIA Centaur CP Immunoassay System BNP kitSiemens Healthcare Diagnostics, Inc
2014-08-13Z-2151-2014Class IILatex Dental Dams labeled as Non-Latex Dental DamsColtene Whaledent Inc
2014-08-13Z-2152-2014Class IIVIDAS TPSABioMerieux SA
2014-08-13Z-2153-2014Class IIPanthera-Puncher 9PerkinElmer Health Sciences, Inc.
2014-08-13Z-2154-2014Class IIIRUSCH Foley Urinary Catheter Insertion Tray with 10cc syringeTeleflex Medical
2014-08-13Z-2156-2014Class IISonopet Ultrasonic Surgical System ConsoleStryker Instruments Div. of Stryker Corporation
2014-08-13Z-2157-2014Class IITranspac IV Trifurcated Monitoring Kit w/84" Safeset ReservoirICU Medical, Inc.
2014-08-13Z-2158-2014Class IITrifurcated Transpac IT Monitoring Kit w/03 ml Flush DevicesICU Medical, Inc.
2014-08-13Z-2159-2014Class IIArterial Safeset Transpac IT w/3 ml Reservoir and Single CSPICU Medical, Inc.
2014-08-13Z-2160-2014Class IITrifurcated Transpac IV Monitoring Kit w/Safeset ReservoirICU Medical, Inc.
2014-08-13Z-2161-2014Class IISingle Transpac IT Monitoring Kit w/03 ml Flush DeviceICU Medical, Inc.
2014-08-13Z-2162-2014Class IIArterial Transpac IT Monitoring Kit w/Safeset ReservoirICU Medical, Inc.
2014-08-13Z-2163-2014Class IITranspac IT w/3 ML/HR MacrodripICU Medical, Inc.
2014-08-13Z-2164-2014Class IISingle Line Transpac IV Monitoring Kit w/03 ml Squeeze Flush DeviceICU Medical, Inc.
2014-08-13Z-2165-2014Class IITranspac IT w/10 cc Safeset ReservoirICU Medical, Inc.
2014-08-13Z-2166-2014Class IIPerkinElmer Specimen Gate Screening Center softwarePerkinElmer Health Sciences, Inc.
2014-08-06Z-2112-2014Class IIPM Wound Gel Rx Wound Dressing IPM Wound Gel is indicated for the…Wellspring Pharmaceutical Corporation
2014-08-06Z-2117-2014Class IICPR Shield With One Way Valve and Barrier FilterDynarex Corporation
2014-08-06Z-2118-2014Class IIMedtronic Nexdrive Micropositioning DriveMedtronic Neuromodulation
2014-08-06Z-2119-2014Class IIEmerald Fiberoptic BladeTeleflex Medical
2014-08-06Z-2121-2014Class IIHorizon Medical Imaging It is a medical image and information…Mckesson Medical Immaging
2014-08-06Z-2122-2014Class IIInTouch Critical Care BedStryker Medical Division of Stryker Corporation
2014-08-06Z-2123-2014Class IIPHAROS Excimer LaserRa Medical Systems Inc
2014-08-06Z-2124-2014Class IIDeRoyal KNEE ARTHROSCOPY PACKDeRoyal Industries Inc
2014-08-06Z-2125-2014Class IIDeRoyal Cardiac Hypothermia TrayDeRoyal Industries Inc
2014-08-06Z-2126-2014Class IIFlowCOUPLERBaxter Healthcare Corporation
2014-08-06Z-2127-2014Class IISmall Bone Innovations 3Small Bone Innovations
2014-08-06Z-2128-2014Class IIHenry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive…Novocol, Inc.
2014-08-06Z-2129-2014Class IIDarby Dental Supply Compolite Bond SE Self-Etch/Light-CuringNovocol, Inc.
2014-08-06Z-2130-2014Class IIRUSCHTeleflex Medical
2014-08-06Z-2131-2014Class IIZimmer Periarticular Locking Plate System Distal Radial Volar Plate…Zimmer, Inc.
2014-08-06Z-2132-2014Class IIMC-500 Multicolor Laser PhotocoagulatorNidek Inc
2014-08-06Z-2133-2014Class IIIDimension¿ Integrated Chemistry Systems intended to measure a variety…Siemens Healthcare Diagnostics, Inc.
2014-08-06Z-2134-2014Class IIPatient Data Manager 2Brainlab AG
2014-07-30Z-2021-2014Class IADVOCATE Redi-Code+ BMB-BA006A Blood Glucose test strips Product…DIABETIC SUPPLY OF SUNCOAST, INC.
2014-07-30Z-2068-2014Class IDATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULEGE Healthcare, LLC
2014-07-30Z-2079-2014Class IIRAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500…Siemens Healthcare Diagnostics Inc
2014-07-30Z-2080-2014Class IIDisposable StrykeFlow TipStryker Endoscopy
2014-07-30Z-2081-2014Class IIAGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is…AGFA Corp.
2014-07-30Z-2082-2014Class IIRECLAIM Taper Protector SleeveDePuy Orthopaedics, Inc.
2014-07-30Z-2083-2014Class IIRECLAIM DISTAL TAPEREDDePuy Orthopaedics, Inc.
2014-07-30Z-2084-2014Class IIRECLAIM DISTAL TAPERED Distal StemDePuy Orthopaedics, Inc.
2014-07-30Z-2085-2014Class IIGE HealthcareGE Healthcare, LLC
2014-07-30Z-2086-2014Class IINOVATION Femoral StemExactech, Inc.
2014-07-30Z-2087-2014Class IISynthes Guide Blocks for the 2 Column Plate 6 Hole HeadSynthes, Inc.
2014-07-30Z-2088-2014Class IIHemochron JrITC-Nexus Dx
2014-07-30Z-2089-2014Class IIPerouse FlamingoPerouse Medical
2014-07-30Z-2090-2014Class IIIZoll Circulation LifeBand Single PackZoll Circulation, Inc.
2014-07-30Z-2091-2014Class IIMK5 NX Controller--Wheelchair controllerInvacare Corporation
2014-07-30Z-2092-2014Class IISolanas 2Alphatec Spine, Inc.
2014-07-30Z-2093-2014Class IIOxygen MaskSalter Labs
2014-07-30Z-2094-2014Class IISarns D4 Aortic Arch Cannulae 6Terumo Cardiovascular Systems Corporation
2014-07-30Z-2095-2014Class IISarns Flexible Aortic Arch Cannula 8Terumo Cardiovascular Systems Corporation
2014-07-30Z-2096-2014Class IISarns Malleable Dual-stage Venous Return Cannulae 28/38Terumo Cardiovascular Systems Corporation
2014-07-30Z-2097-2014Class IISarns Malleable Venous Return Cannulae 24Terumo Cardiovascular Systems Corporation
2014-07-30Z-2098-2014Class IISarns Soft-arc Aortic Cannula 8Terumo Cardiovascular Systems Corporation
2014-07-30Z-2099-2014Class IISarns Soft-Flow Extended Aortic Cannulae 7Terumo Cardiovascular Systems Corporation
2014-07-30Z-2100-2014Class IISarns Two-stage Venous Return Cannulae 32/40 & 36/51 Fr with 1/2" &…Terumo Cardiovascular Systems Corporation
2014-07-30Z-2101-2014Class IISarns Venoatrial Cannulae 36/46 Fr with 1/2" flare or connector…Terumo Cardiovascular Systems Corporation
2014-07-30Z-2102-2014Class IITerumo Dual-stage Venous Return Cannulae 28/38Terumo Cardiovascular Systems Corporation
2014-07-30Z-2103-2014Class IITerumo TenderFlow Pediatric Venous CannulaeTerumo Cardiovascular Systems Corporation
2014-07-30Z-2104-2014Class IITerumo Three-stage Venous Return Cannulae 28 Fr with 3/8" flareTerumo Cardiovascular Systems Corporation
2014-07-30Z-2105-2014Class IISarns Soft-Flow Aortic Cannulae 6Terumo Cardiovascular Systems Corporation
2014-07-30Z-2106-2014Class IICPB Catheter Kit Product Usage: Venous Return Cannula is indicated…Terumo Cardiovascular Systems Corporation
2014-07-30Z-2107-2014Class IIHudson RCITeleflex Medical
2014-07-30Z-2108-2014Class IIHudson RCITeleflex Medical
2014-07-30Z-2109-2014Class IIQLAB 10 Core Module PN 453561704771Philips Ultrasound, Inc.
2014-07-30Z-2110-2014Class IIQLAB 10Philips Ultrasound, Inc.
2014-07-30Z-2111-2014Class IISiemens syngo Imaging XSSiemens Medical Solutions USA, Inc
2014-07-30Z-2113-2014Class IIInSite HER-2 Detection KitBiogenex Laboratories, Inc.
2014-07-30Z-2114-2014Class IIGE HealthcareGE Healthcare, LLC
2014-07-30Z-2115-2014Class IIPad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P…Heartsine Technologies, Limited
2014-07-30Z-2116-2014Class IIEG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video…Pentax Medical Company
2014-07-23Z-2028-2014Class IISarns Disposable Centrifugal Pump without X-CoatingTerumo Cardiovascular Systems Corporation
2014-07-23Z-2029-2014Class IISarns Disposable Centrifugal Pump with X-CoatingTerumo Cardiovascular Systems Corporation
2014-07-23Z-2030-2014Class IICardiovascular Procedure Kit containing Disposable Centrifugal…Terumo Cardiovascular Systems Corporation
2014-07-23Z-2041-2014Class IIIBBL CrystaLEAD Enteric/NonfermentorBecton Dickinson & Co.
2014-07-23Z-2042-2014Class IIeSiemens Medical Solutions USA, Inc.
2014-07-23Z-2043-2014Class IISymbia E camera systemSiemens Medical Solutions USA, Inc.
2014-07-23Z-2044-2014Class IILynx TM20 Torquemaster Low Speed Handpiece MTI Dental ProductsMTI Precision Products LLC.
2014-07-23Z-2045-2014Class IISUTUREFIX Ultra Anchor XL with oneSmith & Nephew, Inc. Endoscopy Division
2014-07-23Z-2046-2014Class IISUTUREFIX Ultra Anchor XL with oneSmith & Nephew, Inc. Endoscopy Division
2014-07-23Z-2047-2014Class IISUTUREFIX Ultra S with 1 #2 UltrabraidSmith & Nephew, Inc. Endoscopy Division
2014-07-23Z-2048-2014Class IISUTUREFIX Ultra S with 1 #2 Ultrabraid SutureSmith & Nephew, Inc. Endoscopy Division
2014-07-23Z-2049-2014Class IISUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 FastenerSmith & Nephew, Inc. Endoscopy Division
2014-07-23Z-2050-2014Class IIZimmer Dental Tapered Screw-Vent ImplantZimmer, Inc.
2014-07-23Z-2051-2014Class IIShape HF Cardiopulmonary SystemShape Medical Systems, Inc
2014-07-23Z-2052-2014Class IISHAPE ARMStryker Communications
2014-07-23Z-2053-2014Class IISHAPE ARMStryker Communications
2014-07-23Z-2054-2014Class IISHAPE ARMStryker Communications
2014-07-23Z-2055-2014Class IIBAMStryker Communications
2014-07-23Z-2056-2014Class IIBAMStryker Communications
2014-07-23Z-2057-2014Class IIThermo Scientific VersaTREK REDOX 1Remel Inc
2014-07-23Z-2058-2014Class IICoat-A-Count Direct AndrostenedioneSiemens Healthcare Diagnostics Inc.
2014-07-23Z-2059-2014Class IIV-Series Patient Monitoring SystemMindray DS USA, Inc. dba Mindray North America
2014-07-23Z-2060-2014Class IIACL TOPInstrumentation Laboratory Co.
2014-07-23Z-2061-2014Class IIACL TOP 700Instrumentation Laboratory Co.
2014-07-23Z-2062-2014Class IIACL TOP CTSInstrumentation Laboratory Co.
2014-07-23Z-2063-2014Class IIACL TOP 700 LASInstrumentation Laboratory Co.
2014-07-23Z-2064-2014Class IIACL TOP 500 CTSInstrumentation Laboratory Co.
2014-07-23Z-2065-2014Class IIACL TOP 700 CTSInstrumentation Laboratory Co.
2014-07-23Z-2066-2014Class IIACL TOP 300 CTSInstrumentation Laboratory Co.
2014-07-23Z-2067-2014Class IIExcella II Standard Pedicle ScrewInnovasis, Inc
2014-07-23Z-2069-2014Class IICalcium Hydroxide PowderAxcentria Pharmaceuticals, LLC
2014-07-23Z-2070-2014Class IIExcelsior Medical Sterile Triple Lead Tubing Set and Sterile Heavy…Excelsior Medical Corp
2014-07-23Z-2071-2014Class IIISiemens RAPIDComm¿ Data Management SystemSiemens Healthcare Diagnostics Inc
2014-07-23Z-2072-2014Class IIIntegra Camino 110-4 Intracranial PressureIntegra LifeSciences Corp.
2014-07-23Z-2073-2014Class IILPLaser Peripherals LLC
2014-07-23Z-2074-2014Class IIBaxter MiniCap with Povidone-Iodine SolutionBaxter Healthcare Corp.
2014-07-23Z-2075-2014Class IISiemens syngo RT Dosimetrist 2Siemens Medical Solutions USA, Inc
2014-07-23Z-2076-2014Class IITritium Sternal Plate SystemPIONEER SURGICAL TECHNOLOGY, INC.
2014-07-23Z-2077-2014Class IISpacelabs Healthcare Ultraview SL Multigas ModuleSpacelabs Healthcare Inc
2014-07-23Z-2078-2014Class IITitan T 5K Motor Product Usage: Low-speed motor is used with various…Dental EZ Group Star Dental Division
2014-07-16Z-1992-2014Class IIAmerigel Wound Dressing 1 ozKova Laboratories, Inc.
2014-07-16Z-1993-2014Class IIAmerigel Wound Dressing 55 gallons/drumKova Laboratories, Inc.
2014-07-16Z-1994-2014Class IIPatient Side Cart Battery Box used in conjunction with the da Vinci A…Intuitive Surgical, Inc.
2014-07-16Z-1995-2014Class IIHLD SystemCenorin, LLC
2014-07-16Z-1996-2014Class IIHenora REF: 70-4026-09V1 300psi IRGI Medical Manufacturing, Inc.

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