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All years

Medical device recalls reported in 2015

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ReportedRecallClassProductFirm
2015-12-09Z-0361-2016Class IIModel 5001102 MPS Delivery Set w/ arrest agent and additive cassettesQuest Medical, Inc.
2015-12-09Z-0362-2016Class IIStryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only…Stryker Howmedica Osteonics Corp.
2015-12-09Z-0363-2016Class IIDeRoyal sterile custom surgical kits: 1) Emergency CABG Pack PgybkDeRoyal Industries Inc
2015-12-09Z-0364-2016Class IIPatient Support Material Number: 9890 010 87431 used with:…Philips Medical Systems, Inc.
2015-12-09Z-0365-2016Class IIPatient Support Material Number: 9890 010 87431Philips Medical Systems, Inc.
2015-12-09Z-0366-2016Class IIRadiesseMerz North America, Inc.
2015-12-09Z-0367-2016Class IIPROLARYN Injectable Implant 1Merz North America, Inc.
2015-12-09Z-0368-2016Class IIPROLARYN PLUS Injectable Implant 1Merz North America, Inc.
2015-12-02Z-0271-2016Class IExpansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ…Alcon Research, Ltd.
2015-12-02Z-0319-2016Class IISyngo Imaging VB36D_HF02Siemens Medical Solutions USA, Inc
2015-12-02Z-0320-2016Class IIPhilips HeartStart MRx Monitor/DefibrillatorPhilips Electronics North America Corporation
2015-12-02Z-0321-2016Class IITool Legend 16cm 2Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
2015-12-02Z-0322-2016Class IIIThermo Scientific p21 WF1 Ab-3Lab Vision Corporation
2015-12-02Z-0323-2016Class II2Synthes (USA) Products LLC
2015-12-02Z-0324-2016Class IISCFE DriverPega Medical Inc.
2015-12-02Z-0325-2016Class IIIngeniaPhilips Medical Systems, Inc.
2015-12-02Z-0326-2016Class IINxStage System One S CyclerNxStage Medical, Inc.
2015-12-02Z-0327-2016Class IINxStage System One S CyclerNxStage Medical, Inc.
2015-12-02Z-0328-2016Class IIICONSULTBiochemical Diagnostics Inc
2015-12-02Z-0329-2016Class IIPalindrome" Chronic Catheter Kit Symmetrical TipCovidien LLC
2015-12-02Z-0330-2016Class IIPalindrome Precision Chronic Catheter Kit Symmetrical Tip 14Covidien LLC
2015-12-02Z-0331-2016Class IIPalindrome Precision Chronic Catheter Kit Symmetrical TipCovidien LLC
2015-12-02Z-0332-2016Class IIPalindrome Precision Chronic Catheter Kit Symmetrical TipCovidien LLC
2015-12-02Z-0333-2016Class IIPalindrome Precision Chronic Catheter Kit Symmetrical TipCovidien LLC
2015-12-02Z-0334-2016Class IIBD CD64 APC-R700Becton, Dickinson and Company, BD Biosciences
2015-12-02Z-0335-2016Class IINxStage System One S CyclerNxStage Medical, Inc.
2015-12-02Z-0336-2016Class IINxStage System One S CyclerNxStage Medical, Inc.
2015-12-02Z-0337-2016Class IINxStage System One S Cycler -High Permeability Hemodialysis System…NxStage Medical, Inc.
2015-12-02Z-0338-2016Class IIrainbow Reusable SensorsMasimo Corporation
2015-12-02Z-0339-2016Class IIDimension Vista SystemSiemens Healthcare Diagnostics, Inc.
2015-12-02Z-0340-2016Class IIADVIA Chemistry Hemoglobin A1c_3Siemens Healthcare Diagnostics, Inc.
2015-12-02Z-0341-2016Class IINovocastra Lyophilized Mouse Monoclonal Antibody CD10Leica Microsystems, Inc.
2015-11-25Z-0230-2016Class IInspiration Ventilator SystemEvent Medical LTD
2015-11-25Z-0272-2016Class IIEasy Dial Oxygen RegulatorPrecision Medical, Inc.
2015-11-25Z-0273-2016Class IIECG Out CablePhilips Electronics North America Corporation
2015-11-25Z-0274-2016Class IIHill-Rom 100 Low BedHill-Rom, Inc.
2015-11-25Z-0275-2016Class IIGMK Hinge knee prosthesisMedacta Usa
2015-11-25Z-0276-2016Class IISynthes Application Instrument for Sternal ZIPFIXSynthes (USA) Products LLC
2015-11-25Z-0277-2016Class IITaut Intraducers 10/BX7Teleflex Medical
2015-11-25Z-0278-2016Class IIHARMONIC ACE+ 7 Laparoscopic Shears with Advanced HemostasisEthicon Endo-Surgery Inc
2015-11-25Z-0279-2016Class IIMiniArc Pro Single incision Sling SystemAstora
2015-11-25Z-0280-2016Class IICyberonics Vagus Nerve StimulatorCyberonics, Inc
2015-11-25Z-0281-2016Class IIStryker PCA 10 Degree Hooded Acetabular Insert ID 22mmStryker Howmedica Osteonics Corp.
2015-11-25Z-0282-2016Class IIBrainLAB Image Guided SurgeryBrainlab AG
2015-11-25Z-0283-2016Class IIIMPAXAGFA Healthcare Corp.
2015-11-25Z-0284-2016Class IIPrism Medical C-300 Consumer Ceiling LiftErgoSafe Products, LLC (DBA) Prism Medical
2015-11-25Z-0285-2016Class IIPrism Medical P-300 Portable Consumer LiftErgoSafe Products, LLC (DBA) Prism Medical
2015-11-25Z-0286-2016Class IICIVCO Infiniti Plus Needle GuideCivco Medical Instruments Co. Inc.
2015-11-25Z-0287-2016Class IICIVCO Needle Guide Starter KitCivco Medical Instruments Co. Inc.
2015-11-25Z-0288-2016Class IICIVCO Biopsy Starter KitCivco Medical Instruments Co. Inc.
2015-11-25Z-0289-2016Class IICIVCO Tracking Bracket Starter KitCivco Medical Instruments Co. Inc.
2015-11-25Z-0290-2016Class IICIVCO Sales Demo KitCivco Medical Instruments Co. Inc.
2015-11-25Z-0291-2016Class IIIBaxter HomeChoice and HomeChoice Pro APD systemsBaxter Healthcare Corp.
2015-11-25Z-0292-2016Class IIECG Electrodes: 50007  Stablebase SBW55 50675  Stablebase SBW55-15…Leonhard Lang Medizintechnik GmbH
2015-11-25Z-0293-2016Class IINeptune PlusTZ Medical Inc.
2015-11-25Z-0294-2016Class IIFresenius 132 Gallon GranuFlo Dissolution UnitFresenius Medical Care Renal Therapies Group, LLC
2015-11-25Z-0295-2016Class IIFresenius 132 Gallon Dry Acid Dissolution UnitFresenius Medical Care Renal Therapies Group, LLC
2015-11-25Z-0296-2016Class IIFresenius Modified Mixer MotorFresenius Medical Care Renal Therapies Group, LLC
2015-11-25Z-0297-2016Class IIBulk Loader Module for cobas p 512/612 Pre-analytical sample handling…Roche Diagnostics Operations, Inc.
2015-11-25Z-0298-2016Class II1 Step 12 Panel CupAmeditech Inc
2015-11-25Z-0299-2016Class II10-Panel Pipette Drug ScreenAmeditech Inc
2015-11-25Z-0300-2016Class II11 Panel CupAmeditech Inc
2015-11-25Z-0301-2016Class II11 Panel Dip CardAmeditech Inc
2015-11-25Z-0302-2016Class II12-Panel Dip Drug Screen with adulterantAmeditech Inc
2015-11-25Z-0303-2016Class IIArcPoint Labs 10 Panel Dip ScreenAmeditech Inc
2015-11-25Z-0304-2016Class IICLIA RDTC 12-Panel Cup and CLIA RDTC 12-Panel CupAmeditech Inc
2015-11-25Z-0305-2016Class IIDrugCheck Pipette 10 Drug TestAmeditech Inc
2015-11-25Z-0306-2016Class IIDrugCheck Waived 12 Panel Cup w/AdultAmeditech Inc
2015-11-25Z-0307-2016Class IIDrugSmart 10 Test CupAmeditech Inc
2015-11-25Z-0308-2016Class IIDrugSmart 11 Test CupAmeditech Inc
2015-11-25Z-0309-2016Class IIDrugSmart DipAmeditech Inc
2015-11-25Z-0310-2016Class IIEDI BZO UNCUT SHEET-CARDAmeditech Inc
2015-11-25Z-0311-2016Class IIiCup Drug Screen CupAmeditech Inc
2015-11-25Z-0312-2016Class IIImmutest 10 Pnl Drug Screen Cup w/ AdultAmeditech Inc
2015-11-25Z-0313-2016Class IIMicro Screen 6 Panel Cup with AdultAmeditech Inc
2015-11-25Z-0314-2016Class IIPremier Clia Waived 12 panel Tilt CupAmeditech Inc
2015-11-25Z-0315-2016Class IIProScreen 10 Drug Panel Cassette TestAmeditech Inc
2015-11-25Z-0316-2016Class IIThe Drug Detection Agency 6 Panel Cup Body and Lid w/AdultAmeditech Inc
2015-11-25Z-0317-2016Class IITHERMO FISHER 6 DRUG CASSETTEAmeditech Inc
2015-11-25Z-0318-2016Class IISilverStatTZ Medical Inc.
2015-11-18Z-0128-2016Class IIVilla Sistemi Rotograph EVO 3D X-rayVilla Radiology Systems LLC
2015-11-18Z-0129-2016Class IIOwandy Radiology I -MAX Touch 3D X-rayVilla Radiology Systems LLC
2015-11-18Z-0211-2016Class IRotaWire Elite and wireClip TorquerBoston Scientific Corporation
2015-11-18Z-0212-2016Class IRotaWire Elite and wireClip TorquerBoston Scientific Corporation
2015-11-18Z-0232-2016Class IIBoston Scientific SQ-RX Model 1010 subcutaneous pulse generatorBoston Scientific Corporation
2015-11-18Z-0233-2016Class IIMyelo-Nate CSF Sampling KitUtah Medical Products, Inc
2015-11-18Z-0234-2016Class IImiraDry System consisting of the MD4000-MC ConsoleMiramar Labs, Inc.
2015-11-18Z-0235-2016Class IISSS Reprocessed ZimmerStryker Sustainability Solutions
2015-11-18Z-0236-2016Class IISynthes Small Notch Titanium Reconstructive Plate setSynthes (USA) Products LLC
2015-11-18Z-0237-2016Class IITEKIA Single Piece Hydrophilic Acrylic Intraocular LensesTekia, Inc.
2015-11-18Z-0238-2016Class IIFocus Diagnostics Anaplasma Phagocytophilum IFA IgM Test KitFocus Diagnostics Inc
2015-11-18Z-0239-2016Class IIAccess CEA AssayBeckman Coulter Inc.
2015-11-18Z-0240-2016Class IIDeRoyal Sterile Custom Surgical Kits containing 3M DuraPrepDeRoyal Industries Inc
2015-11-18Z-0241-2016Class IIDeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M…DeRoyal Industries Inc
2015-11-18Z-0242-2016Class IITriton Infusion PumpWalkMed Infusion, LLC
2015-11-18Z-0243-2016Class IIAmphirion Deep OTW PTA Balloon Catheter: Model numbers: US:…Medtronic Vascular, Inc.
2015-11-18Z-0244-2016Class IICook Medical CXI Support Catheter 2Cook Inc.
2015-11-18Z-0245-2016Class IIR¿sch Flexi-Slip Endotracheal Tube Stylet with Soft Distal TipTeleflex Medical
2015-11-18Z-0246-2016Class IIRusch Flexi-slip tracheal tube StyletTeleflex Medical
2015-11-18Z-0247-2016Class IIMaquet Getinge GroupMaquet Cardiovascular Us Sales, Llc
2015-11-18Z-0248-2016Class IIMaquet Getinge GroupMaquet Cardiovascular Us Sales, Llc
2015-11-18Z-0249-2016Class IIStryker OrthopaedicsStryker Howmedica Osteonics Corp.
2015-11-18Z-0250-2016Class IINovoCut Suture ManagerCeterix Orthopedics, Inc.
2015-11-18Z-0251-2016Class IIShimadzu C-arm TableShimadzu Medical Systems
2015-11-18Z-0252-2016Class IISmooth Muscle ActionBiocare Medical, LLC
2015-11-18Z-0253-2016Class IIIMILEX PESSARY KITCooperSurgical, Inc.
2015-11-18Z-0254-2016Class IIGE HealthcareGE Healthcare
2015-11-18Z-0255-2016Class IIGE HealthcareGE Healthcare
2015-11-18Z-0256-2016Class IIGE HealthcareGE Healthcare
2015-11-18Z-0257-2016Class IIGE HealthcareGE Healthcare
2015-11-18Z-0258-2016Class IIGE HealthcareGE Healthcare
2015-11-18Z-0259-2016Class IIGE HealthcareGE Healthcare
2015-11-18Z-0260-2016Class IIGE HealthcareGE Healthcare
2015-11-18Z-0261-2016Class IIStryker Orthopaedics Tapers LFIT V40 Vitallium femoral headsStryker Howmedica Osteonics Corp.
2015-11-18Z-0262-2016Class IIPhilips HeartStart MRx Monitor/Defibrillator Models:M3535APhilips Medical Systems, Inc.
2015-11-18Z-0263-2016Class IISamsung GM60A-40S Intended for use in generating radiographic images…NeuroLogica Corporation
2015-11-18Z-0264-2016Class IICARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humansInnokas Medical Oy
2015-11-18Z-0265-2016Class IIMODULARIS VARIOSTARSiemens Medical Solutions USA, Inc
2015-11-18Z-0266-2016Class IIBiomet 3i Narrow Right Angle Large Driver TipBiomet 3i, LLC
2015-11-18Z-0267-2016Class IIBiomet 3i Narrow Right Angle Square Driver TipBiomet 3i, LLC
2015-11-18Z-0268-2016Class IIMedtronic Perfusion Tubing PacksMedtronic Perfusion Systems
2015-11-18Z-0269-2016Class IIVentilator TubingInstrumentation Industries Inc
2015-11-18Z-0270-2016Class IIStryker Radius 5Stryker Spine
2015-11-11Z-0151-2016Class IHAMILTON-G5 Ventilator with software versions between V2Hamilton Medical, Inc.
2015-11-11Z-0194-2016Class IIBaxter 15L Cycler Drainage Bag SterileBaxter Healthcare Corp.
2015-11-11Z-0195-2016Class IICustom Pak 9319-27Alcon Research, Ltd.
2015-11-11Z-0196-2016Class IIMR Surgical Suite II TableGE Medical Systems, LLC
2015-11-11Z-0197-2016Class IIGEMINI PET/CT SystemPhilips Medical Systems (Cleveland) Inc
2015-11-11Z-0198-2016Class IIIAntibacterial Hydro Personal CatheterC.R. Bard, Inc.
2015-11-11Z-0199-2016Class IIRobotic hand accessory to InMotion ArmInteractive Motion Technologies, Inc.
2015-11-11Z-0200-2016Class IIMedtronic Achieve CablesMedtronic Inc.
2015-11-11Z-0201-2016Class IINovation Element Press-FitExactech, Inc.
2015-11-11Z-0202-2016Class IIIVITROS Chemistry Products Calibrator Kit 9 CalibratorOrtho-Clinical Diagnostics
2015-11-11Z-0203-2016Class IIMaxAn 4Biomet Spine, LLC
2015-11-11Z-0204-2016Class IIPhilips HeartStart MRx Monitor/Defibrillators Models: M3535A and…Philips Medical Systems, Inc.
2015-11-11Z-0205-2016Class IIArthroscopic Energy 50¿ Probe with SuctionConMed Corporation
2015-11-11Z-0206-2016Class IIBAUSCH + LOMB Biotrue ONEday lensesBausch & Lomb Inc Irb
2015-11-11Z-0207-2016Class IIARROW PICC Kit featuring Chlorag+ard Technology Midline…Arrow International Inc
2015-11-11Z-0208-2016Class IIeSiemens Medical Solutions USA, Inc.
2015-11-11Z-0209-2016Class IIiOS Galileo Application Version 1Otto Bock Healthcare GmbH
2015-11-11Z-0210-2016Class IIIAMSCO 400 and AMSCO C Small Steam SterilizersSteris Corporation
2015-11-11Z-0213-2016Class IIHelioseal F Sealant Refill 1 x 1Ivoclar A. G.
2015-11-11Z-0214-2016Class IIEon 100 system included the following product reference numbers and…ELITech Clinical Systems SAS
2015-11-11Z-0215-2016Class IIEon 300 system includes the following product reference numbers and…ELITech Clinical Systems SAS
2015-11-11Z-0216-2016Class IIELITech Clinical Systems reagents used on the Selectra ProS and ProM…ELITech Clinical Systems SAS
2015-11-11Z-0217-2016Class IIEnvoy 500 system includes the following product reference numbers and…ELITech Clinical Systems SAS
2015-11-11Z-0218-2016Class IIDigital LightboxBrainlab AG
2015-11-11Z-0219-2016Class IIHeartStart MRx monitor/defibrillator Models M3535APhilips Medical Systems, Inc.
2015-11-11Z-0220-2016Class IIEnVision FLEX/HRP visualization reagent found in the following kits:…Dako North America Inc.
2015-11-11Z-0221-2016Class IISmartSite Extension SetCareFusion 303, Inc.
2015-11-11Z-0222-2016Class IIStryker UniVise Spinous Process Fixation Plate System InserterStryker Spine
2015-11-11Z-0223-2016Class IIFLAIR Endovascular Stent GraftBard Peripheral Vascular Inc
2015-11-11Z-0224-2016Class IIRobotic Arm Interactive OrthopedicMako Surgical Corporation
2015-11-11Z-0225-2016Class IIThe Centricity PACS-IW with Universal Viewer is a device that…GE Healthcare
2015-11-11Z-0226-2016Class IIThe Centricity Universal Viewer Version is a device that displays…GE Healthcare
2015-11-11Z-0227-2016Class IISurgical DisplayBarco Inc.
2015-11-11Z-0228-2016Class IIMATResponder TourniquetPyng Medical Corporation
2015-11-11Z-0229-2016Class IIRegard Custom Surgical PackResource Optimization & Innovation Llc
2015-11-11Z-0231-2016Class IIVITROS 5Ortho-Clinical Diagnostics
2015-11-04Z-0118-2016Class IICIOS ALPHASiemens Medical Solutions USA, Inc
2015-11-04Z-0159-2016Class IICC cartridges for IRMA TRUPOINT Blood Gas AnalyzerLifeHealth, LLC
2015-11-04Z-0160-2016Class IIBG cartridges for IRMA TRUPOINT Blood Gas AnalyzerLifeHealth, LLC
2015-11-04Z-0161-2016Class IINipro Safe Touch TULIP Safety Fistula NeedleNipro Medical Corporation
2015-11-04Z-0162-2016Class IISignature Patient-Specific Surgical GuidesMaterialise N.V.
2015-11-04Z-0163-2016Class IIARCHITECT i2000SR System The Abbott ARCHITECT System is intended for…Abbott Laboratories, Inc
2015-11-04Z-0164-2016Class IISentinel MULTIGENT Ammonia Ultra ReagentSentinel CH SpA
2015-11-04Z-0165-2016Class IIExprt Precision System: Revision KneeEncore Medical, Lp
2015-11-04Z-0166-2016Class IIPerkin Elmer Specimen GatePerkin Elmer Life Sciences Inc
2015-11-04Z-0167-2016Class II2Synthes (USA) Products LLC
2015-11-04Z-0168-2016Class IIONCOR Avant GardeSiemens Medical Solutions USA, Inc
2015-11-04Z-0169-2016Class IIWelch Allyn KleenSpec Corded Illumination SystemWelch Allyn Inc
2015-11-04Z-0170-2016Class IIARIA Radiation OncologyVarian Medical Systems, Inc.
2015-11-04Z-0171-2016Class IIIBD CD3Becton, Dickinson and Company, BD Biosciences
2015-11-04Z-0172-2016Class IISpacelabs Healthcare CardioCall ECG Event RecorderSpacelabs Healthcare Inc
2015-11-04Z-0173-2016Class IIBrilliance 16-SlicePhilips Medical Systems (Cleveland) Inc
2015-11-04Z-0174-2016Class IIBrilliance 64 Computed Tomography X-ray systemsPhilips Medical Systems (Cleveland) Inc
2015-11-04Z-0175-2016Class IIIngenuity Core Computed Tomography X-ray systemsPhilips Medical Systems (Cleveland) Inc
2015-11-04Z-0176-2016Class IIIngenuity Core 128 Computed Tomography X-ray systemsPhilips Medical Systems (Cleveland) Inc
2015-11-04Z-0177-2016Class IIBrilliance Big BorePhilips Medical Systems (Cleveland) Inc
2015-11-04Z-0178-2016Class IIIngenuity Flex Computed Tomography X-ray systemsPhilips Medical Systems (Cleveland) Inc
2015-11-04Z-0179-2016Class IITuron Shoulder Impaction Fixture REF 804-15-102 The Turon and RSP…Encore Medical, Lp
2015-11-04Z-0180-2016Class IIReverse Shoulder Prosthesis Stem Impaction Fixture REF 804-03-053 The…Encore Medical, Lp
2015-11-04Z-0181-2016Class IIMonacoElekta, Inc.
2015-11-04Z-0182-2016Class IIACUSON SC2000 ultrasound systems model 10433816 Imaging system that…Siemens Medical Solutions USA, Inc.
2015-11-04Z-0183-2016Class IIADVIA Chemistry XPT Chemistry SystemsSiemens Healthcare Diagnostics, Inc.
2015-11-04Z-0184-2016Class IIRegardResource Optimization & Innovation Llc
2015-11-04Z-0185-2016Class IIRegardResource Optimization & Innovation Llc
2015-11-04Z-0186-2016Class IIRegardResource Optimization & Innovation Llc
2015-11-04Z-0187-2016Class IIRegardResource Optimization & Innovation Llc
2015-11-04Z-0188-2016Class IIRegardResource Optimization & Innovation Llc
2015-11-04Z-0189-2016Class IIRegardResource Optimization & Innovation Llc
2015-11-04Z-0190-2016Class IIRegardResource Optimization & Innovation Llc
2015-11-04Z-0191-2016Class IIRegardResource Optimization & Innovation Llc
2015-11-04Z-0192-2016Class IISynthes Threaded Plate Holder- Long for 3Synthes (USA) Products LLC
2015-11-04Z-0193-2016Class IIIntegra¿ Bone Marrow Biopsy Trays Catalogue NoIntegra LifeSciences Corp. d.b.a. Integra Pain Management
2015-10-28Z-0130-2016Class IIXiO Radiation Treatment Planning SystemElekta, Inc.
2015-10-28Z-0131-2016Class IIAltiVate Humeral Socket Shell TrialEncore Medical, Lp
2015-10-28Z-0132-2016Class IIONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE…Baxter Healthcare Corp
2015-10-28Z-0133-2016Class IIAmbitex NMD400 Nitrile Exam Gloves size mediumCardinal Health
2015-10-28Z-0134-2016Class II5Synthes (USA) Products LLC

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