Data Foundry

All years

Medical device recalls reported in 2013

← Newer · Older →

ReportedRecallClassProductFirm
2013-11-27Z-0314-2014Class IIVITROS Chemistry Products GLU Slides packaged as 300 slides/pack…Ortho-Clinical Diagnostics
2013-11-27Z-0315-2014Class IIVITROS Chemistry Products LAC Slides packaged as 300 slides/pack…Ortho-Clinical Diagnostics
2013-11-27Z-0316-2014Class IIVITROS Chemistry Products Li Slides packaged as 300 slides/pack…Ortho-Clinical Diagnostics
2013-11-27Z-0317-2014Class IIVITROS Chemistry Products LIPA Slides packaged as 300 slides/pack…Ortho-Clinical Diagnostics
2013-11-27Z-0318-2014Class IIVITROS Chemistry Products Mg Slides packaged as 300 slides/pack…Ortho-Clinical Diagnostics
2013-11-27Z-0319-2014Class IIVITROS Chemistry Products PHBR Slides packaged as 90 slides/pack…Ortho-Clinical Diagnostics
2013-11-27Z-0320-2014Class IIVITROS Chemistry Products PHOS Slides packaged as 300 slides/pack…Ortho-Clinical Diagnostics
2013-11-27Z-0321-2014Class IIVITROS Chemistry Products PHYT Slides packaged as 90 slides/pack…Ortho-Clinical Diagnostics
2013-11-27Z-0322-2014Class IIVITROS Chemistry Products PROT Slides packaged as 90 slides/pack…Ortho-Clinical Diagnostics
2013-11-27Z-0323-2014Class IIVITROS Chemistry Products SALI Slides packaged as 90 slides/pack…Ortho-Clinical Diagnostics
2013-11-27Z-0324-2014Class IIVITROS Chemistry Products TBIL Slides packaged as 300 slides/pack…Ortho-Clinical Diagnostics
2013-11-27Z-0325-2014Class IIVITROS Chemistry Products THEO Slides packaged as 300 slides/pack…Ortho-Clinical Diagnostics
2013-11-27Z-0326-2014Class IIVITROS Chemistry Products TRIG Slides packaged as 300 slides/pack…Ortho-Clinical Diagnostics
2013-11-27Z-0327-2014Class IIVITROS Chemistry Products UPRO Slides packaged as 90 slides/pack…Ortho-Clinical Diagnostics
2013-11-27Z-0328-2014Class IIVITROS Chemistry Products URIC Slides packaged as 300 slides/pack…Ortho-Clinical Diagnostics
2013-11-27Z-0329-2014Class IIOlympus Endoscopic Flushing PumpOlympus America Inc.
2013-11-27Z-0330-2014Class IIThe Centricity Laboratory System is intended to be an information…GE Healthcare It
2013-11-27Z-0331-2014Class IIALTRUS¿ THERMAL TISSUE FUSIONConMed Corporation
2013-11-27Z-0332-2014Class IIALTRUS¿ THERMAL TISSUE FUSIONConMed Corporation
2013-11-27Z-0333-2014Class IIZeiss brand IOLMasterCarl Zeiss Meditec, Inc.
2013-11-27Z-0334-2014Class IIZeiss brand IOLMaster 500Carl Zeiss Meditec, Inc.
2013-11-27Z-0335-2014Class IIBrilliance iCT Computed Tomography X-Ray SystemPhilips Medical Systems (Cleveland) Inc
2013-11-27Z-0336-2014Class IIVascutek Gelsoft Vascular GraftTerumo Cardiovascular Systems Corporation
2013-11-27Z-0337-2014Class IICentricity Perinatal and Centricity Intensive Care is intended to be…GE Healthcare It
2013-11-27Z-0338-2014Class IIVascu GuardSynovis Surgical Innovations, Inc.
2013-11-27Z-0339-2014Class IIDura GuardSynovis Surgical Innovations, Inc.
2013-11-27Z-0340-2014Class IIReprocessed Diagnostic ElectrophysiologyStryker Sustainability Solutions
2013-11-27Z-0341-2014Class IISynthes Soft Tissue Retractor Small Extendible Offset blade…Synthes USA HQ, Inc.
2013-11-27Z-0342-2014Class IITruSystem Surgical TableTrumpf Medical Systems, Inc.
2013-11-27Z-0343-2014Class IIADVIA 1200 System Software: 1) V2Siemens Healthcare Diagnostics
2013-11-27Z-0344-2014Class IIADVIA 1650 System Software: 1) V4Siemens Healthcare Diagnostics
2013-11-27Z-0345-2014Class IIADVIA 1800 System Software V2Siemens Healthcare Diagnostics
2013-11-27Z-0346-2014Class IIADVIA 2400 System Software V4Siemens Healthcare Diagnostics
2013-11-27Z-0347-2014Class IIPolyglycolic-Lactic Acid Absorbable Surgical Suture Label reads in…Riverpoint Medical, LLC
2013-11-27Z-0348-2014Class IICandela Laser GentleLase ProCandela Corporation
2013-11-27Z-0349-2014Class IThe GemStar Pump is a small and lightweightHospira Inc.
2013-11-27Z-0350-2014Class IThe GemStar Pump is a small and lightweightHospira Inc.
2013-11-27Z-0351-2014Class IISpacelabs Healthcare qube Compact Patient MonitorSpacelabs Healthcare, Llc
2013-11-27Z-0352-2014Class ICAS I/II Absorbers that are parts of the BleaseSirius Anesthesia…Del Mar Reynolds Medical, Ltd.
2013-11-27Z-0353-2014Class IIEpsilon Skin Tensioner:RxRestoration Robotics
2013-11-27Z-0354-2014Class IIARTAS Disposable KitRestoration Robotics
2013-11-27Z-0355-2014Class IISterile Disposable KitRestoration Robotics
2013-11-27Z-0356-2014Class IIARTAS Disposable and Reuseable KitRestoration Robotics
2013-11-27Z-0357-2014Class IITrinica Anterior Lumbar PlateZimmer, Inc.
2013-11-27Z-0358-2014Class IIReady to Use Thymo-CideWexford Labs Inc
2013-11-27Z-0359-2014Class IIBIOMET SpineEbi, Llc
2013-11-27Z-0360-2014Class IISalter Labs EtCO2 Sample line 15'SALTER LABS
2013-11-27Z-0361-2014Class IIAesculap Arcadius XP L Trial Insertion InstrumentAesculap, Inc.
2013-11-27Z-0362-2014Class IIFixed Offset AdapterOssur North America Inc
2013-11-27Z-0363-2014Class IIModel FL14E Rose BedsThe Rose Bed is an AC-powered adjustable…Stryker Medical Division of Stryker Corporation
2013-11-27Z-0364-2014Class IIJuggerknotless Drill BitBiomet, Inc.
2013-11-27Z-0365-2014Class IISiemens Chemistry CalibratorSiemens Healthcare Diagnostics
2013-11-27Z-0366-2014Class IIGreen RuschTeleflex Medical
2013-11-27Z-0367-2014Class IIGE Healthcare Discovery NMCT 670GE Healthcare, LLC
2013-11-27Z-0368-2014Class IIEPIQ 7 Ultrasound SystemPhilips Medical Systems North America Inc.
2013-11-27Z-0369-2014Class IISynthes Titanium Trochanteric Fixation NailSynthes USA HQ, Inc.
2013-11-27Z-0370-2014Class IIMedcare Products Max-500 StandErgosafe Products LLC DBA Prism Medical Services USA
2013-11-27Z-0371-2014Class IIMedcare Products Max-500 Stand-N-WeighErgosafe Products LLC DBA Prism Medical Services USA
2013-11-27Z-0372-2014Class II*** 1) SYMBIQ One-Channel InfuserHospira Inc.
2013-11-27Z-0373-2014Class IIGE Vivid E9 ultrasound systemGE Healthcare, LLC
2013-11-27Z-0375-2014Class IIStryker 1) XIA Torque Wrench 2) XIA 3 Torque Wrench 3) XIA Elegance…Stryker Spine
2013-11-27Z-0376-2014Class IIExciTE F DSC Soft touch Single DoseIvoclar Vivadent, Inc.
2013-11-20Z-0172-2014Class IIArtis zee systems x-raySiemens Medical Solutions USA, Inc
2013-11-20Z-0182-2014Class IIProstiva RF Therapy Hand Piece KitUrologix, Inc.
2013-11-20Z-0183-2014Class IIApplied Medical's Inzii¿ 12/15mm Retrieval SystemApplied Medical Resources Corp
2013-11-20Z-0184-2014Class II2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis…Fresenius Medical Care Holdings, Inc.
2013-11-20Z-0185-2014Class IICombiset Blood Line with BVM for Hemodialysis use Catalog Number:…Fresenius Medical Care Holdings, Inc.
2013-11-20Z-0186-2014Class IICombiset Blood Line Hemodialysis use Catalog Number: 03-2622-3Fresenius Medical Care Holdings, Inc.
2013-11-20Z-0187-2014Class IISafire Duo Ablation Catheter MediGuide EnabledSt. Jude Medical
2013-11-20Z-0188-2014Class IISpacelabs Healthcare elance Vital Signs MonitorSpacelabs Healthcare, Llc
2013-11-20Z-0189-2014Class IISIGMA SPECTRUM Infusion Pump with Master Drug Library componentBaxter Healthcare Corp.
2013-11-20Z-0190-2014Class IISterrad 100NXAdvanced Sterilization Products
2013-11-20Z-0191-2014Class IIDePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code:…DePuy Mitek, Inc., a Johnson & Johnson Co.
2013-11-20Z-0192-2014Class IIDePuy Mitek FMS Outflow Tubing with One-Way valve Product Code:284649…DePuy Mitek, Inc., a Johnson & Johnson Co.
2013-11-20Z-0193-2014Class IISarns" Soft-Flow¿ Aortic Cannula without Suture FlangeTerumo Cardiovascular Systems Corporation
2013-11-20Z-0194-2014Class IISarns" Soft-Flow¿ Aortic Cannula without Suture FlangeTerumo Cardiovascular Systems Corporation
2013-11-20Z-0195-2014Class IISarns" Soft-Flow¿ Aortic Cannula without Suture FlangeTerumo Cardiovascular Systems Corporation
2013-11-20Z-0196-2014Class IISarns" Venous Return CannulaeTerumo Cardiovascular Systems Corporation
2013-11-20Z-0197-2014Class IISIGMA SPECTRUM Infusion Pump with Master Drug LibraryBaxter Healthcare Corp.
2013-11-20Z-0198-2014Class IIPneumatic Systems Operating ManualThe Anspach Effort, Inc.
2013-11-20Z-0199-2014Class IICutting Bur ChartThe Anspach Effort, Inc.
2013-11-20Z-0200-2014Class IIProduct CatalogThe Anspach Effort, Inc.
2013-11-20Z-0201-2014Class IITitan 3T MRI SystemToshiba American Medical Systems Inc
2013-11-20Z-0202-2014Class IISynthes 8Synthes USA HQ, Inc.
2013-11-20Z-0203-2014Class IIPlum A+ Hyperbaric Infusion PumpHospira Inc.
2013-11-20Z-0204-2014Class IIPlum A+ Infusion PumpHospira Inc.
2013-11-20Z-0205-2014Class IIPlum A+ Infusion PumpHospira Inc.
2013-11-20Z-0206-2014Class IIPlum A+3 Infusion Pump SystemHospira Inc.
2013-11-20Z-0207-2014Class IIPlum A+ Infusion PumpHospira Inc.
2013-11-20Z-0208-2014Class IIPlum A+ Infusion PumpHospira Inc.
2013-11-20Z-0209-2014Class II*** 1) Plum A+ Infusion PumpHospira Inc.
2013-11-20Z-0210-2014Class IIComposite Series Skull ClampIntegra LifeSciences Corp.
2013-11-20Z-0211-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0212-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0213-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0214-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0215-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0216-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0217-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0218-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0219-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0220-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0221-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0222-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0223-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0224-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0225-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0226-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0227-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0228-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0229-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0230-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0231-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0232-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0233-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0234-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0235-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0236-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0237-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0238-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0239-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0240-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0241-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0242-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0243-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0244-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0245-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0246-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0247-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0248-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0249-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0250-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0251-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0252-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0253-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0254-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0255-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0256-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0257-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0258-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0259-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0260-2014Class IICarestream Vue PACSCarestream Health Inc.
2013-11-20Z-0269-2014Class IIPhilips brand IntelliSpace PACS 4Philips Healthcare Informatics, Inc.
2013-11-20Z-0270-2014Class IIAW VolumeShare 4GE Healthcare, LLC
2013-11-20Z-0271-2014Class IISiemens syngoSiemens Medical Solutions USA, Inc
2013-11-20Z-0272-2014Class IIBiotene Moisturizing Mouth SprayGlaxoSmithKline, LLC.
2013-11-20Z-0273-2014Class IIOsseocare Pro Console & Set Osseocare ProNobel Biocare Usa Llc
2013-11-20Z-0274-2014Class IIS-LIFT Extension Shims Extension shims are manufactured from grade 5…SpineFrontier, Inc.
2013-11-20Z-0275-2014Class IIDeRoyalDeRoyal Industries Inc
2013-11-20Z-0276-2014Class II3OrthoPediatrics Corp
2013-11-20Z-0277-2014Class IIVerSys¿ Cemented Revision CalcarZimmer, Inc.
2013-11-20Z-0278-2014Class IIMedtronic RestoreUltraMedtronic Neuromodulation
2013-11-20Z-0279-2014Class IIMedtronic Activa PCMedtronic Neuromodulation
2013-11-20Z-0280-2014Class IIAcetabular PressurizerStryker Instruments Div. of Stryker Corporation
2013-11-20Z-0281-2014Class IIRay Station Radiation Therapy Treatment Planning SystemRAYSEARCH LABORATORIES AB
2013-11-20Z-0282-2014Class IIDraeger Movita 603x/DVE 803x Ceiling Supply UnitDraeger Medical, Inc.
2013-11-20Z-0283-2014Class IIThe Plum A+ Hyperbaric Infusion System is a cassette based…Hospira Inc.
2013-11-20Z-0284-2014Class IIThe Plum A+ Infusion System is a cassette based multifunction…Hospira Inc.
2013-11-20Z-0285-2014Class IIThe Plum A+ Infusion System is a cassette based multifunction…Hospira Inc.
2013-11-20Z-0286-2014Class IIThe Plum A+3 Infusion System is a cassette based multifunction…Hospira Inc.
2013-11-20Z-0287-2014Class IIThe Plum A+ Infusion System is a cassette based multifunction…Hospira Inc.
2013-11-20Z-0288-2014Class IIThe Plum A+3 Infusion System is a cassette based multifunction…Hospira Inc.
2013-11-20Z-0289-2014Class IIThe Plum A+3 Infusion System is a cassette based multifunction…Hospira Inc.
2013-11-20Z-0290-2014Class IIThe Plum A+ Infusion System is a cassette based multifunction…Hospira Inc.
2013-11-20Z-0291-2014Class IIAccess 2 Immunoassay SystemBeckman Coulter Inc.
2013-11-13Z-0016-2014Class IISiemens RAD Fluoro Uro SystemsSiemens Medical Solutions USA, Inc
2013-11-13Z-0085-2014Class IBaylis Medical TorFlex Transseptal Guiding SheathBaylis Medical Corp *
2013-11-13Z-0127-2014Class IIDekompressor Percutaneous Discectomy ProbeStryker Instruments Div. of Stryker Corporation
2013-11-13Z-0128-2014Class IIIBlom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and…Helix Medical LLC
2013-11-13Z-0129-2014Class IITi-Magna Fx Washer Ti-Versa-FX¿II Femoral Fixation System S/C Plates…Zimmer, Inc.
2013-11-13Z-0130-2014Class IIGENESISSmith & Nephew Inc
2013-11-13Z-0131-2014Class IIGENESISSmith & Nephew Inc
2013-11-13Z-0132-2014Class IIDRX RevolutionCarestream Health Inc.
2013-11-13Z-0133-2014Class IIThe EkoSonic Endovascular System employs high frequencyEKOS Corporation
2013-11-13Z-0134-2014Class IIEdwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo…Edwards Lifesciences, LLC
2013-11-13Z-0135-2014Class IIEdwards Lifesciences Dispersion Aortic Perfusion Cannula with Duraflo…Edwards Lifesciences, LLC
2013-11-13Z-0136-2014Class IIBayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITSBayer Healthcare Llc
2013-11-13Z-0137-2014Class IISurgicutt fully automated incision making device for bleeding time…ITC-Nexus Dx
2013-11-13Z-0138-2014Class IIStereotactic Circular CollimatorElekta, Inc.
2013-11-13Z-0139-2014Class IIPatient Cart used in conjunction with the da Vinci S surgical and SI…Intuitive Surgical, Inc.
2013-11-13Z-0141-2014Class IIHarmony Equipment Management SystemSteris Corporation
2013-11-13Z-0142-2014Class IIS5 Heart-lung machineSorin Group Deutschland GmbH
2013-11-13Z-0143-2014Class IIDual Luer Lock Cap The device is intended for use as a cap for male…Baxter Healthcare Corp.
2013-11-13Z-0144-2014Class IIMLS Torpedo Mini-Light Ophthalmic single-port illuminationInsight Instruments, Inc.
2013-11-13Z-0145-2014Class IIIndividual units labeled in part: REF: 4630022Richard Wolf Medical Instruments Corp.
2013-11-13Z-0146-2014Class IIIda Vinci Vision System CartIntuitive Surgical, Inc.
2013-11-13Z-0147-2014Class IIUniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The…Beckman Coulter Inc.
2013-11-13Z-0148-2014Class IIFresenius Liberty¿ Cycler Part Number: RTLR180111 Product Usage: The…Fresenius Medical Care Holdings, Inc.
2013-11-13Z-0149-2014Class IIAdjustable Gastric BandEthicon Endo-Surgery Inc
2013-11-13Z-0150-2014Class IIAdjustable Gastric BandEthicon Endo-Surgery Inc
2013-11-13Z-0151-2014Class IIAdjustable Gastric BandEthicon Endo-Surgery Inc
2013-11-13Z-0152-2014Class IIISE REF ValveBeckman Coulter Inc.
2013-11-13Z-0153-2014Class IIISE REF ValveBeckman Coulter Inc.
2013-11-13Z-0154-2014Class IIResolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3Medtronic Vascular, Inc.
2013-11-13Z-0155-2014Class IIIORBIT PTTrumpf Medical Systems
2013-11-13Z-0156-2014Class IIPortex¿ Spinal Tray with Drugs 22g Whitacre/25g WhitacreSmiths Medical ASD, Inc.
2013-11-13Z-0157-2014Class IIPortex¿ Spinal Tray with Drugs 22g/25g QuinckeSmiths Medical ASD, Inc.
2013-11-13Z-0158-2014Class IIPortex¿ Spinal Tray with Drugs 25g WhitacreSmiths Medical ASD, Inc.
2013-11-13Z-0159-2014Class IIPortex¿ Regional Anesthesia Tray with DrugsSmiths Medical ASD, Inc.
2013-11-13Z-0160-2014Class IIPortex¿ Spinal Tray with Drugs 25g WhitacreSmiths Medical ASD, Inc.

← Newer · Older →