Data Foundry

All years

Medical device recalls reported in 2017

Older →

ReportedRecallClassProductFirm
2017-12-27Z-0255-2018Class IIAzurion 3 M12Philips Electronics North America Corporation
2017-12-27Z-0256-2018Class IITERUMOTerumo Cardiovascular Systems Corporation
2017-12-27Z-0257-2018Class IICustom surgical kits containing TERUMOTerumo Cardiovascular Systems Corporation
2017-12-27Z-0262-2018Class IIRezum SystemNXTHERA
2017-12-27Z-0263-2018Class IIXper Flex Cardio Physiomonitoring systemInvivo Corporation
2017-12-27Z-0264-2018Class IIETEST OXACILLIN OX 256 US F100 In vitro diagnosticBioMerieux SA
2017-12-27Z-0265-2018Class IIETEST OXACILLIN OX 256 WW F100 In vitro diagnosticBioMerieux SA
2017-12-27Z-0266-2018Class IIThe GMK knee system: designed for cemented use in total knee…Medacta Usa Inc
2017-12-27Z-0267-2018Class III-125 CE Marked QuickLink CartridgesC.R. Bard, Inc.
2017-12-27Z-0268-2018Class IIIPhilips SureSigns VSi / SureSigns VS2+ vital signs monitor used in…Philips Electronics North America Corporation
2017-12-27Z-0269-2018Class IIExploR Radial Head Replacement SystemZimmer Biomet, Inc.
2017-12-27Z-0271-2018Class IIMedivance ArcticGel Small Pad KitC.R. Bard, Inc.
2017-12-27Z-0272-2018Class II3040-VenaFlow Calf GarmentStryker Sustainability Solutions
2017-12-27Z-0274-2018Class IIQIAamp DSP Virus Kit CatQiagen, GmbH
2017-12-27Z-0275-2018Class IIStroke Fast PackStryker Neurovascular
2017-12-27Z-0276-2018Class IIStroke Fast PackStryker Neurovascular
2017-12-27Z-0277-2018Class IITrevoStryker Neurovascular
2017-12-27Z-0278-2018Class IIAutomated External DefibrillatorPhilips Electronics North America Corporation
2017-12-27Z-0279-2018Class IIZimmer Dental GemLock RHD2Zimmer Dental Inc
2017-12-27Z-0280-2018Class IIZimmer Dental Tapered SwissPlus & SwissPlus Implant Systems surgical…Zimmer Dental Inc
2017-12-27Z-0281-2018Class IIZimmer Dental Instrument Kit SystemZimmer Dental Inc
2017-12-27Z-0282-2018Class IIZimmer Dental Instrument Kit SystemZimmer Dental Inc
2017-12-27Z-0283-2018Class IISpectra System/Legacy Guided Surgery Handle KitImplant Direct Sybron Manufacturing, LLC
2017-12-27Z-0284-2018Class IITapered Screw-Vent MTX Model TSVTB11Zimmer Dental Inc
2017-12-20Z-0051-2018Class IIUnited Nuclear Scientific High Power Handheld LasersUnited Nuclear Scientific Supplies, LLC
2017-12-20Z-0186-2018Class ILIFEPAKPhysio-Control, Inc.
2017-12-20Z-0187-2018Class ILIFEPAKPhysio-Control, Inc.
2017-12-20Z-0214-2018Class IIGlidesheath Slender Hydrophilic Coated Introducer SheathTerumo Medical Corp
2017-12-20Z-0215-2018Class IIGlidesheath Slender Hydrophilic Coated Introducer SheathTerumo Medical Corp
2017-12-20Z-0216-2018Class IIGlidesheath Slender Hydrophilic Coated Introducer SheathTerumo Medical Corp
2017-12-20Z-0217-2018Class IIGlidesheath Slender Hydrophilic Coated Introducer Sheath A-KitTerumo Medical Corp
2017-12-20Z-0218-2018Class IIGlidesheath Slender Hydrophilic Coated Introducer Sheath A-KitTerumo Medical Corp
2017-12-20Z-0219-2018Class IIGlidesheath Slender Hydrophilic Coated Introducer Sheath A-KitTerumo Medical Corp
2017-12-20Z-0220-2018Class IIGlidesheath Slender Hydrophilic Coated Introducer Sheath A-KitTerumo Medical Corp
2017-12-20Z-0221-2018Class IIGlidesheath Slender Hydrophilic Coated Introducer Sheath A-KitTerumo Medical Corp
2017-12-20Z-0222-2018Class IIGlidesheath Slender Hydrophilic Coated Introducer Sheath A-KitTerumo Medical Corp
2017-12-20Z-0223-2018Class IIGlidesheath Slender Hydrophilic Coated Introducer SheathTerumo Medical Corp
2017-12-20Z-0224-2018Class IIGlidesheath Slender Hydrophilic Coated Introducer SheathTerumo Medical Corp
2017-12-20Z-0225-2018Class IIGlidesheath Slender Hydrophilic Coated Introducer SheathTerumo Medical Corp
2017-12-20Z-0226-2018Class IIGlidesheath Slender Hydrophilic Coated Introducer SheathTerumo Medical Corp
2017-12-20Z-0227-2018Class IIGlidesheath Slender Hydrophilic Coated Introducer SheathTerumo Medical Corp
2017-12-20Z-0228-2018Class IIGlidesheath Slender Hydrophilic Coated Introducer SheathTerumo Medical Corp
2017-12-20Z-0229-2018Class IIGlidesheath Slender Hydrophilic Coated Introducer SheathTerumo Medical Corp
2017-12-20Z-0230-2018Class IIGlidesheath Slender Hydrophilic Coated Introducer SheathTerumo Medical Corp
2017-12-20Z-0231-2018Class IIABL800 analyzer with FLEXQ moduleRadiometer America Inc
2017-12-20Z-0232-2018Class IIFUJIFILM FDR Visionary Suite with CH-200Fujifilm Medical Systems U.S.A., Inc.
2017-12-20Z-0233-2018Class IIBLUE BURN SHEETDukal Corp.
2017-12-20Z-0234-2018Class IIElekta ERGO++ Product Usage: ERGO is often used for stereotactic…Elekta Inc
2017-12-20Z-0235-2018Class IIRemisol Advance SoftwareNormand Informatique
2017-12-20Z-0236-2018Class IIUniCel DxH800Beckman Coulter Inc.
2017-12-20Z-0237-2018Class IIUniCel DxH600Beckman Coulter Inc.
2017-12-20Z-0238-2018Class IIUniCel DxH Slidemaker StainerBeckman Coulter Inc.
2017-12-20Z-0239-2018Class IIPiranha Screw 4Amendia, Inc dba Spinal Elements
2017-12-20Z-0240-2018Class IIXcela PICC Kit with ENDEXO and PASV Valve TechnologyAngiodynamics Inc. (Navilyst Medical Inc.)
2017-12-20Z-0241-2018Class IIXCELA PASV 5F DL 55CM IR-145 Nitinol Wire KIT PGAngiodynamics Inc. (Navilyst Medical Inc.)
2017-12-20Z-0242-2018Class IIXCELA PASV 5F DL 55CM MST-70 KIT PGAngiodynamics Inc. (Navilyst Medical Inc.)
2017-12-20Z-0243-2018Class IIXCELA PASV 5F DL 55CM IR-145 KIT PGAngiodynamics Inc. (Navilyst Medical Inc.)
2017-12-20Z-0244-2018Class IIBio-Stable 5F SL-55CM IR-145 Kit Valved PGAngiodynamics Inc. (Navilyst Medical Inc.)
2017-12-20Z-0245-2018Class IIBio-Stable 5F DL-55CM IR-145 Kit Valved PGAngiodynamics Inc. (Navilyst Medical Inc.)
2017-12-20Z-0246-2018Class IIBio-Stable 5F DL-55CM MST-70 KIT Non-Valved PGAngiodynamics Inc. (Navilyst Medical Inc.)
2017-12-20Z-0247-2018Class IIBio-Stable 5F DL-55CM MST-70 KIT Non-Valved PGAngiodynamics Inc. (Navilyst Medical Inc.)
2017-12-20Z-0248-2018Class IIBio-Stable 5F DL-55CM MST-70 KIT Non-Valved PGAngiodynamics Inc. (Navilyst Medical Inc.)
2017-12-20Z-0249-2018Class IIBio-Stable 5F DL-55CM IR-145 Kit Valved with Nit GWAngiodynamics Inc. (Navilyst Medical Inc.)
2017-12-20Z-0250-2018Class IIBio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GWAngiodynamics Inc. (Navilyst Medical Inc.)
2017-12-20Z-0251-2018Class IIBio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GWAngiodynamics Inc. (Navilyst Medical Inc.)
2017-12-20Z-0252-2018Class IIBio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GWAngiodynamics Inc. (Navilyst Medical Inc.)
2017-12-20Z-0253-2018Class IINonabsorbable suture anchor system intended to reattach soft tissue…ConMed Corporation
2017-12-20Z-0254-2018Class IIenGen Track System with TCAutomation Software Version 4Ortho-Clinical Diagnostics
2017-12-13Z-0193-2018Class IIpmiPro-Med Instruments Gmbh
2017-12-13Z-0195-2018Class IIICU MednetICU Medical Inc
2017-12-13Z-0196-2018Class IITrypticaseTM Soy Agar with 5% Sheep BloodBecton Dickinson & Co.
2017-12-13Z-0197-2018Class IIAccu-Chek Connect diabetes management software appRoche Diabetes Care, Inc.
2017-12-13Z-0198-2018Class IIIBD PhoenixTM APBecton Dickinson & Co.
2017-12-13Z-0199-2018Class IIDeRoyal Sterile Custom kits containing Medline Aplicare Povidone…DeRoyal Industries Inc
2017-12-13Z-0200-2018Class IIVantage Total Ankle Tibial InsertExactech, Inc.
2017-12-13Z-0201-2018Class IIVantage Total Ankle Tibial InsertExactech, Inc.
2017-12-13Z-0202-2018Class IICARESCAPE Patient Data ModuleGE Medical Systems Information Technologies, Inc.
2017-12-13Z-0203-2018Class IIFukuda Denshi patient monitor model DS-8100M and DS-8100N Product…Fukuda Denshi Co., Ltd.
2017-12-13Z-0204-2018Class IIMorning LifeWon Industry Co.
2017-12-13Z-0205-2018Class IICompressible Limb Therapy SystemWon Industry Co.
2017-12-13Z-0206-2018Class IIDial-A-Dose Insulin Delivery DeviceNovo Nordisk Inc
2017-12-13Z-0207-2018Class IIBD Precision Glide Needle 18G x 1 RBBecton Dickinson & Company
2017-12-13Z-0208-2018Class IISolus Flexible wire-reinforced laryngeal mask airways under the…Intersurgical Inc
2017-12-13Z-0209-2018Class IICM0405 Mueller-Hinton Broth IVDRemel Inc
2017-12-13Z-0210-2018Class IISMARTABLATE RF System GeneratorBiosense Webster, Inc.
2017-12-13Z-0211-2018Class IIPENTARAY NAV High-Density Mapping CatheterBiosense Webster, Inc.
2017-12-13Z-0212-2018Class IIPENTARAY NAV High-Density Mapping CatheterBiosense Webster, Inc.
2017-12-13Z-0590-2018Class IIIArctic Sun ArcticGel PadsC.R. Bard, Inc.
2017-12-06Z-0171-2018Class IIBD Phoenix PMIC-107Becton Dickinson & Co.
2017-12-06Z-0172-2018Class IIBRAINLAB EXACTRAC VEROBrainlab AG
2017-12-06Z-0173-2018Class IIDimension Vista Protein 1 CalibratorSiemens Healthcare Diagnostics, Inc.
2017-12-06Z-0174-2018Class IIDimension Vista Protein 1 ControlSiemens Healthcare Diagnostics, Inc.
2017-12-06Z-0175-2018Class IIDimension Vista Protein 1 Control MSiemens Healthcare Diagnostics, Inc.
2017-12-06Z-0176-2018Class IIDimension Vista Protein 1 Control HSiemens Healthcare Diagnostics, Inc.
2017-12-06Z-0177-2018Class IIRosa Spine 1Zimmer Biomet, Inc.
2017-12-06Z-0178-2018Class IIROSA Surgical Device 2Zimmer Biomet, Inc.
2017-12-06Z-0179-2018Class IIArrowArrow International Inc
2017-12-06Z-0180-2018Class IIARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable…Arrow International Inc
2017-12-06Z-0181-2018Class IIARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable…Arrow International Inc
2017-12-06Z-0182-2018Class IIArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central…Arrow International Inc
2017-12-06Z-0183-2018Class IIBD Insulin Syringes with the BD Ultra-FineBecton Dickinson & Company
2017-12-06Z-0184-2018Class IIROSA Surgical Device 2Zimmer Biomet, Inc.
2017-12-06Z-0185-2018Class IIImplantDirect LegacyImplant Direct Sybron Manufacturing, LLC
2017-12-06Z-0188-2018Class IIEverflex Self-Expanding Peripheral Stent with Entrust Delivery System…Medtronic Inc.
2017-12-06Z-0189-2018Class IIVolcano Imaging System s5i REF 807400001Volcano Corporation
2017-12-06Z-0190-2018Class IISIEMENS N Protein Standard SLCSL Behring GmbH
2017-12-06Z-0191-2018Class IISIEMENS N/T Protein Control SL for use on the BN IICSL Behring GmbH
2017-12-06Z-0192-2018Class IIMonarch Airway Clearance SystemHILL-ROM MANUFACTURING, INC.
2017-11-29Z-0072-2018Class IArkon Anesthesia Delivery SystemSpacelabs Healthcare, Ltd.
2017-11-29Z-0105-2018Class IIROSA Brain 3Zimmer Biomet, Inc.
2017-11-29Z-0106-2018Class IISURPLUG MICRO CONNECTOR Item NoICU Medical, Inc.
2017-11-29Z-0107-2018Class IIMedtronic MiniMedMedtronic Inc.
2017-11-29Z-0108-2018Class IIMedtronic MiniMedMedtronic Inc.
2017-11-29Z-0109-2018Class IIMedtronic MiniMedMedtronic Inc.
2017-11-29Z-0110-2018Class IIMedtronic MiniMedMedtronic Inc.
2017-11-29Z-0111-2018Class IIMedtronic MiniMedMedtronic Inc.
2017-11-29Z-0112-2018Class IIMEDLINE PEDI ELBOW CLOSED SUCTION CATHETERMedline Industries Inc
2017-11-29Z-0113-2018Class IIMEDLINE DOUBLE SWIVEL CLOSED SUCTION CATHETERMedline Industries Inc
2017-11-29Z-0114-2018Class II3M Bair Hugger3M Company - Health Care Business
2017-11-29Z-0115-2018Class IIROSA Surgical Device 2Zimmer Biomet, Inc.
2017-11-29Z-0116-2018Class IIROSA BRAIN 3Zimmer Biomet, Inc.
2017-11-29Z-0117-2018Class IIHalyard Closed Suction System for Adults with BALLARD Technology WET…Halyard Health, Inc
2017-11-29Z-0118-2018Class IIHalyard Turbo-Cleaning Closed Suction System for AdultsHalyard Health, Inc
2017-11-29Z-0119-2018Class IIHalyard Closed Suction System for AdultsHalyard Health, Inc
2017-11-29Z-0120-2018Class IIHalyard Closed Suction System for AdultsHalyard Health, Inc
2017-11-29Z-0121-2018Class IIHalyard Turbo-Cleaning Closed Suction System for AdultsHalyard Health, Inc
2017-11-29Z-0122-2018Class IIHalyard Closed Suction System for AdultsHalyard Health, Inc
2017-11-29Z-0123-2018Class IIHalyard Turbo-Cleaning Closed Suction System for AdultsHalyard Health, Inc
2017-11-29Z-0124-2018Class IIHalyard Closed Suction System for AdultsHalyard Health, Inc
2017-11-29Z-0125-2018Class IINOVAPLUS* Endotracheal WET PAK* Closed Suction System for Adults with…Halyard Health, Inc
2017-11-29Z-0126-2018Class IIOptetrak Offset Tibial Tray and ScrewsExactech, Inc.
2017-11-29Z-0127-2018Class IIOptetrak Offset Tibial Tray and ScrewsExactech, Inc.
2017-11-29Z-0128-2018Class IIOptetrak Offset Tibial Tray and ScrewsExactech, Inc.
2017-11-29Z-0129-2018Class IIOptetrak Offset Tibial Tray and ScrewsExactech, Inc.
2017-11-29Z-0130-2018Class IIOptetrak Offset Tibial Tray and ScrewsExactech, Inc.
2017-11-29Z-0131-2018Class IIOptetrak Offset Tibial Tray and ScrewsExactech, Inc.
2017-11-29Z-0132-2018Class IIOptetrak Offset Tibial Tray and ScrewsExactech, Inc.
2017-11-29Z-0133-2018Class IIOptetrak Offset Tibial Tray and ScrewsExactech, Inc.
2017-11-29Z-0134-2018Class IIOptetrak Offset Tibial Tray and ScrewsExactech, Inc.
2017-11-29Z-0135-2018Class IIOptetrak Offset Tibial Tray and ScrewsExactech, Inc.
2017-11-29Z-0136-2018Class IIOptetrak Offset Tibial Tray and ScrewsExactech, Inc.
2017-11-29Z-0137-2018Class IIOptetrak Offset Tibial Tray and ScrewsExactech, Inc.
2017-11-29Z-0138-2018Class IIOptetrak Offset Tibial Tray and ScrewsExactech, Inc.
2017-11-29Z-0139-2018Class IIOptetrak Offset Tibial Tray and ScrewsExactech, Inc.
2017-11-29Z-0140-2018Class IIOptetrak Offset Tibial Tray and ScrewsExactech, Inc.
2017-11-29Z-0141-2018Class IIOptetrak Offset Tibial Tray and ScrewsExactech, Inc.
2017-11-29Z-0142-2018Class IIOptetrak Offset Tibial Tray and ScrewsExactech, Inc.
2017-11-29Z-0143-2018Class IIOptetrak Offset Tibial Tray and ScrewsExactech, Inc.
2017-11-29Z-0144-2018Class IIOptetrak Offset Tibial Tray and ScrewsExactech, Inc.
2017-11-29Z-0145-2018Class IIOptetrak Offset Tibial Tray and ScrewsExactech, Inc.
2017-11-29Z-0146-2018Class IIOptetrak Constrained Condylar Offset ScrewExactech, Inc.
2017-11-29Z-0147-2018Class IIOptetrak Constrained Condylar Offset ScrewExactech, Inc.
2017-11-29Z-0148-2018Class IIOptetrak Constrained Condylar Offset ScrewExactech, Inc.
2017-11-29Z-0149-2018Class IIOptetrak Constrained Condylar Offset ScrewExactech, Inc.
2017-11-29Z-0150-2018Class IIOptetrak Constrained Condylar Offset ScrewExactech, Inc.
2017-11-29Z-0151-2018Class IIOptetrak Constrained Condylar Offset ScrewExactech, Inc.
2017-11-29Z-0152-2018Class IIOptetrak Constrained Condylar Offset ScrewExactech, Inc.
2017-11-29Z-0153-2018Class IIOptetrak Constrained Condylar Offset ScrewExactech, Inc.
2017-11-29Z-0154-2018Class IIOptetrak Constrained Condylar Offset ScrewExactech, Inc.
2017-11-29Z-0155-2018Class IIOptetrak Constrained Condylar Offset ScrewExactech, Inc.
2017-11-29Z-0156-2018Class IIOptetrak Constrained Condylar Offset ScrewExactech, Inc.
2017-11-29Z-0157-2018Class IIOptetrak Constrained Condylar Offset ScrewExactech, Inc.
2017-11-29Z-0158-2018Class IIOptetrak Constrained Condylar Offset ScrewExactech, Inc.
2017-11-29Z-0159-2018Class IIOptetrak Offset Tibial Tray and ScrewsExactech, Inc.
2017-11-29Z-0160-2018Class IIROSA Surgical Device 2Zimmer Biomet, Inc.
2017-11-29Z-0161-2018Class IIROSA Surgical Device 2Zimmer Biomet, Inc.
2017-11-29Z-0162-2018Class IISensicare Green Surgical GloveMedline Industries Inc
2017-11-29Z-0163-2018Class IITransfer/Gait BeltMedline Industries Inc
2017-11-29Z-0164-2018Class IITransfer/Gait BeltMedline Industries Inc
2017-11-29Z-0165-2018Class IIARCHITECT c4000 part number 02P24Abbott Laboratories, Inc
2017-11-29Z-0166-2018Class IITubingAbbott Laboratories, Inc
2017-11-29Z-0167-2018Class IIROSA Brain 3Zimmer Biomet, Inc.
2017-11-29Z-0168-2018Class IISyngoSiemens Medical Solutions USA, Inc
2017-11-29Z-0169-2018Class IIRegard Custom Surgical Pack Packs contain surgical instruments and…Resource Optimization & Innovation Llc
2017-11-29Z-0170-2018Class IITissu-Trans Filtron 1000 Catalog Number 3-TT-FILTRON 1000Shippert Medical Technologies
2017-11-22Z-0090-2018Class IIReservoir Bag for WalkMed Infusion Pump Part Number 204820 Catalog…WalkMed, LLC
2017-11-22Z-0091-2018Class IIAQUIOS CL Flow CytometerBeckman Coulter Inc.
2017-11-22Z-0092-2018Class IIsmith&nephew LEGION L-WEDGESmith & Nephew, Inc.
2017-11-22Z-0093-2018Class IISymbia Intevo 16Siemens Medical Solutions USA, Inc.
2017-11-22Z-0094-2018Class IISymbia Intevo 6Siemens Medical Solutions USA, Inc.
2017-11-22Z-0095-2018Class IIiBalanceArthrex, Inc.
2017-11-22Z-0096-2018Class IIROSA Surgical Device 2Zimmer Biomet, Inc.
2017-11-22Z-0097-2018Class IIsmith&nephew TRIGEN INTERTAN 10SSmith & Nephew, Inc.
2017-11-22Z-0098-2018Class IISTORZ High Flow Insufflation TubingKarl Storz Endoscopy
2017-11-22Z-0099-2018Class IIROSA Surgical Device 2Zimmer Biomet, Inc.
2017-11-22Z-0100-2018Class IIROSA Surgical Device 2Zimmer Biomet, Inc.
2017-11-22Z-0101-2018Class IIPlum 360 Infusion SystemICU Medical Inc
2017-11-22Z-0102-2018Class IIROSA Surgical Device 2Zimmer Biomet, Inc.
2017-11-22Z-0103-2018Class IIHARVESTTerumo BCT, Inc.
2017-11-22Z-0104-2018Class IIHARVESTTerumo BCT, Inc.
2017-11-15Z-0063-2018Class IINorth Star Imaging IncNorth Star Imaging Inc
2017-11-15Z-0064-2018Class IICobalt HV Bone Cement 40GMEncore Medical, Lp
2017-11-15Z-0065-2018Class IICobalt MV Bone Cement 40GMEncore Medical, Lp
2017-11-15Z-0066-2018Class IICobalt MV with GentamicinEncore Medical, Lp
2017-11-15Z-0067-2018Class IICobalt HV with GentamicinEncore Medical, Lp
2017-11-15Z-0068-2018Class IIDelta Cup Beater  PositionerLimacorporate S.p.A
2017-11-15Z-0069-2018Class IIAMSWindstone Medical Packaging, Inc.
2017-11-15Z-0070-2018Class IICustom Ti MAK RS OSS Segmental Femoral Rotating Hinged KneeZimmer Biomet, Inc.
2017-11-15Z-0071-2018Class IIAERO IOL Injection System containing 10 Z28 Cartridges per boxAaren Scientific Inc.
2017-11-15Z-0073-2018Class IIElectrohydraulic lithotripter probeNorthgate Technologies, Inc.

Older →