Data Foundry

All years

Medical device recalls reported in 2014

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ReportedRecallClassProductFirm
2014-12-24Z-0738-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0739-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0740-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0741-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0742-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0743-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0744-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0745-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0746-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0747-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0748-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0749-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0750-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0751-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0752-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0753-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0754-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0755-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0756-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0757-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0758-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0759-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0760-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0761-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0762-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0763-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0764-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0765-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0766-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0767-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0768-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0769-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0770-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0771-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0772-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0773-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0774-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0775-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0776-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0777-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0778-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0779-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0780-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0781-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0782-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0783-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0784-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0785-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0786-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0787-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0788-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0789-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0790-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0791-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0792-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0793-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0794-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0795-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0796-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0797-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0798-2015Class IIPKGStryker Endoscopy
2014-12-24Z-0799-2015Class IISheridan/CF Cuffed Tracheal TubeTeleflex Medical
2014-12-24Z-0800-2015Class IIDRX-Revolution Mobile X-Ray SystemCarestream Health Inc
2014-12-24Z-0801-2015Class IITurbo Troponin I For in vitro diagnostic use for the quantitative…Siemens Healthcare Diagnostics, Inc.
2014-12-24Z-0803-2015Class IISpecialty Audible Torque Wrench Mfg by: Stryker SpineStryker Spine
2014-12-24Z-0804-2015Class IIIRadiomat M+ NIF 14 x 17AGFA Healthcare Corp.
2014-12-24Z-0805-2015Class IIAMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193…American Medical Systems, Inc.
2014-12-24Z-0806-2015Class IIAdVance"Male Sling SystemAmerican Medical Systems, Inc.
2014-12-24Z-0807-2015Class IIBiograph mCT Flow Edge-4RSiemens Medical Solutions USA Inc.
2014-12-24Z-0808-2015Class IIBiograph mCT Flow 40-4RSiemens Medical Solutions USA Inc.
2014-12-24Z-0809-2015Class IIBiograph mCT X-4RSiemens Medical Solutions USA Inc.
2014-12-24Z-0810-2015Class IIBiograph mCT SSiemens Medical Solutions USA Inc.
2014-12-24Z-0811-2015Class IIBiograph mCT SSiemens Medical Solutions USA Inc.
2014-12-24Z-0812-2015Class IIASTS-LG1212: Anterior Lumbar Interbody Fusion Spine Truss System4-Web Inc.
2014-12-24Z-0813-2015Class IIAscension Orthopedics PyroSphere CMC & PyroSphere TMTIntegra LifeSciences Corp.
2014-12-24Z-0814-2015Class IIIAesculap Miethke Shunt SystemAesculap, Inc.
2014-12-24Z-0815-2015Class IIAdditional devices identified in new FSN MA-FCO 83000190: QLAB…Philips Ultrasound, Inc.
2014-12-24Z-0816-2015Class IIEPIQ 5 Ultrasound SystemPhilips Ultrasound, Inc.
2014-12-24Z-0817-2015Class IIEPIQ 7 Ultrasound SystemPhilips Ultrasound, Inc.
2014-12-24Z-0818-2015Class IIQ-Station Quantification SoftwarePhilips Ultrasound, Inc.
2014-12-24Z-0819-2015Class IIITrinity biotech CaptiaClark Laboratories, Inc. (dba,Trinity Biotech USA)
2014-12-24Z-0820-2015Class IICARESTREAM DIRECTVIEW CR Software Generates digital mammographic…Carestream Health, Inc.
2014-12-24Z-0821-2015Class IIVERO Linear Accelerator SystemMITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
2014-12-24Z-0822-2015Class IIDevice Brand Name: Sirius Polish Cemented Stem 34B Device…Biomet, Inc.
2014-12-24Z-0823-2015Class IISirius Polish Cemented Stem 38C Catalog Number: 51-199335 Lot Number…Biomet, Inc.
2014-12-24Z-0824-2015Class IIBone ScrewZimmer Manufacturing B.V.
2014-12-24Z-0825-2015Class IICeramic Femoral HeadDePuy Orthopaedics, Inc.
2014-12-24Z-0826-2015Class IIWECK Hemoclip¿ Traditional Medium Tantalum Ligating ClipsTeleflex Medical
2014-12-24Z-0827-2015Class IIGlucose HexokinaseJAS Diagnostics Inc.
2014-12-24Z-0828-2015Class IIRESTORIS PST Straight Shell Inserter An impactor is a reusable…Mako Surgical Corporation
2014-12-24Z-0829-2015Class IIRESTORIS PST Acetabular Straight Shell Impactors An impactor is a…Mako Surgical Corporation
2014-12-24Z-0830-2015Class IIRESTORIS PST Acetabular Offset Shell Impactors An impactor is a…Mako Surgical Corporation
2014-12-24Z-0831-2015Class IIIntegra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon…Integra LifeSciences Corp.
2014-12-17Z-0180-2015Class ICovidien Puritan Bennett 980 VentilatorNellcor Puritan Bennett Inc. (dba Covidien LP)
2014-12-17Z-0203-2015Class IIBrightView XCT is a gamma camera for Single Photon Emission Computed…Philips Medical Systems, Inc.
2014-12-17Z-0503-2015Class IICrocodileSnug Seat Inc
2014-12-17Z-0507-2015Class IITomoTherapy Treatment System with software versions 2TomoTherapy Incorporated
2014-12-17Z-0509-2015Class IITotal Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti…Biomet Microfixation, LLC
2014-12-17Z-0510-2015Class IITotal Temporomandibular Joint Replacement System- 45mm Lft Stand Off…Biomet Microfixation, LLC
2014-12-17Z-0511-2015Class IITotal Temporomandibular Joint Replacement System- 45mm Rt Narrow Ti…Biomet Microfixation, LLC
2014-12-17Z-0512-2015Class IITotal Temporomandibular Joint Replacement System- 45mm Rt Stand Off…Biomet Microfixation, LLC
2014-12-17Z-0513-2015Class IITotal Temporomandibular Joint Replacement System- 50mm Lft Narrow Ti…Biomet Microfixation, LLC
2014-12-17Z-0514-2015Class IITotal Temporomandibular Joint Replacement System- 50mm Lft Stand Off…Biomet Microfixation, LLC
2014-12-17Z-0515-2015Class IITotal Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti…Biomet Microfixation, LLC
2014-12-17Z-0516-2015Class IITotal Temporomandibular Joint Replacement System- 50mm Rt Stand Off…Biomet Microfixation, LLC
2014-12-17Z-0517-2015Class IITotal Temporomandibular Joint Replacement System- 50mm Rt Standard Ti…Biomet Microfixation, LLC
2014-12-17Z-0518-2015Class IITotal Temporomandibular Joint Replacement System- 50mm Lft Standard…Biomet Microfixation, LLC
2014-12-17Z-0519-2015Class IITotal Temporomandibular Joint Replacement System- 55mm Lft Standard…Biomet Microfixation, LLC
2014-12-17Z-0520-2015Class IITotal Temporomandibular Joint Replacement System- 55mm Rt Standard Ti…Biomet Microfixation, LLC
2014-12-17Z-0521-2015Class IITotal Temporomandibular Joint Replacement System- 45mm Lft Standard…Biomet Microfixation, LLC
2014-12-17Z-0522-2015Class IITotal Temporomandibular Joint Replacement System- 45mm Rt Standard TI…Biomet Microfixation, LLC
2014-12-17Z-0523-2015Class IIMammomat Inspiration system: Product Usage: mammography examsSiemens Medical Solutions USA, Inc
2014-12-17Z-0524-2015Class IIMedtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion SetsMedtronic MiniMed Inc.
2014-12-17Z-0525-2015Class IIDistal Access Catheter: Model Numbers: 90121Concentric Medical Inc
2014-12-17Z-0527-2015Class IIAlcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101…Alcon Research, Ltd.
2014-12-17Z-0528-2015Class IITrevo Pro 4 Stent RetrieverConcentric Medical Inc
2014-12-17Z-0529-2015Class IISoft Contact LensCooper Vision Caribbean Corp.
2014-12-17Z-0530-2015Class IIAbbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium…Abbott Medical Optics Inc (AMO)
2014-12-17Z-0531-2015Class IIThe Affinity Fusion Oxygenator with Integrated Arterial Filter and…Medtronic Perfusion Systems
2014-12-17Z-0532-2015Class IIA uterine tenaculum is a hook-like instrument used to seize and hold…Instrumed International, Inc.
2014-12-17Z-0533-2015Class IIAn endometrial suction curette is a device used to remove material…Instrumed International, Inc.
2014-12-17Z-0534-2015Class IIA zipser clamp is an instrument used to compress reduce blood flow to…Instrumed International, Inc.
2014-12-17Z-0535-2015Class IIA trocar is a sharp-pointed instrument used with a cannula for…Instrumed International, Inc.
2014-12-17Z-0536-2015Class IIAn external vein stripper is an extravascular device used to remove a…Instrumed International, Inc.
2014-12-17Z-0537-2015Class IIManual bunnell cranial drills are bone cutting and drilling…Instrumed International, Inc.
2014-12-17Z-0538-2015Class IIA circumcision clamp is an instrument used to compress the foreskin…Instrumed International, Inc.
2014-12-17Z-0539-2015Class IIManual trephines are bone cutting and drilling instruments that are…Instrumed International, Inc.
2014-12-17Z-0540-2015Class IIHudson braces are bone cutting and drilling instruments that are used…Instrumed International, Inc.
2014-12-17Z-0541-2015Class IIHudson cerebellar extensions are bone cutting and drilling…Instrumed International, Inc.
2014-12-17Z-0542-2015Class IICushing perforating drills are bone cutting and drilling instruments…Instrumed International, Inc.
2014-12-17Z-0543-2015Class IICushing burrs are bone cutting and drilling instruments that are used…Instrumed International, Inc.
2014-12-17Z-0544-2015Class IIHudson burrs are bone cutting and drilling instruments that are used…Instrumed International, Inc.
2014-12-17Z-0545-2015Class IIMcKenzie Perforator Drills are bone cutting and drilling instruments…Instrumed International, Inc.
2014-12-17Z-0546-2015Class IID'errico perforator drills are bone cutting and drilling instruments…Instrumed International, Inc.
2014-12-17Z-0547-2015Class IIMcKenzie enlarging burrs are bone cutting and drilling instruments…Instrumed International, Inc.
2014-12-17Z-0548-2015Class IIHudson cranial drill setsInstrumed International, Inc.
2014-12-17Z-0549-2015Class IIGalt trephines are bone cutting and drilling instruments that are…Instrumed International, Inc.
2014-12-17Z-0550-2015Class IIGardner-Wells traction tongs are skull tongs for traction used to…Instrumed International, Inc.
2014-12-17Z-0551-2015Class IIReplacement screw non-springloaded traction tongs are skull tongs for…Instrumed International, Inc.
2014-12-17Z-0552-2015Class IILock nuts for titanium traction tongs are used in traction skull…Instrumed International, Inc.
2014-12-17Z-0553-2015Class IITitanium fixation screwsInstrumed International, Inc.
2014-12-17Z-0554-2015Class IITraction tong replacement screwsInstrumed International, Inc.
2014-12-17Z-0555-2015Class IIGardner-Wells wrenches are used in traction skull tongs for traction…Instrumed International, Inc.
2014-12-17Z-0556-2015Class IICVB distraction screws are bone cutting and drilling instruments that…Instrumed International, Inc.
2014-12-17Z-0557-2015Class IICloward Spanner gauges are bone cutting and drilling instruments that…Instrumed International, Inc.
2014-12-17Z-0558-2015Class IITonometers are manual devices intended to measure intraocular…Instrumed International, Inc.
2014-12-17Z-0559-2015Class IISchoitz weights are manual devices used with Schoitz tonometers and…Instrumed International, Inc.
2014-12-17Z-0560-2015Class IIRapid Centesis CatheterPfm Medical Inc
2014-12-17Z-0561-2015Class IIASEPT Pleural Drainage SystemPfm Medical Inc
2014-12-17Z-0562-2015Class IIASEPT 600 ml Drainage KitPfm Medical Inc
2014-12-17Z-0563-2015Class IIMicro Introducer KitPfm Medical Inc
2014-12-17Z-0564-2015Class II6F x 60 cm Dual Lumen CT PICCPfm Medical Inc
2014-12-17Z-0565-2015Class IIASEPT Peritoneal Drainage SystemPfm Medical Inc
2014-12-17Z-0566-2015Class IIThoracentesis & Paracentesis Procedure TrayPfm Medical Inc
2014-12-17Z-0567-2015Class IIVeta Peritoneal Catheter KitPfm Medical Inc
2014-12-17Z-0568-2015Class IIASEPT 2000 ml Drainage BagPfm Medical Inc
2014-12-17Z-0569-2015Class II1488 HD 3-Chip CameraStryker Endoscopy
2014-12-17Z-0570-2015Class II1488 HD 3-Chip Inline CameraStryker Endoscopy
2014-12-17Z-0571-2015Class II1488 HD 3-Chip CameraStryker Endoscopy
2014-12-17Z-0572-2015Class IIBD Insyte Autoguard Catheter An active safety engineered peripheral…Becton Dickinson & Company
2014-12-17Z-0573-2015Class IIArrow Nerve Block ComponentArrow International Inc
2014-12-17Z-0574-2015Class IIZimmer Title 2 Bone Screw Remover InstrumentZimmer, Inc.
2014-12-17Z-0575-2015Class IIINOMAX DSIR Nitric Oxide delivery systemINO Therapeutics (dba Ikaria)
2014-12-17Z-0576-2015Class IISyngoSiemens Medical Solutions USA, Inc
2014-12-17Z-0577-2015Class IIInvacare Perfecto 2 V Oxygen Concentrator The finished device is…Invacare Corporation
2014-12-17Z-0578-2015Class IIOxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml…Remel Inc
2014-12-17Z-0579-2015Class IIModel Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated…ArthroCare Medical Corporation
2014-12-17Z-0580-2015Class IIIntellaMap Orion High Resolution Mapping CatheterBoston Scientific Corp
2014-12-17Z-0581-2015Class IIConformis iTotal CR G2 Knee Replacement System Catalog/Model #:…ConforMIS, Inc.
2014-12-17Z-0582-2015Class IIAlign Radial StemsSkeletal Dynamics
2014-12-17Z-0588-2015Class IIMEVION S250Mevion Medical Systems, Inc.
2014-12-17Z-0589-2015Class IILEGIONSmith & Nephew, Inc.
2014-12-17Z-0590-2015Class IILEGIONSmith & Nephew, Inc.
2014-12-17Z-0591-2015Class IILEGIONSmith & Nephew, Inc.
2014-12-10Z-0237-2015Class ISurgical packsCustomed, Inc
2014-12-10Z-0238-2015Class IIrrigation Tray With Bulb SyringeCustomed, Inc
2014-12-10Z-0239-2015Class IUniversal Drainage TrayCustomed, Inc
2014-12-10Z-0240-2015Class IWound Closure Tray ICustomed, Inc
2014-12-10Z-0241-2015Class IWound Closure Tray IICustomed, Inc
2014-12-10Z-0242-2015Class ITracheotomy Care KitCustomed, Inc
2014-12-10Z-0243-2015Class ISuction Catheter KitCustomed, Inc
2014-12-10Z-0244-2015Class IUretheral Catheter TrayCustomed, Inc
2014-12-10Z-0245-2015Class ISurgeon Reinforced Gown XLCustomed, Inc
2014-12-10Z-0246-2015Class ISurgeon Gown Poly Reinforced LgcCustomed, Inc
2014-12-10Z-0247-2015Class IWound Management Tray IllCustomed, Inc
2014-12-10Z-0248-2015Class IUtility Drape End ProductCustomed, Inc
2014-12-10Z-0249-2015Class IIncision & Drainage TrayCustomed, Inc
2014-12-10Z-0250-2015Class ISkin Staple RemovalCustomed, Inc
2014-12-10Z-0251-2015Class IWound Management TrayCustomed, Inc
2014-12-10Z-0252-2015Class IWound Management Tray IICustomed, Inc
2014-12-10Z-0253-2015Class IGown Surgical Non Reinforced XLCustomed, Inc
2014-12-10Z-0254-2015Class IWound Management Tray Ryder MemorialCustomed, Inc
2014-12-10Z-0255-2015Class ILeggings W/7'' CuffCustomed, Inc
2014-12-10Z-0256-2015Class IMinor Laceration TrayCustomed, Inc
2014-12-10Z-0257-2015Class IMayo Stand Cover W/CSR WrapCustomed, Inc
2014-12-10Z-0258-2015Class IWound Management TrayCustomed, Inc
2014-12-10Z-0259-2015Class IGown Surg Fully Impervious LargeCustomed, Inc
2014-12-10Z-0260-2015Class IGown Surgical Poly Reinforced XL X-LongCustomed, Inc
2014-12-10Z-0261-2015Class IGown Surgical Non Reinforced XXLCustomed, Inc
2014-12-10Z-0262-2015Class IGown Fabric Reinforced XXLCustomed, Inc

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