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Medical device recalls reported in 2018

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ReportedRecallClassProductFirm
2018-07-25Z-2479-2018Class IIHitachi Oasis MRI system Product Usage: Hitachi MR system is an…Hitachi Medical Systems America Inc
2018-07-25Z-2480-2018Class IIPresource PBDSCardinal Health 200, LLC
2018-07-25Z-2481-2018Class IIPresource PBDSCardinal Health 200, LLC
2018-07-25Z-2482-2018Class IIPresource PBDSCardinal Health 200, LLC
2018-07-25Z-2483-2018Class IIPresource PBDSCardinal Health 200, LLC
2018-07-25Z-2484-2018Class IIReprocessed HARMONIC Ace¿ +7Stryker Sustainability Solutions
2018-07-25Z-2485-2018Class IIHydroline Trumpet Valve with Pulse Wave CassetteCardinal Health 200, LLC
2018-07-25Z-2486-2018Class IIHydroline Trumpet Valve with Pulse Wave CassetteCardinal Health 200, LLC
2018-07-25Z-2487-2018Class IIHydroline Trumpet Valve with Pulse Wave CassetteCardinal Health 200, LLC
2018-07-25Z-2488-2018Class IIHydroline Trumpet Valve with Pulse Wave CassetteCardinal Health 200, LLC
2018-07-25Z-2489-2018Class IIHydroline Trumpet Valve with Pulse Wave CassetteCardinal Health 200, LLC
2018-07-25Z-2490-2018Class IIHydroline Trumpet ValveCardinal Health 200, LLC
2018-07-25Z-2491-2018Class IIHydroline Trumpet ValveCardinal Health 200, LLC
2018-07-25Z-2492-2018Class IIHydroline Trumpet ValveCardinal Health 200, LLC
2018-07-25Z-2493-2018Class IIHydroline Trumpet ValveCardinal Health 200, LLC
2018-07-25Z-2494-2018Class IIHydroline Trumpet ValveCardinal Health 200, LLC
2018-07-25Z-2495-2018Class IIHydroline Trumpet ValveCardinal Health 200, LLC
2018-07-25Z-2496-2018Class IIIngenuity Digital PET/CT SystemPhilips Medical Systems (Cleveland) Inc
2018-07-25Z-2497-2018Class IIRayStation stand-alone software treatment planning systemRAYSEARCH LABORATORIES AB
2018-07-25Z-2501-2018Class IIVisualase Cooled Laser Applicator SystemMedtronic Navigation, Inc.
2018-07-25Z-2502-2018Class IIVOLISTA StandOP Surgical LightMaquet SAS
2018-07-25Z-2503-2018Class IIEndo GIA 45 mm Articulating Medium/Thick Reload with Tri-Staple…COVIDIEN MEDTRONIC
2018-07-25Z-2504-2018Class IIEndo GIA 60 mm Articulating Medium/Thick Reload with…COVIDIEN MEDTRONIC
2018-07-25Z-2505-2018Class IIEndo GIA 60 mm Extra Thick Black Articulating Reload with Tri-Staple…COVIDIEN MEDTRONIC
2018-07-25Z-2506-2018Class IIEndo GIA 60 mm Articulating Vascular/Medium Loading Unit with…COVIDIEN MEDTRONIC
2018-07-25Z-2507-2018Class IITri-Staple 2COVIDIEN MEDTRONIC
2018-07-25Z-2508-2018Class IITri-Staple 2COVIDIEN MEDTRONIC
2018-07-25Z-2509-2018Class IIEndo GIA 45mm Gray Articulating Vascular Reload with Tri-Staple…COVIDIEN MEDTRONIC
2018-07-25Z-2510-2018Class IIEndo GIA 45 mm Extra Thick Black Articulating Reload with Tri-Staple…COVIDIEN MEDTRONIC
2018-07-25Z-2511-2018Class IIEndo GIA 45 mm Articulating Vascular/Medium Loading Unit with…COVIDIEN MEDTRONIC
2018-07-25Z-2512-2018Class IIEndo GIA 45mm Curved Tip Articulating Vascular/Medium Reload with…COVIDIEN MEDTRONIC
2018-07-25Z-2513-2018Class IITri-Staple 2COVIDIEN MEDTRONIC
2018-07-25Z-2514-2018Class IITri-Staple 2COVIDIEN MEDTRONIC
2018-07-25Z-2515-2018Class IITri-Staple 2COVIDIEN MEDTRONIC
2018-07-25Z-2516-2018Class IITri-Staple 2COVIDIEN MEDTRONIC
2018-07-18Z-2378-2018Class IIBARD MYPICC KitMedline Industries, Inc.
2018-07-18Z-2379-2018Class IIBCI Advisor Vital Signs MonitorSmiths Medical ASD Inc.
2018-07-18Z-2380-2018Class IIda Vinci Xi EndoWrist Stapler 45 Reload BlueIntuitive Surgical, Inc.
2018-07-18Z-2381-2018Class IIda Vinci Xi EndoWrist Stapler 45 Reload GreenIntuitive Surgical, Inc.
2018-07-18Z-2382-2018Class IIVPS Rhythm ECG Accessory Pack with Johans AdapterArrow International Inc
2018-07-18Z-2383-2018Class IIVPS Rhythm ECG Accessory PackArrow International Inc
2018-07-18Z-2384-2018Class IIVPS TipTracker Stylet AccessoryArrow International Inc
2018-07-18Z-2385-2018Class IIPeripherally Inserted Midline Catheter Kit with Placement WireArrow International Inc
2018-07-18Z-2386-2018Class IIDiscovery IGS 730 Interventional Fluoroscopic X-ray SystemsGE Medical Systems, SCS
2018-07-18Z-2387-2018Class IIInnova IGS 630/520/530/540 Interventional Fluoroscopic X-ray SystemsGE Medical Systems, SCS
2018-07-18Z-2388-2018Class IIDiscovery IGS 740 Interventional Fluoroscopic X-ray SystemsGE Medical Systems, SCS
2018-07-18Z-2389-2018Class IIElecsys Vitamin D total IIRoche Diagnostics Corporation
2018-07-18Z-2390-2018Class IIElecsys Vitamin D total IIRoche Diagnostics Corporation
2018-07-18Z-2391-2018Class IINOVAPLUSEkla Corporation
2018-07-18Z-2392-2018Class IIReliance 1227 Cart and Utensil Washer/DisinfectorSteris Corporation
2018-07-18Z-2393-2018Class IITibial NailStryker GmbH
2018-07-18Z-2394-2018Class IIFemoral NailStryker GmbH
2018-07-18Z-2395-2018Class IIFemoral NailStryker GmbH
2018-07-18Z-2396-2018Class IIFemoral NailStryker GmbH
2018-07-18Z-2397-2018Class IIFemoral NailStryker GmbH
2018-07-18Z-2398-2018Class IIFemoral NailStryker GmbH
2018-07-18Z-2399-2018Class IIFemoral NailStryker GmbH
2018-07-18Z-2400-2018Class IIFemoral NailStryker GmbH
2018-07-18Z-2401-2018Class IIFemoral NailStryker GmbH
2018-07-18Z-2402-2018Class IIFemoral NailStryker GmbH
2018-07-18Z-2403-2018Class IIFemoral NailStryker GmbH
2018-07-18Z-2404-2018Class IIFemoral NailStryker GmbH
2018-07-18Z-2405-2018Class IIFemoral NailStryker GmbH
2018-07-18Z-2406-2018Class IIFemoral NailStryker GmbH
2018-07-18Z-2407-2018Class IIAnkle Arthrodesis NailStryker GmbH
2018-07-18Z-2408-2018Class IIAnkle Arthrodesis NailStryker GmbH
2018-07-18Z-2409-2018Class IICryptococcal Antigen Lateral Flow AssayImmuno-Mycologics, Inc
2018-07-18Z-2410-2018Class IIVacuum RegulatorOhio Medical Corporation
2018-07-18Z-2411-2018Class IIFDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZERFort Defiance Industries, LLC
2018-07-18Z-2412-2018Class IIPercepta CRT-P MRI SureScanMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2018-07-18Z-2413-2018Class IIPercepta Quad CRT-P MRI SureScanMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2018-07-18Z-2414-2018Class IIPercepta CRT-P MRI SureScanMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2018-07-18Z-2415-2018Class IIPercepta Quad CRT-P MRI SureScanMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2018-07-18Z-2416-2018Class IIMedtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator…Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2018-07-18Z-2417-2018Class IIMedtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator…Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2018-07-18Z-2418-2018Class IIMedtronic EnTrust SingleChamber Implantable Cardioverter…Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2018-07-18Z-2419-2018Class IIMedtronic EnTrust SingleChamber Implantable Cardioverter…Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2018-07-18Z-2420-2018Class IIMedtronic EnTrust Escudo D144VRCMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2018-07-18Z-2421-2018Class IIMedtronic EnTrust Escudo D144DRGMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2018-07-18Z-2422-2018Class IIAperFix AM Femoral ImplantCayenne Medical Inc.
2018-07-18Z-2423-2018Class IIHyalomatrixAnika Therapeutics, Inc.
2018-07-18Z-2424-2018Class IIProteus 235Ion Beam Applications S.A.
2018-07-18Z-2425-2018Class IIPD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine…Dako North America Inc.
2018-07-18Z-2426-2018Class IICoronary SinusStryker Sustainability Solutions
2018-07-18Z-2427-2018Class IILigaSure" Exact Dissector Nano Coated 20Covidien LLC
2018-07-18Z-2428-2018Class IIBioMerieux mini VIDAS System in combination with Quality Control…bioMerieux, Inc.
2018-07-18Z-2429-2018Class IIBioMerieux VIDAS System in combination with Quality Control VIDAS*bioMerieux, Inc.
2018-07-11Z-2292-2018Class IILFIT Anatomic CoCr Femoral HeadsHowmedica Osteonics Corp.
2018-07-11Z-2293-2018Class IILFIT Anatomic CoCr Femoral HeadsHowmedica Osteonics Corp.
2018-07-11Z-2294-2018Class IILFIT Anatomic CoCr Femoral HeadsHowmedica Osteonics Corp.
2018-07-11Z-2295-2018Class IILFIT Anatomic CoCr Femoral HeadsHowmedica Osteonics Corp.
2018-07-11Z-2296-2018Class IILFIT Anatomic CoCr Femoral HeadsHowmedica Osteonics Corp.
2018-07-11Z-2297-2018Class IILFIT Anatomic CoCr Femoral HeadsHowmedica Osteonics Corp.
2018-07-11Z-2298-2018Class IILFIT Anatomic CoCr Femoral HeadsHowmedica Osteonics Corp.
2018-07-11Z-2299-2018Class IILFIT Anatomic CoCr Femoral HeadsHowmedica Osteonics Corp.
2018-07-11Z-2332-2018Class IIIECOLAB MICROTEK Rolled Probe CoverECOLAB INC
2018-07-11Z-2333-2018Class IIIECOLAB MICROTEK Rolled Probe CoverECOLAB INC
2018-07-11Z-2334-2018Class IIStSt Jude Medical Inc.
2018-07-11Z-2335-2018Class IIMerlin PCS Programmer Software: 3330 The Merlin PCS programmerSt Jude Medical Inc.
2018-07-11Z-2336-2018Class IIMulti-Lumen Central Venous Catheterization Set with Blue FlexTip…Arrow International Inc
2018-07-11Z-2337-2018Class IIAngio-Seal Evolution Vascular Closure DeviceTerumo Medical Corp
2018-07-11Z-2338-2018Class IICannulated Driver HandleTrilliant Surgical Ltd.
2018-07-11Z-2339-2018Class IIRatcheting Cannulated Driver HandleTrilliant Surgical Ltd.
2018-07-11Z-2340-2018Class IIGE Healthcare CARESCAPE Monitor B650GE Healthcare Finland Oy
2018-07-11Z-2341-2018Class IIda Vinci X Surgical SystemIntuitive Surgical, Inc.
2018-07-11Z-2342-2018Class IISafety Sideport Knife 1Beaver Visitec
2018-07-11Z-2343-2018Class II26-Lead Transfer Set for use with APEX¿ Compounding SystemB. Braun Medical, Inc.
2018-07-11Z-2344-2018Class IIVITROS Chemistry Products PHYT SlidesOrtho-Clinical Diagnostics
2018-07-11Z-2345-2018Class IImicroTargeting" Drive SystemFHC, Inc.
2018-07-11Z-2346-2018Class IImicroTargeting" Drive SystemFHC, Inc.
2018-07-11Z-2347-2018Class IImicroTargeting" Drive SystemFHC, Inc.
2018-07-11Z-2348-2018Class IImicroTargeting" Drive SystemFHC, Inc.
2018-07-11Z-2349-2018Class IImicroTargeting" STar" Drive SystemFHC, Inc.
2018-07-11Z-2350-2018Class IImicroTargeting" STar" Drive SystemFHC, Inc.
2018-07-11Z-2351-2018Class IImicroTargeting" STar" Drive SystemFHC, Inc.
2018-07-11Z-2352-2018Class IImicroTargeting" STar" Drive SystemFHC, Inc.
2018-07-11Z-2353-2018Class IImicroTargeting" Lead Adapter for microTargeting" DriveFHC, Inc.
2018-07-11Z-2354-2018Class IImicroTargeting" Lead Adapter for STar" DriveFHC, Inc.
2018-07-11Z-2355-2018Class IImicroTargeting" Drive System Distributed by MedtronicFHC, Inc.
2018-07-11Z-2356-2018Class IImicroTargeting" Drive System Distributed by MedtronicFHC, Inc.
2018-07-11Z-2357-2018Class IImicroTargeting" STar" Drive SystemFHC, Inc.
2018-07-11Z-2358-2018Class IImicroTargeting" STar" Drive SystemFHC, Inc.
2018-07-11Z-2359-2018Class IImicrotargeting" Depth Stop AdapterFHC, Inc.
2018-07-11Z-2360-2018Class IIVulcan Fast Red Chromogen Kit 2Biocare Medical, LLC
2018-07-11Z-2361-2018Class IIZimmer M/L Taper Hip Prosthesis Plasma SprayedZimmer Biomet, Inc.
2018-07-11Z-2362-2018Class IIZimmer¿ M/L Taper Hip Prosthesis Plasma SprayedZimmer Biomet, Inc.
2018-07-11Z-2363-2018Class IIZimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology CementlessZimmer Biomet, Inc.
2018-07-11Z-2364-2018Class IIZimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology CementlessZimmer Biomet, Inc.
2018-07-11Z-2365-2018Class IIZimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology CementlessZimmer Biomet, Inc.
2018-07-11Z-2366-2018Class IIZimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology CementlessZimmer Biomet, Inc.
2018-07-11Z-2367-2018Class IIZimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology CementlessZimmer Biomet, Inc.
2018-07-11Z-2368-2018Class IIZimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology CementlessZimmer Biomet, Inc.
2018-07-11Z-2369-2018Class IIZimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology CementlessZimmer Biomet, Inc.
2018-07-11Z-2370-2018Class IIZimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology CementlessZimmer Biomet, Inc.
2018-07-11Z-2371-2018Class IIZimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology CementlessZimmer Biomet, Inc.
2018-07-11Z-2372-2018Class IIZimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology CementlessZimmer Biomet, Inc.
2018-07-11Z-2373-2018Class IIZimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology CementlessZimmer Biomet, Inc.
2018-07-11Z-2374-2018Class IIZimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology CementlessZimmer Biomet, Inc.
2018-07-11Z-2375-2018Class IIZimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology CementlessZimmer Biomet, Inc.
2018-07-11Z-2376-2018Class IIREPLANT 5Implant Direct Sybron Manufacturing, LLC
2018-07-11Z-2377-2018Class IIMedtronic MiniMed Paradigm Veo Insulin Pump Product Catalog Number:…Medtronic Inc.
2018-07-04Z-2273-2018Class IIBrilliance Big Bore Radiology 728244Philips Medical Systems (Cleveland) Inc
2018-07-04Z-2274-2018Class IIPhilips Ingenuity Core 728321Philips Medical Systems (Cleveland) Inc
2018-07-04Z-2275-2018Class IIIngenuity Core128 728323Philips Medical Systems (Cleveland) Inc
2018-07-04Z-2276-2018Class IIIngenuity TF PET/CT 882442Philips Medical Systems (Cleveland) Inc
2018-07-04Z-2277-2018Class IIIngenuity Core128/Elite China 728324Philips Medical Systems (Cleveland) Inc
2018-07-04Z-2278-2018Class IIRandox Liquid Assayed Specific Protein ControlRandox Laboratories Ltd.
2018-07-04Z-2279-2018Class IIRandox Liquid Assayed Specific Protein ControlRandox Laboratories Ltd.
2018-07-04Z-2280-2018Class IIRandox Liquid Assayed Specific Protein ControlRandox Laboratories Ltd.
2018-07-04Z-2281-2018Class IICS-7Konica Minolta Medical Imaging USA, Inc.
2018-07-04Z-2282-2018Class IIImagePilotKonica Minolta Medical Imaging USA, Inc.
2018-07-04Z-2283-2018Class IIARTIS Pheno Interventional Fluoroscopic X-Ray SystemSiemens Medical Solutions USA, Inc
2018-07-04Z-2284-2018Class IIThe Proton Therapy SystemIon Beam Applications S.A.
2018-07-04Z-2285-2018Class IISpace Pump IV SetB. Braun Medical, Inc.
2018-07-04Z-2286-2018Class IIABX Pentra Micro ALBUMIN 2 CPHoriba Instruments, Inc dba Horiba Medical
2018-07-04Z-2287-2018Class IITeleflex MEDICAL PillingTeleflex Medical Europe Ltd
2018-07-04Z-2288-2018Class IIHLD Systems 600 Series Washer/PasteurizerCenorin, LLC
2018-07-04Z-2289-2018Class IIVanguard Complete Knee SystemZimmer Biomet, Inc.
2018-07-04Z-2290-2018Class IIRayStation Radiation Therapy Treatment Planning SystemRAYSEARCH LABORATORIES AB
2018-07-04Z-2291-2018Class IIAmalgatome SDExsurco Medical
2018-07-04Z-2300-2018Class IIOmniDiagnost-Eleva X-ray system Angiographic and DiagnosticPhilips Medical Systems Nederlands
2018-07-04Z-2301-2018Class IIOmniDiagnost Classic X-ray system Angiographic and DiagnosticPhilips Medical Systems Nederlands
2018-07-04Z-2302-2018Class IIFlexible Smoothbore Breathing Circuit with Exhalation Port 22mmIntersurgical Inc
2018-07-04Z-2303-2018Class IIArtis Q biplaneSiemens Medical Solutions USA, Inc
2018-07-04Z-2304-2018Class IIArtis Q ceilingSiemens Medical Solutions USA, Inc
2018-07-04Z-2305-2018Class IIArtis QSiemens Medical Solutions USA, Inc
2018-07-04Z-2306-2018Class IIArtis QSiemens Medical Solutions USA, Inc
2018-07-04Z-2307-2018Class IIArtis QSiemens Medical Solutions USA, Inc
2018-07-04Z-2308-2018Class IIArtis zee biplaneSiemens Medical Solutions USA, Inc
2018-07-04Z-2309-2018Class IIArtis zee biplane MNSiemens Medical Solutions USA, Inc
2018-07-04Z-2310-2018Class IIArtis zee ceilingSiemens Medical Solutions USA, Inc
2018-07-04Z-2311-2018Class IIArtis zee floorSiemens Medical Solutions USA, Inc
2018-07-04Z-2312-2018Class IIArtis zee floor MNSiemens Medical Solutions USA, Inc
2018-07-04Z-2313-2018Class IIArtis zee MPSiemens Medical Solutions USA, Inc
2018-07-04Z-2314-2018Class IIArtis zeegoSiemens Medical Solutions USA, Inc
2018-07-04Z-2315-2018Class IIDiagnostic Ultrasound SystemToshiba American Medical Systems Inc
2018-07-04Z-2317-2018Class IISingle Chamber Temporary External PacemakerMedtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2018-07-04Z-2318-2018Class IICurrentSt Jude Medical Inc.
2018-07-04Z-2319-2018Class IIEllipseSt Jude Medical Inc.
2018-07-04Z-2320-2018Class IIFortifySt Jude Medical Inc.
2018-07-04Z-2321-2018Class IIFortify AssuraSt Jude Medical Inc.
2018-07-04Z-2322-2018Class IIPromoteSt Jude Medical Inc.
2018-07-04Z-2323-2018Class IIPromote QuadraSt Jude Medical Inc.
2018-07-04Z-2324-2018Class IIQuadra AssuraSt Jude Medical Inc.
2018-07-04Z-2325-2018Class IIQuadra Assura MPSt Jude Medical Inc.
2018-07-04Z-2326-2018Class IIUnifySt Jude Medical Inc.
2018-07-04Z-2327-2018Class IIUnify AssuraSt Jude Medical Inc.
2018-07-04Z-2328-2018Class IIUnify QuadraSt Jude Medical Inc.
2018-07-04Z-2329-2018Class IIMerlin PCS programmerSt Jude Medical Inc.
2018-07-04Z-2330-2018Class IISafe N Simple No-Sting Skin Barrier FilmSafe N Simple, LLC
2018-07-04Z-2331-2018Class IIVIDAS FSHBioMerieux SA
2018-06-27Z-2230-2018Class IIDRILL PT GUIDE WIRE 3Zimmer Biomet, Inc.
2018-06-27Z-2231-2018Class IIDRILL PT GUIDE WIRE 2MM X 60CMZimmer Biomet, Inc.
2018-06-27Z-2232-2018Class IIBALL TIP GUIDE WIRE 3Zimmer Biomet, Inc.
2018-06-27Z-2233-2018Class IIBALL TIP GUIDE WIRE 3Zimmer Biomet, Inc.
2018-06-27Z-2234-2018Class IIGUIDE WIRE w/ BALL TIP 2Zimmer Biomet, Inc.
2018-06-27Z-2235-2018Class IIBALL TIP GUIDE WIRE 2Zimmer Biomet, Inc.
2018-06-27Z-2236-2018Class IIG-PIN 2Zimmer Biomet, Inc.
2018-06-27Z-2237-2018Class IIG-PIN 2Zimmer Biomet, Inc.
2018-06-27Z-2238-2018Class IIG-PIN 2Zimmer Biomet, Inc.

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