Data Foundry

All years

Medical device recalls reported in 2015

← Newer · Older →

ReportedRecallClassProductFirm
2015-07-29Z-2130-2015Class IIPerkin Elmer WIZARD2 1-detectorPerkinelmer
2015-07-29Z-2131-2015Class IIVolcano s5/s5i/CORE Intravascular Ultrasound Systems with software…Volcano Corporation
2015-07-29Z-2132-2015Class IIVolcano s5/s5i/CORE Intravascular Ultrasound Systems software…Volcano Corporation
2015-07-29Z-2133-2015Class IIVolcano s5/s5i/CORE Intravascular Ultrasound Systems software…Volcano Corporation
2015-07-29Z-2134-2015Class IIVolcano s5/s5i/CORE Intravascular Ultrasound Systems software…Volcano Corporation
2015-07-29Z-2135-2015Class IIVolcano s5/s5i/CORE Intravascular Ultrasound Systems software…Volcano Corporation
2015-07-29Z-2136-2015Class IIVolcano s5/s5i/CORE Intravascular Ultrasound Systems software…Volcano Corporation
2015-07-29Z-2137-2015Class IIATTUNE FB PS ARTICULATION SURFACE SIZES 3-8 INTENDED USE: The Tibial…DePuy Orthopaedics, Inc.
2015-07-29Z-2138-2015Class IIATTUNE FB CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial…DePuy Orthopaedics, Inc.
2015-07-29Z-2139-2015Class IIATTUNE RP PS ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial…DePuy Orthopaedics, Inc.
2015-07-29Z-2140-2015Class IIATTUNE CONV RP CR ARTICULATION SURFACE SZ1DePuy Orthopaedics, Inc.
2015-07-29Z-2141-2015Class IIATTUNE RP CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial…DePuy Orthopaedics, Inc.
2015-07-29Z-2142-2015Class IIATTUNE CONV FB PS ARTICULATION SURFACE SZ1-10 INTENDED USE: The…DePuy Orthopaedics, Inc.
2015-07-29Z-2143-2015Class IIATTUNE CONV RP PS ARTICULATION SURFACE SZ1-9 INTENDED USE: The Tibial…DePuy Orthopaedics, Inc.
2015-07-29Z-2144-2015Class IIATTUNE CONV RP PS TB TRL SZ10 INTENDED USE: The Tibial Articulation…DePuy Orthopaedics, Inc.
2015-07-29Z-2145-2015Class IIATTUNE CONV FB CR ARTICULATION SURFACE SZ1 INTENDED USE: The Tibial…DePuy Orthopaedics, Inc.
2015-07-29Z-2146-2015Class IIATTUNE CONV FB CR TB TRL SZ3DePuy Orthopaedics, Inc.
2015-07-29Z-2147-2015Class IIInfant Heel Warmer and Infant Gel WarmerCooperSurgical, Inc.
2015-07-29Z-2148-2015Class IIThe EKOS EkoSonic Control Unit is intended exclusively for use with…EKOS Corporation
2015-07-29Z-2149-2015Class IITHOMAS by Gardner DenverGardner Denver Thomas Inc
2015-07-29Z-2150-2015Class IITHOMAS by Gardner DenverGardner Denver Thomas Inc
2015-07-29Z-2151-2015Class IITHOMAS by Gardner DenverGardner Denver Thomas Inc
2015-07-29Z-2152-2015Class IIPolaris 4Biomet Spine, LLC
2015-07-29Z-2153-2015Class IIBausch & Lomb SofPort Advanced Optics Aspheric LensBausch & Lomb Surgical, Inc.
2015-07-29Z-2154-2015Class IIBausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The…Bausch & Lomb Surgical, Inc.
2015-07-29Z-2155-2015Class IICochlear Nucleus Sterile Silicone Template Product Usage: The…Cochlear Americas Inc.
2015-07-29Z-2156-2015Class IISureflex 150 Lithotripsy FiberAmerican Medical Systems Innovation Center - Silicon Valley
2015-07-29Z-2157-2015Class IISureflex 200 Lithotripsy FiberAmerican Medical Systems Innovation Center - Silicon Valley
2015-07-29Z-2158-2015Class IISureflex 273 Lithotripsy FiberAmerican Medical Systems Innovation Center - Silicon Valley
2015-07-29Z-2159-2015Class IISureflex 365 Lithotripsy FiberAmerican Medical Systems Innovation Center - Silicon Valley
2015-07-29Z-2160-2015Class IISureflex 550 Lithotripsy FiberAmerican Medical Systems Innovation Center - Silicon Valley
2015-07-29Z-2161-2015Class IISureflex 910 Lithotripsy FiberAmerican Medical Systems Innovation Center - Silicon Valley
2015-07-29Z-2162-2015Class II200¿M Lithotripsy Fiber- ReusableAmerican Medical Systems Innovation Center - Silicon Valley
2015-07-29Z-2163-2015Class II365¿M Lithotripsy Fiber- ReusableAmerican Medical Systems Innovation Center - Silicon Valley
2015-07-29Z-2164-2015Class IIFiber StripperAmerican Medical Systems Innovation Center - Silicon Valley
2015-07-29Z-2165-2015Class IIFiber StripperAmerican Medical Systems Innovation Center - Silicon Valley
2015-07-29Z-2166-2015Class IIFiber StripperAmerican Medical Systems Innovation Center - Silicon Valley
2015-07-29Z-2167-2015Class IIFiber StripperAmerican Medical Systems Innovation Center - Silicon Valley
2015-07-29Z-2168-2015Class IIFiber StripperAmerican Medical Systems Innovation Center - Silicon Valley
2015-07-29Z-2169-2015Class IIFiber StripperAmerican Medical Systems Innovation Center - Silicon Valley
2015-07-29Z-2170-2015Class IIFiber CleaverAmerican Medical Systems Innovation Center - Silicon Valley
2015-07-29Z-2171-2015Class II1X1 Cleaving TilesAmerican Medical Systems Innovation Center - Silicon Valley
2015-07-29Z-2172-2015Class IIToolAmerican Medical Systems Innovation Center - Silicon Valley
2015-07-29Z-2173-2015Class IIToolAmerican Medical Systems Innovation Center - Silicon Valley
2015-07-29Z-2174-2015Class IIToolAmerican Medical Systems Innovation Center - Silicon Valley
2015-07-29Z-2175-2015Class IIToolAmerican Medical Systems Innovation Center - Silicon Valley
2015-07-29Z-2176-2015Class IIToolAmerican Medical Systems Innovation Center - Silicon Valley
2015-07-29Z-2177-2015Class IIToolAmerican Medical Systems Innovation Center - Silicon Valley
2015-07-29Z-2178-2015Class IIToolAmerican Medical Systems Innovation Center - Silicon Valley
2015-07-29Z-2179-2015Class IIToolAmerican Medical Systems Innovation Center - Silicon Valley
2015-07-29Z-2180-2015Class IIToolAmerican Medical Systems Innovation Center - Silicon Valley
2015-07-29Z-2181-2015Class IIToolAmerican Medical Systems Innovation Center - Silicon Valley
2015-07-29Z-2182-2015Class IIToolAmerican Medical Systems Innovation Center - Silicon Valley
2015-07-29Z-2183-2015Class IIToolAmerican Medical Systems Innovation Center - Silicon Valley
2015-07-29Z-2184-2015Class IIStripperAmerican Medical Systems Innovation Center - Silicon Valley
2015-07-29Z-2185-2015Class IIStripperAmerican Medical Systems Innovation Center - Silicon Valley
2015-07-29Z-2186-2015Class IIStripperAmerican Medical Systems Innovation Center - Silicon Valley
2015-07-29Z-2187-2015Class IIStripperAmerican Medical Systems Innovation Center - Silicon Valley
2015-07-29Z-2188-2015Class IIBone Marrow Aspiration Needle 15G x 2Argon Medical Devices, Inc
2015-07-29Z-2189-2015Class IIT-Lok Bone Marrow Biopsy Needle 8G x 4 Ext CanArgon Medical Devices, Inc
2015-07-29Z-2190-2015Class IIMermaid Medical M-Biopsy Coaxial Introducer NeedleMermaid Medical A/S
2015-07-29Z-2191-2015Class IIAmerican Catheter / Cholangiogram Catheter 9100 SeriesAmerican Catheter Corp
2015-07-29Z-2192-2015Class IIHardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires:…Hardy Diagnostics
2015-07-29Z-2193-2015Class IIGEMINI GXL 16 Slice CT/PET SystemPhilips Medical Systems (Cleveland) Inc
2015-07-29Z-2194-2015Class IIGEMINI LXL CT/PET SystemPhilips Medical Systems (Cleveland) Inc
2015-07-29Z-2195-2015Class IIGEMINI TF 16 Slice CT/PET SystemPhilips Medical Systems (Cleveland) Inc
2015-07-29Z-2196-2015Class IIGEMINI TF 64 Slice CT/PET SystemPhilips Medical Systems (Cleveland) Inc
2015-07-29Z-2197-2015Class IIGEMINI TF Ready CT/PET SystemPhilips Medical Systems (Cleveland) Inc
2015-07-29Z-2198-2015Class IIGEMINI TF Base CT/PET SystemPhilips Medical Systems (Cleveland) Inc
2015-07-29Z-2199-2015Class IIGEMINI TF Big Bore CT/PET SystemPhilips Medical Systems (Cleveland) Inc
2015-07-29Z-2200-2015Class IIPinnacle3 Software Version 9Philips Electronics North America Corporation
2015-07-29Z-2201-2015Class IIiovera 155 Smart TipMyoscience Inc
2015-07-29Z-2202-2015Class IIARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott…Abbott Laboratories
2015-07-29Z-2203-2015Class IIHead Holder shipped with Ingenuity Core Computed Tomography X-ray…Philips Medical Systems (Cleveland) Inc
2015-07-29Z-2204-2015Class IIHead Holder shipped with Ingenuity Core 128 Computed Tomography X-ray…Philips Medical Systems (Cleveland) Inc
2015-07-29Z-2205-2015Class IIHead Holder shipped with Ingenuity CT Computed Tomography X-ray…Philips Medical Systems (Cleveland) Inc
2015-07-29Z-2207-2015Class IIADVIA Centaur Tni-Ultra AssaySiemens Healthcare Diagnostics, Inc
2015-07-29Z-2208-2015Class IISilhouette Lift brochure Silhouette Sutures are for use in midface…Silhouette Lift, Inc.
2015-07-22Z-2058-2015Class IIABiomet, Inc.
2015-07-22Z-2059-2015Class IIAltiva / Exactech SpineExactech, Inc.
2015-07-22Z-2060-2015Class IIZNN Antegrade Femoral NailZimmer, Inc.
2015-07-22Z-2061-2015Class IIIMPAX AgilityAGFA Healthcare Corp.
2015-07-22Z-2062-2015Class II0210-312-000-Woundcare Replacement kit with soft tipStryker Instruments Div. of Stryker Corporation
2015-07-22Z-2063-2015Class IIMOSAIQ Oncology Information System MOSAIQ is an oncology information…Elekta, Inc.
2015-07-22Z-2064-2015Class IIApex ARC Hip StemOmnilife Science Inc.
2015-07-22Z-2065-2015Class IIOxford Femoral Drill Guide Lateral IM Adapter Product Usage: Drill…Biomet, Inc.
2015-07-22Z-2066-2015Class IIIG7 Variant Elution Buffer HiS noTosoh Bioscience, Inc.
2015-07-22Z-2067-2015Class IIDual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system…Nidek Inc
2015-07-22Z-2068-2015Class IIEndophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser…Nidek Inc
2015-07-22Z-2070-2015Class IIExactech Ambassador Cervical Plate System The Exactech Ambassador…Exactech, Inc.
2015-07-22Z-2071-2015Class IIExactech Single Barrel Drill Guides The Single Barrel Drill Guide is…Exactech, Inc.
2015-07-22Z-2072-2015Class IIABiomet, Inc.
2015-07-22Z-2073-2015Class IIEtac Supporter toilet armrest Etac Supporter toilet armrests are…Etac Supply Center Ab
2015-07-22Z-2074-2015Class IIAbutment Retrieval Instrument Zirconia CC RP/WPNobel Biocare Usa Llc
2015-07-22Z-2075-2015Class IIAllofix Insertion KitMusculoskeletal Transplant Foundation, Inc.
2015-07-22Z-2076-2015Class IISorin Stockert Heater-Cooler 3TSorin Group USA, Inc.
2015-07-22Z-2077-2015Class IISorin Stockert Heater-Cooler 3TSorin Group USA, Inc.
2015-07-22Z-2078-2015Class IISorin Stockert Heater-Cooler 3TSorin Group USA, Inc.
2015-07-22Z-2079-2015Class IISorin Stockert Heater-Cooler 3TSorin Group USA, Inc.
2015-07-22Z-2080-2015Class IISorin Stockert Heater-Cooler 3TSorin Group USA, Inc.
2015-07-22Z-2081-2015Class IISorin Stockert Heater-Cooler 3TSorin Group USA, Inc.
2015-07-22Z-2082-2015Class IIAutopen Classic Automatic insulin delivery penOwen Mumford USA, Inc.
2015-07-22Z-2083-2015Class IIThe FLOW-i Anesthesia System Axillary O2 and Suction ModuleMaquet Cardiovascular Us Sales, Llc
2015-07-22Z-2084-2015Class IINDI Disposable Reflective Marker Spheres for Brainlab IGSNorthern Digital Inc.
2015-07-22Z-2085-2015Class IIPatient Handling SystemViewray Incorporated
2015-07-22Z-2086-2015Class II16mm Chisel BladeSynthes (USA) Products LLC
2015-07-22Z-2087-2015Class IIRadiForce GX540Eizo Corporation
2015-07-22Z-2088-2015Class IIRadiForce RX650Eizo Corporation
2015-07-22Z-2089-2015Class IIRadiForce RX850Eizo Corporation
2015-07-22Z-2090-2015Class IIIBD Flow CytometersBD Biosciences, Systems & Reagents
2015-07-22Z-2091-2015Class IIHelical Blade Inserter for Trochanteric Fixation Nail-ADVANCEDSynthes (USA) Products LLC
2015-07-22Z-2092-2015Class IIReamer / Irrigator / AspiratorSynthes, Inc.
2015-07-22Z-2093-2015Class IINDI Disposable Reflective Marker Spheres for Brainlab IGSNorthern Digital Inc.
2015-07-22Z-2094-2015Class IIBreas Vivo 50 Home Care Ventilator Product Usage: Respiratory CareBreas Medical AB
2015-07-22Z-2095-2015Class IIAlere i fluAlere Scarborough, Inc. dba Binax, Inc.
2015-07-15Z-1950-2015Class IShiley NeonatalCovidien LP (formerly Nellcor Puritan Bennett Inc.)
2015-07-15Z-1951-2015Class IShiley NeonatalCovidien LP (formerly Nellcor Puritan Bennett Inc.)
2015-07-15Z-1986-2015Class IIPrimusBTE Technologies, Inc.
2015-07-15Z-1987-2015Class IIPhilips GoSafe Communicator 7000L Personal emergency response systemLifeline Systems, Incorporated
2015-07-15Z-1988-2015Class IINatrelle Re-sterilizable Breast Implant SizerAllergan Inc
2015-07-15Z-1989-2015Class IINakoma-SL Anterior Cervical Plating System's Variable Single Barrel…Alliance Partners LLC
2015-07-15Z-1990-2015Class IIThe PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical…Maquet Cardiovascular Us Sales, Llc
2015-07-15Z-1992-2015Class IIBreast PackStradis Healthcare, LLC.
2015-07-15Z-1993-2015Class IIBasic PackStradis Healthcare, LLC.
2015-07-15Z-1994-2015Class IIAdvanced Vein CareStradis Healthcare, LLC.
2015-07-15Z-1995-2015Class IIVein PackStradis Healthcare, LLC.
2015-07-15Z-1996-2015Class IIEndovenous KitStradis Healthcare, LLC.
2015-07-15Z-1997-2015Class IIPhleb Pack and Laser Phleb PackStradis Healthcare, LLC.
2015-07-15Z-1998-2015Class IIStandard PackStradis Healthcare, LLC.
2015-07-15Z-1999-2015Class IILipo PackStradis Healthcare, LLC.
2015-07-15Z-2000-2015Class IILipo/Buttocks PackStradis Healthcare, LLC.
2015-07-15Z-2001-2015Class IIVaginal Rejuvenation PackStradis Healthcare, LLC.
2015-07-15Z-2002-2015Class IIGeneral PackStradis Healthcare, LLC.
2015-07-15Z-2003-2015Class IIVein & Vascular PackStradis Healthcare, LLC.
2015-07-15Z-2004-2015Class IILaser Evlt Pack and Laser One Leg EvltStradis Healthcare, LLC.
2015-07-15Z-2005-2015Class IIBreast Augmentation Pack and Breast Augmentation Expanded PackStradis Healthcare, LLC.
2015-07-15Z-2006-2015Class IITummy Tuck PackStradis Healthcare, LLC.
2015-07-15Z-2007-2015Class IISurgical Pack and General Surgery PackStradis Healthcare, LLC.
2015-07-15Z-2008-2015Class IIMississippi PackStradis Healthcare, LLC.
2015-07-15Z-2009-2015Class IIFace Lift PackStradis Healthcare, LLC.
2015-07-15Z-2010-2015Class IIPlastic Pack and Plastic HNP PackStradis Healthcare, LLC.
2015-07-15Z-2011-2015Class IISuction PackStradis Healthcare, LLC.
2015-07-15Z-2012-2015Class IIACL PackStradis Healthcare, LLC.
2015-07-15Z-2013-2015Class IIHand PackStradis Healthcare, LLC.
2015-07-15Z-2014-2015Class IILima PackStradis Healthcare, LLC.
2015-07-15Z-2015-2015Class IISkin and Vein PackStradis Healthcare, LLC.
2015-07-15Z-2016-2015Class IIVasc Custom KitStradis Healthcare, LLC.
2015-07-15Z-2017-2015Class IIBariatric PackStradis Healthcare, LLC.
2015-07-15Z-2018-2015Class IIFace Neck PackStradis Healthcare, LLC.
2015-07-15Z-2019-2015Class IIAbdominal Pack and Abdom PackStradis Healthcare, LLC.
2015-07-15Z-2020-2015Class IIStradi 4500Stradis Healthcare, LLC.
2015-07-15Z-2021-2015Class IIGyn PackStradis Healthcare, LLC.
2015-07-15Z-2022-2015Class IIHead & Neck PackStradis Healthcare, LLC.
2015-07-15Z-2023-2015Class IIEye PackStradis Healthcare, LLC.
2015-07-15Z-2024-2015Class IIGlaucoma PackStradis Healthcare, LLC.
2015-07-15Z-2025-2015Class IIShoulder PackStradis Healthcare, LLC.
2015-07-15Z-2026-2015Class IIKnee Arthro Pack and Knee Arthro Pack IIStradis Healthcare, LLC.
2015-07-15Z-2027-2015Class IIENT PackStradis Healthcare, LLC.
2015-07-15Z-2028-2015Class IIHand PackStradis Healthcare, LLC.
2015-07-15Z-2029-2015Class IIPodiatry PackStradis Healthcare, LLC.
2015-07-15Z-2030-2015Class IIMinor Pack and Minor Pack II PackStradis Healthcare, LLC.
2015-07-15Z-2031-2015Class IINeurosurgery PackStradis Healthcare, LLC.
2015-07-15Z-2032-2015Class IICysto PackStradis Healthcare, LLC.
2015-07-15Z-2033-2015Class IIOpen PackStradis Healthcare, LLC.
2015-07-15Z-2034-2015Class IIPediatric PackStradis Healthcare, LLC.
2015-07-15Z-2035-2015Class IIFace Lift PackStradis Healthcare, LLC.
2015-07-15Z-2036-2015Class IISet Up PackStradis Healthcare, LLC.
2015-07-15Z-2037-2015Class IIBlepharoplasty PackStradis Healthcare, LLC.
2015-07-15Z-2038-2015Class IICustom PackStradis Healthcare, LLC.
2015-07-15Z-2039-2015Class IIDND PackStradis Healthcare, LLC.
2015-07-15Z-2040-2015Class IIOrthopedic Split Drape PackStradis Healthcare, LLC.
2015-07-15Z-2041-2015Class IIArthroscopy PackStradis Healthcare, LLC.
2015-07-15Z-2042-2015Class IIUpper Extremity PackStradis Healthcare, LLC.
2015-07-15Z-2043-2015Class IIVolcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and…Volcano Corp
2015-07-15Z-2044-2015Class IIVolcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and…Volcano Corp
2015-07-15Z-2045-2015Class IIComboMap Intravascular Flow and Pressure SystemVolcano Corp
2015-07-15Z-2046-2015Class IIABiomet, Inc.
2015-07-15Z-2047-2015Class IIIPowerPICC SOLO Catheter with Sherlock 3CG TPS Stylet 4F Maximal…Bard Access Systems
2015-07-15Z-2048-2015Class IIIPowerPICC SOLO Catheter with Sherlock 3CGBard Access Systems
2015-07-15Z-2049-2015Class IIIPowerPICC SOLO Catheter with Tip Location SystemBard Access Systems
2015-07-15Z-2050-2015Class IIIPowerPICC SOLO2 Catheter 4F Maximal Barrier Tray with MicrointroducerBard Access Systems
2015-07-15Z-2051-2015Class IITITANIUM END CAP WITH T40 STARDRIVE RECESSSynthes, Inc.
2015-07-15Z-2052-2015Class IIBlock Versions Used by Dental Offices often referred to as chairside…3M Company - Health Care Business
2015-07-15Z-2053-2015Class IISonger Spinal Cable SystemRTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
2015-07-15Z-2054-2015Class IISiemens Healthcare Diagnostics Dimension Vista SystemsSiemens Healthcare Diagnostics, Inc.
2015-07-15Z-2055-2015Class IIILombart 90D Clear with case Visualization during diagnosis and laser…Volk Optical Inc
2015-07-15Z-2056-2015Class IIIntegra¿ Long Epidural Steroid Injection NeedleIntegra LifeSciences Corp. d.b.a. Integra Pain Management
2015-07-08Z-1847-2015Class IIMedtronic Navigated Cannulated Taps Individual cannulated taps are…Medtronic Navigation, Inc.
2015-07-08Z-1848-2015Class IISlipped Capital Femoral EpiphysisPega Medical Inc.
2015-07-08Z-1849-2015Class IIThe VariSource iX series afterloader systems are computer controlled…Varian Medical Systems Inc
2015-07-08Z-1850-2015Class IIPalindrome SI Chronic Catheter Kit 14Covidien LLC
2015-07-08Z-1851-2015Class IIPalindrome SI Chronic Catheter Kit 14Covidien LLC
2015-07-08Z-1852-2015Class IIPalindrome SI Chronic Catheter Kit 14Covidien LLC
2015-07-08Z-1853-2015Class IIPalindrome SI Chronic Catheter Kit 14Covidien LLC
2015-07-08Z-1854-2015Class IIPalindrome SI Chronic Catheter Kit 14Covidien LLC
2015-07-08Z-1857-2015Class IIPalindrome SI Chronic Catheter Sport Pack 14Covidien LLC
2015-07-08Z-1858-2015Class IIPalindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14Covidien LLC
2015-07-08Z-1859-2015Class IIPalindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14Covidien LLC
2015-07-08Z-1860-2015Class IIPalindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14Covidien LLC
2015-07-08Z-1861-2015Class IIPalindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14Covidien LLC

← Newer · Older →