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Medical device recalls reported in 2015

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ReportedRecallClassProductFirm
2015-10-28Z-0135-2016Class IIAll Philips IngeniaPhilips Medical Systems, Inc.
2015-10-28Z-0136-2016Class IINeuro Combo Set Case The cases hold surgical instrumentation in place…Biomet Microfixation, LLC
2015-10-28Z-0137-2016Class IIThinflap System Case The cases hold surgical instrumentation in place…Biomet Microfixation, LLC
2015-10-28Z-0138-2016Class IIConForMIS iUni Unicondylar Knee Replacement System: iUNI G2ConforMIS, Inc.
2015-10-28Z-0139-2016Class IIConForMIS Unicondylar Knee Replacement System iUNI G2ConforMIS, Inc.
2015-10-28Z-0140-2016Class IIConForMIS iUNI Unicondylar Knee Replacement System iUNI G2ConforMIS, Inc.
2015-10-28Z-0141-2016Class IIConForMIS iUni Unicondylar Knee Replacement System- iUNI G2ConforMIS, Inc.
2015-10-28Z-0142-2016Class IIConForMIS iDuo Bicompartmental Knee Replacement System iDUO G2ConforMIS, Inc.
2015-10-28Z-0143-2016Class IIConForMIS iDuo Knee Bicompartmental Knee Replacement SystemConforMIS, Inc.
2015-10-28Z-0144-2016Class IIConFormis iTotal CR Knee Replacement System- ITOTAL CRConforMIS, Inc.
2015-10-28Z-0145-2016Class IIConForMIS iTotal CRConforMIS, Inc.
2015-10-28Z-0146-2016Class IIConFormis iTotal CR Knee Replacement System- iTOTAL CRConforMIS, Inc.
2015-10-28Z-0147-2016Class IIConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL…ConforMIS, Inc.
2015-10-28Z-0148-2016Class IIConFormis iDUO G2ConforMIS, Inc.
2015-10-28Z-0149-2016Class IINatus neoBLUE 3 Phototherapy system or Neonatal PhototherapyNatus Medical Incorporated
2015-10-28Z-0150-2016Class IIPerifix Continous Epidural Anesthesia Pain Control TraysB. Braun Medical, Inc.
2015-10-28Z-0152-2016Class IIPORT-A-CATH Plastic Hub NeedlesSmiths Medical ASD, Inc.
2015-10-28Z-0153-2016Class IIOneTray Sealed Sterilization Containers Product Usage: A rigid…Innovative Sterlization Technologies LLC
2015-10-28Z-0154-2016Class IITELETOM EQUIPMENT MANAGEMENT SYSTEM 4 and 6 series TELETOM is…Berchtold Corp.
2015-10-28Z-0155-2016Class IISmith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3Smith & Nephew, Inc., Endoscopy Div.
2015-10-28Z-0156-2016Class IISmith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4Smith & Nephew, Inc., Endoscopy Div.
2015-10-28Z-0157-2016Class IISmith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6Smith & Nephew, Inc., Endoscopy Div.
2015-10-28Z-0158-2016Class IISmith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 8Smith & Nephew, Inc., Endoscopy Div.
2015-10-21Z-0013-2016Class IIToshiba Aquilion CT System TSX-101AToshiba American Medical Systems Inc
2015-10-21Z-0014-2016Class IIToshiba Aquilion CT System TSX-301AToshiba American Medical Systems Inc
2015-10-21Z-0015-2016Class IIToshiba Aquilion CT System TSX-301BToshiba American Medical Systems Inc
2015-10-21Z-0016-2016Class IIToshiba Aquilion CT System TSX-301CToshiba American Medical Systems Inc
2015-10-21Z-0017-2016Class IIToshiba Aquilion CT System TSX-302AToshiba American Medical Systems Inc
2015-10-21Z-0018-2016Class IIToshiba Aquilion CT System TSX-303AToshiba American Medical Systems Inc
2015-10-21Z-0115-2016Class IIMRIdian¿ ViewRay¿ Radiation Therapy SystemViewray Incorporated
2015-10-21Z-0116-2016Class IIDistal Access CathetersConcentric Medical Inc
2015-10-21Z-0117-2016Class IINicoletOne Software v5Natus Neurology Inc
2015-10-21Z-0119-2016Class IIZimmer Natural Nail CM LongZimmer Gmbh
2015-10-21Z-0120-2016Class II-Pipeline Embolization Device -Pipeline Flex Embolization Device The…Micro Therapeutics Inc, Dba Ev3 Neurovascular
2015-10-21Z-0121-2016Class IIMonodeDJO, LLC
2015-10-21Z-0122-2016Class IIIAlere Cholestech LDX Multianalyte ControlsAlere San Diego, Inc.
2015-10-21Z-0123-2016Class IIThe Ebb Complete Tamponade SystemClinical Innovations, LLC
2015-10-21Z-0124-2016Class IISynthes 2Synthes (USA) Products LLC
2015-10-21Z-0125-2016Class IIInserter for Titanium Elastic NailsSynthes (USA) Products LLC
2015-10-21Z-0126-2016Class IISynthes Screw InserterSynthes (USA) Products LLC
2015-10-21Z-0127-2016Class II4FR Single Lumen Pressure Injectable PICCArrow International Inc
2015-10-14Z-0005-2016Class IICelesteion PCA-9000A/2 PET/CT SystemToshiba American Medical Systems Inc
2015-10-14Z-0019-2016Class IISOMATOM Definition EdgeSiemens Medical Solutions USA, Inc
2015-10-14Z-0020-2016Class IISOMATOM Definition FlashSiemens Medical Solutions USA, Inc
2015-10-14Z-0021-2016Class IISOMATOM Definition ASSiemens Medical Solutions USA, Inc
2015-10-14Z-0022-2016Class IIMedtronic Medical Device Identification Card for SureScan pacemaker…Medtronic Inc. Cardiac Rhythm Disease Management
2015-10-14Z-0023-2016Class IICentricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a…GE Healthcare
2015-10-14Z-0024-2016Class IISynthes Periarticular Insertion Handle for 4Synthes (USA) Products LLC
2015-10-14Z-0025-2016Class IIUniversal Compact Head Ring Adapter PlateIntegra LifeSciences Corp.
2015-10-14Z-0026-2016Class IIOrtho OS Solutions UltOS 3Ortho Solutions Inc
2015-10-14Z-0027-2016Class IIZimmer Universal Locking SystemZimmer, Inc.
2015-10-14Z-0028-2016Class IIregard Item Number: 800091Resource Optimization & Innovation Llc
2015-10-14Z-0029-2016Class IIregard Item Number: 800401Resource Optimization & Innovation Llc
2015-10-14Z-0030-2016Class IIregard Item Number: 800407Resource Optimization & Innovation Llc
2015-10-14Z-0031-2016Class IIregard Item Number: 800408Resource Optimization & Innovation Llc
2015-10-14Z-0032-2016Class IIregard Item Number: 800409Resource Optimization & Innovation Llc
2015-10-14Z-0033-2016Class IIregard Item Number: 800410Resource Optimization & Innovation Llc
2015-10-14Z-0034-2016Class IIregard Item Number: 800411Resource Optimization & Innovation Llc
2015-10-14Z-0035-2016Class IIregard Item Number: 800413Resource Optimization & Innovation Llc
2015-10-14Z-0036-2016Class IIregard Item Number: 800414Resource Optimization & Innovation Llc
2015-10-14Z-0037-2016Class IIregard Item Number: 800415Resource Optimization & Innovation Llc
2015-10-14Z-0038-2016Class IIregard Item Number: 800416Resource Optimization & Innovation Llc
2015-10-14Z-0039-2016Class IIregard Item Number: 800417Resource Optimization & Innovation Llc
2015-10-14Z-0040-2016Class IIregard Item Number: 800418Resource Optimization & Innovation Llc
2015-10-14Z-0041-2016Class IIregard Item Number: 800419Resource Optimization & Innovation Llc
2015-10-14Z-0042-2016Class IIregard Item Number: 800422Resource Optimization & Innovation Llc
2015-10-14Z-0043-2016Class IIregard Item Number: 800425Resource Optimization & Innovation Llc
2015-10-14Z-0044-2016Class IIregard Item Number: 800508Resource Optimization & Innovation Llc
2015-10-14Z-0045-2016Class IIregard Item Number: 800514Resource Optimization & Innovation Llc
2015-10-14Z-0046-2016Class IIregard Item Number: 800524Resource Optimization & Innovation Llc
2015-10-14Z-0047-2016Class IIregard Item Number: 800525Resource Optimization & Innovation Llc
2015-10-14Z-0048-2016Class IIregard Item Number: 800526Resource Optimization & Innovation Llc
2015-10-14Z-0049-2016Class IIregard Item Number: 800527Resource Optimization & Innovation Llc
2015-10-14Z-0050-2016Class IIregard Item Number: 800528Resource Optimization & Innovation Llc
2015-10-14Z-0051-2016Class IIregard Item Number: 800531Resource Optimization & Innovation Llc
2015-10-14Z-0052-2016Class IIregard Item Number: 800532Resource Optimization & Innovation Llc
2015-10-14Z-0053-2016Class IIregard Item Number: 800533Resource Optimization & Innovation Llc
2015-10-14Z-0054-2016Class IIregard Item Number: 800535Resource Optimization & Innovation Llc
2015-10-14Z-0055-2016Class IIregard Item Number: 800546Resource Optimization & Innovation Llc
2015-10-14Z-0056-2016Class IIregard Item Number: 800548Resource Optimization & Innovation Llc
2015-10-14Z-0057-2016Class IIregard Item Number: 800549Resource Optimization & Innovation Llc
2015-10-14Z-0058-2016Class IIregard Item Number: 800550Resource Optimization & Innovation Llc
2015-10-14Z-0059-2016Class IIregard Item Number: 800551Resource Optimization & Innovation Llc
2015-10-14Z-0060-2016Class IIregard Item Number: 800553Resource Optimization & Innovation Llc
2015-10-14Z-0061-2016Class IIregard Item Number: 800554Resource Optimization & Innovation Llc
2015-10-14Z-0062-2016Class IIregard Item Number: 800555Resource Optimization & Innovation Llc
2015-10-14Z-0063-2016Class IIregard Item Number: 800557Resource Optimization & Innovation Llc
2015-10-14Z-0064-2016Class IIregard Item Number: 800558Resource Optimization & Innovation Llc
2015-10-14Z-0065-2016Class IIregard Item Number: 800559Resource Optimization & Innovation Llc
2015-10-14Z-0066-2016Class IIregard Item Number: 800560Resource Optimization & Innovation Llc
2015-10-14Z-0067-2016Class IIregard Item Number: 800562Resource Optimization & Innovation Llc
2015-10-14Z-0068-2016Class IIregard Item Number: 800565Resource Optimization & Innovation Llc
2015-10-14Z-0069-2016Class IIregard Item Number: 800566Resource Optimization & Innovation Llc
2015-10-14Z-0070-2016Class IIregard Item Number: 800567Resource Optimization & Innovation Llc
2015-10-14Z-0071-2016Class IIregard Item Number: 800568Resource Optimization & Innovation Llc
2015-10-14Z-0072-2016Class IIregard Item Number: 800569Resource Optimization & Innovation Llc
2015-10-14Z-0073-2016Class IIregard Item Number: 800597Resource Optimization & Innovation Llc
2015-10-14Z-0074-2016Class IIregard Item Number: 800599Resource Optimization & Innovation Llc
2015-10-14Z-0075-2016Class IIregard Item Number: 800615Resource Optimization & Innovation Llc
2015-10-14Z-0076-2016Class IIregard Item Number: 800617Resource Optimization & Innovation Llc
2015-10-14Z-0077-2016Class IIregard Item Number: 800623Resource Optimization & Innovation Llc
2015-10-14Z-0078-2016Class IIregard Item Number: 880321Resource Optimization & Innovation Llc
2015-10-14Z-0079-2016Class IIregard Item Number: 880323Resource Optimization & Innovation Llc
2015-10-14Z-0080-2016Class IIregard Item Number: 880326Resource Optimization & Innovation Llc
2015-10-14Z-0081-2016Class IIregard Item Number: 880327Resource Optimization & Innovation Llc
2015-10-14Z-0082-2016Class IIregard Item Number: 880328Resource Optimization & Innovation Llc
2015-10-14Z-0083-2016Class IIregard Item Number: 880330Resource Optimization & Innovation Llc
2015-10-14Z-0084-2016Class IIregard Item Number: 880331Resource Optimization & Innovation Llc
2015-10-14Z-0085-2016Class IIregard Item Number: 800036002Resource Optimization & Innovation Llc
2015-10-14Z-0086-2016Class IIregard Item Number: 800036003Resource Optimization & Innovation Llc
2015-10-14Z-0087-2016Class IIregard Item Number: 800091001Resource Optimization & Innovation Llc
2015-10-14Z-0088-2016Class IIregard Item Number: 800407001Resource Optimization & Innovation Llc
2015-10-14Z-0089-2016Class IIregard Item Number: 800408001Resource Optimization & Innovation Llc
2015-10-14Z-0090-2016Class IIregard Item Number: 800410001Resource Optimization & Innovation Llc
2015-10-14Z-0091-2016Class IIregard Item Number: 800411001Resource Optimization & Innovation Llc
2015-10-14Z-0092-2016Class IIregard Item Number: 800411002Resource Optimization & Innovation Llc
2015-10-14Z-0093-2016Class IIregard Item Number: 800413001Resource Optimization & Innovation Llc
2015-10-14Z-0094-2016Class IIregard Item Number: 800422001Resource Optimization & Innovation Llc
2015-10-14Z-0095-2016Class IIregard Item Number: 800524001Resource Optimization & Innovation Llc
2015-10-14Z-0096-2016Class IIregard Item Number: 800528001Resource Optimization & Innovation Llc
2015-10-14Z-0097-2016Class IIregard Item Number: 800554001Resource Optimization & Innovation Llc
2015-10-14Z-0098-2016Class IIregard Item Number: 800554002Resource Optimization & Innovation Llc
2015-10-14Z-0099-2016Class IIregard Item Number: 800560001Resource Optimization & Innovation Llc
2015-10-14Z-0100-2016Class IIregard Item Number 800565001Resource Optimization & Innovation Llc
2015-10-14Z-0101-2016Class IIregard Item Number 800567001Resource Optimization & Innovation Llc
2015-10-14Z-0102-2016Class IIregard Item Number 800568001Resource Optimization & Innovation Llc
2015-10-14Z-0103-2016Class IIregard Item Number: 800569001Resource Optimization & Innovation Llc
2015-10-14Z-0104-2016Class IIregard Item Number: 880327002Resource Optimization & Innovation Llc
2015-10-14Z-0105-2016Class IIICooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for…CooperSurgical, Inc.
2015-10-14Z-0106-2016Class IISyngo RT OncologistSiemens Medical Solutions USA, Inc
2015-10-14Z-0107-2016Class IISOMATOM ForceSiemens Medical Solutions USA, Inc
2015-10-14Z-0108-2016Class IIMICroSTREP plus 1 PanelBeckman Coulter Inc.
2015-10-14Z-0109-2016Class IIMICroSTREP plus 2 PanelBeckman Coulter Inc.
2015-10-14Z-0110-2016Class IIAccess Free T3 Reagent KitBeckman Coulter Inc.
2015-10-14Z-0111-2016Class IISpecialist 2 IntramedullaryDePuy Orthopaedics, Inc.
2015-10-14Z-0112-2016Class IIMonaco Radiation Treatment Planning SystemElekta, Inc.
2015-10-14Z-0113-2016Class IIMAJ-1606 Instrument Channel AdaptorOlympus Corporation of the Americas
2015-10-14Z-0114-2016Class IIDisposable Paper Filter for Sterilization Containers PaperStryker Craniomaxillofacial Division
2015-10-07Z-0001-2016Class IIHistolock Resection DeviceUS Endoscopy Group Inc
2015-10-07Z-0002-2016Class IICarto 3 EP Navigation SystemBiosense Webster, Inc.
2015-10-07Z-0003-2016Class IISOUNDSTAR eco 8F and 10F Diagnostic Ultrasound CathetersBiosense Webster, Inc.
2015-10-07Z-0004-2016Class IIPhilips GoSafe Mobile Help ButtonLifeline Systems, Incorporated
2015-10-07Z-2743-2015Class IPROFEMUR PLUS CoCr MODULAR NECKMicroPort Orthopedics, Inc.
2015-10-07Z-2818-2015Class IIEVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180Olympus Corporation of the Americas
2015-10-07Z-2819-2015Class IIZimmerSTERILMED, INC.
2015-10-07Z-2820-2015Class IIZimmer Guide Wires for orthopedic proceduresZimmer, Inc.
2015-10-07Z-2821-2015Class IIASP-1020 LipoTower with Aspiration PumpMicroAire Surgical Instruments, LLC
2015-10-07Z-2822-2015Class IIASP-1021 LipoTower with Aspiration Pump and Tumescent PumpMicroAire Surgical Instruments, LLC
2015-10-07Z-2823-2015Class IIP/N: 9735023Medtronic Navigation, Inc.
2015-10-07Z-2824-2015Class IIP/N: 9734856Medtronic Navigation, Inc.
2015-10-07Z-2825-2015Class IIArrow Kits with Medtronic Covidien 0Arrow International Inc
2015-10-07Z-2826-2015Class IIFerno iNX Wheeled StretcherFerno-Washington Inc
2015-09-30Z-2780-2015Class IIThruPort Knot PusherEdwards Lifesciences, LLC
2015-09-30Z-2786-2015Class IITerumo Custom Cardiovascular Procedure Kit Tubing Pack P/N: 66041-1…Terumo Cardiovascular Systems Corp
2015-09-30Z-2787-2015Class IITerumo Custom Cardiovascular Procedure Kit X-Coated Adult Pak P/N:…Terumo Cardiovascular Systems Corp
2015-09-30Z-2788-2015Class IITerumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack…Terumo Cardiovascular Systems Corp
2015-09-30Z-2789-2015Class IITerumo Custom Cardiovascular Procedure Kit X-Coated Pediatric Pack…Terumo Cardiovascular Systems Corp
2015-09-30Z-2790-2015Class IITerumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack…Terumo Cardiovascular Systems Corp
2015-09-30Z-2791-2015Class IITerumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main…Terumo Cardiovascular Systems Corp
2015-09-30Z-2792-2015Class IITerumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main…Terumo Cardiovascular Systems Corp
2015-09-30Z-2793-2015Class IIMicrotek MedicalEcolab Inc
2015-09-30Z-2794-2015Class IIDynamic Locking Screw SystemSynthes (USA) Products LLC
2015-09-30Z-2795-2015Class IIDisposable Reflective Marker Spheres The Disposable Reflective Marker…Brainlab AG
2015-09-30Z-2796-2015Class II3OrthoPediatrics Corp
2015-09-30Z-2797-2015Class IIContra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and…Bien Air Dental SA
2015-09-30Z-2798-2015Class IIRegard Custom Surgical PackResource Optimization & Innovation Llc
2015-09-30Z-2799-2015Class IIRegard Custom Surgical PackResource Optimization & Innovation Llc
2015-09-30Z-2800-2015Class IIPenBlade Safety ScalpelZien Medical Technologies, Inc
2015-09-30Z-2801-2015Class IILightspeed 16 CTGE Healthcare
2015-09-30Z-2802-2015Class IIPET Discovery LSGE Healthcare
2015-09-30Z-2803-2015Class IIPET Discovery ST 16GE Healthcare
2015-09-30Z-2804-2015Class IIThe Leica ASP6025 Tissue ProcessorLeica Microsystems, Inc.
2015-09-30Z-2805-2015Class IIFujinon/Fujifilm Processor EPX 2500 Operation ManualFujifilm Medical Systems U.S.A., Inc.
2015-09-30Z-2806-2015Class IIFujifilm Processor EPX 2500 High Definition EndoscopyFujifilm Medical Systems U.S.A., Inc.
2015-09-30Z-2807-2015Class IIEVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180VOlympus America Inc.
2015-09-30Z-2808-2015Class IIMarketing brochures for the PowerPICC and PowerPICC SOLO cathetersBard Access Systems
2015-09-30Z-2809-2015Class IIMicroScan LabPro Information Manager SystemBeckman Coulter Inc.
2015-09-30Z-2810-2015Class IITrident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant…Stryker Howmedica Osteonics Corp.
2015-09-30Z-2811-2015Class IISynthes Cranial Flap Tube Clamp and Crimping Device Product Usage:…Synthes (USA) Products LLC
2015-09-30Z-2812-2015Class IIARTISTESiemens Medical Solutions USA, Inc
2015-09-30Z-2813-2015Class IISiemens RAPIDPoint 500 Measurement Cartridge LactateSiemens Healthcare Diagnostics Inc
2015-09-30Z-2814-2015Class IISiemens RAPIDPoint 500 Measurement Cartridge LactateSiemens Healthcare Diagnostics Inc
2015-09-30Z-2815-2015Class IISiemens RAPIDPoint 500 Measurement Cartridge LactateSiemens Healthcare Diagnostics Inc
2015-09-30Z-2816-2015Class IISiemens RAPIDPoint 500 Measurement Cartridge LactateSiemens Healthcare Diagnostics Inc
2015-09-30Z-2817-2015Class IIICD4Becton, Dickinson and Company, BD Biosciences
2015-09-23Z-2731-2015Class ITemporary Total Artificial HeartSynCardia Systems Inc.
2015-09-23Z-2760-2015Class IIUCLA Abutment Hexed Castable Cylinder 3Biomet 3i, LLC
2015-09-23Z-2761-2015Class IIHemocor High Performance HemoconcentratorMedivators, Inc.
2015-09-23Z-2762-2015Class IIXGAUZE Trauma DressingRevmedx Inc
2015-09-23Z-2763-2015Class IICIVCO Shoulder RetractorsMed Tec Inc
2015-09-23Z-2764-2015Class IIIPointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube…Pointe Scientific, Inc.
2015-09-23Z-2765-2015Class IIBoston ScientificBoston Scientific Corporation
2015-09-23Z-2766-2015Class IIBoston ScientificBoston Scientific Corporation
2015-09-23Z-2767-2015Class IINICO Myriad Console Model number NN-7000 The Myriad System is a…Nico Corp.
2015-09-23Z-2768-2015Class IIMedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 mlMedtestDx, Inc.
2015-09-23Z-2769-2015Class IIVoyant Open Fusion Device Models: EB040 and EB040+ Product Usage: The…Applied Medical Resources Corp
2015-09-23Z-2770-2015Class IILumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut…Lumenis
2015-09-23Z-2771-2015Class IISony LMD-1951MDSony Medical Systems
2015-09-23Z-2772-2015Class IIAliquot Delivery KitOrthovita, Inc., dBA Stryker Orthobiologics.
2015-09-23Z-2773-2015Class IIIPointe Scientific Creatinine Reagent Catalog number C7539-150 in…Pointe Scientific, Inc.

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