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Medical device recalls reported in 2017

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ReportedRecallClassProductFirm
2017-11-15Z-0074-2018Class IIVITEK2 GP-IDBiomerieux Inc
2017-11-15Z-0075-2018Class IIHARVEST TERUMOBCTTerumo BCT, Inc.
2017-11-15Z-0076-2018Class IIFlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow…Sorin Group USA, Inc.
2017-11-15Z-0077-2018Class IIRESONATE EL ICD VRBoston Scientific Corporation
2017-11-15Z-0078-2018Class IIRESONATE EL ICD DRBoston Scientific Corporation
2017-11-15Z-0079-2018Class IIVIGILANT X4 CRT-DBoston Scientific Corporation
2017-11-15Z-0080-2018Class IIMOMENTUM X4 CRT-DBoston Scientific Corporation
2017-11-15Z-0081-2018Class IIRESONATE X4 CRT-DBoston Scientific Corporation
2017-11-15Z-0082-2018Class IIXper Flex Cardio PhysioMonitoring system The Xper Flex Cardio…Invivo Corporation
2017-11-15Z-0083-2018Class IIWECKTeleflex Medical
2017-11-15Z-0084-2018Class IIBD Vacutainer Sodium Polyanetholesulfonate 5Becton Dickinson & Company
2017-11-15Z-0085-2018Class IICustom surgical kits labeled as follows:Bioseal Corporation
2017-11-15Z-0086-2018Class IINucliSENS Lysis Buffer Extended lot for RES 76675BioMerieux SA
2017-11-15Z-0087-2018Class IIRX-2 COUDE Epidural NeedleEpimed International
2017-11-15Z-0088-2018Class IICOUDE Blunt Nerve Block NeedleEpimed International
2017-11-15Z-0089-2018Class IITUOHY Epidural NeedleEpimed International
2017-11-08Z-0052-2018Class IITHERMI250 Radiofrequency SystemBios S.r.l.
2017-11-08Z-0053-2018Class IIAlcon Custom PakAlcon Research, LTD.
2017-11-08Z-0054-2018Class IITHERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-SBiosense Webster, Inc.
2017-11-08Z-0055-2018Class IITHERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-SBiosense Webster, Inc.
2017-11-08Z-0056-2018Class IITHERMOCOOL SMARTTOUCH Bi-Directional Navigation CatheterBiosense Webster, Inc.
2017-11-08Z-0057-2018Class IITHERMOCOOL SMARTTOUCH Uni-Directional Navigation CatheterBiosense Webster, Inc.
2017-11-08Z-0058-2018Class IITHERMOCOOL SF NAV Catheters Model NumbersBiosense Webster, Inc.
2017-11-08Z-0059-2018Class IITeleflexTeleflex Medical
2017-11-08Z-0060-2018Class IICADDSmiths Medical ASD Inc.
2017-11-08Z-0061-2018Class IICADDSmiths Medical ASD Inc.
2017-11-08Z-0062-2018Class IICADDSmiths Medical ASD Inc.
2017-11-01Z-0021-2018Class IThe OriGen Reinforced Dual Lumen catheterOriGen Biomedical, Inc.
2017-11-01Z-0041-2018Class IIEMPOWR PS KNEEEncore Medical, Lp
2017-11-01Z-0042-2018Class IIEMPOWR PS KNEEEncore Medical, Lp
2017-11-01Z-0043-2018Class IIMicroPort Orthopedics SCHANZ SCREW SELF DRILLMicroPort Orthopedics Inc.
2017-11-01Z-0044-2018Class IIBARD MAX-CORE Disposable Core Biopsy InstrumentBard Peripheral Vascular Inc
2017-11-01Z-0045-2018Class IISysmex FluorocellSysmex America, Inc.
2017-11-01Z-0046-2018Class IIPower Processor 1K StockyardBeckman Coulter Inc.
2017-11-01Z-0047-2018Class IITorque wrench used on the bolts for the Symbia T2 model 10275008Siemens Medical Solutions USA, Inc.
2017-11-01Z-0048-2018Class IIGORE TAGW L Gore & Associates, Inc.
2017-11-01Z-0049-2018Class IIAblathermEdap Technomed Inc.
2017-11-01Z-0050-2018Class IIOncentra Brachy 4Nucletron BV
2017-10-25Z-0012-2018Class IIToshiba Medical Kalare Fluoroscopic X-Ray SystemToshiba American Medical Systems Inc
2017-10-25Z-0015-2018Class IIPhilips Healthcare Brilliance 64 SystemPhilips Electronics North America Corporation
2017-10-25Z-0016-2018Class IIPhilips Healthcare Ingenuity Core X-RayPhilips Electronics North America Corporation
2017-10-25Z-0017-2018Class IIPhilips Healthcare Ingenuity CT X-RayPhilips Electronics North America Corporation
2017-10-25Z-0018-2018Class IIPhilips Healthcare Ingenuity Core128 X-RayPhilips Electronics North America Corporation
2017-10-25Z-0019-2018Class IIPhilips Healthcare Brilliance iCT X-RayPhilips Electronics North America Corporation
2017-10-25Z-0020-2018Class IIPhilips Healthcare Brilliance iCT SP X-RayPhilips Electronics North America Corporation
2017-10-25Z-0022-2018Class IIProclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite…St. Jude Medical, Inc.
2017-10-25Z-0023-2018Class IIInfinity 5 Implantable Pulse Generator and Infinity 7 Implantable…St. Jude Medical, Inc.
2017-10-25Z-0024-2018Class IIProclaim DRG Implantable Pulse Generator Model 3664St. Jude Medical, Inc.
2017-10-25Z-0025-2018Class IIVCLASMedtronic Navigation, Inc.
2017-10-25Z-0026-2018Class IIAlaris Pump Module model 8100 manufactured between November 2011 and…CareFusion 303, Inc.
2017-10-25Z-0027-2018Class IIPantherHologic, Inc
2017-10-25Z-0028-2018Class IIXpert EV AssayCepheid
2017-10-25Z-0029-2018Class IIAnthem Model Numbers: PM3210St Jude Medical Inc.
2017-10-25Z-0030-2018Class IIAssurity Model Numbers: PM1240St Jude Medical Inc.
2017-10-25Z-0031-2018Class IIAssurity MRI Model Numbers: PM1272St Jude Medical Inc.
2017-10-25Z-0032-2018Class IIMerlin PCS 3650 Programmer with Model 3330 Software Version 23St Jude Medical Inc.
2017-10-25Z-0033-2018Class IIMerlin@Home Software Model EX2000 v8St Jude Medical Inc.
2017-10-25Z-0034-2018Class IIPM1214 NUANCE SR RFSt Jude Medical Inc.
2017-10-25Z-0035-2018Class IIPM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST These low voltageSt Jude Medical Inc.
2017-10-25Z-0036-2018Class IIPM 1250 and PM 2250 ZENEXSt Jude Medical Inc.
2017-10-25Z-0037-2018Class IIPM 1260 ASSURITY + These low voltageSt Jude Medical Inc.
2017-10-25Z-0038-2018Class IIPM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltageSt Jude Medical Inc.
2017-10-25Z-0039-2018Class IIPilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d)…Teleflex Medical
2017-10-25Z-0040-2018Class IIGenesys spineGenesys Orthopedics Systems, LLC
2017-10-18Z-0003-2018Class IFortify VRSt Jude Medical Inc.
2017-10-18Z-0004-2018Class IUnifySt Jude Medical Inc.
2017-10-18Z-0011-2018Class IIARCHITECT c4000 Cuvette SegmentAbbott Laboratories, Inc
2017-10-18Z-0013-2018Class IIPRISM MEDICAL A-625Handicare Usa Inc
2017-10-18Z-0014-2018Class IICarina Mobile LiftsHandicare AB
2017-10-11Z-0001-2018Class IICarl Zeiss INTRABEAM PRS 500Carl Zeiss Meditec AG
2017-10-11Z-0002-2018Class IIHuman Alpha-1-Antitrypsin Kit for use on the SPAPlus analyserThe Binding Site Group, Ltd.
2017-10-11Z-0005-2018Class IIElectric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400…Permobil, Ab
2017-10-11Z-0006-2018Class IIElectric Wheelchair bases: a) C300 b) C350 c) C400 d) C500Permobil, Ab
2017-10-11Z-0007-2018Class IIImplant Direct Swish Duo-Grip Healing CollarImplant Direct Sybron Manufacturing, LLC
2017-10-11Z-3237-2017Class IIAutoCheck5+Radiometer America Inc
2017-10-11Z-3238-2017Class IIBOMImed Disposable Fiber Optic Medium Laryngoscope HandleBomimed
2017-10-11Z-3239-2017Class IIIVEA Product Part Number 16100 Model 500AFirefly Medical, Inc.
2017-10-11Z-3240-2017Class IISECUREThe Metrix Company
2017-10-04Z-3106-2017Class ISpectranetics Bridge Occlusion Balloon catheterSpectranetics Corporation
2017-10-04Z-3144-2017Class IIZimmer Trabecular Metal Reverse Shoulder System InstrumentationZimmer Biomet, Inc.
2017-10-04Z-3145-2017Class IIHerbert Cannulated Bone Screw SystemZimmer Biomet, Inc.
2017-10-04Z-3146-2017Class IILong Drill 1/4 inchZimmer Biomet, Inc.
2017-10-04Z-3147-2017Class IIM/DN Intramedullary Fixation Femoral Drill 3Zimmer Biomet, Inc.
2017-10-04Z-3148-2017Class IIECT Internal Fracture Fixation Drill 1Zimmer Biomet, Inc.
2017-10-04Z-3149-2017Class IIZimmer Periarticular Locking Plate System Locking Screw Tap Standard…Zimmer Biomet, Inc.
2017-10-04Z-3150-2017Class IIECT Internal Fracture Fixation Quick-Connect DrillZimmer Biomet, Inc.
2017-10-04Z-3151-2017Class IIZimmer Natural Nail System Calibrated Drill Long 4Zimmer Biomet, Inc.
2017-10-04Z-3152-2017Class IIDrill Bit Jacobs Chuck 1Zimmer Biomet, Inc.
2017-10-04Z-3153-2017Class IIDrill Bit Quick-Connect 1Zimmer Biomet, Inc.
2017-10-04Z-3154-2017Class IINCB Periprosthetic Plate System Drill Bit With Quick-Coupling 3Zimmer Biomet, Inc.
2017-10-04Z-3155-2017Class IIM/DN Intramedullary Fixation Distal Drill 3Zimmer Biomet, Inc.
2017-10-04Z-3156-2017Class IIECT Internal Fracture Fixation Long DrillZimmer Biomet, Inc.
2017-10-04Z-3157-2017Class IINCB Periprosthetic Plate System Drill Bit With Quick-Coupling 4Zimmer Biomet, Inc.
2017-10-04Z-3158-2017Class IIM/DN Intramedullary Fixation Distal Drill Pilot Tip 3Zimmer Biomet, Inc.
2017-10-04Z-3159-2017Class IIM/DNZimmer Biomet, Inc.
2017-10-04Z-3160-2017Class IIM/DN Intramedullary Fixation Femoral Drill Large 5Zimmer Biomet, Inc.
2017-10-04Z-3161-2017Class IIECT Internal Fracture Fixation Drill Bits 1Zimmer Biomet, Inc.
2017-10-04Z-3162-2017Class IIECT Internal Fracture Fixation Drill 1Zimmer Biomet, Inc.
2017-10-04Z-3163-2017Class IIECT Internal Fracture Fixation Drill Bits 1Zimmer Biomet, Inc.
2017-10-04Z-3164-2017Class IIECT Internal Fracture Fixation Drill 2Zimmer Biomet, Inc.
2017-10-04Z-3165-2017Class IIECT Internal Fracture Fixation Drill Bits 2Zimmer Biomet, Inc.
2017-10-04Z-3166-2017Class IIECT Internal Fracture Fixation Drill 2Zimmer Biomet, Inc.
2017-10-04Z-3167-2017Class IIECT Internal Fixation Drill Bits 2Zimmer Biomet, Inc.
2017-10-04Z-3168-2017Class IIECT Internal Fracture Fixation Drill 2Zimmer Biomet, Inc.
2017-10-04Z-3169-2017Class IIECT Internal Fracture Fixation Drill Bits 2Zimmer Biomet, Inc.
2017-10-04Z-3170-2017Class IIECT Internal Fracture Fixation Drill 3Zimmer Biomet, Inc.
2017-10-04Z-3171-2017Class IIECT Internal Fracture Fixation Drill Bits 3Zimmer Biomet, Inc.
2017-10-04Z-3172-2017Class IIECT Internal Fracture Fixation Drill 3Zimmer Biomet, Inc.
2017-10-04Z-3173-2017Class IIECT Internal Fracture Fixation Drill Bits 3Zimmer Biomet, Inc.
2017-10-04Z-3174-2017Class IIStraight Shank Drill Bit 4Zimmer Biomet, Inc.
2017-10-04Z-3175-2017Class IIStraight Shank Drill Bits 4Zimmer Biomet, Inc.
2017-10-04Z-3176-2017Class IIECT Internal Fracture Fixation Drill 4Zimmer Biomet, Inc.
2017-10-04Z-3177-2017Class IIECT Internal Fracture Fixation Drill Bits 4Zimmer Biomet, Inc.
2017-10-04Z-3178-2017Class IIZimmer Periarticular Locking Plate SystemZimmer Biomet, Inc.
2017-10-04Z-3179-2017Class IIZimmer Periarticular Locking Plate System Cannulated Drill Standard…Zimmer Biomet, Inc.
2017-10-04Z-3180-2017Class IIZimmer Periarticular Locking Plate System Drill Standard 2Zimmer Biomet, Inc.
2017-10-04Z-3181-2017Class IIZimmer Periarticular Locking Plate System Drill Standard 2Zimmer Biomet, Inc.
2017-10-04Z-3182-2017Class IIECT Internal Fracture Fixation Quick-Connect Drill 2Zimmer Biomet, Inc.
2017-10-04Z-3183-2017Class IIECT Internal Fracture Fixation Quick-Connect Drill 2Zimmer Biomet, Inc.
2017-10-04Z-3184-2017Class IIECT Internal Fracture Fixation Quick-Connect Drill 2Zimmer Biomet, Inc.
2017-10-04Z-3185-2017Class IIECT Internal Fracture Fixation Quick-Connect Drill 2Zimmer Biomet, Inc.
2017-10-04Z-3186-2017Class IIECT Internal Fracture Fixation Quick-Connect Drill 2Zimmer Biomet, Inc.
2017-10-04Z-3187-2017Class IIECT Internal Fracture Fixation Quick-Connect Drill 3Zimmer Biomet, Inc.
2017-10-04Z-3188-2017Class IIECT Internal Fracture Fixation Quick-Connect Drill 4Zimmer Biomet, Inc.
2017-10-04Z-3189-2017Class IIZimmer Natural Nail System Calibrated Drill Short 4Zimmer Biomet, Inc.
2017-10-04Z-3190-2017Class IIDrill Bit Jacobs Chuck 2Zimmer Biomet, Inc.
2017-10-04Z-3191-2017Class IIDrill Bit Jacobs Chuck 3Zimmer Biomet, Inc.
2017-10-04Z-3192-2017Class IIDrill Bit Quick-Connect 1Zimmer Biomet, Inc.
2017-10-04Z-3193-2017Class IIDrill Bit Quick-Connect 2Zimmer Biomet, Inc.
2017-10-04Z-3194-2017Class IIDrill Bit Quick-Connect 2Zimmer Biomet, Inc.
2017-10-04Z-3195-2017Class IIDrill Bit Quick-Connect 2Zimmer Biomet, Inc.
2017-10-04Z-3196-2017Class IIDrill Bit Quick-Connect 3Zimmer Biomet, Inc.
2017-10-04Z-3197-2017Class IIDrill Bit Quick-Connect 3Zimmer Biomet, Inc.
2017-10-04Z-3198-2017Class IIDrill bit Quick-Connect 3-Fluted 2Zimmer Biomet, Inc.
2017-10-04Z-3199-2017Class IIDrill Bit Quick-Connect 3-Fluted 4Zimmer Biomet, Inc.
2017-10-04Z-3200-2017Class IIDrill Bit Quick-Connect Calibrated 3-Fluted 2Zimmer Biomet, Inc.
2017-10-04Z-3201-2017Class IIZimmer Natural Nail System Freehand Drill 4Zimmer Biomet, Inc.
2017-10-04Z-3202-2017Class IIDrill Bit Quick-Connect 4Zimmer Biomet, Inc.
2017-10-04Z-3203-2017Class IIDrill Bit Quick-Connect 3Zimmer Biomet, Inc.
2017-10-04Z-3204-2017Class IIGuide Sleeve 3Zimmer Dental Inc
2017-10-04Z-3205-2017Class IITHREAD RETRIEVAL DRILL REF 2224Zimmer Dental Inc
2017-10-04Z-3206-2017Class IIABUT GOLD FRICTION-FITZimmer Dental Inc
2017-10-04Z-3207-2017Class IITRY-INZimmer Dental Inc
2017-10-04Z-3208-2017Class IIIMPRESSION CAP CONT 3Zimmer Dental Inc
2017-10-04Z-3209-2017Class IIWAXING COPINGZimmer Dental Inc
2017-10-04Z-3210-2017Class IIIMPLANTZimmer Dental Inc
2017-10-04Z-3211-2017Class IIIMRIS DEERFIELD IMAGINGDeerfield Imaging
2017-10-04Z-3212-2017Class IILMATeleflex Medical
2017-10-04Z-3213-2017Class IIUniPercSmiths Medical ASD Inc.
2017-10-04Z-3214-2017Class IIUltradent ProductsUltradent Products, Inc.
2017-10-04Z-3215-2017Class IIUltradent ProductsUltradent Products, Inc.
2017-10-04Z-3216-2017Class IIUltradent ProductsUltradent Products, Inc.
2017-10-04Z-3217-2017Class IIUltradent ProductsUltradent Products, Inc.
2017-10-04Z-3218-2017Class IIUltradent ProductsUltradent Products, Inc.
2017-10-04Z-3219-2017Class IIPercuvance Gripper Grasper Tool Tip The Percutaneous Surgical System…Teleflex Medical
2017-10-04Z-3220-2017Class IIPercuvance Clip Applier Tool Tip The Percutaneous Surgical System…Teleflex Medical
2017-10-04Z-3221-2017Class IIPercuvance Johans Grasper Tool Tip The Percutaneous Surgical System…Teleflex Medical
2017-10-04Z-3222-2017Class IIPercuvance Maryland Dissector Tool Tip The Percutaneous Surgical…Teleflex Medical
2017-10-04Z-3223-2017Class IIPercuvance Scissors Tool Tip The Percutaneous Surgical System with…Teleflex Medical
2017-10-04Z-3224-2017Class IIPercuvance 29cm Shaft The Percutaneous Surgical System with 5mm…Teleflex Medical
2017-10-04Z-3225-2017Class IIFUJINON ED-530XTFujifilm Medical Systems U.S.A., Inc.
2017-10-04Z-3226-2017Class IIBard Magic 3 Antibacterial Hydrophilic Intermittent Catheter FemaleC.R. Bard, Inc.
2017-10-04Z-3227-2017Class IIMedtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mmMedtronic Vascular, Inc.
2017-10-04Z-3228-2017Class IIPlatinium VR 1210Sorin Group Italia SRL - CRF
2017-10-04Z-3229-2017Class IIPlatinium DR 1510Sorin Group Italia SRL - CRF
2017-10-04Z-3230-2017Class IIPlatinium CRT DF1 1711Sorin Group Italia SRL - CRF
2017-10-04Z-3231-2017Class IIPlatinium VR DF4 1240Sorin Group Italia SRL - CRF
2017-10-04Z-3232-2017Class IIPlatinium DR DF4 1540Sorin Group Italia SRL - CRF
2017-10-04Z-3233-2017Class IIPlatinium CRT-D 1741Sorin Group Italia SRL - CRF
2017-10-04Z-3234-2017Class IINOVADAQ SPY-PHI DrapeNOVADAQ TECHNOLOGIES INC.
2017-10-04Z-3235-2017Class IINOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI SystemNOVADAQ TECHNOLOGIES INC.
2017-10-04Z-3236-2017Class IINOVADAQ SPY-PHI DrapeNOVADAQ TECHNOLOGIES INC.
2017-09-27Z-3134-2017Class IIVITEKBiomerieux Inc
2017-09-27Z-3135-2017Class IIAQUIOS CL Flow Cytometer System The AQUIOS CL Flow Cytometer is…Beckman Coulter Inc.
2017-09-27Z-3136-2017Class IIEuphora Rapid Exchange Balloon Dilatation CatheterMedtronic Vascular Galway DBA Medtronic Ireland
2017-09-27Z-3137-2017Class IISolarice Rapid Exchange Balloon Dilatation CatheterMedtronic Vascular Galway DBA Medtronic Ireland
2017-09-27Z-3138-2017Class IIK-AssayKamiya Biomedical Company, LLC
2017-09-27Z-3139-2017Class IISpine Referencing InstrumentationMedtronic Navigation, Inc.
2017-09-27Z-3140-2017Class IISpine Referencing InstrumentationMedtronic Navigation, Inc.
2017-09-27Z-3141-2017Class IISpine Referencing InstrumentationMedtronic Navigation, Inc.
2017-09-27Z-3142-2017Class IISpine Referencing InstrumentationMedtronic Navigation, Inc.
2017-09-27Z-3143-2017Class IISpine Referencing InstrumentationMedtronic Navigation, Inc.
2017-09-20Z-2870-2017Class IIX-Laser Laser Light Show projector models AuroraX-Laser Llc
2017-09-20Z-3109-2017Class ISkintact Electrode for DefibrillationLeonhard Lang Medizintechnik GmbH
2017-09-20Z-3111-2017Class IIToshiba Medical RadrexToshiba American Medical Systems
2017-09-20Z-3115-2017Class IISpectra-System/Legacy Guided Surgery Handle KitImplant Direct Sybron Manufacturing, LLC
2017-09-20Z-3116-2017Class IIBD Needle 22GA 1-1/2in SafetyGlideBecton Dickinson & Company
2017-09-20Z-3117-2017Class IIHerga foot switchZimmer Biomet, Inc.
2017-09-20Z-3118-2017Class IISekisui Diagnostics Sekure Chemistry Acetaminophen L3KBeckman Coulter Inc.
2017-09-20Z-3119-2017Class IIeMAG SystembioMerieux, Inc.
2017-09-20Z-3120-2017Class IICell MarqueLeica Biosystems Richmond Inc.
2017-09-20Z-3121-2017Class IICell MarqueLeica Biosystems Richmond Inc.
2017-09-20Z-3122-2017Class IICell MarqueLeica Biosystems Richmond Inc.
2017-09-20Z-3123-2017Class IICell MarqueLeica Biosystems Richmond Inc.
2017-09-20Z-3124-2017Class IICell MarqueLeica Biosystems Richmond Inc.
2017-09-20Z-3125-2017Class IICell MarqueLeica Biosystems Richmond Inc.
2017-09-20Z-3126-2017Class IICell MarqueLeica Biosystems Richmond Inc.
2017-09-20Z-3127-2017Class IIFirebird NXG Spinal Fixation System Decorticating PlanerOrthofix, Inc
2017-09-20Z-3128-2017Class IIFujifilm Endoscope Model ED-530XT Product Usage: This product is a…Fujifilm Medical Systems U.S.A., Inc.
2017-09-20Z-3129-2017Class IIFujifilm Endoscope Models ED-250XL5 ED-250XT5 ED-450XT5 ED-450XL5…Fujifilm Medical Systems U.S.A., Inc.

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