Medical device recalls reported in 2018

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Reported	Recall	Class	Product	Firm
2018-02-07	Z-0479-2018	Class II	Affixus Hip Fracture Nail	Zimmer Biomet, Inc.
2018-02-07	Z-0480-2018	Class II	Affixus Hip Fracture Nail	Zimmer Biomet, Inc.
2018-02-07	Z-0481-2018	Class II	Affixus Hip Fracture Nail	Zimmer Biomet, Inc.
2018-02-07	Z-0482-2018	Class II	Affixus Hip Fracture Nail	Zimmer Biomet, Inc.
2018-02-07	Z-0483-2018	Class II	Affixus Hip Fracture Nail	Zimmer Biomet, Inc.
2018-02-07	Z-0484-2018	Class II	Affixus Hip Fracture Nail	Zimmer Biomet, Inc.
2018-02-07	Z-0485-2018	Class II	Empty IntraVia Container with Non-DEHP Fluid Path	Baxter Healthcare Corporation
2018-02-07	Z-0487-2018	Class II	GE HEALTHCARE CARESCAPE Central Station	GE Medical Systems Information Technologies, Inc.
2018-02-07	Z-0488-2018	Class II	BARD UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR	C.R. Bard, Inc.
2018-02-07	Z-0490-2018	Class II	Hemofiltration Standard Pack including BC 60 Plus-T 8036	Maquet
2018-02-07	Z-0491-2018	Class II	Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900	Tosoh Bioscience Inc
2018-02-07	Z-0492-2018	Class II	Tosoh¿Sorter 9tray	Tosoh Bioscience Inc
2018-02-07	Z-0493-2018	Class II	10 ML REAGENT CUP	Horiba Instruments, Inc dba Horiba Medical
2018-02-07	Z-0494-2018	Class II	15 ML REAGENT CUP	Horiba Instruments, Inc dba Horiba Medical
2018-02-07	Z-0495-2018	Class II	Syngo	Siemens Medical Solutions USA, Inc
2018-02-07	Z-0496-2018	Class II	Hemosphere System with the following three components: HEM1 Advanced…	Edwards Lifesciences, LLC
2018-02-07	Z-0497-2018	Class II	Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient…	Smiths Medical ASD Inc.
2018-02-07	Z-0498-2018	Class II	cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number:…	Roche Diagnostics Corporation
2018-02-07	Z-0499-2018	Class II	Roche / Hitachi MODULAR Analyzer Systems-Immunoassay…	Roche Diagnostics Corporation
2018-02-07	Z-0500-2018	Class II	bvi Beaver EdgeAhead Safety Knife	Beaver-Visitec International Inc.
2018-02-07	Z-0501-2018	Class II	bvi Beaver Safety Sideport Knife:	Beaver-Visitec International Inc.
2018-02-07	Z-0502-2018	Class II	bvi Beaver Xstar Safety Slit Knife:	Beaver-Visitec International Inc.
2018-02-07	Z-0503-2018	Class II	bvi Beaver Xstar Safety Crescent	Beaver-Visitec International Inc.
2018-02-07	Z-0504-2018	Class II	bvi Beaver Optimum Safety Sideport Knife:	Beaver-Visitec International Inc.
2018-01-31	Z-0343-2018	Class I	Infant AirLife single-limb	Vyaire Medical
2018-01-31	Z-0344-2018	Class I	Infant AirLife Dual-	Vyaire Medical
2018-01-31	Z-0345-2018	Class I	Adult Air-Life single-limb circuit	Vyaire Medical
2018-01-31	Z-0346-2018	Class I	Adult AirLife dual-limb	Vyaire Medical
2018-01-31	Z-0392-2018	Class II	BD MAXTM Vaginal Panel	Becton Dickinson & Co.
2018-01-31	Z-0393-2018	Class II	BD MAX" UVE Specimen Collection Kit	Becton Dickinson & Co.
2018-01-31	Z-0394-2018	Class II	BD MAX" CT/GC/TV	Becton Dickinson & Co.
2018-01-31	Z-0395-2018	Class II	Measurement Specialties Reusable Temperature Probe Autoclavable	Measurement Specialties Inc
2018-01-31	Z-0396-2018	Class II	smith&nephew Mini-Fragment Plating System	Smith & Nephew, Inc.
2018-01-31	Z-0397-2018	Class II	smith&nephew Mini-Fragment Plating System	Smith & Nephew, Inc.
2018-01-31	Z-0398-2018	Class II	OSCILLATING SAW ATTACHMENT Surgical instrument motors and…	The Anspach Effort, Inc.
2018-01-31	Z-0399-2018	Class II	MyCareLink Patient Monitors	Medtronic Inc., Cardiac Rhythm and Heart Failure
2018-01-31	Z-0400-2018	Class II	MyCareLink Smart Patient Monitors	Medtronic Inc., Cardiac Rhythm and Heart Failure
2018-01-31	Z-0401-2018	Class II	CP5 Centrifugal Pump	Sorin Group Deutschland GmbH
2018-01-31	Z-0402-2018	Class II	Brilliance iCT SP	Philips Medical Systems (Cleveland) Inc
2018-01-31	Z-0403-2018	Class II	Brilliance iCT	Philips Medical Systems (Cleveland) Inc
2018-01-31	Z-0404-2018	Class II	daVinci X EndoWrist	Intuitive Surgical, Inc.
2018-01-31	Z-0405-2018	Class II	Syngo Imaging version V31	Siemens Medical Solutions USA, Inc.
2018-01-31	Z-0406-2018	Class II	Radial Osteotome Blade	Smith & Nephew, Inc.
2018-01-31	Z-0407-2018	Class II	PURE OXYGEN CONCENTRATOR	Inovo, Inc
2018-01-31	Z-0408-2018	Class II	smith&nephew	Smith & Nephew, Inc.
2018-01-31	Z-0409-2018	Class II	Smith & Nephew Taylor Spatial Frame Website software	Smith & Nephew, Inc.
2018-01-31	Z-0410-2018	Class II	TUMARK Q	Somatex Medical Technologies GmbH
2018-01-31	Z-0411-2018	Class II	MARS Treatment Kit	Baxter Healthcare Corporation
2018-01-24	Z-0334-2018	Class II	DeRoyal Sterile Custom kits containing Covidien-Dover	DeRoyal Industries Inc
2018-01-24	Z-0335-2018	Class II	Intellicuff Standalone	Hamilton Medical, Inc.
2018-01-24	Z-0336-2018	Class II	TRYPTIK	SPINEART SA
2018-01-24	Z-0337-2018	Class II	TRYPTIK	SPINEART SA
2018-01-24	Z-0338-2018	Class II	TRYPTIK	SPINEART SA
2018-01-24	Z-0339-2018	Class II	TRYPTIK	SPINEART SA
2018-01-24	Z-0340-2018	Class II	TRYPTIK	SPINEART SA
2018-01-24	Z-0341-2018	Class II	TRYPTIK	SPINEART SA
2018-01-24	Z-0342-2018	Class II	TRYPTIK	SPINEART SA
2018-01-24	Z-0347-2018	Class II	Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever	Stryker Neurovascular
2018-01-24	Z-0348-2018	Class II	ECG Out Cable	Philips Electronics North America Corporation
2018-01-24	Z-0349-2018	Class II	Persona Partial Knee System	Zimmer Biomet, Inc.
2018-01-24	Z-0350-2018	Class II	Fellows "Mighty 8" Power strip	Merge Healthcare, Inc.
2018-01-24	Z-0351-2018	Class II	Affirm Lateral Arm Upright Biopsy Accessory	Hologic, Inc.
2018-01-24	Z-0352-2018	Class II	Medtronic KYPHON	Medtronic Sofamor Danek USA Inc
2018-01-24	Z-0353-2018	Class II	LifeVest Wearable Defibrillator Model 4000	Zoll Manufacturing Corp.
2018-01-24	Z-0354-2018	Class II	ACCOLADE SR Pacemaker	Boston Scientific Corporation
2018-01-24	Z-0355-2018	Class II	ACCOLADE DR Pacemaker	Boston Scientific Corporation
2018-01-24	Z-0356-2018	Class II	ACCOLADE EL DR Pacemaker	Boston Scientific Corporation
2018-01-24	Z-0357-2018	Class II	ACCOLADE MRI SR Pacemaker	Boston Scientific Corporation
2018-01-24	Z-0358-2018	Class II	ACCOLADE MRI DR Pacemaker	Boston Scientific Corporation
2018-01-24	Z-0359-2018	Class II	ACCOLADE MRI EL DR Pacemaker	Boston Scientific Corporation
2018-01-24	Z-0360-2018	Class II	VALITUDE CRT-P Pacemaker	Boston Scientific Corporation
2018-01-24	Z-0361-2018	Class II	VALITUDE X4 CRT-P Pacemaker	Boston Scientific Corporation
2018-01-24	Z-0362-2018	Class II	ALTRUA 2 SR Pacemaker	Boston Scientific Corporation
2018-01-24	Z-0363-2018	Class II	ALTRUA 2 DR Pacemaker	Boston Scientific Corporation
2018-01-24	Z-0364-2018	Class II	ALTRUA 2 EL DR Pacemaker	Boston Scientific Corporation
2018-01-24	Z-0365-2018	Class II	VISIONIST CRT-P Pacemaker	Boston Scientific Corporation
2018-01-24	Z-0366-2018	Class II	VISIONIST X4 CRT-P Pacemaker	Boston Scientific Corporation
2018-01-24	Z-0367-2018	Class II	ESSENTIO SR Pacemaker	Boston Scientific Corporation
2018-01-24	Z-0368-2018	Class II	ESSENTIO DR Pacemaker	Boston Scientific Corporation
2018-01-24	Z-0369-2018	Class II	ESSENTIO MRI SR Pacemaker	Boston Scientific Corporation
2018-01-24	Z-0370-2018	Class II	ESSENTIO MRI DR Pacemaker	Boston Scientific Corporation
2018-01-24	Z-0371-2018	Class II	ESSENTIO EL DR Pacemaker	Boston Scientific Corporation
2018-01-24	Z-0372-2018	Class II	ESSENTIO MRI EL DR Pacemaker	Boston Scientific Corporation
2018-01-24	Z-0373-2018	Class II	PROPONENT SR Pacemaker	Boston Scientific Corporation
2018-01-24	Z-0374-2018	Class II	PROPONENT DR Pacemaker	Boston Scientific Corporation
2018-01-24	Z-0375-2018	Class II	PROPONENT EL DR Pacemaker	Boston Scientific Corporation
2018-01-24	Z-0376-2018	Class II	PROPONENT VDD SL Pacemaker	Boston Scientific Corporation
2018-01-24	Z-0377-2018	Class II	PROPONENT MRI Pacemaker	Boston Scientific Corporation
2018-01-24	Z-0378-2018	Class II	Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000…	Roche Diagnostics Corporation
2018-01-24	Z-0380-2018	Class II	RayStation Product Usage: is a software system designed for treatment…	RAYSEARCH LABORATORIES AB
2018-01-24	Z-0381-2018	Class II	Unifine Pentips 5mm x 31G pen needles	Owen Mumford USA, Inc.
2018-01-24	Z-0382-2018	Class II	Unifine Pentips 5mm x 31G pen needles	Owen Mumford USA, Inc.
2018-01-24	Z-0383-2018	Class II	PriMatrix¿ is an acellular dermal tissue matrix derived from fetal…	TEI Biosciences
2018-01-24	Z-0384-2018	Class II	Small Particle Aerosol Generator Model SPAG-2 6000 Series	Valeant Pharmacueticals International
2018-01-24	Z-0385-2018	Class II	Aspire HD Plus	Fujifilm Medical Systems U.S.A., Inc.
2018-01-24	Z-0386-2018	Class II	ASPIRE Cristalle	Fujifilm Medical Systems U.S.A., Inc.
2018-01-24	Z-0387-2018	Class II	Phadia 1000 Instrument	Phadia US Inc
2018-01-24	Z-0388-2018	Class II	Brilliance iCT Intended to produce images of the head and body by…	Philips Medical Systems (Cleveland) Inc
2018-01-24	Z-0389-2018	Class II	Brilliance 64	Philips Medical Systems (Cleveland) Inc
2018-01-24	Z-0390-2018	Class II	Ingenuity Core	Philips Medical Systems (Cleveland) Inc
2018-01-24	Z-0391-2018	Class II	Ingenuity Core 128	Philips Medical Systems (Cleveland) Inc
2018-01-17	Z-0258-2018	Class II	Mobile Mini C-arm system Part # 1000-0001	Orthoscan, Inc.
2018-01-17	Z-0259-2018	Class II	Mobile Mini C-arm system Part # 1000-0004	Orthoscan, Inc.
2018-01-17	Z-0260-2018	Class II	Mobile Mini C-arm system Part # 1000-0005	Orthoscan, Inc.
2018-01-17	Z-0261-2018	Class II	Mobile Mini C-arm system Part # 1000-0004-FD	Orthoscan, Inc.
2018-01-17	Z-0293-2018	Class I	Certitude Delivery System and any associated Multipacks Models	Edwards Lifesciences, LLC
2018-01-17	Z-0294-2018	Class I	LIFEPAK 20e DEFIBRILLATOR/MONITOR	Physio-Control, Inc.
2018-01-17	Z-0317-2018	Class II	Freedom60 Precision Flow Rate Tubing Sets	Repro-Med Systems, Inc.
2018-01-17	Z-0318-2018	Class II	HIgH-Flo Subcutaneous Safety Needle Sets	Repro-Med Systems, Inc.
2018-01-17	Z-0319-2018	Class II	Sundream 12 V tanning bed	ProSun International, LLC
2018-01-17	Z-0320-2018	Class II	Brainlab Navigation System Spine & Trauma 3D with component Brainlab…	Brainlab AG
2018-01-17	Z-0321-2018	Class II	UNIVERSAL FLEX2 BREATHING CIRCUIT	King Systems Corp. dba Ambu, Inc.
2018-01-17	Z-0322-2018	Class II	Alaris Syringe Pump	CareFusion 303, Inc.
2018-01-17	Z-0323-2018	Class II	Alaris PCA Pump	CareFusion 303, Inc.
2018-01-17	Z-0324-2018	Class II	Cordis S	Cordis Corporation
2018-01-17	Z-0325-2018	Class II	Mac Pin Non-Cannulated Screw	Amendia, Inc
2018-01-17	Z-0326-2018	Class II	DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE	Encore Medical, Lp
2018-01-17	Z-0327-2018	Class II	EMPOWR Porous Knee System TIBIAL PUNCH	Encore Medical, Lp
2018-01-17	Z-0328-2018	Class II	EMPOWR Porous Knee System TIBIAL PUNCH	Encore Medical, Lp
2018-01-17	Z-0329-2018	Class II	EMPOWR Porous Knee System TIBIAL PUNCH	Encore Medical, Lp
2018-01-17	Z-0330-2018	Class II	CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system…	Philips Electronics North America Corporation
2018-01-17	Z-0331-2018	Class II	Philips Healthcare Brilliance iCT computed tomography x-ray system	Philips Medical Systems (Cleveland) Inc
2018-01-17	Z-0332-2018	Class II	Philips Healthcare Brilliance iCT SP computed tomography x-ray system	Philips Medical Systems (Cleveland) Inc
2018-01-17	Z-0333-2018	Class II	Philips Healthcare IQon Spectral CT computed tomography x-ray system	Philips Medical Systems (Cleveland) Inc
2018-01-10	Z-0296-2018	Class II	Lateral Troch Plate Full Crimp	Zimmer Biomet, Inc.
2018-01-10	Z-0297-2018	Class II	Lateral Troch Plate Full Crimp	Zimmer Biomet, Inc.
2018-01-10	Z-0298-2018	Class II	COMP 12MM HUM FRAC STEM MACRO	Zimmer Biomet, Inc.
2018-01-10	Z-0299-2018	Class II	COMP PRIMARY STEM 8MM MINI	Zimmer Biomet, Inc.
2018-01-10	Z-0300-2018	Class II	ECHO POR FMRL NC 9X125	Zimmer Biomet, Inc.
2018-01-10	Z-0301-2018	Class II	CER OPTION TYPE 1 TPR SLEVE -6	Zimmer Biomet, Inc.
2018-01-10	Z-0302-2018	Class II	CER BIOLOXD OPTION HD 32MM	Zimmer Biomet, Inc.
2018-01-10	Z-0303-2018	Class II	OSS CEMENTED IM STEM 12X150	Zimmer Biomet, Inc.
2018-01-10	Z-0304-2018	Class II	RED SEXP DSTL FEM 19CM RT ASSY	Zimmer Biomet, Inc.
2018-01-10	Z-0305-2018	Class II	RED SEXP DSTL FEM 19CM LT ASSY	Zimmer Biomet, Inc.
2018-01-10	Z-0306-2018	Class II	Euro Diagnostica DIASTAT ANA	Euro Diagnostica AB
2018-01-10	Z-0307-2018	Class II	CADD-Legacy 1	Smiths Medical ASD Inc.
2018-01-10	Z-0308-2018	Class III	Access 2 Immunoassay System	Beckman Coulter Inc.
2018-01-10	Z-0309-2018	Class III	Access 2 Immunoassay System	Beckman Coulter Inc.
2018-01-10	Z-0310-2018	Class III	UniCel DxC 600i SYNCHRON Access Clinical Systems	Beckman Coulter Inc.
2018-01-10	Z-0311-2018	Class II	Mobile Detector Holder	Philips Electronics North America Corporation
2018-01-10	Z-0312-2018	Class II	PPS RingLoc+ Acetabular Shell	Zimmer Biomet, Inc.
2018-01-10	Z-0313-2018	Class II	Medfusion	Smiths Medical ASD Inc.
2018-01-10	Z-0314-2018	Class II	Medfusion	Smiths Medical ASD Inc.
2018-01-10	Z-0315-2018	Class II	SafetyGlide Needle	Centurion Medical Products Corporation
2018-01-10	Z-0316-2018	Class II	Ceres Self-Drilling Variable Screw 4	Amendia, Inc
2018-01-03	Z-0213-2018	Class I	St	Sterilmed Inc
2018-01-03	Z-0270-2018	Class II	L3 Security & Detection System Cabinet X-ray system used for security…	L3 Security & Detection
2018-01-03	Z-0273-2018	Class II	VITROS Chemistry Products PHYT Slides	Ortho-Clinical Diagnostics
2018-01-03	Z-0285-2018	Class II	Rx series HbA1c REF/Catalog Number HA3830	Randox Laboratories Ltd.
2018-01-03	Z-0286-2018	Class II	Hi-Art	Accuray Incorporated
2018-01-03	Z-0287-2018	Class II	TomoHD	Accuray Incorporated
2018-01-03	Z-0288-2018	Class II	TomoH	Accuray Incorporated
2018-01-03	Z-0289-2018	Class II	TomoHDA	Accuray Incorporated
2018-01-03	Z-0290-2018	Class II	Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum	Remel Inc
2018-01-03	Z-0291-2018	Class II	Orthofix Power Drill Torque Limiter	Orthofix Srl
2018-01-03	Z-0292-2018	Class II	IntelliVue Multi Measurement Server	Philips Electronics North America Corporation
2018-01-03	Z-0295-2018	Class II	Sterile Elastic Esmark Bandage	Medline Industries Inc

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