Medical device recalls reported in 2018

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Reported	Recall	Class	Product	Firm
2018-08-15	Z-2676-2018	Class II	Lateral Assembly	Howmedica Osteonics Corp.
2018-08-15	Z-2677-2018	Class II	rHead Stem Implant Plasma Coated	Howmedica Osteonics Corp.
2018-08-15	Z-2678-2018	Class II	rHead Stem Implant Plasma Coated	Howmedica Osteonics Corp.
2018-08-15	Z-2679-2018	Class II	rHead Stem Implant Plasma Coated	Howmedica Osteonics Corp.
2018-08-15	Z-2680-2018	Class II	rHead Stem Implant Plasma Coated	Howmedica Osteonics Corp.
2018-08-15	Z-2681-2018	Class II	rHead Stem Implant 6mm Collar	Howmedica Osteonics Corp.
2018-08-15	Z-2682-2018	Class II	rHead Stem Implant 6mm Collar	Howmedica Osteonics Corp.
2018-08-15	Z-2683-2018	Class II	rHead Stem Implant 6mm Collar	Howmedica Osteonics Corp.
2018-08-15	Z-2684-2018	Class II	rHead Stem Implant 6mm Collar	Howmedica Osteonics Corp.
2018-08-15	Z-2685-2018	Class II	rHead Recon Stem Implant Plasma Coated	Howmedica Osteonics Corp.
2018-08-15	Z-2686-2018	Class II	rHead Recon Stem Implant Plasma Coated	Howmedica Osteonics Corp.
2018-08-15	Z-2687-2018	Class II	rHead Recon Stem Implant Plasma Coated	Howmedica Osteonics Corp.
2018-08-15	Z-2688-2018	Class II	rHead Recon Stem Implant Plasma Coated	Howmedica Osteonics Corp.
2018-08-15	Z-2689-2018	Class II	rHead Recon Stem Implant 6mm Collar	Howmedica Osteonics Corp.
2018-08-15	Z-2690-2018	Class II	rHead Recon Stem Implant 6mm Collar	Howmedica Osteonics Corp.
2018-08-15	Z-2691-2018	Class II	rHead Recon Stem Implant 6mm Collar	Howmedica Osteonics Corp.
2018-08-15	Z-2692-2018	Class II	rHead Recon Stem Implant 6mm Collar	Howmedica Osteonics Corp.
2018-08-15	Z-2693-2018	Class II	Radio Capitellum Large	Howmedica Osteonics Corp.
2018-08-15	Z-2694-2018	Class II	Radio Capitellum Small	Howmedica Osteonics Corp.
2018-08-15	Z-2695-2018	Class II	Radio Capitellum Large	Howmedica Osteonics Corp.
2018-08-15	Z-2696-2018	Class II	Radio Capitellum Small	Howmedica Osteonics Corp.
2018-08-15	Z-2697-2018	Class II	Radial Head Assy Size #2	Howmedica Osteonics Corp.
2018-08-15	Z-2698-2018	Class II	Radial Head Assy Size #3	Howmedica Osteonics Corp.
2018-08-15	Z-2699-2018	Class II	Radial Head Assy Size #4	Howmedica Osteonics Corp.
2018-08-15	Z-2700-2018	Class II	Radio Capitellum	Howmedica Osteonics Corp.
2018-08-15	Z-2701-2018	Class II	Radio Capitellum	Howmedica Osteonics Corp.
2018-08-15	Z-2702-2018	Class II	Radio Capitellum	Howmedica Osteonics Corp.
2018-08-15	Z-2703-2018	Class II	rHead Standard Extended Stem	Howmedica Osteonics Corp.
2018-08-15	Z-2704-2018	Class II	rHead Standard Extended Stem	Howmedica Osteonics Corp.
2018-08-15	Z-2705-2018	Class II	rHead Standard Extended Stem	Howmedica Osteonics Corp.
2018-08-15	Z-2706-2018	Class II	rHead Standard Extended Stem	Howmedica Osteonics Corp.
2018-08-15	Z-2707-2018	Class II	rHead Recon Extended Stem Size 1	Howmedica Osteonics Corp.
2018-08-15	Z-2708-2018	Class II	rHead Recon Extended Stem Size 2	Howmedica Osteonics Corp.
2018-08-15	Z-2709-2018	Class II	rHead Recon Extended Stem Size 3	Howmedica Osteonics Corp.
2018-08-15	Z-2710-2018	Class II	Radio Capitellum Broach Large	Howmedica Osteonics Corp.
2018-08-15	Z-2711-2018	Class II	#2 Bipolar radial head Implant	Howmedica Osteonics Corp.
2018-08-15	Z-2712-2018	Class II	#3 Bipolar radial head Implant	Howmedica Osteonics Corp.
2018-08-15	Z-2713-2018	Class II	#4 Bipolar radial head Implant	Howmedica Osteonics Corp.
2018-08-15	Z-2714-2018	Class II	#1 Bipolar stem implant	Howmedica Osteonics Corp.
2018-08-15	Z-2715-2018	Class II	rHead Recon Stem Implant non-coated	Howmedica Osteonics Corp.
2018-08-15	Z-2716-2018	Class II	#2 Bipolar stem implant	Howmedica Osteonics Corp.
2018-08-15	Z-2717-2018	Class II	rHead Recon Stem Implant non-coated	Howmedica Osteonics Corp.
2018-08-15	Z-2718-2018	Class II	#3 Bipolar stem implant	Howmedica Osteonics Corp.
2018-08-15	Z-2719-2018	Class II	rHead Recon Stem Implant non-coated	Howmedica Osteonics Corp.
2018-08-15	Z-2720-2018	Class II	#4 Bipolar stem implant	Howmedica Osteonics Corp.
2018-08-15	Z-2721-2018	Class II	rHead Recon Stem Implant non-coated	Howmedica Osteonics Corp.
2018-08-15	Z-2722-2018	Class II	radial head implant #2	Howmedica Osteonics Corp.
2018-08-15	Z-2723-2018	Class II	radial head implant #3	Howmedica Osteonics Corp.
2018-08-15	Z-2724-2018	Class II	radial head implant #4	Howmedica Osteonics Corp.
2018-08-15	Z-2725-2018	Class II	radial stem implant #1	Howmedica Osteonics Corp.
2018-08-15	Z-2726-2018	Class II	rHead	Howmedica Osteonics Corp.
2018-08-15	Z-2727-2018	Class II	radial stem implant #2	Howmedica Osteonics Corp.
2018-08-15	Z-2728-2018	Class II	radial stem implant #2	Howmedica Osteonics Corp.
2018-08-15	Z-2729-2018	Class II	radial stem implant #3	Howmedica Osteonics Corp.
2018-08-15	Z-2730-2018	Class II	rHead	Howmedica Osteonics Corp.
2018-08-15	Z-2731-2018	Class II	radial stem implant #4	Howmedica Osteonics Corp.
2018-08-15	Z-2732-2018	Class II	rHead	Howmedica Osteonics Corp.
2018-08-15	Z-2733-2018	Class II	Mallinckrodt Pharmaceuticals INOflo DS	INO therapeutics LLC/dba ikaria
2018-08-15	Z-2734-2018	Class II	Waterpik Sonic-Fusion Professional	Water Pik, Inc.
2018-08-15	Z-2735-2018	Class II	Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a…	Boston Scientific Corporation
2018-08-15	Z-2736-2018	Class II	iTOVi Tracker/Scanner	Hudson Scientific LLC
2018-08-15	Z-2737-2018	Class II	Natus Neurology ErgoJust Carts labeled as the following: ICU Cart…	Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
2018-08-15	Z-2738-2018	Class II	The Neonatal Flow Sensor Cable used on devices CARESCAPE R860	Datex-Ohmeda, Inc.
2018-08-15	Z-2739-2018	Class II	VitalGo Total Lift Bed VG-TLB425T-TQR	Vitalgo Inc.
2018-08-15	Z-2740-2018	Class II	Slit Knife 2	Beaver Visitec
2018-08-08	Z-2472-2018	Class II	SOMATOM Emotion 6	Siemens Medical Solutions USA, Inc
2018-08-08	Z-2473-2018	Class II	SOMATOM Emotion 16	Siemens Medical Solutions USA, Inc
2018-08-08	Z-2474-2018	Class II	SOMATOM Perspective	Siemens Medical Solutions USA, Inc
2018-08-08	Z-2475-2018	Class II	SOMATOM Perspective 16	Siemens Medical Solutions USA, Inc
2018-08-08	Z-2476-2018	Class II	SOMATOM Scope	Siemens Medical Solutions USA, Inc
2018-08-08	Z-2477-2018	Class II	SOMATOM Scope Power	Siemens Medical Solutions USA, Inc
2018-08-08	Z-2478-2018	Class II	SOMATOM Spirit	Siemens Medical Solutions USA, Inc
2018-08-08	Z-2558-2018	Class II	1) ELITE HV	Galt Medical Corporation
2018-08-08	Z-2559-2018	Class II	1) Vascular Dilator	Galt Medical Corporation
2018-08-08	Z-2560-2018	Class II	1) Drainer Centesis Catheter	Galt Medical Corporation
2018-08-08	Z-2561-2018	Class II	1) TVS LPA	Galt Medical Corporation
2018-08-08	Z-2562-2018	Class II	Elite HV Introducer	Galt Medical Corporation
2018-08-08	Z-2563-2018	Class II	Centeze Centesis Catheter	Galt Medical Corporation
2018-08-08	Z-2564-2018	Class II	TVS LPA	Galt Medical Corporation
2018-08-08	Z-2565-2018	Class II	Tearaway Introducers	Galt Medical Corporation
2018-08-08	Z-2566-2018	Class II	Merge Unity software	Merge Healthcare, Inc.
2018-08-08	Z-2567-2018	Class II	Custom Made Implant System with Minimum Invasive Grower	Howmedica Osteonics Corp.
2018-08-08	Z-2568-2018	Class II	Nicolet¿ Ambulatory EEG	Natus Neurology Inc
2018-08-08	Z-2569-2018	Class II	FlowGate2 Balloon Guide Catheter	Stryker Neurovascular
2018-08-08	Z-2570-2018	Class II	XLTEK EMU40EX EEG Headbox	Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
2018-08-08	Z-2571-2018	Class II	Drill	Cayenne Medical Inc.
2018-08-08	Z-2572-2018	Class II	VNS Therapy Programming System	LivaNova USA Inc
2018-08-08	Z-2573-2018	Class III	Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro…	Diamedix Corporation
2018-08-08	Z-2574-2018	Class III	Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro…	Diamedix Corporation
2018-08-08	Z-2575-2018	Class II	Liquid Cardiac Control	Randox Laboratories Ltd.
2018-08-08	Z-2576-2018	Class II	Percutaneous Sheath Introducer Kit for use with 7	Arrow International Inc
2018-08-08	Z-2578-2018	Class II	Discovery IQ 2	GE Healthcare, LLC
2018-08-08	Z-2579-2018	Class II	Discovery MI Digital Ready	GE Healthcare, LLC
2018-08-08	Z-2580-2018	Class II	Discovery MI	GE Healthcare, LLC
2018-08-08	Z-2581-2018	Class II	Discovery RT labeled as: a	GE Healthcare, LLC
2018-08-08	Z-2582-2018	Class II	Revolution CT 160 1	GE Healthcare, LLC
2018-08-08	Z-2583-2018	Class II	CT Goldseal Optima CT 600	GE Healthcare, LLC
2018-08-08	Z-2584-2018	Class II	Revolution EVO 3	GE Healthcare, LLC
2018-08-08	Z-2585-2018	Class II	Optima CT 520	GE Healthcare, LLC
2018-08-08	Z-2586-2018	Class II	Optima CT 540	GE Healthcare, LLC
2018-08-08	Z-2587-2018	Class II	CT Goldseal BrightSpeed 16 PWR TIO 2 YR	GE Healthcare, LLC
2018-08-08	Z-2588-2018	Class II	VIDAS LH	bioMerieux, Inc.
2018-08-08	Z-2590-2018	Class II	Final Pack	Envoy Medical Corporation
2018-08-08	Z-2591-2018	Class II	ENVOY 500 ISE CALIBRATOR KIT	ELITech Clinical Systems SAS
2018-08-08	Z-2592-2018	Class II	MAYFIELD INFINITY XR2 BASE UNIT	Integra LifeSciences Corp.
2018-08-08	Z-2593-2018	Class II	MAYFIELD Infinity XR2 Base Unit-Extended	Integra LifeSciences Corp.
2018-08-08	Z-2594-2018	Class II	MAYFIELD INFINITY XR2 LOW PROFILE BASE UNIT	Integra LifeSciences Corp.
2018-08-08	Z-2595-2018	Class II	MAYFIELD SPINE TABLE ADAPTOR RADIOLUCENT	Integra LifeSciences Corp.
2018-08-08	Z-2596-2018	Class II	EZ1 DSP Virus Kit	QIAGEN
2018-08-08	Z-2597-2018	Class II	power cord for:	Baxter Healthcare Corporation
2018-08-08	Z-2598-2018	Class III	BD FACS Universal Loader	Becton, Dickinson and Company, BD Biosciences
2018-08-08	Z-2599-2018	Class II	MicroScan Pos Combo Panel Type 43	Beckman Coulter Inc.
2018-08-08	Z-2600-2018	Class II	Instrument trays used to store AltiVate Small Shell Trials	Encore Medical, Lp
2018-08-08	Z-2601-2018	Class II	Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21	Covidien LLC
2018-08-08	Z-2602-2018	Class II	Zimmer Dermatone AN	Zimmer Surgical Inc
2018-08-01	Z-2498-2018	Class II	Allura Xper Product Usage: Vascular	Philips Healthcare
2018-08-01	Z-2499-2018	Class II	UNIQ Product Usage: Vascular	Philips Healthcare
2018-08-01	Z-2500-2018	Class II	Centron Product Usage: Vascular	Philips Healthcare
2018-08-01	Z-2517-2018	Class II	2M insert 15degree for MUTARS RS cup and LUMiC TiN orthopedic hip…	IMPLANTCAST GMBH
2018-08-01	Z-2518-2018	Class II	Uretero-reno videoscope URF-V2 Uretero-reno videoscope URF-V2R	Olympus Corporation of the Americas
2018-08-01	Z-2519-2018	Class II	Uretero-reno fiberscope URF-P6	Olympus Corporation of the Americas
2018-08-01	Z-2520-2018	Class II	Uretero-reno fiberscope URF-P6RP6	Olympus Corporation of the Americas
2018-08-01	Z-2521-2018	Class II	CORAIL Cementless Femoral Stem HA Coated Standard Size 11	DePuy Orthopaedics, Inc.
2018-08-01	Z-2522-2018	Class II	CardioMEMS HF System Hospital and Patient Electronics Units:	Abbott Laboratories, Inc.
2018-08-01	Z-2523-2018	Class II	Brivo XR385	GE Healthcare, LLC
2018-08-01	Z-2524-2018	Class II	ARTIS Pheno	Siemens Medical Solutions USA, Inc
2018-08-01	Z-2525-2018	Class II	AXIOM Artis with Laird Cooling Unit for SSFD: Material # 7555118	Siemens Medical Solutions USA, Inc
2018-08-01	Z-2526-2018	Class II	Artis zee systems with Laird Cooling Unit for SSFD: Material # 7555118	Siemens Medical Solutions USA, Inc
2018-08-01	Z-2527-2018	Class II	MR Surgical Suite Option Product The MR Surgical Option when…	GE Medical Systems, LLC
2018-08-01	Z-2528-2018	Class II	Invia Motion Negative Pressure Wound Therapy System	Medela Inc
2018-08-01	Z-2529-2018	Class II	Nobel Biocare 17¿ Multi-Unit Abutment	Nobel Biocare Usa Llc
2018-08-01	Z-2530-2018	Class III	Vivo 65	Human Design Medical Llc
2018-08-01	Z-2531-2018	Class II	Access Hi-Low Exam Tables	Brewer Company, LLC
2018-08-01	Z-2532-2018	Class II	PDS Plus Antibacterial	Ethicon, Inc.
2018-08-01	Z-2533-2018	Class II	PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm	Ethicon, Inc.
2018-08-01	Z-2534-2018	Class II	PDS II	Ethicon, Inc.
2018-08-01	Z-2535-2018	Class II	HexaPOD evo RT Couch Top	Elekta, Inc.
2018-08-01	Z-2536-2018	Class II	Arctic Sun Temperature Management System	Bard Medical Division
2018-08-01	Z-2537-2018	Class II	Patient Positioning System with KRC2 controller using software…	Forte Automation Systems Inc
2018-08-01	Z-2538-2018	Class II	BLAST Bandage	Tactical Medical Solutions, Inc.
2018-08-01	Z-2539-2018	Class II	AD-TECH Medical Instrument Corporation Drill Sleeve Guides…	Ad-Tech Medical Instrument Corporation
2018-08-01	Z-2540-2018	Class II	OMNI Hip System	OMNIlife science Inc.
2018-08-01	Z-2541-2018	Class II	PR4100 Microplate Reader US	Bio-Rad Laboratories Inc
2018-08-01	Z-2542-2018	Class II	Gibco CTS OpTmizer T Cell Expansion Serum Free Medium	Life Technologies, Corp.
2018-08-01	Z-2543-2018	Class II	GIBCO CTS AIM V Serum-Free Media	Life Technologies, Corp.
2018-08-01	Z-2544-2018	Class II	Gibco Dulbecco's Modified Eagle Medium	Life Technologies, Corp.
2018-08-01	Z-2545-2018	Class II	Gibco Dulbecco's Modified Eagle Medium	Life Technologies, Corp.
2018-08-01	Z-2546-2018	Class II	Gibco RPMI 1640 Medium	Life Technologies, Corp.
2018-08-01	Z-2547-2018	Class II	Gibco Dulbecco's Modified Eagle Medium	Life Technologies, Corp.
2018-08-01	Z-2548-2018	Class II	AperFix Femoral Implant Coring Removal Drill	Cayenne Medical Inc.
2018-08-01	Z-2549-2018	Class II	Prevent G Safety Winged Blood Collection Set Glide	Guangzhou Improve Medical Instruments Co., Ltd.
2018-08-01	Z-2550-2018	Class II	Tubing Pack Convenience Kit	Terumo Cardiovascular Systems Corp
2018-08-01	Z-2551-2018	Class II	ImplantDirect	Implant Direct Sybron Manufacturing, LLC
2018-08-01	Z-2554-2018	Class II	RayStation Radiation Therapy Treatment Planning System	RAYSEARCH LABORATORIES AB
2018-08-01	Z-2555-2018	Class II	Leica Microsystems products labeled as the following: Leica M320…	Leica Microsystems, Inc.
2018-08-01	Z-2556-2018	Class II	BioGlue Spreader Tip	CryoLife, Inc.
2018-08-01	Z-2557-2018	Class II	cobas m 511 integrated hematology analyzer	Roche Diagnostics Hematology
2018-07-25	Z-2316-2018	Class II	MX-10 surveillance laser system Product Usage: The expected usage of…	Wescam Inc
2018-07-25	Z-2430-2018	Class II	Apollo XT Suture Anchor	Valeris Medical, LLC
2018-07-25	Z-2431-2018	Class II	Vectris	Medtronic Neuromodulation
2018-07-25	Z-2432-2018	Class II	Vectris	Medtronic Neuromodulation
2018-07-25	Z-2433-2018	Class II	AesDex	AESDEX
2018-07-25	Z-2434-2018	Class II	AesDex	AESDEX
2018-07-25	Z-2435-2018	Class II	Edwards SAPIEN 3 Transcatheter Heart Valve	Edwards Lifesciences, LLC
2018-07-25	Z-2436-2018	Class II	Dimension Vista¿ CTNI Sample Diluent	Siemens Healthcare Diagnostics, Inc.
2018-07-25	Z-2437-2018	Class II	Dimension Vista¿ MULTI 1 SDIL	Siemens Healthcare Diagnostics, Inc.
2018-07-25	Z-2438-2018	Class II	Dimension Vista¿ MULTI 2 SDIL	Siemens Healthcare Diagnostics, Inc.
2018-07-25	Z-2439-2018	Class II	AdvanDx QuickFISH Slides	Opgen Inc
2018-07-25	Z-2440-2018	Class II	MED-RX	Canadian Hospital Specialties
2018-07-25	Z-2441-2018	Class II	Disinfection unit UV	Zeiss, Carl Inc
2018-07-25	Z-2442-2018	Class II	Health Harmony Mobile application software Product Usage: Care…	Intel-GE Care Innovations LLC
2018-07-25	Z-2443-2018	Class II	UNI-CP	NewDeal SA
2018-07-25	Z-2444-2018	Class II	ADVANSYS TTC	NewDeal SA
2018-07-25	Z-2445-2018	Class II	ADVANSYS MLP/DLP	NewDeal SA
2018-07-25	Z-2446-2018	Class II	Large QWIX	NewDeal SA
2018-07-25	Z-2447-2018	Class II	TIBIAXYS	NewDeal SA
2018-07-25	Z-2448-2018	Class II	PROLENE SUTURE MONO BLUE	Ethicon, Inc.
2018-07-25	Z-2449-2018	Class II	PROLENE SUTURE BLUE 4X90CM M1	Ethicon, Inc.
2018-07-25	Z-2450-2018	Class II	PROLENE SUTURE 4-36"	Ethicon, Inc.
2018-07-25	Z-2451-2018	Class II	PROLENE SUTURE 4-36"	Ethicon, Inc.
2018-07-25	Z-2452-2018	Class II	PROLENE SUTURE 30"	Ethicon, Inc.
2018-07-25	Z-2453-2018	Class II	PROLENE SUTURE 36"	Ethicon, Inc.
2018-07-25	Z-2454-2018	Class II	PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG	Ethicon, Inc.
2018-07-25	Z-2455-2018	Class II	PROLENE SUTURE 30"	Ethicon, Inc.
2018-07-25	Z-2456-2018	Class II	PROLENE SUTURE 30"	Ethicon, Inc.
2018-07-25	Z-2457-2018	Class II	PROLENE SUTURE 24"	Ethicon, Inc.
2018-07-25	Z-2458-2018	Class II	PROLENE SUTURE 24"	Ethicon, Inc.
2018-07-25	Z-2459-2018	Class II	PROLENE SUTURE 36"	Ethicon, Inc.
2018-07-25	Z-2460-2018	Class II	PROLENE SUTURE 4"	Ethicon, Inc.
2018-07-25	Z-2461-2018	Class II	PROLENE SUTURE BLUE 48" 4-0 D/A SH-1	Ethicon, Inc.
2018-07-25	Z-2462-2018	Class II	PROLENE SUTURE 36"	Ethicon, Inc.
2018-07-25	Z-2463-2018	Class II	PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C	Ethicon, Inc.
2018-07-25	Z-2464-2018	Class II	PROLENE SUTURE BLUE 18" 7-0 D/A BV-1	Ethicon, Inc.
2018-07-25	Z-2465-2018	Class II	PRONOVA SUTURE BLUE MONO POLY	Ethicon, Inc.
2018-07-25	Z-2466-2018	Class II	PRONOVA SUTURE BLUE 122CM M1	Ethicon, Inc.
2018-07-25	Z-2467-2018	Class II	T2100 Micro flex Drive Treadmill	GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
2018-07-25	Z-2468-2018	Class II	Fx SOLUTIONS CENTERED HEAD CoCr 50x19	Fx Solutions
2018-07-25	Z-2469-2018	Class II	Fx SOLUTIONS OFFSET HEAD CoCr 50x20	Fx Solutions
2018-07-25	Z-2470-2018	Class II	Proteus 235	Ion Beam Applications S.A.
2018-07-25	Z-2471-2018	Class II	t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4	Tandem Diabetes Care Inc

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