Medical device recalls reported in 2018

← Newer · Older →

Reported	Recall	Class	Product	Firm
2018-08-29	Z-2838-2018	Class II	3D V	Siemens Medical Solutions USA, Inc
2018-08-29	Z-2839-2018	Class II	Hitachi Scenaria CT system Product Usage: The SCENARIA CT system is…	Hitachi Medical Systems America Inc
2018-08-29	Z-2840-2018	Class II	ELEKTA Digital Accelerator under the following brand names: Elekta…	Elekta, Inc.
2018-08-29	Z-2841-2018	Class II	DigitalDiagnost 2	Philips Medical Systems Gmbh, DMC
2018-08-29	Z-2842-2018	Class II	DigitalDiagnost 4 Flex / Value	Philips Medical Systems Gmbh, DMC
2018-08-29	Z-2843-2018	Class II	DigitalDiagnost 4	Philips Medical Systems Gmbh, DMC
2018-08-29	Z-2844-2018	Class II	DigitalDiagnost Release 3	Philips Medical Systems Gmbh, DMC
2018-08-29	Z-2845-2018	Class II	DigitalDiagnost Release 3	Philips Medical Systems Gmbh, DMC
2018-08-29	Z-2846-2018	Class II	BuckyDiagnost Ceiling System	Philips Medical Systems Gmbh, DMC
2018-08-29	Z-2847-2018	Class II	CombiDiagnost R90	Philips Medical Systems Gmbh, DMC
2018-08-29	Z-2848-2018	Class II	DigitalDiagnost 2	Philips Medical Systems Gmbh, DMC
2018-08-29	Z-2849-2018	Class II	DigitalDiagnost 4 Chest / Emergency	Philips Medical Systems Gmbh, DMC
2018-08-29	Z-2850-2018	Class II	DigitalDiagnost 4 Flex / Value	Philips Medical Systems Gmbh, DMC
2018-08-29	Z-2851-2018	Class II	DigitalDiagnost 4 High Performance	Philips Medical Systems Gmbh, DMC
2018-08-29	Z-2852-2018	Class II	DigitalDiagnost 4	Philips Medical Systems Gmbh, DMC
2018-08-29	Z-2853-2018	Class II	DigitalDiagnost 4	Philips Medical Systems Gmbh, DMC
2018-08-29	Z-2854-2018	Class II	DigitalDiagnost 4	Philips Medical Systems Gmbh, DMC
2018-08-29	Z-2855-2018	Class II	DigitalDiagnost 4	Philips Medical Systems Gmbh, DMC
2018-08-29	Z-2856-2018	Class II	DigitalDiagnost Classic 1	Philips Medical Systems Gmbh, DMC
2018-08-29	Z-2857-2018	Class II	DigitalDiagnost Classic	Philips Medical Systems Gmbh, DMC
2018-08-29	Z-2858-2018	Class II	DigitalDiagnost Dual Detector	Philips Medical Systems Gmbh, DMC
2018-08-29	Z-2859-2018	Class II	DigitalDiagnost Dual Detector	Philips Medical Systems Gmbh, DMC
2018-08-29	Z-2860-2018	Class II	DigitalDiagnost Rel	Philips Medical Systems Gmbh, DMC
2018-08-29	Z-2861-2018	Class II	DigitalDiagnost Release 3	Philips Medical Systems Gmbh, DMC
2018-08-29	Z-2862-2018	Class II	DigitalDiagnost Release 3	Philips Medical Systems Gmbh, DMC
2018-08-29	Z-2863-2018	Class II	DigitalDiagnost Single Detector	Philips Medical Systems Gmbh, DMC
2018-08-29	Z-2864-2018	Class II	DigitalDiagnost Upgrades	Philips Medical Systems Gmbh, DMC
2018-08-29	Z-2865-2018	Class II	DigitalDiagnost	Philips Medical Systems Gmbh, DMC
2018-08-29	Z-2866-2018	Class II	DigitalDiagnost	Philips Medical Systems Gmbh, DMC
2018-08-29	Z-2867-2018	Class II	EasyDiagnost Eleva DRF	Philips Medical Systems Gmbh, DMC
2018-08-29	Z-2868-2018	Class II	EasyDiagnost Eleva DRF	Philips Medical Systems Gmbh, DMC
2018-08-29	Z-2869-2018	Class II	BD BBL GC-Lect Agar	Becton Dickinson & Co.
2018-08-29	Z-2870-2018	Class II	GE Healthcare Revolution EVO	GE Healthcare Japan Corporation
2018-08-29	Z-2871-2018	Class II	GE Healthcare Optima CT660	GE Healthcare Japan Corporation
2018-08-29	Z-2872-2018	Class II	GE Healthcare Optima CT540	GE Healthcare Japan Corporation
2018-08-29	Z-2873-2018	Class II	GE Healthcare Optima CT660	GE Healthcare Japan Corporation
2018-08-29	Z-2874-2018	Class II	bioM¿rieux VITEK 2 NH ID Test Kit Product Usage: Is an automated…	Biomerieux Inc
2018-08-29	Z-2875-2018	Class II	Connecting Bolt	Zimmer Biomet, Inc.
2018-08-29	Z-2876-2018	Class II	Persona Partial Knee System Spacer Block Alignment Tower	Zimmer Biomet, Inc.
2018-08-29	Z-2877-2018	Class II	Ulnar Osteotomy Compression Plate	TriMed Inc.
2018-08-29	Z-2879-2018	Class II	CoLink	In2bones USA, LLC
2018-08-29	Z-2880-2018	Class II	CoLink	In2bones USA, LLC
2018-08-29	Z-2881-2018	Class II	Dymaxeon 5	Back 2 Basics Direct LLC
2018-08-29	Z-2882-2018	Class II	Vertebral Motion Analyzer	Ortho Kinematics, Inc
2018-08-29	Z-2883-2018	Class II	GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT	Smith & Nephew, Inc.
2018-08-29	Z-2884-2018	Class II	Stryker T2 ANKLE ARTHRODESIS NAIL RIGHT 10MMX200MM Item Number:…	Stryker GmbH
2018-08-29	Z-2885-2018	Class II	O-Two Equinox¿ Relieve N2O/O2 Analgesic Gas Mixing and Delivery…	O-Two Medical Technologies, Inc.
2018-08-29	Z-2886-2018	Class II	Pediatric Two-Lumen Central Venous Catheterization Kit with Blue…	Arrow International Inc
2018-08-29	Z-2887-2018	Class II	CAREstream ProNox Nitrous Oxide Delivery System labeled as the…	CAREstream Medical LLC
2018-08-29	Z-2888-2018	Class II	CIVCO lnfiniti Needle Guide Bracket	Civco Medical Instruments Co. Inc.
2018-08-29	Z-2889-2018	Class II	Vertebral Motion Analyzer	Ortho Kinematics, Inc
2018-08-29	Z-2890-2018	Class II	Vertebral Motion Analyzer	Ortho Kinematics, Inc
2018-08-29	Z-2891-2018	Class II	Vertebral Motion Analyzer	Ortho Kinematics, Inc
2018-08-29	Z-2892-2018	Class II	Philips SureSigns VSV	Philips Electronics North America Corporation
2018-08-29	Z-2893-2018	Class II	Philips SureSigns VS3 Vital Signs Monitor	Philips Electronics North America Corporation
2018-08-29	Z-2894-2018	Class II	Philips SureSigns VS4 Vital Signs Monitor	Philips Electronics North America Corporation
2018-08-29	Z-2895-2018	Class II	Philips SureSigns VM 3/4/6/8 Patient Monitors	Philips Electronics North America Corporation
2018-08-29	Z-2896-2018	Class II	Philips SureSigns VS2 monitor	Philips Electronics North America Corporation
2018-08-29	Z-2897-2018	Class II	Artholine Punch B 4	Richard Wolf GmbH
2018-08-29	Z-2916-2018	Class II	Johnson and Johnson Vision Care 1-Day ACUVUE MOIST Daily Wear	Johnson & Johnson Vision Care, Inc.
2018-08-29	Z-2917-2018	Class II	MOSAIQ Oncology Information System	Elekta, Inc.
2018-08-29	Z-2918-2018	Class II	Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay	Euro Diagnostica AB
2018-08-29	Z-2919-2018	Class III	is a quantitative/qualitative enzyme-linked immunosorbent assay	Euro Diagnostica AB
2018-08-29	Z-2920-2018	Class III	is a quantitative/qualitative enzyme-linked immunosorbent assay	Euro Diagnostica AB
2018-08-29	Z-2921-2018	Class III	is a quantitative/qualitative enzyme-linked immunosorbent assay	Euro Diagnostica AB
2018-08-29	Z-2922-2018	Class III	is a qualitative indirect enzyme immunoassay enzyme-linked…	Euro Diagnostica AB
2018-08-22	Z-2589-2018	Class I	Arkon Anesthesia Delivery System with Arkon Software Version 2	Spacelabs Healthcare, Ltd.
2018-08-22	Z-2742-2018	Class II	1mL Medallion Syringes Are used to inject fluids into	Merit Medical Systems, Inc.
2018-08-22	Z-2743-2018	Class II	Apollo Lap-Band AP System Small with RapidPort EZ Product Usage: The…	Apollo Endosurgery Inc
2018-08-22	Z-2744-2018	Class II	AbViser AutoValve IAP	ConvaTec, Inc
2018-08-22	Z-2745-2018	Class II	G8 Automated HPLC Analyzer: HLC-723G8-ST	Tosoh Bioscience Inc
2018-08-22	Z-2746-2018	Class II	MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product…	Mevion Medical Systems, Inc.
2018-08-22	Z-2747-2018	Class II	Artis Q	Siemens Medical Solutions USA, Inc
2018-08-22	Z-2748-2018	Class II	ARTIS Pheno Model 10849000	Siemens Medical Solutions USA, Inc
2018-08-22	Z-2749-2018	Class III	EZ Single Cytofunnel Brown	Richard-Allan Scientific Company
2018-08-22	Z-2750-2018	Class II	CDI Blood parameter monitoring system 500 H/SAT	Terumo Cardiovascular Systems Corporation
2018-08-22	Z-2751-2018	Class II	Monitor with one Blood Parameter Module and one HSat Probe	Terumo Cardiovascular Systems Corporation
2018-08-22	Z-2786-2018	Class III	Clarity Urocheck 10SG Urinalysis Strips	Clarity Diagnostics Llc
2018-08-22	Z-2787-2018	Class II	TCube One Step Multi-Drug Oral Fluid Test Cube	Guangzhou Wondfo Biotech Co., Ltd.
2018-08-22	Z-2788-2018	Class II	TCube One Step Multi-Drug Oral Fluid Test Cube	Guangzhou Wondfo Biotech Co., Ltd.
2018-08-22	Z-2789-2018	Class II	TCube One Step Multi-Drug Oral Fluid Test Cube	Guangzhou Wondfo Biotech Co., Ltd.
2018-08-22	Z-2790-2018	Class II	Improve Blood Collection Sets with Multiple Sample Luer Adapter	Guangzhou Improve Medical Instruments Co., Ltd.
2018-08-22	Z-2791-2018	Class II	VentriClear Ventricular Drainage Catheter Set	Cook Inc.
2018-08-22	Z-2792-2018	Class II	MegaPower Electrosurgical Generator	Megadyne Medical Products, Inc.
2018-08-22	Z-2793-2018	Class II	NxStage Express Fluid Warmer	NxStage Medical, Inc.
2018-08-22	Z-2794-2018	Class II	Rio System Irrigation Clip	Mako Surgical Corporation
2018-08-22	Z-2795-2018	Class II	Hamilton-C1 Ventilator Unit Product Usage: The HAMILTON-C1 ventilator…	Hamilton Medical AG
2018-08-22	Z-2796-2018	Class II	Hamilton-C3 Ventilator Unit Product Usage: The HAMILTON-C3 ventilator…	Hamilton Medical AG
2018-08-22	Z-2797-2018	Class II	20 cm	ICU Medical de Mexico, S.A. de C.V.
2018-08-22	Z-2798-2018	Class II	165 cm	ICU Medical de Mexico, S.A. de C.V.
2018-08-22	Z-2799-2018	Class II	30 cm	ICU Medical de Mexico, S.A. de C.V.
2018-08-22	Z-2800-2018	Class II	DISTALE	ICU Medical de Mexico, S.A. de C.V.
2018-08-22	Z-2801-2018	Class II	216 cm	ICU Medical de Mexico, S.A. de C.V.
2018-08-22	Z-2802-2018	Class II	43 cm	ICU Medical de Mexico, S.A. de C.V.
2018-08-22	Z-2803-2018	Class II	18 cm	ICU Medical de Mexico, S.A. de C.V.
2018-08-22	Z-2804-2018	Class II	28 cm	ICU Medical de Mexico, S.A. de C.V.
2018-08-22	Z-2805-2018	Class II	PROXIMALE	ICU Medical de Mexico, S.A. de C.V.
2018-08-22	Z-2806-2018	Class II	Kit w/3 Ext Sets	ICU Medical de Mexico, S.A. de C.V.
2018-08-22	Z-2807-2018	Class II	191 cm	ICU Medical de Mexico, S.A. de C.V.
2018-08-22	Z-2808-2018	Class II	40 cm	ICU Medical de Mexico, S.A. de C.V.
2018-08-22	Z-2809-2018	Class II	PROXIMALE	ICU Medical de Mexico, S.A. de C.V.
2018-08-22	Z-2810-2018	Class II	38 cm	ICU Medical de Mexico, S.A. de C.V.
2018-08-22	Z-2811-2018	Class II	61 cm	ICU Medical de Mexico, S.A. de C.V.
2018-08-22	Z-2812-2018	Class II	10" Smallbore Ext Set w/6-Port NanoClave Manifold	ICU Medical de Mexico, S.A. de C.V.
2018-08-22	Z-2813-2018	Class II	10" Smallbore Ext Set w/6-Port NanoClave Manifold	ICU Medical de Mexico, S.A. de C.V.
2018-08-22	Z-2814-2018	Class II	11" Smallbore Ext Set w/NanoClave	ICU Medical de Mexico, S.A. de C.V.
2018-08-22	Z-2815-2018	Class II	10" Smallbore Ext Set w/6-Port NanoClave Manifold	ICU Medical de Mexico, S.A. de C.V.
2018-08-22	Z-2816-2018	Class II	6" Smallbore Ext Set w/6-Port NanoClave Manifold	ICU Medical de Mexico, S.A. de C.V.
2018-08-22	Z-2818-2018	Class II	HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for…	Arrow International Inc
2018-08-22	Z-2819-2018	Class II	HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for…	Arrow International Inc
2018-08-22	Z-2820-2018	Class II	ARCOS Modular Revision Hip System	Zimmer Biomet, Inc.
2018-08-22	Z-2821-2018	Class II	ECHO Bi-Metric Hip System	Zimmer Biomet, Inc.
2018-08-22	Z-2822-2018	Class II	NICO Shepherd' s Hook	Nico Corp.
2018-08-22	Z-2823-2018	Class II	Flex-Neck Classic Peritoneal Dialysis Catheter	Merit Medical Systems, Inc.
2018-08-22	Z-2824-2018	Class II	Sorin Platinium CRT-D 1711 DF-1	Sorin CRM SAS
2018-08-22	Z-2825-2018	Class II	Sorin Platinium CRT-D 1741 DF-4	Sorin CRM SAS
2018-08-22	Z-2827-2018	Class III	Tosoh Bioscience AIA Analyte Application Manual	Tosoh Bioscience Inc
2018-08-22	Z-2828-2018	Class II	Powder Free Vinyl Exam Gloves	Cypress Medical Products LLC
2018-08-22	Z-2829-2018	Class II	Nokia BPM+ Wireless Blood Pressure Monitor Product System	Withings Sas
2018-08-22	Z-2830-2018	Class II	O-SPOT REF 791	Beekley Corporation
2018-08-22	Z-2831-2018	Class II	S-SPOT REF 777	Beekley Corporation
2018-08-22	Z-2832-2018	Class II	TomoSPOT REF 782	Beekley Corporation
2018-08-22	Z-2835-2018	Class II	The da Vinci Xi Surgical System	Intuitive Surgical, Inc.
2018-08-22	Z-2836-2018	Class II	Salivary Estradiol ELISA	DRG Instruments GmbH
2018-08-15	Z-2552-2018	Class I	AirLife Resuscitation Device	Vyaire Medical
2018-08-15	Z-2553-2018	Class I	AirLife Resuscitation Device	Vyaire Medical
2018-08-15	Z-2577-2018	Class I	AmniSure ROM Test under the following labels: 1) Catalog Number…	Qiagen Sciences, Inc.
2018-08-15	Z-2603-2018	Class II	Medtronic CD HORIZON Spinal System is intended to help provide…	Medtronic Sofamor Danek USA Inc
2018-08-15	Z-2604-2018	Class II	Modera Modular Pedicle Screw System Shank Insertion Instrument	New Era Orthopaedics, LLc
2018-08-15	Z-2605-2018	Class II	Think Surgical Cutter	Think Surgical, Inc.
2018-08-15	Z-2606-2018	Class II	119" Blood Set w/200 Micron Filter	ICU Medical, Inc.
2018-08-15	Z-2607-2018	Class II	185 cm	ICU Medical, Inc.
2018-08-15	Z-2608-2018	Class II	108" 20 Drop Blood Set w/200 Micron Filter	ICU Medical, Inc.
2018-08-15	Z-2609-2018	Class II	168 cm	ICU Medical, Inc.
2018-08-15	Z-2610-2018	Class II	32"	ICU Medical, Inc.
2018-08-15	Z-2611-2018	Class II	32"	ICU Medical, Inc.
2018-08-15	Z-2612-2018	Class II	218 cm	ICU Medical, Inc.
2018-08-15	Z-2613-2018	Class II	Lopez Valve¿ w/Red Cap	ICU Medical, Inc.
2018-08-15	Z-2614-2018	Class II	Lopez Valve¿	ICU Medical, Inc.
2018-08-15	Z-2615-2018	Class II	112" Y-Type Blood Set w/170 Micron Filter	ICU Medical, Inc.
2018-08-15	Z-2616-2018	Class II	137"	ICU Medical, Inc.
2018-08-15	Z-2617-2018	Class II	94"	ICU Medical, Inc.
2018-08-15	Z-2618-2018	Class II	88"	ICU Medical, Inc.
2018-08-15	Z-2619-2018	Class II	147"	ICU Medical, Inc.
2018-08-15	Z-2620-2018	Class II	135"	ICU Medical, Inc.
2018-08-15	Z-2621-2018	Class II	140"	ICU Medical, Inc.
2018-08-15	Z-2622-2018	Class II	84" Y-Type Blood Set w/170 Micron Filter	ICU Medical, Inc.
2018-08-15	Z-2623-2018	Class II	84"	ICU Medical, Inc.
2018-08-15	Z-2624-2018	Class II	85"	ICU Medical, Inc.
2018-08-15	Z-2625-2018	Class II	99"	ICU Medical, Inc.
2018-08-15	Z-2626-2018	Class II	99"	ICU Medical, Inc.
2018-08-15	Z-2627-2018	Class II	120"	ICU Medical, Inc.
2018-08-15	Z-2628-2018	Class II	121"	ICU Medical, Inc.
2018-08-15	Z-2629-2018	Class II	132"	ICU Medical, Inc.
2018-08-15	Z-2630-2018	Class II	175"	ICU Medical, Inc.
2018-08-15	Z-2631-2018	Class II	140"	ICU Medical, Inc.
2018-08-15	Z-2632-2018	Class II	100"	ICU Medical, Inc.
2018-08-15	Z-2633-2018	Class II	125"	ICU Medical, Inc.
2018-08-15	Z-2634-2018	Class II	164"	ICU Medical, Inc.
2018-08-15	Z-2635-2018	Class II	105"	ICU Medical, Inc.
2018-08-15	Z-2636-2018	Class II	94"	ICU Medical, Inc.
2018-08-15	Z-2637-2018	Class II	80"	ICU Medical, Inc.
2018-08-15	Z-2638-2018	Class II	162" Y-Type Blood Set w/170 Micron Filter	ICU Medical, Inc.
2018-08-15	Z-2639-2018	Class II	128"	ICU Medical, Inc.
2018-08-15	Z-2640-2018	Class II	112"	ICU Medical, Inc.
2018-08-15	Z-2641-2018	Class II	88"	ICU Medical, Inc.
2018-08-15	Z-2642-2018	Class II	100"	ICU Medical, Inc.
2018-08-15	Z-2643-2018	Class II	99"	ICU Medical, Inc.
2018-08-15	Z-2644-2018	Class II	99"	ICU Medical, Inc.
2018-08-15	Z-2645-2018	Class II	98"	ICU Medical, Inc.
2018-08-15	Z-2646-2018	Class II	132"	ICU Medical, Inc.
2018-08-15	Z-2647-2018	Class II	134"	ICU Medical, Inc.
2018-08-15	Z-2648-2018	Class II	143"	ICU Medical, Inc.
2018-08-15	Z-2649-2018	Class II	159"	ICU Medical, Inc.
2018-08-15	Z-2650-2018	Class II	115"	ICU Medical, Inc.
2018-08-15	Z-2651-2018	Class II	139"	ICU Medical, Inc.
2018-08-15	Z-2652-2018	Class II	125"	ICU Medical, Inc.
2018-08-15	Z-2653-2018	Class II	98"	ICU Medical, Inc.
2018-08-15	Z-2654-2018	Class II	126"	ICU Medical, Inc.
2018-08-15	Z-2655-2018	Class II	107"	ICU Medical, Inc.
2018-08-15	Z-2656-2018	Class II	117"	ICU Medical, Inc.
2018-08-15	Z-2657-2018	Class II	116"	ICU Medical, Inc.
2018-08-15	Z-2658-2018	Class II	120"	ICU Medical, Inc.
2018-08-15	Z-2659-2018	Class II	Leica M530 OHX Microscope System Supplied with 100	Leica Microsystems, Inc.
2018-08-15	Z-2660-2018	Class II	Quick Connect 272 KG Scale used with Maxi Sky 2 ceiling lift The…	Arjohuntleigh Magog
2018-08-15	Z-2661-2018	Class II	Q-Connect 272 KG Scale used with Maxi Sky 2 ceiling lift The Scale is…	Arjohuntleigh Magog
2018-08-15	Z-2662-2018	Class II	Medfusion Syringe Infusion Pump	Smiths Medical ASD Inc.
2018-08-15	Z-2663-2018	Class II	Lateral Assembly	Howmedica Osteonics Corp.
2018-08-15	Z-2664-2018	Class II	Lateral Assembly	Howmedica Osteonics Corp.
2018-08-15	Z-2665-2018	Class II	Lateral Assembly	Howmedica Osteonics Corp.
2018-08-15	Z-2666-2018	Class II	Lateral Assembly	Howmedica Osteonics Corp.
2018-08-15	Z-2667-2018	Class II	Lat Assembly	Howmedica Osteonics Corp.
2018-08-15	Z-2668-2018	Class II	Lat Assembly	Howmedica Osteonics Corp.
2018-08-15	Z-2669-2018	Class II	Lat Assembly	Howmedica Osteonics Corp.
2018-08-15	Z-2670-2018	Class II	Lat Assembly	Howmedica Osteonics Corp.
2018-08-15	Z-2671-2018	Class II	Lateral Assembly	Howmedica Osteonics Corp.
2018-08-15	Z-2672-2018	Class II	Lateral Assembly	Howmedica Osteonics Corp.
2018-08-15	Z-2673-2018	Class II	Lateral Assembly	Howmedica Osteonics Corp.
2018-08-15	Z-2674-2018	Class II	Lateral Assembly	Howmedica Osteonics Corp.
2018-08-15	Z-2675-2018	Class II	Lateral Assembly	Howmedica Osteonics Corp.

← Newer · Older →