Medical device recalls reported in 2019

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Reported	Recall	Class	Product	Firm
2019-04-03	Z-1051-2019	Class II	BD Synapsys Laboratory Solutions Catalog Number:444150 Product Usage:…	Becton Dickinson & Co.
2019-04-03	Z-1052-2019	Class II	MultiDiagnost-Eleva	Philips North America, LLC
2019-04-03	Z-1053-2019	Class II	Urodiagnost	Philips North America, LLC
2019-04-03	Z-1054-2019	Class II	Omnidiagnost Classic	Philips North America, LLC
2019-04-03	Z-1055-2019	Class II	MultiDiagnost Eleva w/ Flat Detector	Philips North America, LLC
2019-04-03	Z-1056-2019	Class II	URODiagnost Eleva	Philips North America, LLC
2019-04-03	Z-1057-2019	Class II	Randox Blood Gas Control Level 2 -Model BG5002	Randox Laboratories Ltd.
2019-04-03	Z-1058-2019	Class II	Sunset Compressor Nebulizer	SANRAI INTERNATIONAL LLC
2019-04-03	Z-1059-2019	Class II	Vacuum Unit for CATSmart Vacuum Pump	Fenwal Inc
2019-04-03	Z-1060-2019	Class III	Integrated ECG cable with 3-lead leadwires labeled as the following: 1	GE Healthcare, LLC
2019-04-03	Z-1061-2019	Class II	Paltop Premium Surgical Kit-containing the 1	Keystone Dental Inc
2019-04-03	Z-1062-2019	Class II	Paltop Fully Guided Surgical Kit- containing the 1	Keystone Dental Inc
2019-04-03	Z-1063-2019	Class II	Paltop 1	Keystone Dental Inc
2019-04-03	Z-1064-2019	Class II	Paltop 1	Keystone Dental Inc
2019-04-03	Z-1065-2019	Class II	Accelerate Pheno system	Accelerate Diagnostics Inc
2019-04-03	Z-1066-2019	Class II	BVI Visitec Soft Tip Cannula	Beaver Visitec
2019-04-03	Z-1067-2019	Class II	Lithium-ion Rechargeable Batteries for the Philips MX40 Wearable…	Philips North America, LLC
2019-04-03	Z-1068-2019	Class II	Laparotomy Sponge with the following product description and model…	Medical Action Industries Inc
2019-04-03	Z-1069-2019	Class III	Medtronic Pulmonary Vein Ablation Catheter	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
2019-04-03	Z-1070-2019	Class II	ICU Medical	ICU Medical, Inc.
2019-04-03	Z-1071-2019	Class II	ICU Medical	ICU Medical, Inc.
2019-04-03	Z-1072-2019	Class II	ICU Medical	ICU Medical, Inc.
2019-04-03	Z-1073-2019	Class II	On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The…	CryoLife, Inc.
2019-03-27	Z-1014-2019	Class II	Dimension Vista 500	Siemens Healthcare Diagnostics, Inc.
2019-03-27	Z-1015-2019	Class II	Dimension Vista 1500	Siemens Healthcare Diagnostics, Inc.
2019-03-27	Z-1016-2019	Class II	Fructosamine Calibrator	Randox Laboratories Ltd.
2019-03-27	Z-1017-2019	Class II	Fructosamine Control 1	Randox Laboratories Ltd.
2019-03-27	Z-1018-2019	Class II	Fructosamine Control 3	Randox Laboratories Ltd.
2019-03-27	Z-1019-2019	Class II	aap Implante AG	AAP Implantate Ag
2019-03-27	Z-1020-2019	Class II	Covidien Force TriVerse electrosurgical device 10 cord-Intended as…	Covidien, PLC
2019-03-27	Z-1021-2019	Class III	Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach	Cook Medical Incorporated
2019-03-27	Z-1022-2019	Class III	Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach	Cook Medical Incorporated
2019-03-27	Z-1023-2019	Class III	Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein…	Cook Medical Incorporated
2019-03-27	Z-1024-2019	Class III	Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach	Cook Medical Incorporated
2019-03-27	Z-1025-2019	Class III	Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach	Cook Medical Incorporated
2019-03-27	Z-1026-2019	Class III	Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular…	Cook Medical Incorporated
2019-03-27	Z-1027-2019	Class II	Plain and Chromic Gut Absorbable Surgical Sutures	CP Medical Inc
2019-03-27	Z-1028-2019	Class II	smith&nephew SMF	Smith & Nephew, Inc.
2019-03-27	Z-1029-2019	Class II	smith&nephew SMF	Smith & Nephew, Inc.
2019-03-27	Z-1030-2019	Class II	CTL Medical Hex Driver	CTL Medical Corporation
2019-03-27	Z-1031-2019	Class II	CTL Medical Hex Driver MIS	CTL Medical Corporation
2019-03-27	Z-1032-2019	Class II	Gentrix Surgical Matrix Thick	ACell, Inc
2019-03-27	Z-1033-2019	Class II	Gentrix Surgical Matrix Thick	ACell, Inc
2019-03-27	Z-1034-2019	Class III	PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8	Agfa N.V.
2019-03-27	Z-1035-2019	Class II	Forceps Blue	ConvaTec, Inc
2019-03-27	Z-1036-2019	Class II	Feeding Tube Metric	ConvaTec, Inc
2019-03-27	Z-1037-2019	Class II	Nelaton Urinary Catheter	ConvaTec, Inc
2019-03-27	Z-1038-2019	Class II	FilterFlow Suction Handle CH24	ConvaTec, Inc
2019-03-27	Z-1039-2019	Class II	SHIMADZU MobileDaRt Evolution	Shimadzu Medical Systems Usa Com
2019-03-27	Z-1040-2019	Class II	Fujifilm FDR Go PLUS	Fujifilm Medical Systems U.S.A., Inc.
2019-03-20	Z-0979-2019	Class I	Cook Transseptal Needle	Cook Inc.
2019-03-20	Z-0991-2019	Class II	AVE 2 Birthing Bed	Linet Spol. S.r.o.
2019-03-20	Z-0992-2019	Class II	VITROS Chemistry Products Na+ Slides	Ortho-Clinical Diagnostics
2019-03-20	Z-0993-2019	Class II	Durex Real Feel	Reckitt Benckiser LLC
2019-03-20	Z-0994-2019	Class II	Durex Pleasure Pack	Reckitt Benckiser LLC
2019-03-20	Z-0995-2019	Class II	AMSCO 3000 Series Washer/Disinfector Model # 3052	Steris Corporation
2019-03-20	Z-0996-2019	Class II	AMSCO 5000 Series Washer/Disinfector Model # 5052	Steris Corporation
2019-03-20	Z-0997-2019	Class II	Ossur Skull Pin	Ossur Americas
2019-03-20	Z-0998-2019	Class II	Ossur Skull Pin	Ossur Americas
2019-03-20	Z-0999-2019	Class II	Ossur OB Resolve	Ossur Americas
2019-03-20	Z-1000-2019	Class II	Ossur CB Resolve	Ossur Americas
2019-03-20	Z-1001-2019	Class II	Ossur	Ossur Americas
2019-03-20	Z-1002-2019	Class II	Ossur	Ossur Americas
2019-03-20	Z-1003-2019	Class II	Ossur	Ossur Americas
2019-03-20	Z-1004-2019	Class II	Ossur	Ossur Americas
2019-03-20	Z-1005-2019	Class II	NexGenTrabecular Metal Tibial Half Block Augment	Zimmer Trabecular Metal Technology, Inc.
2019-03-20	Z-1006-2019	Class II	NexGenTrabecular Metal Tibial Half Block Augment	Zimmer Trabecular Metal Technology, Inc.
2019-03-20	Z-1007-2019	Class II	Olympus GF-UCT180 Ultrasound Gastrovideoscope	Olympus Corporation of the Americas
2019-03-20	Z-1008-2019	Class II	Olympus GIF-H180J Gastrointestinal Videoscope	Olympus Corporation of the Americas
2019-03-20	Z-1009-2019	Class II	Olympus PCF-Q180AC Video Colonoscope	Olympus Corporation of the Americas
2019-03-20	Z-1010-2019	Class II	Olympus TJF-Q180V Duodenoscope	Olympus Corporation of the Americas
2019-03-20	Z-1011-2019	Class II	US Endoscopy Padlock Clip defect closure system Ref: C910001 The…	US Endoscopy Group Inc
2019-03-20	Z-1012-2019	Class II	Flexima Duodenal Bend Biliary Stent with Delivery System	Boston Scientific Corporation
2019-03-20	Z-1013-2019	Class II	Flexima Duodenal Bend Biliary Stent with Delivery System	Boston Scientific Corporation
2019-03-13	Z-0865-2019	Class I	Raindrop Near Vision Inlay	RVO 2.0, INC
2019-03-13	Z-0970-2019	Class II	C2 CryoBalloon Controller	PENTAX of America Inc
2019-03-13	Z-0971-2019	Class II	ARCHITECT MAGNESIUM	Abbott Laboratories, Inc
2019-03-13	Z-0972-2019	Class II	Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with…	Zimmer Biomet, Inc.
2019-03-13	Z-0973-2019	Class II	Stryker Sustainability Solutions	Stryker Sustainability Solutions
2019-03-13	Z-0974-2019	Class II	Infinity Delta Family patient monitors The Infinity Delta Series	Draegar Medical Systems, Inc.
2019-03-13	Z-0975-2019	Class II	Omega Systems These devices are intended to be used in the…	Draegar Medical Systems, Inc.
2019-03-13	Z-0980-2019	Class II	Instrument Tray	Stryker GmbH
2019-03-13	Z-0981-2019	Class II	BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use with the…	Becton Dickinson & Co.
2019-03-13	Z-0982-2019	Class II	Cepheid Respiratory Control Panel Catalog #8199 for in vitro…	Microbiologics Inc
2019-03-13	Z-0983-2019	Class II	AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower…	Maquet Cardiovascular, LLC
2019-03-13	Z-0984-2019	Class II	Uroskop Omnia -fluoroscopic X-ray system Model # 10094910 The Uroskop…	Siemens Medical Solutions USA, Inc
2019-03-13	Z-0985-2019	Class II	Uroskop Omnia Max -fluoroscopic X-ray system Model # 10762473 Uroskop…	Siemens Medical Solutions USA, Inc
2019-03-13	Z-0987-2019	Class II	Maquet XS Flat Screen Monitor Holder	GETINGE US SALES LLC
2019-03-13	Z-0988-2019	Class II	Maquet XS Flat Screen Monitor Holder	GETINGE US SALES LLC
2019-03-13	Z-0989-2019	Class II	Maquet XS Flat Screen Monitor Holder	GETINGE US SALES LLC
2019-03-13	Z-0990-2019	Class II	Maquet XS Flat Screen Monitor Holder	GETINGE US SALES LLC
2019-03-06	Z-0805-2019	Class I	icumedical ChemoLock Vial Spike	ICU Medical, Inc.
2019-03-06	Z-0862-2019	Class I	LIFEPAK 15 Monitor/Defibrillator Product Usage: The LIFEPAK	Physio-Control Inc
2019-03-06	Z-0863-2019	Class I	LIFEPAK 15 Monitor/Defibrillator service kits Product Usage: The…	Physio-Control Inc
2019-03-06	Z-0866-2019	Class II	Vitality¿ Spinal Fixation System	Zimmer Biomet Spine Inc.
2019-03-06	Z-0867-2019	Class II	Vitality¿ Spinal Fixation System	Zimmer Biomet Spine Inc.
2019-03-06	Z-0868-2019	Class II	Vitality¿ Spinal Fixation System	Zimmer Biomet Spine Inc.
2019-03-06	Z-0869-2019	Class II	Prodiva CS	Philips Medical Systems Nederlands
2019-03-06	Z-0870-2019	Class II	Prodiva CX	Philips Medical Systems Nederlands
2019-03-06	Z-0871-2019	Class II	Multiva 1	Philips Medical Systems Nederlands
2019-03-06	Z-0872-2019	Class II	Multiva 1	Philips Medical Systems Nederlands
2019-03-06	Z-0873-2019	Class II	Multiva 1	Philips Medical Systems Nederlands
2019-03-06	Z-0874-2019	Class II	Intera 0	Philips Medical Systems Nederlands
2019-03-06	Z-0875-2019	Class II	Intera 1	Philips Medical Systems Nederlands
2019-03-06	Z-0876-2019	Class II	Intera 1	Philips Medical Systems Nederlands
2019-03-06	Z-0877-2019	Class II	Intera 1	Philips Medical Systems Nederlands
2019-03-06	Z-0878-2019	Class II	Intera 1	Philips Medical Systems Nederlands
2019-03-06	Z-0879-2019	Class II	Intera 1	Philips Medical Systems Nederlands
2019-03-06	Z-0880-2019	Class II	Intera 1	Philips Medical Systems Nederlands
2019-03-06	Z-0881-2019	Class II	Intera 1	Philips Medical Systems Nederlands
2019-03-06	Z-0882-2019	Class II	Enterprise 1	Philips Medical Systems Nederlands
2019-03-06	Z-0883-2019	Class II	Intera 3	Philips Medical Systems Nederlands
2019-03-06	Z-0884-2019	Class II	Achieva XR 1	Philips Medical Systems Nederlands
2019-03-06	Z-0885-2019	Class II	Intera IT	Philips Medical Systems Nederlands
2019-03-06	Z-0886-2019	Class II	Intera 1	Philips Medical Systems Nederlands
2019-03-06	Z-0887-2019	Class II	Intera Achieva 1	Philips Medical Systems Nederlands
2019-03-06	Z-0888-2019	Class II	Intera Achieva 1	Philips Medical Systems Nederlands
2019-03-06	Z-0889-2019	Class II	Intera Achieva 1	Philips Medical Systems Nederlands
2019-03-06	Z-0890-2019	Class II	Intera 1	Philips Medical Systems Nederlands
2019-03-06	Z-0891-2019	Class II	Intera Achieva 1	Philips Medical Systems Nederlands
2019-03-06	Z-0892-2019	Class II	Intera Achieva 1	Philips Medical Systems Nederlands
2019-03-06	Z-0893-2019	Class II	Achieva 3	Philips Medical Systems Nederlands
2019-03-06	Z-0894-2019	Class II	Achieva 1	Philips Medical Systems Nederlands
2019-03-06	Z-0895-2019	Class II	Intera 1	Philips Medical Systems Nederlands
2019-03-06	Z-0896-2019	Class II	Achieva 1	Philips Medical Systems Nederlands
2019-03-06	Z-0897-2019	Class II	Achieva 7	Philips Medical Systems Nederlands
2019-03-06	Z-0898-2019	Class II	Panorama 1	Philips Medical Systems Nederlands
2019-03-06	Z-0899-2019	Class II	Achieva XR 1	Philips Medical Systems Nederlands
2019-03-06	Z-0900-2019	Class II	SmartPath to dStream for 1	Philips Medical Systems Nederlands
2019-03-06	Z-0901-2019	Class II	Ingenia 1	Philips Medical Systems Nederlands
2019-03-06	Z-0902-2019	Class II	Ingenia 1	Philips Medical Systems Nederlands
2019-03-06	Z-0903-2019	Class II	SmartPath to dStream for XR and 3	Philips Medical Systems Nederlands
2019-03-06	Z-0904-2019	Class II	Ingenia 3	Philips Medical Systems Nederlands
2019-03-06	Z-0905-2019	Class II	Achieva 3	Philips Medical Systems Nederlands
2019-03-06	Z-0906-2019	Class II	Achieva 3	Philips Medical Systems Nederlands
2019-03-06	Z-0907-2019	Class II	Achieva 1	Philips Medical Systems Nederlands
2019-03-06	Z-0908-2019	Class II	Intera 1	Philips Medical Systems Nederlands
2019-03-06	Z-0909-2019	Class II	Achieva 1	Philips Medical Systems Nederlands
2019-03-06	Z-0910-2019	Class II	Ingenia 1	Philips Medical Systems Nederlands
2019-03-06	Z-0911-2019	Class II	Ingenia 3	Philips Medical Systems Nederlands
2019-03-06	Z-0912-2019	Class II	Achieva 1	Philips Medical Systems Nederlands
2019-03-06	Z-0913-2019	Class II	Achieva 3	Philips Medical Systems Nederlands
2019-03-06	Z-0914-2019	Class II	Achieva 3	Philips Medical Systems Nederlands
2019-03-06	Z-0915-2019	Class II	Achieva 1	Philips Medical Systems Nederlands
2019-03-06	Z-0916-2019	Class II	Ingenia 1	Philips Medical Systems Nederlands
2019-03-06	Z-0917-2019	Class II	Panorama 1	Philips Medical Systems Nederlands
2019-03-06	Z-0918-2019	Class II	Ingenia 3	Philips Medical Systems Nederlands
2019-03-06	Z-0919-2019	Class II	Ingenia 1	Philips Medical Systems Nederlands
2019-03-06	Z-0920-2019	Class II	Ingenia Ambition S	Philips Medical Systems Nederlands
2019-03-06	Z-0921-2019	Class II	Ingenia Ambition X	Philips Medical Systems Nederlands
2019-03-06	Z-0922-2019	Class II	Ingenia Elition S	Philips Medical Systems Nederlands
2019-03-06	Z-0923-2019	Class II	Ingenia Elition X	Philips Medical Systems Nederlands
2019-03-06	Z-0924-2019	Class II	MR-OR 1	Philips Medical Systems Nederlands
2019-03-06	Z-0925-2019	Class II	MR-OR 3	Philips Medical Systems Nederlands
2019-03-06	Z-0926-2019	Class II	MR RT	Philips Medical Systems Nederlands
2019-03-06	Z-0927-2019	Class II	Achieva 3	Philips Medical Systems Nederlands
2019-03-06	Z-0928-2019	Class II	Achieva 3	Philips Medical Systems Nederlands
2019-03-06	Z-0929-2019	Class II	NZM101 Ingenia 1	Philips Medical Systems Nederlands
2019-03-06	Z-0930-2019	Class II	MARLIN 1	Philips Medical Systems Nederlands
2019-03-06	Z-0931-2019	Class II	Multiva 1	Philips Medical Systems Nederlands
2019-03-06	Z-0932-2019	Class II	Multiva 1	Philips Medical Systems Nederlands
2019-03-06	Z-0933-2019	Class II	Phoenix AST-s Indicator	Becton Dickinson & Co.
2019-03-06	Z-0934-2019	Class II	Phoenix AST Indicator	Becton Dickinson & Co.
2019-03-06	Z-0935-2019	Class II	Phoenix AP AST Indicator Bag	Becton Dickinson & Co.
2019-03-06	Z-0936-2019	Class II	Sensis Vibe System	Siemens Medical Solutions USA, Inc
2019-03-06	Z-0937-2019	Class II	Vanguard Knee System Series-A Standard Patella sizes 31mm Item…	Zimmer Biomet, Inc.
2019-03-06	Z-0938-2019	Class II	Vanguard Knee System Series-A Standard Patella sizes 34mm Item…	Zimmer Biomet, Inc.
2019-03-06	Z-0939-2019	Class II	The WinStation Retinal Imager	Merge Healthcare, Inc.
2019-03-06	Z-0940-2019	Class II	AF w/AS 550 x 1-14ML/HR CPNB	Arrow International Inc
2019-03-06	Z-0941-2019	Class II	AF w/AS 550x 0	Arrow International Inc
2019-03-06	Z-0942-2019	Class II	AF550x5ML/H 2ML 60LO 6" CATH	Arrow International Inc
2019-03-06	Z-0943-2019	Class II	AF550x5ML/H 2ML 60LO 6" DUAL CATHS	Arrow International Inc
2019-03-06	Z-0944-2019	Class II	0F 550 x 8ML/HR 2ML 60LO CPNB	Arrow International Inc
2019-03-06	Z-0945-2019	Class II	AF 550 x 5ML/H 6" CATH	Arrow International Inc
2019-03-06	Z-0946-2019	Class II	AF 550 x 5ML/H 6" DUAL CATHS	Arrow International Inc
2019-03-06	Z-0947-2019	Class II	AF 550 x 5ML/H FH DL 30hole SAT C	Arrow International Inc
2019-03-06	Z-0948-2019	Class II	AF 550 x 5ML/HR 2ML 60LO CPNB	Arrow International Inc
2019-03-06	Z-0949-2019	Class II	AF 550 x 5ML/HR CPNB	Arrow International Inc
2019-03-06	Z-0950-2019	Class II	AF 550 x 8ML/HR 2ML 15LO CPNBMT8015XL CP	Arrow International Inc
2019-03-06	Z-0951-2019	Class II	AF 550x8ML/H 2ML 15LO 8	Arrow International Inc
2019-03-06	Z-0952-2019	Class II	AF w/AS 550 x 0	Arrow International Inc
2019-03-06	Z-0953-2019	Class II	AF w/AS 550 x 1-14 ml/hr	Arrow International Inc
2019-03-06	Z-0954-2019	Class II	AF w/AS 550 x 1-14ML/HR 2ML-15LO CPNB	Arrow International Inc
2019-03-06	Z-0955-2019	Class II	AF w/AS 550 x 1-14ML/HR 2ML-30LO CPNB	Arrow International Inc
2019-03-06	Z-0956-2019	Class II	AF w/AS 550 x 1-14ML/HR 5ML-60LO CPNB	Arrow International Inc
2019-03-06	Z-0957-2019	Class II	Curity All Purpose Sponges	Cardinal Health 200, LLC
2019-03-06	Z-0958-2019	Class II	Equinoxe Preserve Humeral Stem	Exactech, Inc.
2019-03-06	Z-0959-2019	Class II	BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system…	Shimadzu Medical Systems Usa Com
2019-03-06	Z-0960-2019	Class II	PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for…	Abbott Vascular
2019-03-06	Z-0961-2019	Class II	Alcon or Endure Ophthalmic Microscope Product Usage: Used for low…	Alcon Research Laboratories Ltd.
2019-03-06	Z-0962-2019	Class II	Vitek 2 reagent cards: a) GN ID	Organon Teknika Inc
2019-03-06	Z-0963-2019	Class II	Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation…	BrosMed Medical Co.,Ltd.
2019-03-06	Z-0964-2019	Class II	Bag size #4 Custom Convenience Kits Usage: Surgical convenience kits…	American Contract Systems, Inc.
2019-03-06	Z-0965-2019	Class II	Monaco Radiation Treatment Planning	Elekta, Inc.
2019-03-06	Z-0966-2019	Class II	Cardiovascular Procedure Kit	Terumo Cardiovascular Systems Corporation
2019-03-06	Z-0967-2019	Class II	Entuit Secure Gastrointestinal Suture Anchor Set	Cook Inc.
2019-03-06	Z-0968-2019	Class II	Entuit Secure Gastrointestinal Suture Anchor Set	Cook Inc.
2019-03-06	Z-0969-2019	Class II	Draco Enzymatic Deep-Cleaning Pads	Madison Polymeric Engineering
2019-02-27	Z-0838-2019	Class II	PROVEO 8 Ophthalmic Microscope System optical instrument for…	Leica Microsystems, Inc.
2019-02-27	Z-0839-2019	Class II	Randox CALCIUM	Randox Laboratories Ltd.

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