Medical device recalls reported in 2017

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Reported	Recall	Class	Product	Firm
2017-05-31	Z-2161-2017	Class II	CORFLO	CORPAK MedSystems, Inc.
2017-05-31	Z-2162-2017	Class II	CORFLO	CORPAK MedSystems, Inc.
2017-05-31	Z-2163-2017	Class II	CORFLO PEG Kit	CORPAK MedSystems, Inc.
2017-05-31	Z-2164-2017	Class II	SENSATION PLUS¿ 8Fr	Datascope Corporation
2017-05-24	Z-1893-2017	Class II	Ziehm Imaging solo FD Mobile Fluoroscopic C-arm	Ziehm Imaging Inc
2017-05-24	Z-1898-2017	Class I	Wingman 35 Crossing Catheter	ReFlow Medical
2017-05-24	Z-1925-2017	Class I	Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number:…	Magellan Diagnostics, Inc.
2017-05-24	Z-1926-2017	Class I	Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number:…	Magellan Diagnostics, Inc.
2017-05-24	Z-2037-2017	Class I	NC Trek RX Coronary Dilatation Catheter	Abbott Vascular
2017-05-24	Z-2038-2017	Class I	NC Traveler RX Coronary Dilatation Catheter	Abbott Vascular
2017-05-24	Z-2039-2017	Class I	NC Tenku RX PTCA Balloon Catheter	Abbott Vascular
2017-05-24	Z-2061-2017	Class I	Philips V60 Ventilators	Respironics California Inc
2017-05-24	Z-2072-2017	Class II	GIZA Vertebral Body Replacement	Eden Spine Europe SA
2017-05-24	Z-2073-2017	Class II	Biomet Microfixation TraumaOne System Surgical Tray	Biomet Microfixation, LLC
2017-05-24	Z-2074-2017	Class II	Access BR Monitor	Beckman Coulter Inc.
2017-05-24	Z-2075-2017	Class III	Navitrack¿ System	Orthosoft, Inc. dba Zimmer CAS
2017-05-24	Z-2076-2017	Class II	Navitrack System	Orthosoft, Inc. dba Zimmer CAS
2017-05-24	Z-2077-2017	Class II	enGen	Ortho-Clinical Diagnostics
2017-05-24	Z-2078-2017	Class II	Lactate Reagent	Beckman Coulter Inc.
2017-05-24	Z-2079-2017	Class II	Uric Acid Reagent	Beckman Coulter Inc.
2017-05-24	Z-2080-2017	Class II	Enzymatic Creatinine Reagent	Beckman Coulter Inc.
2017-05-24	Z-2081-2017	Class II	Cholesterol Reagent	Beckman Coulter Inc.
2017-05-24	Z-2082-2017	Class II	HDL Cholesterol Reagent	Beckman Coulter Inc.
2017-05-24	Z-2083-2017	Class II	Triglycerides Reagent	Beckman Coulter Inc.
2017-05-24	Z-2084-2017	Class II	Salicylate Reagent	Beckman Coulter Inc.
2017-05-24	Z-2085-2017	Class II	ADVIA Centaur Systems Insulin Calibrator	Siemens Healthcare Diagnostics, Inc
2017-05-24	Z-2086-2017	Class II	ADVIA Centaur Systems Insulin ReadyPack	Siemens Healthcare Diagnostics, Inc
2017-05-24	Z-2087-2017	Class II	GP161R	Aesculap Implant Systems LLC
2017-05-24	Z-2088-2017	Class II	GP321R	Aesculap Implant Systems LLC
2017-05-24	Z-2089-2017	Class II	GE426R	Aesculap Implant Systems LLC
2017-05-24	Z-2090-2017	Class II	Arietta 70 Ultrasound System Intended for use by trained personnel	Hitachi Medical Systems America Inc
2017-05-24	Z-2091-2017	Class II	VORTRAN Automatic Resuscitator	Vortran Medical Technology 1, Inc
2017-05-24	Z-2092-2017	Class II	VORTRAN Automatic Resuscitator	Vortran Medical Technology 1, Inc
2017-05-24	Z-2093-2017	Class II	Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for…	Del Mar Reynolds Medical, Ltd.
2017-05-24	Z-2094-2017	Class II	ARIES System and ARIES M1 System	Luminex Corporation
2017-05-24	Z-2095-2017	Class II	ETEST ETP32	BioMerieux SA
2017-05-24	Z-2096-2017	Class II	AMO 25GA Vitrectomy Cutter	Abbott Medical Optics Inc. (AMO)
2017-05-24	Z-2097-2017	Class II	Proton therapy system -Proteus 235 aka Proteus Plus	Ion Beam Applications S.A.
2017-05-24	Z-2098-2017	Class II	SoftPort Easy-Load Lens Delivery System Model: EZ-28V Is used for the…	Bausch & Lomb Surgical, Inc.
2017-05-24	Z-2100-2017	Class II	Mobius3D Product Usage: Mobius3D software is used for quality…	Mobius Medical Systems, LP
2017-05-24	Z-2101-2017	Class II	White OR Towels	Medical Action Industries Inc
2017-05-24	Z-2102-2017	Class II	Blue OR Towels	Medical Action Industries Inc
2017-05-24	Z-2103-2017	Class II	16 mm Distraction Pin	MEDLINE INDUSTRIES INC
2017-05-24	Z-2104-2017	Class II	16 mm [or 18 mm] Distraction Pin	MEDLINE INDUSTRIES INC
2017-05-24	Z-2105-2017	Class II	10 mm Distraction Pin	MEDLINE INDUSTRIES INC
2017-05-24	Z-2106-2017	Class II	14 mm Distraction Pin	MEDLINE INDUSTRIES INC
2017-05-24	Z-2107-2017	Class II	12 mm Distraction Pin	MEDLINE INDUSTRIES INC
2017-05-24	Z-2108-2017	Class II	WECK Visistat 35R Disposable Skin Stapler	Teleflex Medical
2017-05-24	Z-2110-2017	Class II	Brennen Skin Graft Mesher	Molnlycke Health Care, Inc
2017-05-24	Z-2111-2017	Class II	Normed General Instruments 503004541: Werber Countersink Cannulated…	Zimmer Gmbh
2017-05-24	Z-2112-2017	Class II	OVATIO Models: VR 6250	Sorin Group Italia SRL - CRF
2017-05-24	Z-2113-2017	Class II	PARADYM Models: VR 8250	Sorin Group Italia SRL - CRF
2017-05-24	Z-2114-2017	Class II	INTENSIA Models: VR 124	Sorin Group Italia SRL - CRF
2017-05-24	Z-2115-2017	Class II	NexGen Offset Stem Extension	Zimmer Biomet, Inc.
2017-05-24	Z-2116-2017	Class III	Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP…	Medtest Holdings, Inc.
2017-05-17	Z-2036-2017	Class II	PERI-LOC VOLAR DISTAL RADIUS	Smith & Nephew, Inc.
2017-05-17	Z-2040-2017	Class II	RAPIDPoint¿ 500 Blood Gas Analyzer with v2	Siemens Healthcare Diagnostics Inc
2017-05-17	Z-2041-2017	Class II	Anthrex Bio-SwiveLock SP Vented	Arthrex, Inc.
2017-05-17	Z-2042-2017	Class II	Anthrex PEEK SwiveLock SP Vented	Arthrex, Inc.
2017-05-17	Z-2043-2017	Class II	Anthrex Bio Composite SwiveLock SP Vented	Arthrex, Inc.
2017-05-17	Z-2044-2017	Class II	Anthrex PEEK SwiveLock SP Vented	Arthrex, Inc.
2017-05-17	Z-2045-2017	Class II	Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP…	Arthrex, Inc.
2017-05-17	Z-2046-2017	Class II	Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching	Arthrex, Inc.
2017-05-17	Z-2047-2017	Class II	Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS	Medtronic Sofamor Danek USA Inc
2017-05-17	Z-2048-2017	Class II	NDI P7 Position Sensor	Orthosoft, Inc. dba Zimmer CAS
2017-05-17	Z-2049-2017	Class II	Sample probes associated with: cobas 6000 Series System	Roche Diagnostics Corporation
2017-05-17	Z-2050-2017	Class II	Mederi Stretta Catheter and Accessory Kit	Mederi Therapeutics, Inc
2017-05-17	Z-2054-2017	Class II	CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual…	CooperSurgical, Inc.
2017-05-17	Z-2055-2017	Class II	Linear Straight Broach Handle	Greatbatch Medical
2017-05-17	Z-2056-2017	Class II	Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement…	Zimmer Biomet, Inc.
2017-05-17	Z-2057-2017	Class II	MEDHOT MTI 2000 THERMAL IMAGING SYSTEM	Med-Hot Thermal Imaging, Inc.
2017-05-17	Z-2058-2017	Class II	Medi-Therm Hyper/Hypothermia System	Stryker Medical Division of Stryker Corporation
2017-05-17	Z-2059-2017	Class II	Bone Dowell Harvest Tubes	Zimmer Biomet, Inc.
2017-05-17	Z-2060-2017	Class II	Savaria SL-1000 Stairlift	Savaria Concord Lifts, Inc.
2017-05-17	Z-2062-2017	Class II	Healon	Abbott Medical Optics Inc. (AMO)
2017-05-17	Z-2063-2017	Class II	Healon GV	Abbott Medical Optics Inc. (AMO)
2017-05-17	Z-2064-2017	Class II	Healon Duet	Abbott Medical Optics Inc. (AMO)
2017-05-17	Z-2065-2017	Class II	Healon 5 Pro	Abbott Medical Optics Inc. (AMO)
2017-05-17	Z-2066-2017	Class II	Healon Pro	Abbott Medical Optics Inc. (AMO)
2017-05-17	Z-2067-2017	Class II	Healon V	Abbott Medical Optics Inc. (AMO)
2017-05-17	Z-2068-2017	Class II	Regenerex Patella RGX 3 PEG SER A PATELLA 28MM RGX 3 PEG SER A…	Zimmer Biomet, Inc.
2017-05-17	Z-2069-2017	Class II	Microfil Composite Instruments are packaged in an unsealed plastic…	Almore International Inc
2017-05-17	Z-2070-2017	Class II	Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline…	Mentor Texas, LP.
2017-05-17	Z-2071-2017	Class II	Stryker PROFESS Registration Kit	Stryker Instruments Div. of Stryker Corporation
2017-05-10	Z-1874-2017	Class I	Newport Medical HT70 and HT70- Plus Ventilators	Newport Medical Instruments Inc
2017-05-10	Z-1890-2017	Class II	MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2	Medtronic Inc.
2017-05-10	Z-1891-2017	Class II	DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE	PEROUSE MEDICAL
2017-05-10	Z-1892-2017	Class III	The TM Ardis Interbody System implant is a convex	Zimmer Trabecular Metal Technology, Inc.
2017-05-10	Z-1894-2017	Class II	Sonesta S2	Sonesta Medical Ab
2017-05-10	Z-1895-2017	Class II	Shandon Rapid Chrome Kwik-Diff Kit Part Number: 9990700 Shandon Rapid…	Richard-Allan Scientific Company
2017-05-10	Z-1896-2017	Class II	SurFlo IV Catheter	Terumo Medical Corporation
2017-05-10	Z-1897-2017	Class II	BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic…	Becton Dickinson & Company
2017-05-10	Z-1899-2017	Class II	Accu-Chek Connect Diabetes Management App versions 2	Roche Diabetes Care, Inc.
2017-05-10	Z-1900-2017	Class II	MR GHIATAS Beaded Breast Localization Wire	Bard Peripheral Vascular Inc
2017-05-10	Z-1901-2017	Class II	Dressing Knee/Shldr	Breg Inc
2017-05-10	Z-1902-2017	Class II	Dressing M/U XL	Breg Inc
2017-05-10	Z-1903-2017	Class II	Dressing Rect L	Breg Inc
2017-05-10	Z-1904-2017	Class II	Dressing	Breg Inc
2017-05-10	Z-1905-2017	Class II	Dressing Shldr	Breg Inc
2017-05-10	Z-1906-2017	Class II	Dressing Shldr XL	Breg Inc
2017-05-10	Z-1907-2017	Class II	Dressing Back	Breg Inc
2017-05-10	Z-1908-2017	Class II	If Hip	Breg Inc
2017-05-10	Z-1909-2017	Class II	RENOVATION	Smith & Nephew, Inc.
2017-05-10	Z-1910-2017	Class II	RENOVATION	Smith & Nephew, Inc.
2017-05-10	Z-1911-2017	Class II	RENOVATION	Smith & Nephew, Inc.
2017-05-10	Z-1912-2017	Class II	RENOVATION	Smith & Nephew, Inc.
2017-05-10	Z-1913-2017	Class II	RENOVATION	Smith & Nephew, Inc.
2017-05-10	Z-1914-2017	Class II	RENOVATION	Smith & Nephew, Inc.
2017-05-10	Z-1915-2017	Class II	RENOVATION	Smith & Nephew, Inc.
2017-05-10	Z-1916-2017	Class II	RENOVATION	Smith & Nephew, Inc.
2017-05-10	Z-1917-2017	Class II	RENOVATION	Smith & Nephew, Inc.
2017-05-10	Z-1918-2017	Class II	RENOVATION	Smith & Nephew, Inc.
2017-05-10	Z-1919-2017	Class II	RENOVATION	Smith & Nephew, Inc.
2017-05-10	Z-1920-2017	Class II	RENOVATION	Smith & Nephew, Inc.
2017-05-10	Z-1921-2017	Class II	ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready…	Roho Inc.
2017-05-10	Z-1922-2017	Class II	The JETSTREAM is a rotational atherectomy catheter system designed…	Boston Scientific Corporation
2017-05-10	Z-1923-2017	Class II	Schiller AG ISA CO2 Sensor	Merge Healthcare, Inc.
2017-05-10	Z-1924-2017	Class II	Second generation neoBLUE LED Phototherapy Light	Natus Medical Incorporated
2017-05-10	Z-1927-2017	Class II	Dale Medical Stabilock Endotracheal Tube Holder Product # 270 The…	Dale Medical Products, Inc.
2017-05-10	Z-1928-2017	Class II	Dale Medical Stabilock Endotracheal Adhesive Base Product # 273 The…	Dale Medical Products, Inc.
2017-05-10	Z-1929-2017	Class II	Olympus ENDOEYE HD II Video Telescopes Models: WA50040A Endoeye HD II	Olympus Corporation of the Americas
2017-05-10	Z-1930-2017	Class II	14cm QD Angle Attachment Product Usage: Product attachment	The Anspach Effort, Inc.
2017-05-10	Z-1931-2017	Class II	AL-III W/ male disconnect and 20ft hose Product Usage: Pneumatic…	The Anspach Effort, Inc.
2017-05-10	Z-1932-2017	Class II	AL-III W/ male disconnect and 30ft hose Product Usage: Pneumatic…	The Anspach Effort, Inc.
2017-05-10	Z-1933-2017	Class II	Foot control irrigation system Product Usage: Pneumatic system	The Anspach Effort, Inc.
2017-05-10	Z-1934-2017	Class II	Autolube-III Product Usage: Pneumatic system	The Anspach Effort, Inc.
2017-05-10	Z-1935-2017	Class II	Autolube-III with 20ft hose Product Usage: Pneumatic system	The Anspach Effort, Inc.
2017-05-10	Z-1936-2017	Class II	AL-III-DISS Adapter Product Usage: Pneumatic system	The Anspach Effort, Inc.
2017-05-10	Z-1937-2017	Class II	Autolube-III with Foot Guard Product Usage: Pneumatic system	The Anspach Effort, Inc.
2017-05-10	Z-1938-2017	Class II	Autolube-III with Irrigation Product Usage: Pneumatic system	The Anspach Effort, Inc.
2017-05-10	Z-1939-2017	Class II	Autolube-III with NK Product Usage: Pneumatic system	The Anspach Effort, Inc.
2017-05-10	Z-1940-2017	Class II	19cm Attachment	The Anspach Effort, Inc.
2017-05-10	Z-1941-2017	Class II	BLACKMAX-NEURO LOW PRESSURE Product Usage: Pneumatic system	The Anspach Effort, Inc.
2017-05-10	Z-1942-2017	Class II	IMRI AIR CONTROL Product Usage: Pneumatic system	The Anspach Effort, Inc.
2017-05-10	Z-1943-2017	Class II	IMRI MOTOR Product Usage: Pneumatic system	The Anspach Effort, Inc.
2017-05-10	Z-1944-2017	Class II	XMAX Motor	The Anspach Effort, Inc.
2017-05-10	Z-1945-2017	Class II	XMAX Motor	The Anspach Effort, Inc.
2017-05-10	Z-1946-2017	Class II	Electronic Foot Control with Direction or Irrigation Switches Product…	The Anspach Effort, Inc.
2017-05-10	Z-1947-2017	Class II	Electric Handpiece EM Hand Control Product Usage: Electric system	The Anspach Effort, Inc.
2017-05-10	Z-1948-2017	Class II	Electronic Foot Control with Direction Switch Product Usage: Electric…	The Anspach Effort, Inc.
2017-05-10	Z-1949-2017	Class II	Electronic Foot Control with Direction or Irrigation Switches Product…	The Anspach Effort, Inc.
2017-05-10	Z-1950-2017	Class II	eMax2 Motor Assembly Product Usage: Electric system	The Anspach Effort, Inc.
2017-05-10	Z-1951-2017	Class II	eMax2 Hybrid Hand Control Product Usage: Electric system	The Anspach Effort, Inc.
2017-05-10	Z-1952-2017	Class II	eMax2 PLUS Product Usage: Electric system	The Anspach Effort, Inc.
2017-05-10	Z-1953-2017	Class II	Foot Control	The Anspach Effort, Inc.
2017-05-10	Z-1954-2017	Class II	Foot Control without Switches	The Anspach Effort, Inc.
2017-05-10	Z-1955-2017	Class II	Console	The Anspach Effort, Inc.
2017-05-10	Z-1956-2017	Class II	System Console	The Anspach Effort, Inc.
2017-05-10	Z-1957-2017	Class II	System Console	The Anspach Effort, Inc.
2017-05-10	Z-1958-2017	Class II	7	The Anspach Effort, Inc.
2017-05-10	Z-1959-2017	Class II	19CM ATTACHMENT	The Anspach Effort, Inc.
2017-05-10	Z-1960-2017	Class II	11	The Anspach Effort, Inc.
2017-05-10	Z-1961-2017	Class II	LARGE CRANIOTOME	The Anspach Effort, Inc.
2017-05-10	Z-1962-2017	Class II	STANDARD CRANIOTOME	The Anspach Effort, Inc.
2017-05-10	Z-1963-2017	Class II	GREEN ROTATING CRANIOTOME	The Anspach Effort, Inc.
2017-05-10	Z-1964-2017	Class II	ADJUSTABLE DRILL GUIDE	The Anspach Effort, Inc.
2017-05-10	Z-1965-2017	Class II	16CM MIN INVASIVE ATTACH	The Anspach Effort, Inc.
2017-05-10	Z-1966-2017	Class II	KEYLESS DRIVER	The Anspach Effort, Inc.
2017-05-10	Z-1967-2017	Class II	22CM MICRO REVISION ATTACH	The Anspach Effort, Inc.
2017-05-10	Z-1968-2017	Class II	16	The Anspach Effort, Inc.
2017-05-10	Z-1969-2017	Class II	9	The Anspach Effort, Inc.
2017-05-10	Z-1970-2017	Class II	CONTRA ANGLE ATTACHMENT	The Anspach Effort, Inc.
2017-05-10	Z-1971-2017	Class II	90 DEG RIGHT ANGLE ATTACH	The Anspach Effort, Inc.
2017-05-10	Z-1972-2017	Class II	11CM ANGLE ATTACHMENT	The Anspach Effort, Inc.
2017-05-10	Z-1973-2017	Class II	10	The Anspach Effort, Inc.
2017-05-10	Z-1974-2017	Class II	14CM ANGLE ATTACHMENT	The Anspach Effort, Inc.
2017-05-10	Z-1975-2017	Class II	13	The Anspach Effort, Inc.
2017-05-10	Z-1976-2017	Class II	8CM ANGLE ATTACHMENT	The Anspach Effort, Inc.
2017-05-10	Z-1977-2017	Class II	7	The Anspach Effort, Inc.
2017-05-10	Z-1978-2017	Class II	26	The Anspach Effort, Inc.
2017-05-10	Z-1979-2017	Class II	B-SAGITTAL ASSEMBLY Product Usage: Pneumatic system	The Anspach Effort, Inc.
2017-05-10	Z-1980-2017	Class II	6	The Anspach Effort, Inc.
2017-05-10	Z-1981-2017	Class II	12	The Anspach Effort, Inc.
2017-05-10	Z-1982-2017	Class II	5	The Anspach Effort, Inc.
2017-05-10	Z-1983-2017	Class II	PEDIATRIC CRANIOTOME	The Anspach Effort, Inc.
2017-05-10	Z-1984-2017	Class II	8	The Anspach Effort, Inc.
2017-05-10	Z-1985-2017	Class II	6	The Anspach Effort, Inc.
2017-05-10	Z-1986-2017	Class II	Adult Craniotome Product Usage: Pneumatic system	The Anspach Effort, Inc.
2017-05-10	Z-1987-2017	Class II	6	The Anspach Effort, Inc.
2017-05-10	Z-1988-2017	Class II	Rotating Adult Craniotome Product Usage: Pneumatic system	The Anspach Effort, Inc.
2017-05-10	Z-1989-2017	Class II	Large Craniotome Product Usage: Pneumatic system	The Anspach Effort, Inc.
2017-05-10	Z-1990-2017	Class II	Rotating Large Craniotome	The Anspach Effort, Inc.
2017-05-10	Z-1991-2017	Class II	Pediatric Craniotome	The Anspach Effort, Inc.
2017-05-10	Z-1992-2017	Class II	Compact Speed Reducer	The Anspach Effort, Inc.
2017-05-10	Z-1993-2017	Class II	Compact Speed Reducer	The Anspach Effort, Inc.
2017-05-10	Z-1994-2017	Class II	Chuck Driver System	The Anspach Effort, Inc.
2017-05-10	Z-1995-2017	Class II	Keyless Driver Product Usage: Pneumatic system	The Anspach Effort, Inc.
2017-05-10	Z-1996-2017	Class II	IMRI CRANI-A ATTACHMENT Product Usage: Pneumatic system	The Anspach Effort, Inc.
2017-05-10	Z-1997-2017	Class II	IMRI SHORT ATTACHMENT Product Usage: Pneumatic system	The Anspach Effort, Inc.
2017-05-10	Z-1998-2017	Class II	IMRI SHORT HD ATTACHMENT Product Usage: Pneumatic system	The Anspach Effort, Inc.
2017-05-10	Z-1999-2017	Class II	11	The Anspach Effort, Inc.
2017-05-10	Z-2000-2017	Class II	10	The Anspach Effort, Inc.
2017-05-10	Z-2001-2017	Class II	12	The Anspach Effort, Inc.
2017-05-10	Z-2002-2017	Class II	10	The Anspach Effort, Inc.
2017-05-10	Z-2003-2017	Class II	Bearing Sleeve	The Anspach Effort, Inc.
2017-05-10	Z-2004-2017	Class II	Bearing Sleeve	The Anspach Effort, Inc.
2017-05-10	Z-2005-2017	Class II	Bearing Sleeve	The Anspach Effort, Inc.
2017-05-10	Z-2006-2017	Class II	Bearing Sleeve	The Anspach Effort, Inc.
2017-05-10	Z-2007-2017	Class II	Bearing Sleeve	The Anspach Effort, Inc.
2017-05-10	Z-2008-2017	Class II	Bearing Sleeve	The Anspach Effort, Inc.

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