FDA Device · 2016
FDA Device recalls in 2016
RecallRadar indexes 3,246 FDA Device recall notices published in 2016. By classification: 116 Class I, 3,050 Class II, 80 Class III.
- BIOGRAPH 6-4R TruePoint w/TrueV, MATERIAL NUMBER 10097290 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT…
FDA Device · Class II · 2016-06-29 · Siemens Medical Solutions Usa - Xcela Hybrid PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN H965952440 & UPN H965952450, Rx ONLY The Xcela PICC wit…
FDA Device · Class II · 2016-06-22 · Navilyst Medical An Angiodyamics - AVEA Standard with Compressor ventilator, 17312-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad s…
FDA Device · Class I · 2016-06-22 · Carefusion 211 - Vaxcel PICC with PASV Intermediate Safety MST Kit under the following labels: 1) 3F, UPN H965454370, 2) 4F UPN M001455940 & 3) 5F UPN M0014…
FDA Device · Class II · 2016-06-22 · Navilyst Medical An Angiodyamics - Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001454560, Rx ONLY & 2) 5F, UPN M001454610, Rx ONLY. The Vaxce…
FDA Device · Class II · 2016-06-22 · Navilyst Medical An Angiodyamics - TCA Board, 16542A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a prede…
FDA Device · Class I · 2016-06-22 · Carefusion 211 - BioSync Anatomic Cotton Wedge, 16 x 6.5 mm
FDA Device · Class II · 2016-06-22 · Arthrex - BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458980, Rx ONLY The Xcela PICC with PASV, Xcela Hybr…
FDA Device · Class II · 2016-06-22 · Navilyst Medical An Angiodyamics - BioSync Anatomic Cotton Wedge, 20 x 6.5 mm
FDA Device · Class II · 2016-06-22 · Arthrex - LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed
FDA Device · Class II · 2016-06-22 · Physio Control - BioFlo PICC with ENDEXO and PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965458410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PI…
FDA Device · Class II · 2016-06-22 · Navilyst Medical An Angiodyamics - Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066
FDA Device · Class II · 2016-06-22 · Natus Medical - 00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM 00720504222 ACETAB.CUPW/SH,0DEG,22MMX42MM 00720504622 ACETAB.CUPW/SH,0DEG,22MMX46MM 00720504828 A…
FDA Device · Class II · 2016-06-22 · Zimmer Trabecular Metal Technology - The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use i…
FDA Device · Class II · 2016-06-22 · Sysmex - BioFlo PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458430 & UPN H965458840, Rx ONLY The Xcela PICC with PASV,…
FDA Device · Class II · 2016-06-22 · Navilyst Medical An Angiodyamics - Protura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number MT6XSM1.7.0), and 1.7.1 (Part Number MT…
FDA Device · Class II · 2016-06-22 · Med Tec - Ariol is an automated scanning microscope and image analysis system
FDA Device · Class III · 2016-06-22 · Leica Biosystems Richmond - AVEA GDE/UIM upgrade kit, 12283-PMN A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by…
FDA Device · Class I · 2016-06-22 · Carefusion 211 - BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (C…
FDA Device · Class II · 2016-06-22 · Siemens Medical Solutions Usa - REV. SHELL LINER 0D 28X48 00700504828 REV. SHELL LINER 10D 28X50 00701005028 REV. SHELL LINER 10D 28X52 00701005228 REV. SHELL LINER 10D 28…
FDA Device · Class II · 2016-06-22 · Zimmer Trabecular Metal Technology - Vaxcel PICC with PASV Catheter Kit under the following labels: 1) 3F, UPN H965454350, Rx ONLY, 2) 4F, UPN M001454550, Rx ONLY & 3) 5F, UPN…
FDA Device · Class II · 2016-06-22 · Navilyst Medical An Angiodyamics - Gas Delivery Engine (GDE)-1st Generation, 16222-001-99 A continuous ventilator intended to mechanically control or assist broad spectrum pa…
FDA Device · Class I · 2016-06-22 · Carefusion 211 - Excelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10 mL syringe)
FDA Device · Class II · 2016-06-22 · Excelsior Medical - LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile
FDA Device · Class II · 2016-06-22 · Synthes Usa Products - Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Guide Wire for fixation of fractures that occur in and between the proximal…
FDA Device · Class II · 2016-06-22 · Carbofix Orthopedics - BioSync Anatomic Cotton Wedge, 20 x 4.5 mm
FDA Device · Class II · 2016-06-22 · Arthrex - EVARREST Fibrin Sealant Patch, Manufactured by: Omrix Biopharmaceuticals, Ltd, Israel
FDA Device · Class II · 2016-06-22 · Ethicon - Xcela Hybrid PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965952420 & UPN H965952460, Rx ONLY The Xcela PICC with PASV, Xcela…
FDA Device · Class II · 2016-06-22 · Navilyst Medical An Angiodyamics - Access 2 Immunoassay System, Remanufactured, Catalog No. 386220 is an invitro diagnostic device used for the quantitative, semi-quantitativ…
FDA Device · Class II · 2016-06-22 · Beckman Coulter - BIOGRAPH mCT S(20) - 4R, MATERIAL NUMBER 10528958 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (C…
FDA Device · Class II · 2016-06-22 · Siemens Medical Solutions Usa - Xcela PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965251290 & H965457420, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PIC…
FDA Device · Class II · 2016-06-22 · Navilyst Medical An Angiodyamics - BioSync Anatomic Cotton Wedge, 16 x 4.5 mm
FDA Device · Class II · 2016-06-22 · Arthrex - Gas Delivery Engine (GDE), 16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by de…
FDA Device · Class I · 2016-06-22 · Carefusion 211 - BioFlo PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965458420 & UPN H965458930, Rx ONLY The Xcela PICC with PASV,…
FDA Device · Class II · 2016-06-22 · Navilyst Medical An Angiodyamics - Universal Battery Charger II (UBC II)
FDA Device · Class II · 2016-06-22 · The Anspach Effort - Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT)…
FDA Device · Class II · 2016-06-22 · Siemens Medical Solutions Usa - Vaxcel PICC with PASV MST-30 Kit under the following labels: 1) 4F, UPN M001454570, Rx ONLY, 2) 5F, UPN M001454620 & UPN M001454720, Rx ONL…
FDA Device · Class II · 2016-06-22 · Navilyst Medical An Angiodyamics - AVEA Comprehensive ventilator-refurbished, R17310-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad s…
FDA Device · Class I · 2016-06-22 · Carefusion 211 - The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile
FDA Device · Class II · 2016-06-22 · Miami Fat Supply - BioFlo PICC with ENDEXO and PASV Valve Technology, Maximal Barrier Nursing Kit, UPN H965750211 The Xcela PICC with PASV, Xcela Hybrid PICC…
FDA Device · Class II · 2016-06-22 · Navilyst Medical An Angiodyamics - BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, Catheter Kit, UPN H965459410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC…
FDA Device · Class II · 2016-06-22 · Navilyst Medical An Angiodyamics - Vaxcel PICC with PASV MST-60 Kit under the following labels: 1) 3F, UPN H965454360, Rx ONLY, 2) 4F, UPN M001454590, Rx ONLY, 3) 5F, UPN's M…
FDA Device · Class II · 2016-06-22 · Navilyst Medical An Angiodyamics - Vaxcel PICC with PASV IR-145 Kit under the following labels: 1) 4F, UPN M001454580, Rx ONLY, 2) 5F, UPN M001454630, Rx ONLY & 3) 6F, UPN M0…
FDA Device · Class II · 2016-06-22 · Navilyst Medical An Angiodyamics - Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder (AS) System 2.0. The Dome Centric connects the Humeral Stem to…
FDA Device · Class II · 2016-06-22 · Zimmer - BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10528956 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (C…
FDA Device · Class II · 2016-06-22 · Siemens Medical Solutions Usa - AVEA Standard ventilator, 17311-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient…
FDA Device · Class I · 2016-06-22 · Carefusion 211 - Stryker PowerPRO (XT, IT, or TL) Cots Stretcher, Wheeled The Stryker Power-PRO" are powered ambulance cots are designed to support and tran…
FDA Device · Class II · 2016-06-22 · Stryker Medical Division - AVEA GDE upgrade kit, 12284-PMN A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by deli…
FDA Device · Class I · 2016-06-22 · Carefusion 211 - Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Me…
FDA Device · Class II · 2016-06-22 · Fsc Laboratories - POROUS PATELLA 32MM X 10MM - 00587806532 POROUS PATELLA 35MM X 10MM- 00587806535 POROUS PATELLA 38MM X 10MM - 00587806538 POROUS PATELLA 41…
FDA Device · Class II · 2016-06-22 · Zimmer Trabecular Metal Technology - AVEA Comprehensive ventilator, 17310-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum pat…
FDA Device · Class I · 2016-06-22 · Carefusion 211 - BioSync Anatomic Cotton Wedge, 16 x 5.5 mm
FDA Device · Class II · 2016-06-22 · Arthrex - Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Sets with Bioline Coating are for single use only
FDA Device · Class II · 2016-06-22 · Datascope - TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm Screws The FS2030 Depth Gauge is used by the physician to determin…
FDA Device · Class II · 2016-06-22 · Integra Lifesciences - AVEA Standard with Compressor ventilator-refurbished, R17312-xx (xx = 0-14) A continuous ventilator intended to mechanically control or ass…
FDA Device · Class I · 2016-06-22 · Carefusion 211 - TM MONO TIB STR GRN SZ 5 - 00588606510 TM MONO TIB STR GRN SZ 5 12MM - 00588606512 TM MONO TIB STR GRN SZ 5 14MM - 00588606514 TM MONO TIB…
FDA Device · Class II · 2016-06-22 · Zimmer Trabecular Metal Technology - Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001455910, Rx ONLY The Vaxcel PICC with PASV is indicated for…
FDA Device · Class II · 2016-06-22 · Navilyst Medical An Angiodyamics - Xcela PICC with PASV Valve Technology Catheter Kit, 6F-55cm, UPN H965457410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV,…
FDA Device · Class II · 2016-06-22 · Navilyst Medical An Angiodyamics - STAAR AQ Cartridge-FP, guide and delivery system for Intraocular lenses
FDA Device · Class II · 2016-06-22 · Staar Surgical - TM LPS TIB SZ 3 C/D, 10MM - 00588605310 TM LPS TIB SZ 3 C/D, 12MM - 00588605312 TM LPS TIB SZ 3 C/D, 14MM - 00588605314 TM LPS TIB SZ 3 C/D…
FDA Device · Class II · 2016-06-22 · Zimmer Trabecular Metal Technology - Gas Delivery Engine (GDE)-refurbished, R16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient br…
FDA Device · Class I · 2016-06-22 · Carefusion 211 - AVEA Standard ventilator-refurbished, R17311-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectr…
FDA Device · Class I · 2016-06-22 · Carefusion 211 - TM CR TIB SZ 3 C-H, 10MM- 00588604310 TM CR TIB SZ 3 C-H, 12 mm - 00588604312 TM CR TIB SZ 3 C-H, 14MM - 00588604314 TM CR TIB SZ 3 C-H, 17…
FDA Device · Class II · 2016-06-22 · Zimmer Trabecular Metal Technology - Xcela Hybrid PICC with PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965952410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC wi…
FDA Device · Class II · 2016-06-22 · Navilyst Medical An Angiodyamics - Xcela Hybrid PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965952430 & H965952470, Rx ONLY The Xcela PICC with PASV, Xcela Hyb…
FDA Device · Class II · 2016-06-22 · Navilyst Medical An Angiodyamics - BioSync Anatomic Cotton Wedge, 20 x 5.5 mm
FDA Device · Class II · 2016-06-22 · Arthrex - BioFlo PICC with ENDEXO and PASV Valve Technology, MST-45 Kit, 6F-55cm, UPN H965458440 , Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PIC…
FDA Device · Class II · 2016-06-22 · Navilyst Medical An Angiodyamics - BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965458970, Rx ONLY The Xcela PICC with PASV, Xcela Hybr…
FDA Device · Class II · 2016-06-22 · Navilyst Medical An Angiodyamics - Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid)
FDA Device · Class II · 2016-06-22 · Cordis - Cordis PRECISE (R) RX Nitinol Stent System (Biliary)
FDA Device · Class II · 2016-06-22 · Cordis - Xcela PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965457430, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV,…
FDA Device · Class II · 2016-06-22 · Navilyst Medical An Angiodyamics - Xcela PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN H965457440 Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC…
FDA Device · Class II · 2016-06-22 · Navilyst Medical An Angiodyamics - Ellipse ND: YAG Laser applicator for Ellipse Nordlys system Medical Laser Products
FDA Device · Class II · 2016-06-15 · Ellipse A S - Philips Healthcare Ingenuity Core128 Computed Tomography X-Ray System
FDA Device · Class II · 2016-06-15 · Philips Healthcare - Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/inject…
FDA Device · Class II · 2016-06-15 · Becton Dickinson And - Surgical Table Cushion (HybriGel Pads) HybrGel Pads are an optional accessory to the Operon Surgical Table
FDA Device · Class II · 2016-06-15 · Berchtold - MEGA¿ 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ MEGA¿ 7.5Fr. 40cc Intra-Aortic Balloon Catheter with Inserti…
FDA Device · Class II · 2016-06-15 · Datascope - Philips Healthcare Brilliance iCT Computed Tomography X-Ray System
FDA Device · Class II · 2016-06-15 · Philips Healthcare - Medtronic RestoreSensor, Model 37714
FDA Device · Class II · 2016-06-15 · Medtronic Neuromodulation - Lipase, Catalog No. OSR6x30 Product Usage: Lipase OSR6x30 is intended as a System reagent for the quantitative determination of Lipase acti…
FDA Device · Class II · 2016-06-15 · Beckman Coulter - DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument
FDA Device · Class II · 2016-06-15 · Synthes Usa Products - Optima 1.5T MR430s MR Scanner, a diagnostic imaging device
FDA Device · Class II · 2016-06-15 · Ge Healthcare - Sterile Sheridan/HVT Cuffed, Murphy Eye, Tracheal Tube, Ref: V5-10314, ID: 7.0 mm, Rx Only, Manufactured by: Teleflex Incorporated
FDA Device · Class II · 2016-06-15 · Teleflex Medical - Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T The product is used as an aid in the i…
FDA Device · Class II · 2016-06-15 · Integrated Science Systems - 1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 30 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Flo…
FDA Device · Class II · 2016-06-15 · Synthes Usa Products - Triglyceride, Catalog No. OSR6x118 Product Usage:Triglyceride OSR6x118 is intended as an Enzymatic colour test for the quantitative determi…
FDA Device · Class II · 2016-06-15 · Beckman Coulter - Philips Healthcare Brilliance iCT SP Computed Tomography X-Ray System
FDA Device · Class II · 2016-06-15 · Philips Healthcare - Philips Healthcare Brilliance 64 Computed Tomography X-Ray System
FDA Device · Class II · 2016-06-15 · Philips Healthcare - Actifuse ABX/Actifuse MIS System A bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not i…
FDA Device · Class II · 2016-06-15 · Apatech - GE Revolution CT The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications
FDA Device · Class II · 2016-06-15 · Ge Healthcare - Maestro Air Motor Pneumatic cranial drill motor
FDA Device · Class II · 2016-06-15 · Stryker Instruments Div - 1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 35 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Flo…
FDA Device · Class II · 2016-06-15 · Synthes Usa Products - The Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and…
FDA Device · Class II · 2016-06-15 · Hospira - Philips Healthcare DigitalDiagnost stationary X-ray system
FDA Device · Class II · 2016-06-15 · Philips Healthcare - Norian Drillable Inject 5 CC-Sterile
FDA Device · Class II · 2016-06-15 · Synthes Usa Products - Norian Drillable Inject 3 CC-Sterile
FDA Device · Class II · 2016-06-15 · Synthes Usa Products - Philips Healthcare Ingenuity CT Computed Tomography X-Ray System
FDA Device · Class II · 2016-06-15 · Philips Healthcare - Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/inject…
FDA Device · Class II · 2016-06-15 · Becton Dickinson And - VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifier No. 10758750002740
FDA Device · Class II · 2016-06-15 · Ortho Clinical Diagnostics - Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set
FDA Device · Class II · 2016-06-15 · Materialise Usa
Other years
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