FDA Device · 2013
FDA Device recalls in 2013
RecallRadar indexes 2,249 FDA Device recall notices published in 2013. By classification: 177 Class I, 1,944 Class II, 128 Class III.
- Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1. Diagn…
FDA Device · Class II · 2013-12-11 · Siemens Healthcare Diagnostics - SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No. 24301-0007T The SmartSite Low Sorbing Infusion Sets with Texium M…
FDA Device · Class II · 2013-12-11 · Carefusion 303 - GENESIS(R) II, MOBILE BEARING ARTICULAR INSERT RIGHT, SIZE 5, 9 MM QTY: (1), REF 71621509, STERILE EO, Smith & Nephew, Inc
FDA Device · Class II · 2013-12-11 · Smith And Nephew - C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator
FDA Device · Class II · 2013-12-11 · Varian Medical Systems - GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 9 MM QTY: (1), REF 71421515, STERILE EO, Smith & Nephew, Inc
FDA Device · Class II · 2013-12-11 · Smith And Nephew - GENESIS(R) II, POSTERIOR STABILIZED ARTICULAR INSERT, SIZE 1-2, 13 MM QTY: (1), REF 71420806, STERILE EO, Smith & Nephew, Inc
FDA Device · Class II · 2013-12-11 · Smith And Nephew - GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), REF 71421516, STERILE EO, Smith & Nephew, Inc
FDA Device · Class II · 2013-12-11 · Smith And Nephew - GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY: (1), REF 71421508, STERILE EO, Smith & Nephew, Inc
FDA Device · Class II · 2013-12-11 · Smith And Nephew - Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a prothrombin time test is useful for monitori…
FDA Device · Class II · 2013-12-11 · Abbott Point - Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the proximal femur
FDA Device · Class II · 2013-12-11 · Synthes Usa Hq - SIEMENS brand ARTISTE Linear Accelerator Linac systems with component: any photon unflat beam option (Multiple X feature) in combination wi…
FDA Device · Class II · 2013-12-11 · Siemens Medical Solutions Usa - syngo(R) Lab Data Manager - Version VA11B and VA12A Systems Securely consolidates data from multiple lab instruments, the LIS and Siemens S…
FDA Device · Class II · 2013-12-11 · Siemens Healthcare Diagnostics - Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P VA Implant 7 MM Height Parallel Sterile is a stand alone anterior…
FDA Device · Class II · 2013-12-11 · Synthes Usa Hq - TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi stol Grip TB-0545IC: THUNDERBEAT 5 mm, 45 em, In li…
FDA Device · Class II · 2013-12-11 · Olympus America - Easy Diagnost Eleva Universal Fluoroscopic applications
FDA Device · Class II · 2013-12-11 · Philips Medical Systems - Navigator HD l3F/15F x 28 cm Ureteral Access Sheath Set Product No M0062502270, RDF Catalog No 250-227, Sterile
FDA Device · Class II · 2013-12-11 · Boston Scientific - Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14
FDA Device · Class II · 2013-12-11 · Sunrise Medical Us - (Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensified f…
FDA Device · Class II · 2013-12-04 · Siemens Medical Solutions Usa - 3M ESPE, Unitek Stainless Steel Permanent Molar Crowns Stainless Steel Crowns, are designed to fill the need for long term provisional cove…
FDA Device · Class III · 2013-12-04 · 3m Health Care Business - Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary and permanent occlusion of cervical segment of cerebral aneurysms and peripher…
FDA Device · Class II · 2013-12-04 · Mizuho America - Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures
FDA Device · Class II · 2013-12-04 · Synthes Usa Hq - Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthro…
FDA Device · Class II · 2013-12-04 · Synthes Usa Hq - CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022
FDA Device · Class II · 2013-12-04 · Medtronic Neurosurgery - Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software version VD10A/G Image intensified Fluoroscopic X-ray system
FDA Device · Class II · 2013-12-04 · Siemens Medical Solutions Usa - Tri-Nex Healing Abutment, 0.50 mm x 5 mm height, Catalog No. HA-L-50-5. The NSI Implant System is intended to be implanted in the upper and…
FDA Device · Class II · 2013-12-04 · Southern Implants - Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress Compression Nut For Blade Guide Sleeve TFN is intended…
FDA Device · Class II · 2013-12-04 · Synthes Usa Hq - Synthes Titanium Minimally Invasive Reduction Screw System Locking Cap, Part Number 04.631.502 Non-cervical spinal fixation devices intende…
FDA Device · Class II · 2013-12-04 · Synthes Usa Hq - SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal…
FDA Device · Class II · 2013-12-04 · Depuy Orthopaedics - SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial ca…
FDA Device · Class II · 2013-12-04 · Depuy Orthopaedics - SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial…
FDA Device · Class II · 2013-12-04 · Depuy Orthopaedics - Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corporation, Deerfield, IL 30015 USA The VIAL-MATE is reconstituti…
FDA Device · Class II · 2013-12-04 · Baxter Healthcare - Product Brand Name(s): Alere Cholestech LDX¿ Lipid Profile"GLU Test Cassette, Model 10-991
FDA Device · Class III · 2013-12-04 · Alere San Diego - SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal ti…
FDA Device · Class II · 2013-12-04 · Depuy Orthopaedics - Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Product Usage: The V Series Monitor is intended for intra hospital u…
FDA Device · Class II · 2013-12-04 · Mindray Ds Usa - 20mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC2000 Product is intended for fluid transfer between…
FDA Device · Class II · 2013-12-04 · B Braun Medical - REF 200068 Security (TM) Enclosed Carpal Tunnel System Blade ( Single) ABS /Stainless Steel Sterile Device, Single Use Only
FDA Device · Class II · 2013-12-04 · Biomet - LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip Driver - Short ("Driver"). Model Number 8630-0107
FDA Device · Class II · 2013-12-04 · Lanx - Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Rack, T-PAL Spacer Remover, Implant Inserter) Synthes Materia…
FDA Device · Class II · 2013-12-04 · Synthes Usa Hq - Single Analyte Urine DAU Control (5 m L Norbuprenorphine, Level II control For In Vitro Diagnostic Use Only. store at 2 - 8 degrees C. Cont…
FDA Device · Class III · 2013-12-04 · Lin Zhi International - Synthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumbar pedical screw system designed to provide flexibility biomechan…
FDA Device · Class II · 2013-12-04 · Synthes Usa Hq - Synthes Matrix 5.5.mm Left and Right Coronal Bender Product Usage: The Matrix 5.5.mm Left and Right Coronal Bender are used together to ben…
FDA Device · Class II · 2013-12-04 · Synthes Usa Hq - Medtronic Strata II Shunt Assembly Kit, Small, Catalog No. 27848
FDA Device · Class II · 2013-12-04 · Medtronic Neurosurgery - Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large bones and large bone fragments and for slip…
FDA Device · Class II · 2013-12-04 · Synthes Usa Hq - SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibi…
FDA Device · Class II · 2013-12-04 · Depuy Orthopaedics - SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial…
FDA Device · Class II · 2013-12-04 · Depuy Orthopaedics - STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat…
FDA Device · Class II · 2013-12-04 · Advanced Sterilization Products - Shortened Plug Driver
FDA Device · Class II · 2013-12-04 · Ebi - 2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusi…
FDA Device · Class II · 2013-12-04 · Synthes Usa Hq - 3.7mm and 5.0mm Dynamic Locking Screw (DLS) Product Usage: 3.7mm and 5.0mm Dynamic Locking Screw (DLS) in combination with Synthes Locking…
FDA Device · Class II · 2013-12-04 · Synthes Usa Hq - SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal…
FDA Device · Class II · 2013-12-04 · Depuy Orthopaedics - Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or fixation, specifically readapta…
FDA Device · Class II · 2013-12-04 · Synthes Usa Hq - Mizuho Sugita Titanium Standard Aneurysm Clip II , Temporary Mini Type No 58 Temporary and permanent occlusion of cervical segment of cereb…
FDA Device · Class II · 2013-12-04 · Mizuho America - ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva Combo System)\ The ACCU-CHEK Combo System is indicated for the…
FDA Device · Class II · 2013-12-04 · Roche Diagnostics Operations - SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 4-7 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibi…
FDA Device · Class II · 2013-12-04 · Depuy Orthopaedics - Medtronic Delta Shunt Assembly Kit with Bioglide Small, Performance Level 1.0, Catalog No. 276201
FDA Device · Class II · 2013-12-04 · Medtronic Neurosurgery - Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector
FDA Device · Class II · 2013-12-04 · Custom Ultrasonics - SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial ca…
FDA Device · Class II · 2013-12-04 · Depuy Orthopaedics - 13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC1300 Product is intended for fluid transfer between…
FDA Device · Class II · 2013-12-04 · B Braun Medical - SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial…
FDA Device · Class II · 2013-12-04 · Depuy Orthopaedics - MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed), Catalog/Part Numbers: 024222
FDA Device · Class III · 2013-12-04 · Thermofisher Scientive - Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand-held device intended for medi…
FDA Device · Class II · 2013-12-04 · Synthes Usa Hq - Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject PMMA cement into vertebral bodies during Vertebroplasty procedure
FDA Device · Class II · 2013-12-04 · Synthes Usa Hq - SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial can…
FDA Device · Class II · 2013-12-04 · Depuy Orthopaedics - SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED SIZE 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibia…
FDA Device · Class II · 2013-12-04 · Depuy Orthopaedics - Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttr…
FDA Device · Class II · 2013-12-04 · Synthes Usa Hq - Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur fractures
FDA Device · Class II · 2013-12-04 · Synthes Usa Hq - STERRAD NX, Product Code: 10033 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat an…
FDA Device · Class II · 2013-12-04 · Advanced Sterilization Products - Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm Product Usage: Intended for fractures, osteotomies, and replantations of small bones including the…
FDA Device · Class II · 2013-12-04 · Synthes Usa Products - Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar is used as part of the…
FDA Device · Class II · 2013-12-04 · Synthes Usa Products - Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Body, Part Number 04.631.500 Non-cervical spinal fixation device…
FDA Device · Class II · 2013-12-04 · Synthes Usa Hq - ARTAS Disposable Kit ( Contains Skin Tensioner FP-45384
FDA Device · Class II · 2013-11-27 · Restoration Robotics - EPIQ 7 Ultrasound System, Model 795200, 795201, 795202
FDA Device · Class II · 2013-11-27 · Philips Medical Systems North America - Medcare Products Max-500 Stand-N-Weigh, Total Support, patient stand, model #400007
FDA Device · Class II · 2013-11-27 · Ergosafe Products - Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number: 9914-00-9015. and Candela Laser Gent…
FDA Device · Class II · 2013-11-27 · Candela - Juggerknotless Drill Bit, REF 110003173, Sterile, Single Use Product Usage: The Juggerknotless Soft Anchors are indicated for soft tissue r…
FDA Device · Class II · 2013-11-27 · Biomet - Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors
FDA Device · Class II · 2013-11-27 · Salter Labs - Green Rusch - Lite Disposable Metal Laryngoscope Ridge Blade to visualize upper airway and aid in placement of tracheal tube
FDA Device · Class II · 2013-11-27 · Teleflex Medical - Olympus Endoscopic Flushing Pump, Model OPF-2. Facilitates washing of tissues to remove blood, feces and other organic matter during endosc…
FDA Device · Class II · 2013-11-27 · Olympus America - Medcare Products Max-500 Stand, Total Support, patient stand, model #400006
FDA Device · Class II · 2013-11-27 · Ergosafe Products - ProVia¿ CROSSING GUIDEWIRE
FDA Device · Class I · 2013-11-27 · Medtronic Vascular - Ready to Use Thymo-Cide, Germicidal Detergent, containing 0.051% thymol, packaged in 1-qt. bottles
FDA Device · Class II · 2013-11-27 · Wexford Labs - VITROS Chemistry Products ALC Slides, 90 slides/pack
FDA Device · Class II · 2013-11-27 · Ortho Clinical Diagnostics - Zinger¿ Stainless Steel Workhorse Guidewire
FDA Device · Class I · 2013-11-27 · Medtronic Vascular - Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP Catheter Cables, Model Numbers: D6-DR-252-RT, F6-QF-252RT, 201101…
FDA Device · Class II · 2013-11-27 · Stryker Sustainability Solutions - ALTRUS¿ THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 16 cm Shaft, REF 60-9520-001, STERILE -- CONMED CORPORATION 525 FRENCH R…
FDA Device · Class II · 2013-11-27 · Conmed - VITROS Chemistry Products PHYT Slides packaged as 90 slides/pack catalog number 8298671 VITROS PHYT Slides quantitatively measure phenytoin…
FDA Device · Class II · 2013-11-27 · Ortho Clinical Diagnostics - Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate…
FDA Device · Class II · 2013-11-27 · Synthes Usa Hq - VITROS Chemistry Products ALKP Slides, 300 slides/pack
FDA Device · Class II · 2013-11-27 · Ortho Clinical Diagnostics - VITROS Chemistry Products AMYL Slides packaged as 300 slides/pack catalog number 1202670 and packaged as 90 slides/pack catalog number 8112…
FDA Device · Class II · 2013-11-27 · Ortho Clinical Diagnostics - VITROS Chemistry Products PHOS Slides packaged as 300 slides/pack catalog number 1513209 VITROS PHOS Slides quantitatively measure phosphor…
FDA Device · Class II · 2013-11-27 · Ortho Clinical Diagnostics - Fixed Offset Adapter, A-642100
FDA Device · Class II · 2013-11-27 · Ossur North America - VITROS Chemistry Products CHOL Slides packaged as 300 slides/pack catalog number 1669829 VITROS CHOL Slides quantitatively measure choleste…
FDA Device · Class II · 2013-11-27 · Ortho Clinical Diagnostics - VITROS Chemistry Products ALB Slides, 90 slides/pack
FDA Device · Class II · 2013-11-27 · Ortho Clinical Diagnostics - VITROS Chemistry Products dHDL Slides packaged as 300 slides/pack catalog number 6801895 VITROS dHDL Slides quantitatively measure HDL chol…
FDA Device · Class II · 2013-11-27 · Ortho Clinical Diagnostics - VITROS Chemistry Products TBIL Slides packaged as 300 slides/pack catalog number 8159931 VITROS TBIL Slides quantitatively measure total bi…
FDA Device · Class II · 2013-11-27 · Ortho Clinical Diagnostics - Centricity Perinatal and Centricity Intensive Care is intended to be used in clinical departments healthcare delivery systems such as a Lab…
FDA Device · Class II · 2013-11-27 · Ge Healthcare It - VITROS Chemistry Products CK-MB Slides packaged as 300 slides/pack catalog number 8058232 and packaged as 90 slides/pack catalog number 800…
FDA Device · Class II · 2013-11-27 · Ortho Clinical Diagnostics - Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Z…
FDA Device · Class II · 2013-11-27 · Carl Zeiss Meditec - THUNDER¿ Extra Support Guidewire
FDA Device · Class I · 2013-11-27 · Medtronic Vascular - The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere elec…
FDA Device · Class I · 2013-11-27 · Hospira
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