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.
- Aperio ScanScope System
FDA Device · Class II · 2013-06-26 · Aperio Technologies - Biomet Trauma Phoenix Retrograde Femoral Connecting Bolt Trauma Fixation Systems
FDA Device · Class II · 2013-06-26 · Biomet - Philips BuckyDiagnost Radiographic
FDA Device · Class II · 2013-06-26 · Philips Healthcare - Superior Approach Resection Guide Assembly
FDA Device · Class II · 2013-06-26 · Biomet - ARTISTE with syngo RT Therapist version 4.3 Product Usage: The intended use of the SIEMENS branded ARTISTE family of linear accelerator sys…
FDA Device · Class II · 2013-06-26 · Siemens Medical Solutions Usa - GE Healthcare, PET VCAR. PET VCAR application software is affected if installed on any of the following versions of the Advantage Workstati…
FDA Device · Class II · 2013-06-26 · Ge Healthcare - VITROS Chemistry Products-HCY Reagent packaged in a kit carton
FDA Device · Class II · 2013-06-26 · Ortho Clinical Diagnostics - SybronEndo Replacement AC Power Cord, US Elements Obturation
FDA Device · Class II · 2013-06-26 · Ormco Sybronendo - Zimmer Patient Helper Bed Frame Adapter Assembly The bed frame adapter assembly is intended to be used by qualified medical professionals t…
FDA Device · Class II · 2013-06-26 · Zimmer - Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000.011
FDA Device · Class II · 2013-06-26 · Synthes Usa Hq - BC Hammock Mesh Sling (Medium), product number, 537005
FDA Device · Class II · 2013-06-26 · Prism Medical Services Usa - BC Hammock Mesh Sling (Junior), product number, 537005
FDA Device · Class II · 2013-06-26 · Prism Medical Services Usa - GlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2, 3, 4 and 5 reusable blades Product Usage: The GlideScope Video Laryngos…
FDA Device · Class I · 2013-06-26 · Verathon - MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplemental oxygen to adults
FDA Device · Class II · 2013-06-26 · Linde Gas North America - Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057, 712062 Product Usage: Universal RAD…
FDA Device · Class II · 2013-06-26 · Philips Healthcare - BC Hammock Mesh Sling (Small), product number, 537010
FDA Device · Class II · 2013-06-26 · Prism Medical Services Usa - Echelon, Echelon Oval and Oasis MR imaging device systems
FDA Device · Class II · 2013-06-26 · Hitachi Medical Systems America - BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip¿ Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ul…
FDA Device · Class II · 2013-06-19 · Bard Peripheral Vascular - BARD PERIPHERAL VASCULAR VACCESS¿ PTA Balloon Dilatation Catheters, 8mm x 4cm x 80cm
FDA Device · Class II · 2013-06-19 · Bard Peripheral Vascular - STAR S3 ActiveTrack Excimer System (STAR S3) Mfg by AMO Manufacturing USA, LLC 510 cottonwood Drive Milpitas, CA 95035 The STAR Excimer Las…
FDA Device · Class II · 2013-06-19 · Abbott Medical Optics - ECHELON 60mm Endoscopic Linear Cutter Reloads Black in Flexible Blister pack with Tyvek lid
FDA Device · Class II · 2013-06-19 · Ethicon Endo Surgery - DePuy Glenosphere orientation guide Product Usage: The glenosphere orientation guide is an instrument used in reverse shoulder arthroplasty
FDA Device · Class II · 2013-06-19 · Depuy Orthopaedics - MICROSHEATH¿ - 0.066 (1.7mm) proximal, 0.064 (1.6mm)
FDA Device · Class II · 2013-06-19 · Bard Peripheral Vascular - TX1 Tissue Removal System disposable handpieces
FDA Device · Class II · 2013-06-19 · American Optisurgical - embla Embletta Gold (It functions as a Polysomnography Recorder and Ventilator Effort Recorder)
FDA Device · Class II · 2013-06-19 · Embla System - 90 Degree Cannulated Infant Blade Plate 30mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is int…
FDA Device · Class II · 2013-06-19 · Orthopediatrics - USHER¿ Support Catheter- Angled Tip WL130cm, RI 7F
FDA Device · Class II · 2013-06-19 · Bard Peripheral Vascular - Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099), For use in determining quantitative and/or…
FDA Device · Class II · 2013-06-19 · Siemens Healthcare Diagnostics - StarDental Classique(TM) Diamond Dental Bur
FDA Device · Class II · 2013-06-19 · Dental Ez Stardental Division - VIA Medical Collection Bag
FDA Device · Class II · 2013-06-19 · International Biomedical - 90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is int…
FDA Device · Class II · 2013-06-19 · Orthopediatrics - BARD Biopsy Systems UltraClip Dual Trigger breast tissue marker
FDA Device · Class II · 2013-06-19 · Bard Peripheral Vascular - Brand Name: AFX" Introducer System, Model Number S17-45
FDA Device · Class I · 2013-06-19 · Endologix - Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140
FDA Device · Class II · 2013-06-19 · Applied Medical Resources - AMICUS Exchange Kit
FDA Device · Class II · 2013-06-19 · Fenwal - Deltran Disposable Pressure Transducer Kit (DPT Kit) Extracorporeal disposable pressure transducer and tubing set with integral stopcock an…
FDA Device · Class II · 2013-06-19 · Utah Medical Products - QuickDraw Venous Cannula with Insertion Kit
FDA Device · Class II · 2013-06-19 · Edwards Lifesciences - STAR S4 with Variable Spot Scanning Excimer System (STAR S4) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The…
FDA Device · Class II · 2013-06-19 · Abbott Medical Optics - BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip¿ Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ul…
FDA Device · Class II · 2013-06-19 · Bard Peripheral Vascular - 90 Degree Cannulated Infant Blade Plate 25mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is int…
FDA Device · Class II · 2013-06-19 · Orthopediatrics - STAR S4 IR Excimer System (STAR S4 IR) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser Sys…
FDA Device · Class II · 2013-06-19 · Abbott Medical Optics - ADVIA Centaur¿ iPTH ReadyPack Assay 100 Tests
FDA Device · Class II · 2013-06-12 · Siemens Healthcare Diagnostics - FAST Procedure Kit
FDA Device · Class II · 2013-06-12 · American Optisurgical - Stryker Instruments 0400-760-000 T4 Toga, Pullover, Large Sterile, EO
FDA Device · Class II · 2013-06-12 · Stryker Instruments Div - ADVIA Centaur¿ iPTH ReadyPack Assay 500 Tests
FDA Device · Class II · 2013-06-12 · Siemens Healthcare Diagnostics - Shimadzu Corporation - Mobile DaRt Evolution This device is a mobile X-ray system in order to take general radiography of patients in the h…
FDA Device · Class II · 2013-06-12 · Shimadzu Medical Systems - Stryker Instruments 0400-840-000 T4 Toga, Zipper, Large, Sterile, EO
FDA Device · Class II · 2013-06-12 · Stryker Instruments Div - Stryker Instruments 0400-830-000 T4 Toga, Zipper, Regular, Sterile, EO
FDA Device · Class II · 2013-06-12 · Stryker Instruments Div - Plastic bottle containing 3.5 mL of IgG FITC Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent…
FDA Device · Class III · 2013-06-12 · Bion Enterprises - Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL side)( 6mL/hr ),... found in the following kits GoBlock Kit 510612,…
FDA Device · Class I · 2013-06-12 · Symbios Medical Products - Stryker Instruments 0400-850-100 T5 zipper Toga with Peel Away, Sterile, EO
FDA Device · Class II · 2013-06-12 · Stryker Instruments Div - Hand Controls for Operon D750, D752, D760, D820 and D850 The hand controls are used to operate OPERON surgical tables
FDA Device · Class II · 2013-06-12 · Berchtold - Plastic bottle containing 10.5 mL of IgG Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assa…
FDA Device · Class III · 2013-06-12 · Bion Enterprises - Plastic bottle containing 10.5 mL of IgM Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assa…
FDA Device · Class III · 2013-06-12 · Bion Enterprises - Part510447 Disposable Infusion Pump, ...Elastomeric Pump 600 mL, 2mL/hr/side,... found in the following kits GoPump Kit 510462-BP, 5 " cath…
FDA Device · Class I · 2013-06-12 · Symbios Medical Products - Part 510121 Disposable Infusion Pump, ...Elastomeric Pump 300 mL, 4mL/hr,...sterile.. found in the following kits GoPump Kit 510203-BP, Epi…
FDA Device · Class I · 2013-06-12 · Symbios Medical Products - Versaport Bladeless Optical Trocar With (2) Fixation Cannulae - 5mm Product Code: ONB5STF2C The Versaport" Bladeless Optical 5mm trocars ar…
FDA Device · Class II · 2013-06-12 · Covidien - BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma ca…
FDA Device · Class II · 2013-06-12 · Philips Medical Systems Cleveland - I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Kit, Model #TB089T The intended use of each component in the finished final trays i…
FDA Device · Class II · 2013-06-12 · I Flow - ADVIA Centaur¿ iPTH Calibrator 6 pk
FDA Device · Class II · 2013-06-12 · Siemens Healthcare Diagnostics - Part 510490 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml per side)( 6mL/hr ),... found in the following kits GoBlock Kit 51…
FDA Device · Class I · 2013-06-12 · Symbios Medical Products - Stryker Instruments 0400-820-000 T4 Zipper Toga (L/XL) Sterile, O
FDA Device · Class II · 2013-06-12 · Stryker Instruments Div - Part 510076 Disposable Dual Infusion Pump, ...Elastomeric Dual Pump 300 mL(150 ml/side) 2mL/hr/side,... Sterile, found in the following kit…
FDA Device · Class I · 2013-06-12 · Symbios Medical Products - Straight Impactor - Dorado IBC, Part Number: SI02140
FDA Device · Class II · 2013-06-12 · Spinefrontier - SlingBar 360
FDA Device · Class II · 2013-06-12 · Hill Rom - Part 510613 Disposable Infusion Pump, ...Elastomeric Pump 300mL (150 mL side)( 6mL/hr ),... found in the following kits GoBlock Kit 510612,…
FDA Device · Class I · 2013-06-12 · Symbios Medical Products - Zimmer Air Dermatome II, REF 00-8851-001-01 handpiece, w/o hose, Rx, non-sterile grafting instruments intended to provide variable graft th…
FDA Device · Class II · 2013-06-12 · Zimmer Surgical - Stryker Instruments 0400-820-000S3 T4 Toga w/Inside Shoulder Ties, Sterile, O
FDA Device · Class II · 2013-06-12 · Stryker Instruments Div - E-Z WIDER BARIATRIC CHAIR BED
FDA Device · Class II · 2013-06-12 · Kreg Medical - Stryker Instruments 0400-720-000S5 T5 Pullover Toga w/Peel Away, Sterile, EO
FDA Device · Class II · 2013-06-12 · Stryker Instruments Div - FLEXSTENT Biliary Self-Expanding Stent System
FDA Device · Class II · 2013-06-12 · Cordis - Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Long Product Code: ONB5LGF The Versaport" Bladeless Optical 5mm trocars are…
FDA Device · Class II · 2013-06-12 · Covidien - SlingBar 350
FDA Device · Class II · 2013-06-12 · Hill Rom - Part 510449 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 8mL/hr ),... found in the following kits GoBlock Kit 510472, Disposable S…
FDA Device · Class I · 2013-06-12 · Symbios Medical Products - Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Product Code: ONB5STF The Versaport" Bladeless Optical 5mm trocars are inten…
FDA Device · Class II · 2013-06-12 · Covidien - Part 510636 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 300 ml perside), 2 to 10 ml/hr
FDA Device · Class I · 2013-06-12 · Symbios Medical Products - lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145, Product is manufactured by lnvatec SpA, Roncadelle, Italy,…
FDA Device · Class II · 2013-06-12 · Invatec - FLEXSTENT Biliary Self-Expanding Stent System
FDA Device · Class II · 2013-06-12 · Cordis - Versaport Bladeless Optical Fixation Cannula - 5mm Product Code: ONBFCA5ST The Versaport" Bladeless Optical 5mm trocars are intended for us…
FDA Device · Class II · 2013-06-12 · Covidien - Canister: CO2 canister with GE part numbers 1407-3200-000, 1407-7004-000, or M1084850
FDA Device · Class II · 2013-06-12 · Ge Healthcare - REF 8229705 x1 NIM TriVantage EMG Endotracheal Tube 5.0 mm I.D. x 6.5 mm O.D. Medtronic Xomed, Inc., 6743 Southpoint Drive North, Jacksonvi…
FDA Device · Class I · 2013-06-12 · Medtronic Xomed - ADVIA Centaur iPTH Calibrator 2 pk
FDA Device · Class II · 2013-06-12 · Siemens Healthcare Diagnostics - da Vinci 5 mm Flared Instrument Cannulae for use with the da Vinci S and Si Surgical Systems
FDA Device · Class II · 2013-06-12 · Intuitive Surgical - Stryker Instruments 0400-770-000 T4 Toga, Pullover, Ex-Large Sterile, EO
FDA Device · Class II · 2013-06-12 · Stryker Instruments Div - Part 510180 Disposable Single Infusion Pump, ... Elastomeric Pump 300 mL, 2mL/hr,... found in : GoPump Kit 510201-BP, 5 fenestrated cathete…
FDA Device · Class I · 2013-06-12 · Symbios Medical Products - Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging
FDA Device · Class III · 2013-06-12 · Optovue - Part 510450 Disposable Infusion Pump, ...Elastomeric Pump 600 mL( 10mL/hr ),... found in the following kits GoBlock Kit 510458, Disposable…
FDA Device · Class I · 2013-06-12 · Symbios Medical Products - FLEXSTENT Femoropopliteal Self-Expanding Stent System
FDA Device · Class II · 2013-06-12 · Cordis - The Zimmer Air Dermatome, REF 00- 8801- 001- 00 , Rx, non-sterile grafting instruments intended to provide variable graft thickness and wid…
FDA Device · Class II · 2013-06-12 · Zimmer Surgical - LPC Fine Mesh Cassette for the Leica LPC Printer
FDA Device · Class II · 2013-06-12 · Leica Microsystems - Stryker Instruments 0400-810-000 T4 Zipper Toga (S/M) Sterile, EO
FDA Device · Class II · 2013-06-12 · Stryker Instruments Div - Stryker Instruments 0400-850-000 T4 Toga, Zipper, (XL-Tall) Sterile, EO
FDA Device · Class II · 2013-06-12 · Stryker Instruments Div - Stryker Instruments 0400-710-000 T4 Pullover Toga (S/M) Sterile, EO
FDA Device · Class II · 2013-06-12 · Stryker Instruments Div - 8 mm Monopolar Curved Scissors (a.k.a. Hot Shears) Manufactured and Distributed by: Intuitive Surgical Sunny vale, CA The EndoWrist Monopol…
FDA Device · Class II · 2013-06-12 · Intuitive Surgical - American Optisurgical's TX1 Tissue Removal System Console
FDA Device · Class II · 2013-06-12 · American Optisurgical - Stryker Instruments 0400-850-000S2 T4 Toga, XL, w/Inside Tie) Sterile, EO
FDA Device · Class II · 2013-06-12 · Stryker Instruments Div - Part 510031 Disposable Single Infusion Pump, quantity Includes... TOTAL VOLUME: 150mL, 2 mL/hr continuous Delivery Time : App. 72 hrs when…
FDA Device · Class I · 2013-06-12 · Symbios Medical Products - Stryker Instruments 0400-820-100 T5 Zipper Toga with Peel Away, Sterile, O
FDA Device · Class II · 2013-06-12 · Stryker Instruments Div - Digitex Absorbable Polydiaxanone Suture, Size 2-0. Catalog Number / Code of product: 52031, 5203101400
FDA Device · Class II · 2013-06-12 · Coloplast Manufacturing Us - Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Short Product Code: ONB5SHF The Versaport" Bladeless Optical 5mm trocars are…
FDA Device · Class II · 2013-06-12 · Covidien
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