FDA Device · 2015
FDA Device recalls in 2015
RecallRadar indexes 2,495 FDA Device recall notices published in 2015. By classification: 77 Class I, 2,300 Class II, 118 Class III.
- Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large)
FDA Device · Class II · 2015-09-02 · Synthes Usa Products - APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells
FDA Device · Class II · 2015-09-02 · Omnilife Science - ExacTrac 6.0.x Patient Positioning System, Radiation therapy
FDA Device · Class II · 2015-09-02 · Brainlab Ag - Synthes Application Instrument for Sternal ZIPFIX
FDA Device · Class II · 2015-09-02 · Synthes Usa Products - cobas b 123 Fluid Pack COOX REF 05170036001 400 Product Usage: The cobas b 123 POC system is a fully automated POC system for whole blood i…
FDA Device · Class II · 2015-09-02 · Roche Diagnostics Operations - iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713,800-7714…
FDA Device · Class II · 2015-09-02 · Iris Diagnostics - Offset Femoral Alignment Guide, 2mm x 6¿
FDA Device · Class II · 2015-09-02 · Omnilife Science - RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning
FDA Device · Class II · 2015-09-02 · Raysearch Laboratories Ab - Concave Reamer Head, 16 mm
FDA Device · Class II · 2015-09-02 · Trilliant Surgical - Covidien Argyle Infant Heel Warmers (no tab) Item Code: MH00002N Product Usage: Intended for application of the right amount of heat to an…
FDA Device · Class II · 2015-09-02 · Covidien - Centricity Universal Viewer Product Usage: The Centricity Universal Viewer Version 6.0 software is a picture archiving and communications s…
FDA Device · Class II · 2015-09-02 · Ge Healthcare - HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2-8C…
FDA Device · Class II · 2015-09-02 · Hardy Diagnostics - OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1.00.08 1.05.07 1.10.01, 1.01.02 1.06.02 1.11.02, 1.02.01 1.07.0…
FDA Device · Class II · 2015-09-02 · Nidek - Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1 Product Usage: The DigitalDiagnost is intended for use…
FDA Device · Class II · 2015-09-02 · Philips Electronics North America - LX3 Floor Stand for Endure Luxite Envision Optical System
FDA Device · Class II · 2015-09-02 · Alcon Research - Covidien Argyle Infant Heel Warmers (with tab) Item Code: MH00002T Product Usage: Intended for application of the right amount of heat to a…
FDA Device · Class II · 2015-09-02 · Covidien - MiniCap Extended Life PD Transfer Set (6") with Twist Clamp
FDA Device · Class II · 2015-09-02 · Baxter Healthcare - Zippie IRIS Wheelchair. model EIZ5A in combination with option code 188M02 - MONO Backrest system with Dynamic Backrest option
FDA Device · Class II · 2015-09-02 · Sunrise Medical Us - PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05
FDA Device · Class II · 2015-09-02 · Ptw Freiburg - PICC Kits with Peel-Away Sheath Component
FDA Device · Class II · 2015-09-02 · Arrow International - CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diagnostic X-ray system for general radiographic…
FDA Device · Class II · 2015-09-02 · Carestream Health - Dimension Vista B¿2-Microglobulin Flex Reagent Cartridge (B2MIC)
FDA Device · Class II · 2015-09-02 · Siemens Healthcare Diagnostics - BD CD56 PE Cy 7: NCAM16.2 ASR Analyte Specific Reagent, Catalog number 335809 Hematology: The CD 56 antigen promotes homophilic adhesion in…
FDA Device · Class II · 2015-09-02 · Becton Dickinson And Bd Biosciences - MiniCap Extended Life PD Transfer Set
FDA Device · Class II · 2015-09-02 · Baxter Healthcare - Wheel caster set screw for Ferno iNX Wheeled Stretcher
FDA Device · Class II · 2015-09-02 · Ferno Washington - Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PACS-IW with Universal Viewer is a picture archiving and communicati…
FDA Device · Class II · 2015-09-02 · Ge Healthcare - Stryker Sustainability Solutions CB5LT Ethicon Endo-Surgery, Inc
FDA Device · Class II · 2015-09-02 · Stryker Sustainability Solutions - CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266
FDA Device · Class II · 2015-09-02 · Advanced Sterilization Products - Quickie IRIS Wheelchair. model EIZ4-2 in combination with option code 183M02 - MONO Backrest system with Dynamic Backrest option
FDA Device · Class II · 2015-09-02 · Sunrise Medical Us - MiniCap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp
FDA Device · Class II · 2015-09-02 · Baxter Healthcare - Guardian Real-Time Monitor, Model No. CSS7100
FDA Device · Class II · 2015-09-02 · Medtronic Minimed - 3.0/4.0 Cannulated Drill Bit
FDA Device · Class II · 2015-09-02 · Trilliant Surgical - SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01
FDA Device · Class I · 2015-09-02 · Ethicon Endo Surgery - Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE
FDA Device · Class II · 2015-09-02 · Trilliant Surgical - Bronchial One Lumen Tube - Left
FDA Device · Class II · 2015-08-26 · Teleflex - rHead Lateral Stem, Size 1, Do Not Reuse, Sterile
FDA Device · Class II · 2015-08-26 · Stryker Howmedica Osteonics - Sigmoid Notch, Radial Plate, Small, Sterile, Do Not Reuse, Rx Only
FDA Device · Class II · 2015-08-26 · Stryker Howmedica Osteonics - Bronchial One Lumen Tube - Right
FDA Device · Class II · 2015-08-26 · Teleflex - uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only
FDA Device · Class II · 2015-08-26 · Stryker Howmedica Osteonics - Winco XL Convalescent Recliner - with Steel Casters Long term patient recliner (Nursing, Rehabilitation, Geriatric Home Use, Retirement fac…
FDA Device · Class II · 2015-08-26 · Winco Mfg - Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse, Rx Only
FDA Device · Class II · 2015-08-26 · Stryker Howmedica Osteonics - Winco Drop Arm Care Cliner Standard - with Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities
FDA Device · Class II · 2015-08-26 · Winco Mfg - Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the Insertion Supply Kit, Product Code 51614S. Intermittent catheter
FDA Device · Class II · 2015-08-26 · C R Bard - RenLane Renal Denervation Catheter
FDA Device · Class II · 2015-08-26 · Cordis - Synthes Tibial Nail Wrap Holds 11 Nails and Synthes Intramedullary Nail Wrap Holds 10 Nails
FDA Device · Class II · 2015-08-26 · Synthes Usa Products - IBC Vascular Loop Catalog Number CH111, CH112, CH113, CH114, CH115, CH116, CH118 Product Usage: The IBC Vascular Loop is a single-use, disp…
FDA Device · Class II · 2015-08-26 · International Biophysics - Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668
FDA Device · Class III · 2015-08-26 · Getinge Disinfection Ab - Cell Search Circulating Tumor Kit
FDA Device · Class II · 2015-08-26 · Veridex - IBC Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL36, CVAPL40, CVAPL44, CVAPL48, CVAPL52, APM28BM, APM36BM, APM4…
FDA Device · Class II · 2015-08-26 · International Biophysics - HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Right sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile
FDA Device · Class I · 2015-08-26 · Teleflex Medical - Winco Care Cliner X-Large - with Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities
FDA Device · Class II · 2015-08-26 · Winco Mfg - ADVIA Chemistry Acetaminophen reagents
FDA Device · Class II · 2015-08-26 · Siemens Healthcare Diagnostics - Winco Drop Arm Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities
FDA Device · Class II · 2015-08-26 · Winco Mfg - Winco Designer Care Cliner w/Swing Arms - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities
FDA Device · Class II · 2015-08-26 · Winco Mfg - Winco Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities
FDA Device · Class II · 2015-08-26 · Winco Mfg - Winco Care Cliner Standart - Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities
FDA Device · Class II · 2015-08-26 · Winco Mfg - Winco Elite Care Cliner w/Swing Away Arms Standard - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician…
FDA Device · Class II · 2015-08-26 · Winco Mfg - Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models
FDA Device · Class I · 2015-08-26 · Covidien Formerly Nellcor Puritan Bennett - Siemens Intevo Series system, a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) c…
FDA Device · Class II · 2015-08-26 · Siemens Medical Solutions Usa - Alaris Syringe Pump, Model No. 8110
FDA Device · Class I · 2015-08-26 · Carefusion 303 - Xpert CT/NG Urine Specimen Collection Kit Part number GXCT/NGURINE-50
FDA Device · Class III · 2015-08-26 · Cepheid - HUDSON RCI, Sheridan SHER-I BRONCH Accessory Pack, Rx Only, Sterile
FDA Device · Class I · 2015-08-26 · Teleflex Medical - Bronchial Double Lumen Tube Set (Left), Extra Length, Sterile
FDA Device · Class II · 2015-08-26 · Teleflex - Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number CT/NGSWAB-50
FDA Device · Class III · 2015-08-26 · Cepheid - PS500 of an IACS Workstation Critical Care (Evita Infinity V500)
FDA Device · Class I · 2015-08-26 · Draeger Medical - Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 12 Fr, (30/box), Product Code 51612
FDA Device · Class II · 2015-08-26 · C R Bard - RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray
FDA Device · Class II · 2015-08-26 · Sedecal - Carlens Bronchial Double Lumen Tube Set (Left) Sterile
FDA Device · Class II · 2015-08-26 · Teleflex - HUDSON RCI, Sheridan, SHER-I-SWIV and SHER-I-SWIV/FO Double Swivel, Rx Only, Sterile
FDA Device · Class I · 2015-08-26 · Teleflex Medical - BD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x 100 mm, Sterile
FDA Device · Class III · 2015-08-26 · Becton Dickinson And - Winco Designer Care Cliner - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities
FDA Device · Class II · 2015-08-26 · Winco Mfg - Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only
FDA Device · Class II · 2015-08-26 · Stryker Howmedica Osteonics - IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction Wand is a component of Blood Recovery System for use in open heart pro…
FDA Device · Class II · 2015-08-26 · International Biophysics - Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR REF 5530-G-209 (component of the Triathlon Total Knee System) for fixation to…
FDA Device · Class II · 2015-08-26 · Stryker Howmedica Osteonics - Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 10 Fr, (30/box), Product Code 51610
FDA Device · Class II · 2015-08-26 · C R Bard - Winco Nocturnal Elite Care Cliner - with Nylon Casters Lay Flat Clinical Patient Recliner w/ Trendelenburg (Long Term Oncology, Dialysis, H…
FDA Device · Class II · 2015-08-26 · Winco Mfg - 2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Countersink Part # 210-40-002 NON-STERILE P…
FDA Device · Class II · 2015-08-26 · Trilliant Surgical - Siemens Symbia T Series, a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera…
FDA Device · Class II · 2015-08-26 · Siemens Medical Solutions Usa - Winco Inverness 24-Hour Treatment Recliner - with Nylon Casters Lay Flat Clinical Patient Recliner w/ Trendelenburg (Long Term Oncology, Di…
FDA Device · Class II · 2015-08-26 · Winco Mfg - HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Left sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile
FDA Device · Class I · 2015-08-26 · Teleflex Medical - Tracheopart Set (Left), Sterile
FDA Device · Class II · 2015-08-26 · Teleflex - Radiometer Fixation Kit N20 for the TCM CombiM monitoring system, REF 905-873
FDA Device · Class II · 2015-08-26 · Radiometer America - American Science & Engineering Inc,Gemini Cabinet X-ray system
FDA Device · Class II · 2015-08-26 · American Science And Engineering - Siemens Symbia S Series system, a diagnostic analog or digital detector based planar (2- dimensional) nuclear medicine (NM) imaging system…
FDA Device · Class II · 2015-08-26 · Siemens Medical Solutions Usa - Bronchial Double Lumen Tube Set (Right), Sterile
FDA Device · Class II · 2015-08-26 · Teleflex - White Bronchial Double Lumen Tube Set (Right) Sterile
FDA Device · Class II · 2015-08-26 · Teleflex - Winco Elite Care Cliner w/Swing Away Arms X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician…
FDA Device · Class II · 2015-08-26 · Winco Mfg - Alaris Medley LVP Bezel Assembly
FDA Device · Class I · 2015-08-26 · Elite Biomedical Solutions - Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long
FDA Device · Class II · 2015-08-26 · Synthes Usa Products - Medline Electrical Clipper with Charging base The Electrical Surgical Clipper is intended for the removal of body hair from patients as req…
FDA Device · Class II · 2015-08-26 · Medline Industries - Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 14 Fr, (30/box), Product Code 51614
FDA Device · Class II · 2015-08-26 · C R Bard - Tracheopart Set (Right), Sterile
FDA Device · Class II · 2015-08-26 · Teleflex - Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 16 Fr, (30/box), Product Code 51616
FDA Device · Class II · 2015-08-26 · C R Bard - Medtronic EOPA Arterial Cannula, Model # 77620
FDA Device · Class II · 2015-08-26 · Medtronic Perfusion Systems - Alaris Medley LVP Frame Membrane
FDA Device · Class I · 2015-08-26 · Elite Biomedical Solutions - Bronchial Double Lumen Tube Set (Left), Sterile
FDA Device · Class II · 2015-08-26 · Teleflex - Artis zee/ zeego systems
FDA Device · Class II · 2015-08-26 · Siemens Medical Solutions Usa - Winco Drop Arm Care Cliner Standard - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities
FDA Device · Class II · 2015-08-26 · Winco Mfg - ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended for percutaneous drainage of fluids from body cavities
FDA Device · Class II · 2015-08-19 · Merit Medical Systems - Wall Chart for STERRAD 100NX System, P/N 10104
FDA Device · Class II · 2015-08-19 · Advanced Sterilization Products
Other years
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