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.
- ATTUNE CONV RP PS TB TRL SZ10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the…
FDA Device · Class II · 2015-07-29 · Depuy Orthopaedics - American Catheter / Cholangiogram Catheter 9100 Series
FDA Device · Class II · 2015-07-29 · American Catheter - Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 softwa…
FDA Device · Class II · 2015-07-29 · Volcano - ATTUNE CONV FB CR TB TRL SZ3 - 10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as…
FDA Device · Class II · 2015-07-29 · Depuy Orthopaedics - Head Holder shipped with Ingenuity CT Computed Tomography X-ray Systems
FDA Device · Class II · 2015-07-29 · Philips Medical Systems Cleveland - Sureflex 550 Lithotripsy Fiber, 5x, Blue
FDA Device · Class II · 2015-07-29 · American Medical Systems Innovation Center Silicon Valley - Ring Transjugular Intrahepatic Access Set Product Usage: The Ring Transjugular Intrahepatic Access Sets are intended for transjugular liver…
FDA Device · Class II · 2015-07-29 · Cook - Single Basin Kits, Sterile-.Kits containing the Devon Light Glove Catalog Number/Description: 573509 7696-GSL-VL SINGLE BASIN KIT 573558 76…
FDA Device · Class II · 2015-07-29 · Covidien - Sureflex 200 Lithotripsy Fiber, 5x, Blue
FDA Device · Class II · 2015-07-29 · American Medical Systems Innovation Center Silicon Valley - 0702-001-350Q, Diverter Valve Assembly 0702-001-000, Neptune 2 Rover Ultra (120V) 0702-001-000R, Repair Neptune 2 Rover 0702-002-000, Neptu…
FDA Device · Class II · 2015-07-29 · Stryker Instruments Div - Tool, Stripper W/BLD, 18S, Autoclavable
FDA Device · Class II · 2015-07-29 · American Medical Systems Innovation Center Silicon Valley - GEMINI TF 16 Slice CT/PET System
FDA Device · Class II · 2015-07-29 · Philips Medical Systems Cleveland - Fiber Cleaver
FDA Device · Class II · 2015-07-29 · American Medical Systems Innovation Center Silicon Valley - ATTUNE RP CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to fu…
FDA Device · Class II · 2015-07-29 · Depuy Orthopaedics - Head Holder shipped with Ingenuity Core Computed Tomography X-ray Systems
FDA Device · Class II · 2015-07-29 · Philips Medical Systems Cleveland - Perkin Elmer WIZARD2 10-detector, 1000 samples Product Code: 2470-0200, 3470-0200 The Wizard¿" gamma counter is intended to detect and coun…
FDA Device · Class II · 2015-07-29 · Perkinelmer - Tool, Stripper W/BLD, 44S, Autoclavable
FDA Device · Class II · 2015-07-29 · American Medical Systems Innovation Center Silicon Valley - THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1243 Product Usage: medical aspirator
FDA Device · Class II · 2015-07-29 · Gardner Denver Thomas - NS-3600-B LITE GLOVE 1000/CASE -Bulk, Non-sterile Catalog Number: 571711
FDA Device · Class II · 2015-07-29 · Covidien - Tool, Stripper W/BLD, 12S, Autoclavable
FDA Device · Class II · 2015-07-29 · American Medical Systems Innovation Center Silicon Valley - GEMINI TF Ready CT/PET System
FDA Device · Class II · 2015-07-29 · Philips Medical Systems Cleveland - GE Healthcare Precision 500D Classical R & F system
FDA Device · Class II · 2015-07-29 · Ge Healthcare - Fiber Stripper, 365¿m, Autoclavable
FDA Device · Class II · 2015-07-29 · American Medical Systems Innovation Center Silicon Valley - Tool, Stripper W/BLD, 14S, Nonautoclavable
FDA Device · Class II · 2015-07-29 · American Medical Systems Innovation Center Silicon Valley - Infant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSurgical and Fisher brand as follows : CooperSurgical PN 20418 W…
FDA Device · Class II · 2015-07-29 · Coopersurgical - Delivery/C-Section, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 56479 7335-SMC C-Section Kit 31404851 7382-O…
FDA Device · Class II · 2015-07-29 · Covidien - Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 softwa…
FDA Device · Class II · 2015-07-29 · Volcano - ADVIA Centaur Tni-Ultra Assay
FDA Device · Class II · 2015-07-29 · Siemens Healthcare Diagnostics - Surgical Kit Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 573326 7497-HLS Surgical Kit 573328 7437-NRF SURGIC…
FDA Device · Class II · 2015-07-29 · Covidien - Sureflex 365 Lithotripsy Fiber, 5x, Blue
FDA Device · Class II · 2015-07-29 · American Medical Systems Innovation Center Silicon Valley - Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case
FDA Device · Class II · 2015-07-29 · Custom Healthcare Systems - Silhouette Lift brochure Silhouette Sutures are for use in midface suspension surgery to fixate the cheek subdermis in an elevated position
FDA Device · Class II · 2015-07-29 · Silhouette Lift - Fiber Stripper, 273¿m, Autoclavable
FDA Device · Class II · 2015-07-29 · American Medical Systems Innovation Center Silicon Valley - Covidien Devon Light Gloves, Sterile-Single Units A disposable, sterile, single-use cover for compatible surgical light handles
FDA Device · Class II · 2015-07-29 · Covidien - ATTUNE CONV RP PS ARTICULATION SURFACE SZ1-9 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to…
FDA Device · Class II · 2015-07-29 · Depuy Orthopaedics - HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Stor…
FDA Device · Class II · 2015-07-29 · Hardy Diagnostics - Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone Template is used in the sterile field to c…
FDA Device · Class II · 2015-07-29 · Cochlear Americas - 200¿M Lithotripsy Fiber- Reusable
FDA Device · Class II · 2015-07-29 · American Medical Systems Innovation Center Silicon Valley - Tool, Stripper W/BLD, 28S, Autoclavable
FDA Device · Class II · 2015-07-29 · American Medical Systems Innovation Center Silicon Valley - WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard¿" gamma counter is intended to detect and count gamma radiation emitted…
FDA Device · Class II · 2015-07-29 · Perkinelmer - Tool, Stripper W/BLD, 18S, Nonautoclavable
FDA Device · Class II · 2015-07-29 · American Medical Systems Innovation Center Silicon Valley - GE Healthcare Precision RXi Digital system
FDA Device · Class II · 2015-07-29 · Ge Healthcare - Sureflex 273 Lithotripsy Fiber, 5x, Blue
FDA Device · Class II · 2015-07-29 · American Medical Systems Innovation Center Silicon Valley - Sureflex 910 Lithotripsy Fiber, 5x, Blue
FDA Device · Class II · 2015-07-29 · American Medical Systems Innovation Center Silicon Valley - Minor Surgical Kits, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 573208 7519-DHCG MINOR KIT 573210 7581-CSD…
FDA Device · Class II · 2015-07-29 · Covidien - Augmentation Kit , Sterile-.Kits containing the Devon Light Glove Catalog Number/Description 573732 7620-CWA Augmentation Kit
FDA Device · Class II · 2015-07-29 · Covidien - Perkin Elmer WIZARD2 1-detector,3", 1000 samples Product Code: 2480-0010 The Wizard¿" gamma counter is intended to detect and count gamma r…
FDA Device · Class II · 2015-07-29 · Perkinelmer - Hysto Pack, Non-sterile Part Number Description SA2059B MAJOR BASIN SA2220 HYSTO PACK SA2220A HYSTO PACK
FDA Device · Class II · 2015-07-29 · Covidien - Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product Usage: The CooperSurgical Milex Vaginal-Hymenal Silicone Dilators are use…
FDA Device · Class II · 2015-07-29 · Coopersurgical - Mini-Kits, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description 31141479 K-1842-S OR Mini Kit 31141487 K-1560-S3 OR Mi…
FDA Device · Class II · 2015-07-29 · Covidien - ATTUNE FB PS ARTICULATION SURFACE SIZES 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to f…
FDA Device · Class II · 2015-07-29 · Depuy Orthopaedics - Sureflex 150 Lithotripsy Fiber, 5x, Blue
FDA Device · Class II · 2015-07-29 · American Medical Systems Innovation Center Silicon Valley - Tool, Stripper W/BLD, 14S, Autoclavable
FDA Device · Class II · 2015-07-29 · American Medical Systems Innovation Center Silicon Valley - ATTUNE CONV FB CR ARTICULATION SURFACE SZ1 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to fu…
FDA Device · Class II · 2015-07-29 · Depuy Orthopaedics - ATTUNE FB CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to fu…
FDA Device · Class II · 2015-07-29 · Depuy Orthopaedics - ASC (Breast) Kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Decription: 573328 7437-NRF SURGICAL ASC KIT 50000511 7516-…
FDA Device · Class II · 2015-07-29 · Covidien - ATTUNE CONV FB PS ARTICULATION SURFACE SZ1-10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to…
FDA Device · Class II · 2015-07-29 · Depuy Orthopaedics - GE Healthcare Precision RXi 23A/32A Analog System
FDA Device · Class II · 2015-07-29 · Ge Healthcare - Major Kit, Sterile-.Kits containing the Devon Light Glove Catalog Number:Description 573831B MAJOR KIT
FDA Device · Class II · 2015-07-29 · Covidien - Bone Marrow Aspiration Needle 15G x 2.688 MAX, Part Number DBMNI1501
FDA Device · Class II · 2015-07-29 · Argon Medical Devices - ATTUNE RP PS ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to fu…
FDA Device · Class II · 2015-07-29 · Depuy Orthopaedics - Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 softwa…
FDA Device · Class II · 2015-07-29 · Volcano - Fiber Stripper, 910¿m, Autoclavable
FDA Device · Class II · 2015-07-29 · American Medical Systems Innovation Center Silicon Valley - Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxial Screw, Non-Sterile, Rx Only, REF 14-583020, Biomet Spine and…
FDA Device · Class II · 2015-07-29 · Biomet Spine - T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL
FDA Device · Class II · 2015-07-29 · Argon Medical Devices - Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander is intended for temporary subcutaneous implantation…
FDA Device · Class II · 2015-07-29 · Allergan - Fiber Stripper, 550¿m, Autoclavable
FDA Device · Class II · 2015-07-29 · American Medical Systems Innovation Center Silicon Valley - Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model Numbers 453560446041, 459800091001, 459800220161, 459800232931, 459800235871, 45980…
FDA Device · Class II · 2015-07-29 · Philips Electronics North America - Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 s…
FDA Device · Class II · 2015-07-29 · Volcano - Perkin Elmer WIZARD2 5-detector, 1 000 samples Product Code: 2470-0150, 3470-0150 The Wizard¿" gamma counter is intended to detect and coun…
FDA Device · Class II · 2015-07-29 · Perkinelmer - GEMINI TF Base CT/PET System
FDA Device · Class II · 2015-07-29 · Philips Medical Systems Cleveland - Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM Product Usage: The Stryker SelectCore Variable Throw Biopsy Device is used in ob…
FDA Device · Class II · 2015-07-29 · Stryker Instruments Div - Stripper, 0.3mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endo…
FDA Device · Class II · 2015-07-29 · American Medical Systems Innovation Center Silicon Valley - Flexor RTPS Guiding Sheath Product Usage: The Flexor RTPS Guiding Sheaths are intended for introduction of balloons, closed and non-tapered…
FDA Device · Class II · 2015-07-29 · Cook - iovera 155 Smart Tip
FDA Device · Class II · 2015-07-29 · Myoscience - Surgical Set Up kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 31144895 7614-T4 Single Basin Set Up Kit 31…
FDA Device · Class II · 2015-07-29 · Covidien - Stripper, 0.2mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endo…
FDA Device · Class II · 2015-07-29 · American Medical Systems Innovation Center Silicon Valley - Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 softwa…
FDA Device · Class II · 2015-07-29 · Volcano - The FLOW-i Anesthesia System Axillary O2 and Suction Module, Device Part number: 66 79 847 FLOW-i Anesthesia System: Is indicated for admin…
FDA Device · Class II · 2015-07-22 · Maquet Cardiovascular Us Sales - RadiForce RX850, 8MP Color LCD Monitor, Part Code No. 0FTD1958A2, UPC 690592037180
FDA Device · Class II · 2015-07-22 · Eizo - A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw
FDA Device · Class II · 2015-07-22 · Biomet - Sorin Stockert Heater-Cooler 3T, 208 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours
FDA Device · Class II · 2015-07-22 · Sorin Group Usa - ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device
FDA Device · Class II · 2015-07-22 · Zimmer - 0210-312-000-Woundcare Replacement kit with soft tip
FDA Device · Class II · 2015-07-22 · Stryker Instruments Div - Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107
FDA Device · Class II · 2015-07-22 · Exactech - Sorin Stockert Heater-Cooler 3T, 200 V / 50Hz / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours
FDA Device · Class II · 2015-07-22 · Sorin Group Usa - Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care
FDA Device · Class II · 2015-07-22 · Breas Medical Ab - 16mm Chisel Blade
FDA Device · Class II · 2015-07-22 · Synthes Usa Products - NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) system
FDA Device · Class II · 2015-07-22 · Northern Digital - NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgery) system
FDA Device · Class II · 2015-07-22 · Northern Digital - Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision radiotherapy for le…
FDA Device · Class II · 2015-07-22 · Viewray - Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1: The Nidek Green Laser Photocoagulator Model GYC- 1000 is indic…
FDA Device · Class II · 2015-07-22 · Nidek - MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery
FDA Device · Class II · 2015-07-22 · Elekta - Exactech Single Barrel Drill Guides The Single Barrel Drill Guide is a nonpowered hand-held device intended for medical purposes to manipul…
FDA Device · Class II · 2015-07-22 · Exactech - Sorin Stockert Heater-Cooler 3T, 230 V Temperature control for extracorporeal perfusion of durations up to 6 hours
FDA Device · Class II · 2015-07-22 · Sorin Group Usa - A.L.P.S. - Medium Bone Plate Forceps
FDA Device · Class II · 2015-07-22 · Biomet - IMPAX Agility
FDA Device · Class II · 2015-07-22 · Agfa Healthcare - Sorin Stockert Heater-Cooler 3T, 120 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours
FDA Device · Class II · 2015-07-22 · Sorin Group Usa - G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7. Product Usage: G7 Variant Elut…
FDA Device · Class III · 2015-07-22 · Tosoh Bioscience - Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The product is a non-sterile…
FDA Device · Class II · 2015-07-22 · Owen Mumford Usa
Other years
2026 (2,024) · 2025 (2,908) · 2024 (3,393) · 2023 (2,477) · 2022 (2,191) · 2021 (2,303) · 2020 (3,055) · 2019 (2,801) · 2018 (3,757) · 2017 (2,615) · 2016 (3,246) · 2015 (2,495) · 2014 (3,059) · 2013 (2,249) · 2012 (1,310)