FDA Device · 2014
FDA Device recalls in 2014
RecallRadar indexes 3,059 FDA Device recall notices published in 2014. By classification: 558 Class I, 2,441 Class II, 60 Class III.
- Cannabinoids DAU Calibrator Control Level 1 (62.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentia…
FDA Device · Class II · 2014-03-19 · Lin Zhi International - Smith & Nephew RENASYS-Gauze with Soft Port Kit REF #'s: 66800933, 66800934, 66800935, and 66800936 (The RENASYS Soft Port Dressing Kits ar…
FDA Device · Class II · 2014-03-19 · Smith And Nephew - REF 623411 L, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, Small, Sterile R Qty 1 The S-ROM Hinged knee f…
FDA Device · Class II · 2014-03-19 · Depuy Orthopaedics - 4043-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device Arterial Blood Sampling Line Dr…
FDA Device · Class II · 2014-03-19 · Smiths Medical Asd - Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes Small Notch Titanium Reconstructive Plate set offers fixation…
FDA Device · Class II · 2014-03-19 · Synthes - 4042LH: 3 mL Line Draw, Luer lock syringe (heparin concentration: 7 I.U. per mL)with Filter-Pro¿ device Arterial Blood Sampling Line Draw S…
FDA Device · Class II · 2014-03-19 · Smiths Medical Asd - REF 623401 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, medium, Sterile R Qty 1 The S-ROM Hinged knee f…
FDA Device · Class II · 2014-03-19 · Depuy Orthopaedics - RetCam 3, RetCam Portable and RetCam Shuttle
FDA Device · Class II · 2014-03-19 · Clarity Medical Systems - VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators
FDA Device · Class III · 2014-03-19 · Ortho Clinical Diagnostics - REF 623411 R S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Small, Sterile R Qty 1 The S-ROM Hinged knee f…
FDA Device · Class II · 2014-03-19 · Depuy Orthopaedics - Smith & Nephew RENASYS-AB Abdominal Dressing Kit with Soft Port REF #'s: 66800980 (The RENASYS Soft Port Dressing Kits are used in conjunct…
FDA Device · Class II · 2014-03-19 · Smith And Nephew - Cannabinoids DAU Calibrator Control Level 1 (37.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentia…
FDA Device · Class II · 2014-03-19 · Lin Zhi International - HER2 Image Analysis Manual Read of HER2 Digital Slides ER/PR Image Analysis IHC PR Breast Tissue Manual Read of Digital Slides The ScanScop…
FDA Device · Class II · 2014-03-19 · Leica Biosystems Imaging - 4043W-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, syringe tip cap and 6 mL Luer…
FDA Device · Class II · 2014-03-19 · Smiths Medical Asd - G1777: Umbilical (2) 3 mL Line Draw, Luer lock syringes (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ devices and (2) Needle-P…
FDA Device · Class II · 2014-03-19 · Smiths Medical Asd - 4043G-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device and ice bag Arterial Blood Sam…
FDA Device · Class II · 2014-03-19 · Smiths Medical Asd - Treatment packs used on the VisuMax Laser Keratome
FDA Device · Class II · 2014-03-19 · Carl Zeiss Meditec Ag - Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction
FDA Device · Class II · 2014-03-19 · Horiba Instruments - VERIFY¿ SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, 440-354-2600
FDA Device · Class II · 2014-03-19 · Steris - GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Innova 2121IQ, Innova 3131IQ
FDA Device · Class II · 2014-03-19 · Ge Healthcare - REF 623421 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left , X-Small, Sterile R Qty 1 The S-ROM Hinged knee…
FDA Device · Class II · 2014-03-19 · Depuy Orthopaedics - G1762: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, syringe tip cap, and 5 mL Luer…
FDA Device · Class II · 2014-03-19 · Smiths Medical Asd - 4042E: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device (for sale in Europe only) Arteri…
FDA Device · Class II · 2014-03-19 · Smiths Medical Asd - REF 623401 R, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Medium, Sterile R Qty 1 The S-ROM Hinged knee…
FDA Device · Class II · 2014-03-19 · Depuy Orthopaedics - G2001: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, Needle-Pro¿ Device and 23G x 1…
FDA Device · Class II · 2014-03-19 · Smiths Medical Asd - PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No. D128201, D128202, D128204, D128205, D128207, D128208,…
FDA Device · Class II · 2014-03-19 · Biosense Webster - Gyrus ACMI Disposable Falope-Ring Band Applicator Kits
FDA Device · Class II · 2014-03-19 · Gyrus Medical - Navigator Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing
FDA Device · Class II · 2014-03-19 · Biomet 3i - REF 623421 RS-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right , X-Small, Sterile R Qty 1 The S-ROM Hinged knee…
FDA Device · Class II · 2014-03-19 · Depuy Orthopaedics - Contra-Angle Torque Driver Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing
FDA Device · Class II · 2014-03-19 · Biomet 3i - bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R), bioMerieux, Hazelwood, MO
FDA Device · Class II · 2014-03-19 · Biomerieux - GE Healthcare Infinia and Infinia Hawkeye Nuclear Medicine Systems
FDA Device · Class II · 2014-03-19 · Ge Healthcare - Tapered Navigator Certain Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processi…
FDA Device · Class II · 2014-03-19 · Biomet 3i - MAQUET PLEGIOX Cardioplegia Heat Exchanger The PLEGIOX Cardioplegia Heat Exchanger is used as part of a cardioplegia system to set and main…
FDA Device · Class II · 2014-03-19 · Maquet Cardiovascular Us Sales - G1469J: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device (for sale in Japan only) Arteri…
FDA Device · Class II · 2014-03-19 · Smiths Medical Asd - G1725: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device and 1 mL Line Draw Luer slip syr…
FDA Device · Class II · 2014-03-19 · Smiths Medical Asd - Panaroma Central Station Product Usage: This device can view real time, store, print, graph, and trend patient clinical and demographic data
FDA Device · Class II · 2014-03-19 · Mindray Ds Usa - 4042-2: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device Arterial Blood Sampling Line Dr…
FDA Device · Class II · 2014-03-19 · Smiths Medical Asd - CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II¿ is a semi-automated fluorescence microscope, consist…
FDA Device · Class II · 2014-03-19 · Veridex - Smith & Nephew RENASYS-F XL with Soft Port REF #: 66800797 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative press…
FDA Device · Class II · 2014-03-19 · Smith And Nephew - VerifyNow IIb/IIIa Test, Catalog No. 85310, 10-Test Kit and Catalog No. 85011, 25-Test kit
FDA Device · Class II · 2014-03-19 · Accumetrics - Smith & Nephew RENASYS-F Foam Dressing Kit with Soft Port REF #'s: 66800794, 66800795, and 66800796 (The RENASYS Soft Port Dressing Kits ar…
FDA Device · Class II · 2014-03-19 · Smith And Nephew - 4043E: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device (for sale in Europe only) Arteri…
FDA Device · Class II · 2014-03-19 · Smiths Medical Asd - Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with Q-CPR Meter Option B08 The HeartStart MRx is for use for the te…
FDA Device · Class II · 2014-03-19 · Philips Medical Systems - Smith & Nephew RENASYS Soft Port REF: 66800799 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound th…
FDA Device · Class II · 2014-03-19 · Smith And Nephew - XiO RPT System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brac…
FDA Device · Class II · 2014-03-19 · Elekta - Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A, M3536M,M3536M4,M3536M6,861288,861289,861464,861483,and 861491
FDA Device · Class II · 2014-03-19 · Philips Medical Systems - Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The intended use of the Quasar system is to pe…
FDA Device · Class II · 2014-03-19 · Ge Healthcare - Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25, packaged Tyvek¿ polyester peel…
FDA Device · Class II · 2014-03-19 · Megadyne Medical Products - Smith & Nephew RENASYS-G Sterile, Gauze Dressing Kit with Soft Port REF #'s: 66800961 (The RENASYS Soft Port Dressing Kits are used in conj…
FDA Device · Class II · 2014-03-19 · Smith And Nephew - Contra-Angle Torque Driver Kit For Certain and External Connection Product Usage: Molded plastic tray used in holding various dental instru…
FDA Device · Class II · 2014-03-19 · Biomet 3i - Mar Cor Purification CWP Reverse Osmosis System
FDA Device · Class II · 2014-03-19 · Mar Cor Purification - Contra-Angle Torque Driver Kit For Certain Internal Connection Product Usage: Molded plastic tray used in holding various dental instrument…
FDA Device · Class II · 2014-03-19 · Biomet 3i - 4040-2: Umbilical 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, 22g x 1¿ needle, and…
FDA Device · Class II · 2014-03-19 · Smiths Medical Asd - Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664
FDA Device · Class II · 2014-03-19 · Boston Scientific - GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850
FDA Device · Class II · 2014-03-19 · Ge Healthcare - GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine…
FDA Device · Class II · 2014-03-19 · Ge Healthcare - PRE1055US: Prevena Dressing, 5 Pack (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the environment o…
FDA Device · Class II · 2014-03-12 · Kci Usa - ABX PENTRA Multical
FDA Device · Class II · 2014-03-12 · Horiba Instruments - PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena Incision Management System is intended to manage the environment of s…
FDA Device · Class II · 2014-03-12 · Kci Usa - PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the e…
FDA Device · Class II · 2014-03-12 · Kci Usa - Agility
FDA Device · Class II · 2014-03-12 · Elekta - Punch Hair Matic A surgical hair transplant device designed for automation of follicular transplantation
FDA Device · Class II · 2014-03-12 · Medicamat - Accessory shorts for the AlterG Anti-Gravity treadmill
FDA Device · Class II · 2014-03-12 · Alterg - All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiat…
FDA Device · Class II · 2014-03-12 · Elekta - TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System
FDA Device · Class II · 2014-03-12 · Toshiba American Medical Systems - GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5)
FDA Device · Class II · 2014-03-12 · Ge Healthcare - DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries
FDA Device · Class II · 2014-03-12 · Deroyal Industries - Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV vir…
FDA Device · Class II · 2014-03-12 · Focus Diagnostics - AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002, diopter size: 16.0 and 21.0. Indicated for primary implantation for…
FDA Device · Class II · 2014-03-12 · Amo Puerto Rico Manufacturing - MEDITECH Microbiology - Calculator/data processing module, for clinical use
FDA Device · Class II · 2014-03-12 · Medical Information Technology - PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena Incision Management System is intended to manage the environment o…
FDA Device · Class II · 2014-03-12 · Kci Usa - BencoDental tartar & stain remover ultrasonic cleaning solution Product Usage: Formulated especially for removal of calculus, tartar, tobac…
FDA Device · Class II · 2014-03-12 · Heraeus Kulzer - PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY) Product Usage: The Prevena Incision Management System is intended…
FDA Device · Class II · 2014-03-12 · Kci Usa - *** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE HEMA
FDA Device · Class II · 2014-03-12 · Hospira - PRE1055: Prevena Dressing, 5 Pack Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical i…
FDA Device · Class II · 2014-03-12 · Kci Usa - Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the delivery of radiation to defined targe…
FDA Device · Class II · 2014-03-12 · Elekta - PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: The Prevena Incision Management System is intended to manage the envi…
FDA Device · Class II · 2014-03-12 · Kci Usa - GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the Automatic-View-On- Alarm (AVOA) featur…
FDA Device · Class II · 2014-03-12 · Ge Healthcare - PRE2001: Prevena Incision Management Customizable System Box Product Usage: The Prevena Incision Management System is intended to manage th…
FDA Device · Class II · 2014-03-12 · Kci Usa - Integrity
FDA Device · Class II · 2014-03-12 · Elekta - Model Kodak 2200 Intraoral X-Ray System, Catalog Numbers 5303177, 5303169, 5303151, XR-5154323 -- Carestream Health, Inc
FDA Device · Class II · 2014-03-12 · Carestream Health - Agility
FDA Device · Class II · 2014-03-12 · Elekta - Trilogy Ventilators The Respironics Trilogy 100 system provides continuous or intermittent ventilator support for the care of individuals w…
FDA Device · Class I · 2014-03-12 · Phillips Respironics - RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as the user interface for the SL/…
FDA Device · Class II · 2014-03-12 · Elekta - McKesson Anesthesia Care Product Usage: The McKesson Anesthesia Care system is a computer based system which collects, processes,and record…
FDA Device · Class I · 2014-03-12 · Mckesson Technologies - FMP X-alt Acetabular Liner This acetabular liner is intended for use with DJO Surgical hip systems
FDA Device · Class II · 2014-03-12 · Djo Surgical - Mobile X-ray System, Model: MUX-100, MUX-100H Product Usage: The device is a mobile X-ray system in order to take general radiography of pa…
FDA Device · Class II · 2014-03-12 · Shimadzu Medical Systems - Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream Health, Inc. 150 Verona Street Rochester, NY 14608…
FDA Device · Class II · 2014-03-12 · Carestream Health - Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12 mL syringe
FDA Device · Class III · 2014-03-12 · Medefil - TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System
FDA Device · Class II · 2014-03-12 · Toshiba American Medical Systems - Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate family and this technology include…
FDA Device · Class II · 2014-03-12 · Synthes - Medtronic O-arm Imaging System Mobile X-ray system
FDA Device · Class II · 2014-03-12 · Medtronic Navigation - Greatbatch Medical, Offset Cup Impactor
FDA Device · Class I · 2014-03-12 · Greatbatch Medical - Triton FP Infusion Pump, Part Number 400000, packaged in boxes
FDA Device · Class II · 2014-03-12 · Walkmed Infusion - Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic Syste…
FDA Device · Class II · 2014-03-12 · Mako Surgical - Renasys EZ PLUS, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System
FDA Device · Class II · 2014-03-05 · Smith And Nephew - Optiflux F180NR High Flux Dialyzers
FDA Device · Class II · 2014-03-05 · Fresenius Medical Care Holdings - CATH TRAY
FDA Device · Class I · 2014-03-05 · Medline Industries - 00434811113, REF I4348-111-13 Zimmer Trabecular Metal Shoulder Humeral Stem 48 Degrees 11 mm Stem Diameter 130 mm Stem Length Trabecular Me…
FDA Device · Class II · 2014-03-05 · Zimmer
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)