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.
- Nestle Nutrition, Compat, Enteral Feeding Tube, sterile, 8 French (REF 08310400), 10 French (REF 08310600), and 12 French (REF 08310500)
FDA Device · Class II · 2013-08-14 · Nestle Healthcare Nutrition - List No. 14200-28
FDA Device · Class I · 2013-08-14 · Hospira - Getinge Assure Accufast BI Test Pack w/ 5 Controls, SteriTec Product Code PL 395, Distributor Product Code 61301606638 The Smart-Read Biolo…
FDA Device · Class II · 2013-08-07 · Steritec Products Mfc - Medline Steam Biological Indicators, SteriTec Product Code PL 353, Distributor Product Code MDS200525 EZTest Steam Biological Indicator: Me…
FDA Device · Class II · 2013-08-07 · Steritec Products Mfc - Synthes Synapse SD Drill Guide, Part Number SD389.477, Lot Number 6913900 Indicated for Hooks, Plate/Rods, Rods and Screws when intended to…
FDA Device · Class II · 2013-08-07 · Synthes Usa Hq - ViSi Mobile Monitor, Catalog No. 92-10010 The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified perso…
FDA Device · Class II · 2013-08-07 · Sotera Wireless - AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software Versions), Model Numbers AU5811, AU5821, AU5831 and AU5841
FDA Device · Class II · 2013-08-07 · Beckman Coulter - Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixatio…
FDA Device · Class II · 2013-08-07 · Synthes Usa Hq - Cardinal Steam Biological Indicator, SteriTec Product Code PL 218, Distributor Product Code T40360EZ EZTest Steam Biological Indicator: Mes…
FDA Device · Class II · 2013-08-07 · Steritec Products Mfc - Exactech Articulated Driver A nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices…
FDA Device · Class II · 2013-08-07 · Exactech - Picis ED Pulsecheck - EMR Software Application - 2125, Software Versions: 5.2 and 5.3. The application stores patient information in a data…
FDA Device · Class II · 2013-08-07 · Picis - Inspira AIR Balloon Dilation system
FDA Device · Class II · 2013-08-07 · Acclarent - Omnicycle Elite
FDA Device · Class II · 2013-08-07 · Accelerated Care Plus - GE Healthcare, LOGIQ e Ultrasound System
FDA Device · Class II · 2013-08-07 · Ge Healthcare - Inspira AIR Balloon Dilation system
FDA Device · Class II · 2013-08-07 · Acclarent - Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
FDA Device · Class II · 2013-08-07 · Heartware - Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev
FDA Device · Class II · 2013-08-07 · Spinefrontier - Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes
FDA Device · Class II · 2013-08-07 · Mesa Laboratories Bozeman Manufacturing Facility - Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Product Code PL 200, Distributor Product Code MDS200500IR SteriT…
FDA Device · Class II · 2013-08-07 · Steritec Products Mfc - ViSi Mobile Chest Sensor (3 lead-wire ECG, AAMI), Catalog No. 93-10014 The ViSi Mobile Monitoring System is intended for use by clinicians…
FDA Device · Class II · 2013-08-07 · Sotera Wireless - Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor for the following laboratory applications: fixation,…
FDA Device · Class II · 2013-08-07 · Leica Microsystems - AIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and AIA-600II Analyzers, 1000 tips/bag AIA-Analyzer Tips are disposable…
FDA Device · Class II · 2013-08-07 · Tosoh Smd - Getinge Assure Accufast BI Test Pack w/ 25 Controls, SteriTec Product Code PL 395/25, Distributor Product Code 61301606639 The Smart-Read B…
FDA Device · Class II · 2013-08-07 · Steritec Products Mfc - Inspira AIR Balloon Dilation system
FDA Device · Class II · 2013-08-07 · Acclarent - Mesa Labs Smart-Read 10^5 EZ Test BI Test Pack, SteriTec Product Code PL 298/25, Distributor Product Code SRSP/25 The Smart-Read Biological…
FDA Device · Class II · 2013-08-07 · Steritec Products Mfc - uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2 Doshomachi 3-chome, Chuo-Ku Osaka 540-8605 Japan Di…
FDA Device · Class II · 2013-08-07 · Wako Life Sciences - GE Healthcare, VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM. The device is a general purpose ultrasound system
FDA Device · Class II · 2013-08-07 · Ge Healthcare - Inspira AIR Balloon Dilation system
FDA Device · Class II · 2013-08-07 · Acclarent - Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes
FDA Device · Class II · 2013-08-07 · Mesa Laboratories Bozeman Manufacturing Facility - Inspira AIR Balloon Dilation system
FDA Device · Class II · 2013-08-07 · Acclarent - syngo Dynamics Information System (sDIS) versions 9.5 and VA10A. The syngo¿ Dynamics system is intended for the acceptance, transfer, displ…
FDA Device · Class II · 2013-08-07 · Siemens Medical Solutions Usa - Eon Mini - 3788 (IPG), Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs inclu…
FDA Device · Class II · 2013-08-07 · St Jude Medical - Inspira AIR Balloon Dilation system
FDA Device · Class II · 2013-08-07 · Acclarent - GAMMA3 System Long Nail Kit, R2.0, Ti, Left Distributed in USA by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA A si…
FDA Device · Class II · 2013-08-07 · Stryker Howmedica Osteonics - Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx Non-Sterile
FDA Device · Class II · 2013-08-07 · Custom Spine - Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system
FDA Device · Class II · 2013-08-07 · Siemens Medical Solutions Usa - EZTest Steam Biological Indicator, SteriTec Product Code EZS and EZS-400 EZTest Steam Biological Indicator: Mesa EZTest Steam Biological In…
FDA Device · Class II · 2013-08-07 · Steritec Products Mfc - BD Affirm VPIII Microbial Identification Tests, packaged in kits, 120 test\kit, Catalog # 446257 and 24 test\kit, Catalog # 446252
FDA Device · Class II · 2013-08-07 · Becton Dickinson And - S-LIFT Slap Hammer, Part Number: 11-50204, Revision A The slap hammers are used primarily to remove trial instruments that are used to esti…
FDA Device · Class II · 2013-08-07 · Spinefrontier - Cardinal BI Stat Biological Test Pack with Instant Readout Integrator, SteriTec Product Code PL 160/A, Distributor Product Code T40311PE St…
FDA Device · Class II · 2013-08-07 · Steritec Products Mfc - Inspira AIR Balloon Dilation system
FDA Device · Class II · 2013-08-07 · Acclarent - LPS Lower Extremity Dovetail Intercalary component
FDA Device · Class I · 2013-08-07 · Depuy Orthopaedics - The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and…
FDA Device · Class II · 2013-08-07 · Hospira - BBL Brucella Laked Blood Agar with Kanamycin and Vancomycin (KV), Catalog # 297840, packaged in cartons of 20 plates, labeled in part ***Be…
FDA Device · Class II · 2013-07-31 · Becton Dickinson And - Advanced Orthogonal Percussion Adjusting Instrument Indicated for use by a licensed Chiropractor to assist in making Chiropractic adjustmen…
FDA Device · Class II · 2013-07-31 · Advanced Orthogonal Equipment - AlboGraft Woven with Collagen, Straight 15x30 Catalog Number: ATC1530 AlboGraft Vascular Grafts are made of synthetic material and designed…
FDA Device · Class I · 2013-07-31 · Lemaitre Vascular - BD BBL Vancomycin Screen Agar, carton of 10 plates, catalog # 222204, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Spa…
FDA Device · Class II · 2013-07-31 · Becton Dickinson And - AlboGraft Knitted with Collagen, Straight 40x07 Catalog Number: AMC4007 AlboGraft Vascular Grafts are made of synthetic material and design…
FDA Device · Class I · 2013-07-31 · Lemaitre Vascular - AlboGraft Knitted with Collagen, Straight 40x08 Catalog Number: AMC4008 AlboGraft Vascular Grafts are made of synthetic material and design…
FDA Device · Class I · 2013-07-31 · Lemaitre Vascular - Radiohead Access Point 1.4 GHz Radiohead Access Point Firmware versions: C.00.04 & C.00.05 Part Number: 989803171211 Product Usage: Intelli…
FDA Device · Class II · 2013-07-31 · Philips Healthcare - AlboGraft Knitted with Collagen, Bifurcate 18x09 Catalog Number: AMC1809 AlboGraft Vascular Grafts are made of synthetic material and desig…
FDA Device · Class I · 2013-07-31 · Lemaitre Vascular - Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system
FDA Device · Class I · 2013-07-31 · Ge Healthcare - TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies
FDA Device · Class II · 2013-07-31 · Haemonetics - TotalCare Bed used with AccuMax Quantum VPC mattress AccuMax Quantum Complete mattress, and AccuMax Quantum Convertible mattress The TotalC…
FDA Device · Class II · 2013-07-31 · Hill Rom - Rultract Retractor Ratchet Cover Plate Distributed by Pemco, Inc., Cleveland, OH 44131 Surgical retractor used to lift the incision site
FDA Device · Class II · 2013-07-31 · Pemco - BD BBL Schaedler K-V Agar with 5% Sheep Blood, carton of 20 plates, catalog # 221555, labeled in part ***Becton, Dickinson and Company 7 Lo…
FDA Device · Class II · 2013-07-31 · Becton Dickinson And - Axiom Aristos MX Solid State Flat Panel Digital Imager, Model number 5895003
FDA Device · Class II · 2013-07-31 · Siemens Medical Solutions Usa - STERIS Fine Traction Device, one unit per box Product Usage: The Fine Traction Device is used to provide traction and enable fine adjustmen…
FDA Device · Class II · 2013-07-31 · Steris - Endopath Electrosurgery Probe Plus II, twelve (12) different devices, including hooks, spatulas, right angles, curved dissectors, suction/i…
FDA Device · Class II · 2013-07-31 · Ethicon Endo Surgery - ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed
FDA Device · Class II · 2013-07-31 · Siemens Medical Solutions Usa - AlboGraft Woven with Collagen, Straight 30x16 Catalog Number: ATC3016 AlboGraft Vascular Grafts are made of synthetic material and designed…
FDA Device · Class I · 2013-07-31 · Lemaitre Vascular - Myoscience brand iovera Smart Tip, Myoscience Cryo-Touch IV, a Cryogenic Surgical device, REF Catalog Number: STA0311-10
FDA Device · Class II · 2013-07-31 · Myoscience - Philips HeartStart MRx Monitor/Defibrillator, Model numbers M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 The…
FDA Device · Class II · 2013-07-31 · Philips Healthcare - Medtronic Preimplantation Test Kit, Catalog No. 21047
FDA Device · Class II · 2013-07-31 · Medtronic Neurosurgery - ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device is intended for vertebral body replacement or intervertebral body fusion to aid in…
FDA Device · Class II · 2013-07-31 · Aesculap - AlboGraft Woven with Collagen, Straight 30x24 Catalog Number: ATC3024 AlboGraft Vascular Grafts are made of synthetic material and designed…
FDA Device · Class I · 2013-07-31 · Lemaitre Vascular - HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size)
FDA Device · Class II · 2013-07-31 · Instrumentation Laboratory - AlboGraft Knitted with Collagen, Straight 60x06 Catalog Number: AMC6006 AlboGraft Vascular Grafts are made of synthetic material and design…
FDA Device · Class I · 2013-07-31 · Lemaitre Vascular - GE Healthcare Infinia Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera…
FDA Device · Class I · 2013-07-31 · Ge Healthcare - PASCAL and PASCAL Streamline (532 nm.577 nm)
FDA Device · Class II · 2013-07-31 · Topcon Medical Laser Systems - LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier Convenience Kit (Flex Trays), 10mm M/L Product Usage: The LIGACLIP Endoscopic Rotating…
FDA Device · Class II · 2013-07-31 · Ethicon Endo Surgery - AlboGraft Knitted with Collagen, Bifurcate 18x10 Catalog Number: AMC1810 AlboGraft Vascular Grafts are made of synthetic material and desig…
FDA Device · Class I · 2013-07-31 · Lemaitre Vascular - Stryker brand Neuroform 3 Microdelivery Stent System, 4.5 mm X 20 mm, REF Catalog Number: E345020, Model/Product Number: M003450200, Produc…
FDA Device · Class II · 2013-07-31 · Stryker Neurovascular - Eon and Eon Mini charging system, model numbers Eon -3701 (Wall Charger), 3711 (Portable Charger) and Eon Mini -3721 (Charger)
FDA Device · Class II · 2013-07-31 · St Jude Medical - Dermalight 80 Model Number UVB-080, one unit per box
FDA Device · Class III · 2013-07-31 · National Biological - AlboGraft Knitted with Collagen, Bifurcate 20x10Catalog Number: AMC2010 AlboGraft Vascular Grafts are made of synthetic material and design…
FDA Device · Class I · 2013-07-31 · Lemaitre Vascular - Dermalight 80 Model Number UVB-083, one unit per box
FDA Device · Class III · 2013-07-31 · National Biological - Albo Graft Knitted with Collagen, Bifurcate 16x08 Catalog Number: AMC1608 AlboGraft Vascular Grafts are made of synthetic material and desi…
FDA Device · Class I · 2013-07-31 · Lemaitre Vascular - BD BBL BBE // CDC Anaerobe Laked Sheep Blood Agar with KV, packaged in cartons of 100 plates, Catalog # 297260, and labeled in part ***Bect…
FDA Device · Class II · 2013-07-31 · Becton Dickinson And - The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System
FDA Device · Class II · 2013-07-31 · Physio Control - Spacelabs ARKON Anesthesia Workstation
FDA Device · Class II · 2013-07-31 · Del Mar Reynolds Medical - Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of…
FDA Device · Class I · 2013-07-31 · Ge Healthcare - AlboGraft Knitted with Collagen, Straight 60x07 Catalog Number: AMC6007 AlboGraft Vascular Grafts are made of synthetic material and design…
FDA Device · Class I · 2013-07-31 · Lemaitre Vascular - AlboGraft Knitted with Collagen, Straight 15x06 Catalog Number: AMC1506 AlboGraft Vascular Grafts are made of synthetic material and design…
FDA Device · Class I · 2013-07-31 · Lemaitre Vascular - AlboGraft Knitted with Collagen, Bifurcate 14x08 Catalog Number: AMC1408 AlboGraft Vascular Grafts are made of synthetic material and desig…
FDA Device · Class I · 2013-07-31 · Lemaitre Vascular - LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L, bulk non-sterile Product Usage: The LIGACLIP Endoscopic Rotating Mul…
FDA Device · Class II · 2013-07-31 · Ethicon Endo Surgery - Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system
FDA Device · Class I · 2013-07-31 · Ge Healthcare - AlboGraft Woven with Collagen, Straight 30x18 Catalog Number: ATC3018 AlboGraft Vascular Grafts are made of synthetic material and designed…
FDA Device · Class I · 2013-07-31 · Lemaitre Vascular - LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier…
FDA Device · Class II · 2013-07-31 · Ethicon Endo Surgery - AlboGraft Woven with Collagen, Straight 15x26 Catalog Number: ATC1526 AlboGraft Vascular Grafts are made of synthetic material and designed…
FDA Device · Class I · 2013-07-31 · Lemaitre Vascular - Discovery NM 630, dual detector free-geometry integrated nuclear imaging system
FDA Device · Class I · 2013-07-31 · Ge Healthcare - Sodium Bicarbonate, USP Provided bulk as raw material - label not applicable according to firm Dialysis Grade 1.5 Dialysis Grade 2 As an AP…
FDA Device · Class II · 2013-07-31 · Church And Dwight - BBL Campylobacter CSM Agar (Charcoal-Based Selective Medium), Catalog # 299614, packaged in cartons of 20 plates, and labeled in part ***Be…
FDA Device · Class II · 2013-07-31 · Becton Dickinson And - BD BBL Anaerobe CNA Agar with 5% Sheep Blood // Anaerobe Laked Sheep Blood KV Agar, packaged in cartons of 20 plates, Catalog # 297041, and…
FDA Device · Class II · 2013-07-31 · Becton Dickinson And - 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 I · 2013-07-31 · Ge Healthcare - AlboGraft Knitted with Collagen, Straight 60x08 Catalog Number: AMC6008 AlboGraft Vascular Grafts are made of synthetic material and design…
FDA Device · Class I · 2013-07-31 · Lemaitre Vascular - AlboGraft Woven with Collagen, Straight 30x26 Catalog Number: ATC3026 AlboGraft Vascular Grafts are made of synthetic material and designed…
FDA Device · Class I · 2013-07-31 · Lemaitre Vascular - Swift Mobil shower chair, Swift Mobil 160 shower chair, and Swift Mobil Tilt shower chair
FDA Device · Class II · 2013-07-31 · Etac Supply Center Ab - 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 I · 2013-07-31 · Ge Healthcare - BD BBL CDC Anaerobe 5% Sheep Blood Agar with Kanamycin and Vancomycin (KV), packaged in cartons of 100 plates, Catalog # 221736, and labele…
FDA Device · Class II · 2013-07-31 · Becton Dickinson And
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)