FDA Device · 2016
FDA Device recalls in 2016
RecallRadar indexes 3,246 FDA Device recall notices published in 2016. By classification: 116 Class I, 3,050 Class II, 80 Class III.
- BIOMET 3i LOW PROFILE ABUTMENT HEXED TEMPORARY CYLINDER An endosseous dental implant abutment is a premanufactured prosthetic component dir…
FDA Device · Class II · 2016-12-28 · Biomet 3i - OSCOR ADELANTE BREEZEWAY 8F C70¿ S61CM D66CM Catalog # AB081041 Is designed to facilitate the introduction of catheters to any of the heart…
FDA Device · Class II · 2016-12-28 · Oscor - Best Practices kits containing certain production lots of Clearify Visualization System Item Code: 21-345 Intended to be used prior to and…
FDA Device · Class II · 2016-12-28 · Medtronic - RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR, Rx Only, Sterile, Intermittent self-catheterization
FDA Device · Class II · 2016-12-28 · Teleflex Medical - CARPAL TUNNEL PACK, Surgical Instrument Tray, REF/Catalog No. 3366, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device…
FDA Device · Class II · 2016-12-28 · Robert Busse And D B A Busse Hospital Disposables - BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component…
FDA Device · Class II · 2016-12-28 · Biomet 3i - OSCOR BREEZEWAY 10F S60.8CM D65.6CM FIRM TIP Catalog # AB1061FT Is designed to facilitate the introduction of catheters to any of the heart…
FDA Device · Class II · 2016-12-28 · Oscor - BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic co…
FDA Device · Class II · 2016-12-28 · Biomet 3i - Tibial Component Metal Cased Small Long
FDA Device · Class II · 2016-12-28 · Stanmore Implants Worldwide - MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S79CM D84CM GLOBAL Catalog # 990079-070-000 Is designed to facilitate the introduction…
FDA Device · Class II · 2016-12-28 · Oscor - BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly c…
FDA Device · Class II · 2016-12-28 · Biomet 3i - 8450-107-525 2.5MM Precision Match Head, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used t…
FDA Device · Class II · 2016-12-28 · Stryker Instruments Div - Zeus-P Lumbar Interbody Device
FDA Device · Class II · 2016-12-28 · Amendia - BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component di…
FDA Device · Class II · 2016-12-28 · Biomet 3i - Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion cardiotomy/Venous Reservoir, Perfusion Tubing Packs The Affini…
FDA Device · Class II · 2016-12-28 · Medtronic - OSCOR ADELANTE BREEZEWAY 10F C120¿ S61CM D66CM Catalog # AB101075 Is designed to facilitate the introduction of catheters to any of the hea…
FDA Device · Class II · 2016-12-28 · Oscor - ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T NON-ECHO S PG, Item…
FDA Device · Class III · 2016-12-28 · Angiodynamics - BIOMET 3i LOW PROFILE ABUTMENT QUICKBRIDGE An endosseous dental implant abutment is a premanufactured prosthetic component directly connect…
FDA Device · Class II · 2016-12-28 · Biomet 3i - BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component…
FDA Device · Class II · 2016-12-28 · Biomet 3i - MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBAL Catalog # 990061-055-000 Is designed to facilitate the introduction…
FDA Device · Class II · 2016-12-28 · Oscor - ANGIODYNAMICS 4F Stiffened Micro-Introducer, Item Number H787065971035, Catalog No.REF 06597103 Indicated for percutaneous introduction of…
FDA Device · Class III · 2016-12-28 · Angiodynamics - BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component…
FDA Device · Class II · 2016-12-28 · Biomet 3i - IMMULITE 2000/IMMULITE 2000 XPi Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number L2KPTS2, SMN 10706281 and REF/Catalog Num…
FDA Device · Class II · 2016-12-28 · Siemens Healthcare Diagnostics - BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic componen…
FDA Device · Class II · 2016-12-28 · Biomet 3i - BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly c…
FDA Device · Class II · 2016-12-28 · Biomet 3i - EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative determination of TREC (T-cell receptor excision c…
FDA Device · Class III · 2016-12-28 · Perkinelmer Health Sciences - BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED TEMPORARY CYLINDER An endosseous dental implant abutment is a premanufactured prosthetic component…
FDA Device · Class II · 2016-12-28 · Biomet 3i - BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component di…
FDA Device · Class II · 2016-12-28 · Biomet 3i - 8450-009-030 3.0MM Precision Round, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to rem…
FDA Device · Class II · 2016-12-28 · Stryker Instruments Div - OSCOR ADELANTE BREEZEWAY 8F C70¿ S79CM D84CM Catalog # AB081045 Is designed to facilitate the introduction of catheters to any of the heart…
FDA Device · Class II · 2016-12-28 · Oscor - LMA MADgic, Atomization Device with 3mL Syringe, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via…
FDA Device · Class II · 2016-12-28 · Teleflex Medical - MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Catalog # 990061-090-000 Is designed to facilitate the introduction…
FDA Device · Class II · 2016-12-28 · Oscor - OSCOR ADELANTE BREEZEWAY 10F C55¿ S79CM D84CM Catalog # AB101076 Is designed to facilitate the introduction of catheters to any of the hear…
FDA Device · Class II · 2016-12-28 · Oscor - Perkin Elmer RoboRack 25ul, Clear, Non-Conductive, Filter Tips, Pre-sterilized Item Number: 6000689
FDA Device · Class II · 2016-12-21 · Perkinelmer - Merge Cardio software
FDA Device · Class II · 2016-12-21 · Merge Healthcare - CyberKnife Robotic Radiosurgery System using software version 10.6
FDA Device · Class II · 2016-12-21 · Accuray - IVEA 500A Intended for Med-Surg patient care
FDA Device · Class II · 2016-12-21 · Firefly Medical - Metzenbaum Scissors 7 , Curved, Sterile The Metzenbaum Scissors 7 , Curved Curved are single-use sterile surgical instruments intended for…
FDA Device · Class II · 2016-12-21 · Integra York Pa - MOSAIQ Oncology Information System The product is used to manage workflows for treatment planning and delivery
FDA Device · Class II · 2016-12-21 · Elekta - Carry bar which is an accessory to a lift used for patients in hospitals and other facilities
FDA Device · Class II · 2016-12-21 · Ergosafe Products Dba Prism Medical - Cellfina Prep Pack, Part No. CP1
FDA Device · Class II · 2016-12-21 · Ulthera - Updated Natus neoBLUE blanket LED Phototherapy Systems
FDA Device · Class II · 2016-12-21 · Natus Medical - INOVO Purefill Oxygen Compressor Model PF1100 Is an oxygen refill machine that you can attach to an oxygen concentrator to refill portable…
FDA Device · Class II · 2016-12-21 · Inovo - Lumex, Patriot Full Electric Homecare Bed, & Patriot LX Full Electric Homecare Bed containing the Okin Dumat 3 Head/Foot Motors
FDA Device · Class II · 2016-12-21 · Gf Health Products - Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is used to make the housing resection for the post of the posterior stabil…
FDA Device · Class II · 2016-12-21 · Encore Medical - HF Cable WA00014A, Endoscopic electrosurgical unit and accessories
FDA Device · Class II · 2016-12-21 · Olympus - GE Healthcare, Avance, Avance CS2, Amingo
FDA Device · Class II · 2016-12-21 · Ge Healthcare - The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within…
FDA Device · Class II · 2016-12-21 · Physio Control - Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy
FDA Device · Class II · 2016-12-21 · Natus Medical - Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile
FDA Device · Class II · 2016-12-21 · Integra York Pa - BD Spinal Anesthesia Tray The BD Spinal Anesthesia Tray is intended for use by professional anesthesiologists to perform the spinal anesthe…
FDA Device · Class II · 2016-12-21 · Becton Dickinson And - Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile
FDA Device · Class II · 2016-12-21 · Halyard Health - BD 23 G x .75 in
FDA Device · Class II · 2016-12-21 · Becton Dickinson And - Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry f…
FDA Device · Class II · 2016-12-21 · Stryker Sustainability Solutions - LightMix¿ Zika rRT-PCR Test The LightMix¿ Zika rRT-PCR Test is a real-time RT-PCR test intended for the qualitative detection of RNA from t…
FDA Device · Class II · 2016-12-21 · Roche Molecular Systems - SOMATOM Definition Flash System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruct…
FDA Device · Class II · 2016-12-21 · Siemens Medical Solutions Usa - BARD¿ 70cc Piston Syringe with Catheter Tip, Luer Adapter and Cap, Rx Only, The BARD¿ Syringe is available in a single use plastic design w…
FDA Device · Class II · 2016-12-21 · C R Bard - MicroScan LabPro Data Management System
FDA Device · Class II · 2016-12-21 · Beckman Coulter - SOMATOM Definition Edge System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstructi…
FDA Device · Class II · 2016-12-21 · Siemens Medical Solutions Usa - ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable, Contents: Five (5) Disposable Bipolar Cables,STERILE The Minor Surgery Bipolar Cable…
FDA Device · Class II · 2016-12-21 · Ellman International - Ultrasound Video Bronchoscope The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic vis…
FDA Device · Class II · 2016-12-21 · Pentax - McKesson Powder Free Vinyl Exam Gloves Catalog numbers 14-116, 14-118, 14-120, 14-136, 14-138 and 14-140
FDA Device · Class II · 2016-12-21 · Cypress Medical Products - SOMATOM Definition AS System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruction…
FDA Device · Class II · 2016-12-21 · Siemens Medical Solutions Usa - The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid controls containing BNP, CK MB Mass, Digoxin, D-Dimer, Homocyst…
FDA Device · Class II · 2016-12-21 · Randox Laboratories - Ceramax Skin Barrier Cream: NET WT 0.1 OZ (3 g professional sample - not for retail sale) Under the supervision of a health care profession…
FDA Device · Class II · 2016-12-21 · Oculus Innovative Sciences - BARD¿ Irrigation, Syringe 70cc With Resectoscope Tip, Catheter Tip, Luer Adapter And Cap, Rx Only, Sterile, The BARD¿ Syringe is available…
FDA Device · Class II · 2016-12-21 · C R Bard - Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing…
FDA Device · Class II · 2016-12-21 · Teleflex Medical - WECK Visistat 35W, Disposable Skin Stapler, Rx Only, Sterile, Teleflex Medical, NC 27709
FDA Device · Class II · 2016-12-21 · Teleflex Medical - Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, OR Packaged, Sterile Item Code: 17099
FDA Device · Class II · 2016-12-21 · Covidien - BARD¿ Piston Syringe, 60cc, Rx Only, Sterile, The BARD¿ Syringe is available in a single use plastic design which features a 60cc or 70cc c…
FDA Device · Class II · 2016-12-21 · C R Bard - BARDIA¿ 60cc Piston Irrigation Syringe, Sterile, Rx Only, The BARD¿ Syringe is available in a single use plastic design which features a 60…
FDA Device · Class II · 2016-12-21 · C R Bard - Harmony Insight Diagnostic Monitor Support System - 100 Spring Arm (EMS) The system is intended for use in surgical operating rooms (OR) or…
FDA Device · Class II · 2016-12-21 · Steris - Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only
FDA Device · Class III · 2016-12-21 · Ecolab - Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray Cook Spectrum Minocycline/Rifampin Impregnated Tri…
FDA Device · Class II · 2016-12-21 · Cook - Merge Cardio software
FDA Device · Class II · 2016-12-21 · Merge Healthcare - Performance-LOAD Ambulance Cot Fastener Stretcher, Wheeled
FDA Device · Class II · 2016-12-21 · Stryker Medical Division - Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a N…
FDA Device · Class II · 2016-12-14 · Angiodynamics Navilyst Medical - AMD-Ritmed Transparent Dressing - Window with label, 4 " x 4 3/4" (10 cm x 12 cm), Reorder No./Code A60044-W, Sterile -- 200 Dressings per…
FDA Device · Class II · 2016-12-14 · Amd Ritmed - Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed for treatment planning and analysis of…
FDA Device · Class II · 2016-12-14 · Raysearch Laboratories Ab - Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) Product is intended for use by clinical laboratories in the qualit…
FDA Device · Class III · 2016-12-14 · Orasure Technologies - BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit - 1) UPN # H965750121/Catalog No: 5018265, 2) UPN # H965750131/Catalog No:50…
FDA Device · Class II · 2016-12-14 · Angiodynamics Navilyst Medical - Merge, eFilm Workstation and eFilm Lite eFilm Workstation with Modules is a software application that is used for viewing medical images. e…
FDA Device · Class II · 2016-12-14 · Merge Healthcare - RayStation 4.0, 4.5, 4.7 and 5.0
FDA Device · Class II · 2016-12-14 · Raysearch Laboratories Ab - IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of…
FDA Device · Class II · 2016-12-14 · Philips Medical Systems Cleveland - LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Insert is used in Knee Revision Surgery
FDA Device · Class II · 2016-12-14 · Depuy Orthopaedics - Aequalis Fx2 implant parts and instrument trays
FDA Device · Class II · 2016-12-14 · Tornier - Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY -- product Usage: Dental impression materi…
FDA Device · Class II · 2016-12-14 · Ivoclar Vivadent - ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD
FDA Device · Class II · 2016-12-14 · Siemens Healthcare Diagnostics - Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Product Code 646462, Rx ONLY -- Product Usage: Dental impression mat…
FDA Device · Class II · 2016-12-14 · Ivoclar Vivadent - Elana Surgical KitHUD The Elana Surgical KitHUD, when connected to the Spectranetics Xenon-Chloride Laser Model CVX-300, is indicated for c…
FDA Device · Class II · 2016-12-14 · Elana - MANOS EX (CAT#TY-12-101) Product Usage: Carpal Tunnel Release: as a tool for tissue release of the transverse carpal ligament in patients w…
FDA Device · Class II · 2016-12-14 · Thayer Intellectual Property - Model 37751 Recharger Product Usage: The Medtronic 37751 Recharger is a hand-held device used to charge the battery in a patient s neurosti…
FDA Device · Class II · 2016-12-14 · Medtronic Neuromodulation - Empowr Knee System Product Usage: Non-porous proximal tibial baseplate implants, utilized in either posterior cruciate ligament (PCL) retai…
FDA Device · Class II · 2016-12-14 · Encore Medical - Brilliance 64 728231 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of…
FDA Device · Class II · 2016-12-14 · Philips Medical Systems Cleveland - SOMATOM Force, System x-ray, tomography, computed
FDA Device · Class II · 2016-12-14 · Siemens Medical Solutions Usa - Halyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile), Product Code 44965 NS
FDA Device · Class II · 2016-12-14 · Halyard Health - Merge PACS software
FDA Device · Class II · 2016-12-14 · Merge Healthcare - 3M Universal Electrosurgical Pad, REF 9130 (100 pads / case) and 3M Universal Electrosurgical Pad with Cord, REF 9135-LP (40 pads / case) P…
FDA Device · Class II · 2016-12-14 · 3m Health Care Business - Ingenuity CT 728326 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of…
FDA Device · Class II · 2016-12-14 · Philips Medical Systems Cleveland - Brilliance 64 728232 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of…
FDA Device · Class II · 2016-12-14 · Philips Medical Systems Cleveland
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)