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.
- ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T ECHO B PG, Item Numb…
FDA Device · Class III · 2016-12-28 · Angiodynamics - BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 5MM(H) An endosseous dental implant abutment is a premanufactured prosthetic componen…
FDA Device · Class II · 2016-12-28 · Biomet 3i - MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C120¿ S61CM D66CM GLOBAL Catalog # 990061-120-000 Is designed to facilitate the introductio…
FDA Device · Class II · 2016-12-28 · Oscor - BIOMET 3i LOW PROFILE ABUTMENT TITANIUM RETAINING SCREW An endosseous dental implant abutment is a premanufactured prosthetic component dir…
FDA Device · Class II · 2016-12-28 · Biomet 3i - BIOMET 3i LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component direct…
FDA Device · Class II · 2016-12-28 · Biomet 3i - BIOMET 3i LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component direct…
FDA Device · Class II · 2016-12-28 · Biomet 3i - CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. Radiology: The CyberKnife Robotic Radiosurgery System is indicated for treatm…
FDA Device · Class II · 2016-12-28 · Accuray - Ultroid Mobile Generator/Battery operated unit including the Ultroid Sterile Disposable Probes
FDA Device · Class II · 2016-12-28 · Ultroid Technologies - Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and Nebulae I insufflators are devices that provide CO2 gas di…
FDA Device · Class II · 2016-12-28 · Northgate Technologies - BIOMET 3i LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component direct…
FDA Device · Class II · 2016-12-28 · Biomet 3i - Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed in…
FDA Device · Class II · 2016-12-28 · Amendia - OSCOR ADELANTE BREEZEWAY 10F C70¿ S61CM D66CM Catalog # AB101073 Is designed to facilitate the introduction of catheters to any of the hear…
FDA Device · Class II · 2016-12-28 · Oscor - BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic co…
FDA Device · Class II · 2016-12-28 · Biomet 3i - LMA MADomizer, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, na…
FDA Device · Class II · 2016-12-28 · Teleflex Medical - OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw
FDA Device · Class III · 2016-12-28 · Orthopediatrics - VITROS CRP Slides: 1) VITROS¿ Chemistry Products CRP Slides (250 slides per sales unit), Catalog # 1926740 and 2) , VITROS¿ Chemistry Produ…
FDA Device · Class III · 2016-12-28 · Ortho Clinical Diagnostics - BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic componen…
FDA Device · Class II · 2016-12-28 · Biomet 3i - DELFIA hFSH kit
FDA Device · Class III · 2016-12-28 · Perkinelmer Health Sciences - BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic co…
FDA Device · Class II · 2016-12-28 · Biomet 3i - BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED PREFORMANCE TEMPORARY CYLINDER An endosseous dental implant abutment is a premanufactured prosthet…
FDA Device · Class II · 2016-12-28 · Biomet 3i - BIOMET 3i LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component direct…
FDA Device · Class II · 2016-12-28 · Biomet 3i - OSCOR ADELANTE BREEZWAY 10F STRAIGHT S79CM D84CM Catalog # AB101219 Is designed to facilitate the introduction of catheters to any of the h…
FDA Device · Class II · 2016-12-28 · Oscor - OSCOR ADELANTE BREEZEWAY 10F C90¿ S79CM D84CM Catalog # AB101078 Is designed to facilitate the introduction of catheters to any of the hear…
FDA Device · Class II · 2016-12-28 · Oscor - 8470-009-040 4.0MM Precision Round, 16CM, 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 C90¿ S61CM D66CM Catalog # AB081042 Is designed to facilitate the introduction of catheters to any of the heart…
FDA Device · Class II · 2016-12-28 · Oscor - BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) PICK-UP IMPRESSION COPING An endosseous dental implant abutment is a premanufactured prosthetic…
FDA Device · Class II · 2016-12-28 · Biomet 3i - BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic co…
FDA Device · Class II · 2016-12-28 · Biomet 3i - OSCOR ADELANTE BREEZEWAY 8F C120¿ S79CM D84CM Catalog # AB081047 Is designed to facilitate the introduction of catheters to any of the hear…
FDA Device · Class II · 2016-12-28 · Oscor - Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to…
FDA Device · Class II · 2016-12-28 · Medtronic - LMA MADdy, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal,…
FDA Device · Class II · 2016-12-28 · Teleflex Medical - Acuvance¿2 Safety Catheter, Product No. 1720-AI Product Usage: The Acuvance¿ 2 Safety Catheter is a Peripheral Intravenous Catheter (PIVC).…
FDA Device · Class II · 2016-12-28 · Smiths Medical Asd - Ultroid Sterile Disposable Probes sold individually
FDA Device · Class II · 2016-12-28 · Ultroid Technologies - OSCOR ADELANTE BREEZEWAY 8F STRAIGHT S61CM D66CM Catalog # AB081210 Is designed to facilitate the introduction of catheters to any of the h…
FDA Device · Class II · 2016-12-28 · Oscor - BD SurePathTM Preservative Collection Vials, catalog numbers 490505, 490527, 491095, 491096, and 491097
FDA Device · Class II · 2016-12-28 · Becton Dickinson And - OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB10218 Is designed to facilitate the introduction of catheters to any of the h…
FDA Device · Class II · 2016-12-28 · Oscor - Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile Probes
FDA Device · Class II · 2016-12-28 · Ultroid Technologies - BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic componen…
FDA Device · Class II · 2016-12-28 · Biomet 3i - ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T NON-ECHO B PG, Item…
FDA Device · Class II · 2016-12-28 · Angiodynamics - ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Numb…
FDA Device · Class III · 2016-12-28 · Angiodynamics - BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component di…
FDA Device · Class II · 2016-12-28 · Biomet 3i - BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic componen…
FDA Device · Class II · 2016-12-28 · Biomet 3i - Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit
FDA Device · Class II · 2016-12-28 · Exactech - MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S61CM D66CM GLOBAL Catalog # 990061-070-000 Is designed to facilitate the introduction…
FDA Device · Class II · 2016-12-28 · Oscor - MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBALCatalog # 990061-055-000 Is designed to facilitate the introduction…
FDA Device · Class II · 2016-12-28 · Oscor - BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic co…
FDA Device · Class II · 2016-12-28 · Biomet 3i - BIOMET 3i LOW PROFILE ABUTMENT HEALING CAP 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 ABUTMENT (HEXED) PICK-UP IMPRESSION COPING An endosseous dental implant abutment is a premanufactured prosthetic comp…
FDA Device · Class II · 2016-12-28 · Biomet 3i - Tibial Component Fixed Hinge Small Long
FDA Device · Class II · 2016-12-28 · Stanmore Implants Worldwide - Algovita Spinal Cord Stimulation System, Percutaneous Leads, 8-Electrode Percutaneous Lead Kit
FDA Device · Class II · 2016-12-28 · Nuvectra - IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number LKPTS1, Siemens Material Number (SMN) 10706279 (US)
FDA Device · Class II · 2016-12-28 · Siemens Healthcare Diagnostics - DF Coated Integral Shaft & Stem 15x30x38
FDA Device · Class II · 2016-12-28 · Stanmore Implants Worldwide - PerkinElmer 20ul Clear RoboRack Tip, Pipette (Qty 960) Item Number: 6000677
FDA Device · Class II · 2016-12-28 · Perkinelmer - BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic componen…
FDA Device · Class II · 2016-12-28 · Biomet 3i - Merge OrthoCase software
FDA Device · Class II · 2016-12-28 · Merge Healthcare - BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic co…
FDA Device · Class II · 2016-12-28 · Biomet 3i - 8470-009-030 3.0MM Precision Round, 16CM, 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 - GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Ge…
FDA Device · Class II · 2016-12-28 · Stryker Howmedica Osteonics - OSCOR ADELANTE BREEZEWAY 10F C120¿ S79CM D84CM Catalog # AB101078 Is designed to facilitate the introduction of catheters to any of the hea…
FDA Device · Class II · 2016-12-28 · Oscor - MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S79CM D84CM GLOBAL Catalog # 990079-090-000 Is designed to facilitate the introduction…
FDA Device · Class II · 2016-12-28 · Oscor - OSCOR ADELANTE BREEZEWAY 8F C90¿ S79CM D84CM Catalog # AB081046 Is designed to facilitate the introduction of catheters to any of the heart…
FDA Device · Class II · 2016-12-28 · Oscor - AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999(10)2.2.0 Catalog number: 933-599 The AQURE system manages Radi…
FDA Device · Class II · 2016-12-28 · Radiometer America - ev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO. The PowerCross .018 OTW PTA Dilatation Catheter is intended to dilate stenose…
FDA Device · Class II · 2016-12-28 · Medtronic - OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB101218 Is designed to facilitate the introduction of catheters to any of the…
FDA Device · Class II · 2016-12-28 · Oscor - Femoral Shaft L=120mm
FDA Device · Class II · 2016-12-28 · Stanmore Implants Worldwide - ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM SS/SS ECHO B PG, Item Num…
FDA Device · Class III · 2016-12-28 · Angiodynamics - BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listin…
FDA Device · Class II · 2016-12-28 · Robert Busse And D B A Busse Hospital Disposables - Optimus Fixed Awl
FDA Device · Class II · 2016-12-28 · Amendia - 8450-107-530 3.0MM 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 - OSCOR ADELANTE BREEZEWAY 10F C55¿ S61CM D66CM Catalog # AB101072 Is designed to facilitate the introduction of catheters to any of the hear…
FDA Device · Class II · 2016-12-28 · Oscor - OSCOR ADELANTE BREEZEWAY 8F C120¿ S61CM D66CM Catalog # AB081043 Is designed to facilitate the introduction of catheters to any of the hear…
FDA Device · Class II · 2016-12-28 · Oscor - Black Widow Plate 19mm Plate, Part Number TBP119
FDA Device · Class II · 2016-12-28 · Amendia - BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(H) An endosseous dental implant abutment is a premanufactured prosthetic componen…
FDA Device · Class II · 2016-12-28 · Biomet 3i - LMA MADett, Endotracheal tube Mucosal Atomization Device, Rx only, Product Usage: These products are used for the delivery of topical anest…
FDA Device · Class II · 2016-12-28 · Teleflex Medical - OSCOR ADELANTE BREEZWAY 8F STRAIGHT S79CM D84CM Catalog # AB081211 Is designed to facilitate the introduction of catheters to any of the he…
FDA Device · Class II · 2016-12-28 · Oscor - FLEXI NOZZLE LONG, 10 Boxes of 25 units each Product Usage: These products are used for the delivery of topical anesthesia via an atomized…
FDA Device · Class II · 2016-12-28 · Teleflex Medical - FLEXI NOZZLE SHORT Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal,…
FDA Device · Class II · 2016-12-28 · Teleflex Medical - K-Wire 1.4mm x 12in Non-Threaded, Part Number 9080-12U
FDA Device · Class II · 2016-12-28 · Amendia - Savannah-T Straight Rod, 200mm, Part Number 10704-200
FDA Device · Class II · 2016-12-28 · Amendia - BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) TRANSFER IMPRESSION COPING An endosseous dental implant abutment is a premanufactured prosthetic…
FDA Device · Class II · 2016-12-28 · Biomet 3i - OSCOR ADELANTE BREEZEWAY 10F C70¿ S79CM D84CM Catalog # AB101077 Is designed to facilitate the introduction of catheters to any of the hear…
FDA Device · Class II · 2016-12-28 · Oscor - 8450-010-040 4.0MM Round, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseou…
FDA Device · Class II · 2016-12-28 · Stryker Instruments Div - AbbVie PEG Kit 20 FR
FDA Device · Class II · 2016-12-28 · Abbvie - Femoral Integral Shaft & Stem 15x27 HA Coated
FDA Device · Class II · 2016-12-28 · Stanmore Implants Worldwide - BIOMET 3i LOW PROFILE 17¿ ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component direct…
FDA Device · Class II · 2016-12-28 · Biomet 3i - SET UP PACK Surgical Instrument Tray, REF/Catalog No. 6250R1, STERILE, Rx Only --- busse Hospital Disposables Hauppauge, NY --- Device List…
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 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component…
FDA Device · Class II · 2016-12-28 · Biomet 3i - Synthes VA Implant Rack for the Compact Distal Radius System Tray/Surgical/Instrument
FDA Device · Class II · 2016-12-28 · Synthes Usa Products - OSCOR ADELANTE BREEZEWAY 8F C55¿ S79CM D84CM Catalog # AB081044 Is designed to facilitate the introduction of catheters to any of the heart…
FDA Device · Class II · 2016-12-28 · Oscor - OSCOR ADELANTE BREEZEWAY 8F C55¿ S61CM D66CM Catalog # AB081040 Is designed to facilitate the introduction of catheters to any of the heart…
FDA Device · Class II · 2016-12-28 · Oscor - Ingenia MR-OR
FDA Device · Class II · 2016-12-28 · Philips Electronics North America - Black Widow 6.6mm x 20mm Screw, Part Number TBS020
FDA Device · Class II · 2016-12-28 · Amendia - 8450-009-040 4.0MM 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 - Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell Lanka (pvt) Ltd
FDA Device · Class II · 2016-12-28 · Ansell Healthcare Products - Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with 3mL Syringe and Vial Adapter
FDA Device · Class II · 2016-12-28 · Teleflex Medical - ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Numb…
FDA Device · Class III · 2016-12-28 · Angiodynamics - AMS-651, 120" Microbore extension set with slide clamp
FDA Device · Class II · 2016-12-28 · Vygon Mfg Dba Churchill Medical Systems - 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 - Medi Choice Arm Slings ASL 2103 Small 7.5 x 12.5 Inch 1/EA, 24 ENCA ASL 2104 Medium 8 x 15 Inch 1/EA, 24 ENCA ASL 2105 Large 8.5 x 17.5 Inc…
FDA Device · Class II · 2016-12-28 · Owens And Minor Distribution - MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S79CM D84CM GLOBAL Catalog # 990079-055-000 Is designed to facilitate the introduction…
FDA Device · Class II · 2016-12-28 · Oscor - Ultroid Procedure Pack including the Ultroid Sterile Disposable Probes
FDA Device · Class II · 2016-12-28 · Ultroid Technologies
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)