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.
- TIGR Matrix Surgical Mesh, Model No. NSTM1015, NSTM1520, NSTM2030
FDA Device · Class II · 2016-08-31 · Novus Scientific Ab - 1) The HomeChoice automated peritoneal dialysis system
FDA Device · Class II · 2016-08-31 · Baxter Healthcare - Ziehm Vision RFD Mot, Mobile C-arm for Mobile Fluoroscopic Imaging
FDA Device · Class II · 2016-08-31 · Ziehm Imaging - OEC 9800, fluoroscopic x-ray system
FDA Device · Class II · 2016-08-31 · Ge Oec Medical Systems - Ingenuity Core, Model number 728321 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body…
FDA Device · Class II · 2016-08-31 · Philips Medical Systems Cleveland - Medtronic, Lead Kit for DBS Stimulation
FDA Device · Class II · 2016-08-31 · Medtronic Neuromodulation - Haskal Transjugular Intrahepatic Portal Access Set Introducer, catheter Intended for transjugular liver access in diagnostic and interventi…
FDA Device · Class II · 2016-08-31 · Cook - Transluminal Biliary Biopsy Forceps Set Forceps, Biopsy, Non-Electric Intended for access to and biopsy of tissue within the biliary ductal…
FDA Device · Class II · 2016-08-31 · Cook - Infinite 200 PRO The Tecan Infinite 200 PRO is a multifunctional microplate reader with injector option
FDA Device · Class II · 2016-08-31 · Tecan Us - Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), 10' (3.05m) Cable, Catalog Number 51-7310
FDA Device · Class II · 2016-08-31 · Conmed - Brilliance 64 CT Model number 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the bod…
FDA Device · Class II · 2016-08-31 · Philips Medical Systems Cleveland - Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging
FDA Device · Class II · 2016-08-31 · Ziehm Imaging - Ziehm Vision2, Mobile C-arm for Mobile Fluoroscopic Imaging
FDA Device · Class II · 2016-08-31 · Ziehm Imaging - Conical portio adapter (acorn) small & large are used for examination and diagnosis in conjunction with endoscopic accessories in gynecolog…
FDA Device · Class II · 2016-08-31 · Richard Wolf Medical Instruments - White Lumax Guiding Coaxial Catheter Catheter, Percutaneous Intended for the delivery of angioplasty balloons and other types of interventi…
FDA Device · Class II · 2016-08-31 · Cook - BVX-330BR Bovie Precise 360 Handpiece 33cm, blade Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablat…
FDA Device · Class II · 2016-08-31 · Bovie Medical - Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489
FDA Device · Class I · 2016-08-31 · Cook - Tecan Infinite M1000 The Tecan Infinite M1000 is a multifunctional monochromator based microplate reader that provides high performance for…
FDA Device · Class II · 2016-08-31 · Tecan Us - Valleylab Laparoscopic Wire J-Hook Electrode 36CM Item Code: E277236 The Valleylab Laparoscopic Handset and Electrodes are indicated for us…
FDA Device · Class II · 2016-08-24 · Medtronic - Certain Straight Pick-Up Coping 5.0mm(D) x 0mm(P) Item:IWIP50 Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Locator Extra Light Retention Males 4pk Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Certain Pick-Up Coping 4.1mm(D) x 4.1mm(P) Item: IIIC41 Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Locator Light Retention Replacement Males 4pk Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Xario 100 Diagnostic Ultrasound System, TUS-X100
FDA Device · Class II · 2016-08-24 · Toshiba American Medical Systems - DAL-RO Abutment Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Valleylab Laparoscopic Flat L-Hook Electrode Retractable Item Code: E2784R28ASP The Valleylab Laparoscopic Handset and Electrodes are indic…
FDA Device · Class II · 2016-08-24 · Medtronic - IOL Distal Extension Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - 1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile REF # 1009-00 Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment…
FDA Device · Class II · 2016-08-24 · Lemaitre Vascular - Locator Replacement Housing Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Certain Titanium Large Hexed Screw Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Bard TruGuide Disposable Coaxial Biopsy Needle Mixed Product Part Number C1816B The TruGuide Disposable Coaxial Biopsy Needles are intend…
FDA Device · Class II · 2016-08-24 · Bard Peripheral Vascular - Valleylab Laparoscopic Wire J-Hook Electrode 45CM Item Code: E277345 The Valleylab Laparoscopic Handset and Electrodes are indicated for us…
FDA Device · Class II · 2016-08-24 · Medtronic - Certain Pick-Up Coping 5mm(D) x 5mm(P) Item:IWIP55 Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Certain Hex Try-in Screw (5 pk) Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Locator Extra Light Angled Replacement Males 4pk Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Valleylab Laparoscopic Curved Spatula Electrode Retractable 28CM Item Code: E2781R28ASP The Valleylab Laparoscopic Handset and Electrodes a…
FDA Device · Class II · 2016-08-24 · Medtronic - Locator Abutment Impression Coping Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Certain Straight Pick Up Coping Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Certain Implant Cover Screw Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - ReShape Integrated Dual Balloon System, Gen 1, Catalog No. RSM110, Model No. 01-0013-001 The ReShape Integrated Dual Balloon System is indi…
FDA Device · Class II · 2016-08-24 · Reshape Medical - Gingihue 15 degrees Pre-Angled Post 4mm(D) x 5mm(P) x 2mm(H) Item: PAP452G Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - TRYX Neuro Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable ca…
FDA Device · Class II · 2016-08-24 · Tyrx - IOL Healing Cap Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Certain IOL Abutment Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Certain Gingihue TM 15 degree Angled Post Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Straumann Bone Level Implant, ¿ 4.1mm RC, SLA¿ 12mm, TiZr, NTP Article Number: 021.4512
FDA Device · Class II · 2016-08-24 · Straumann Manufacturing - Valleylab Laparoscopic Wire L-Hook Electrode 28CM Item Code: E278328 The Valleylab Laparoscopic Handset and Electrodes are indicated for us…
FDA Device · Class II · 2016-08-24 · Medtronic - Certain Straight Healing Abutment 4.1mm(D) x 4.1mm(P) x 4mm(H) Item:ISHA44 Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Certain Implant Straight Cover Screw Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Weck EFx Classic Fascial Closure System, Rx Only, Sterile, The product is intended to facilitate placement and withdrawal of suture loops t…
FDA Device · Class II · 2016-08-24 · Teleflex Medical - Certain Pick-Up Coping 4.1mm(D) x 5mm(P) Item: IIIC12 Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Stryker AutoPlex System
FDA Device · Class II · 2016-08-24 · Stryker Instruments Div - Hospira RECEPTAL LINERS: 1L(1000mL), 1.5L (1500mL), 2L (2000mL) 1) List Number 43056-01
FDA Device · Class II · 2016-08-24 · Hospira - Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code: E2783R28ASP The Valleylab Laparoscopic Handset and Electrodes are indic…
FDA Device · Class II · 2016-08-24 · Medtronic - TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverte…
FDA Device · Class II · 2016-08-24 · Tyrx - Certain Twist Lock TM Coping Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Conical 25 degree Angled Abutment Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Conical Abutment Pick-up Coping Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - TRYX Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardiove…
FDA Device · Class II · 2016-08-24 · Tyrx - IOL Transfer Impression Coping Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - IOL Abutment and Screw Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - METS SMILES Total Knee Replacement
FDA Device · Class II · 2016-08-24 · Stanmore Implants Worldwide - 1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm
FDA Device · Class II · 2016-08-24 · Lemaitre Vascular - Certain EP Healing Abutment Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - iConnect Access used with Ortho PACS software provides medical specialists with access to diagnostic quality images, reports, and various t…
FDA Device · Class II · 2016-08-24 · Merge Healthcare - Certain Straight Healing Abutment Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Certain Gingihue 15 degree Angled Post 4.1mm(D) x 5mm(P) x 4mm(H) Item: IPAP454G. Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Temporary Hexed Cylinder Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Gold-Tite Hexed Retaining Screw 3mm Item: GSH30 Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Locator Extended Range Males 4pk Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Certain EP Pick-Up Coping Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Gold Slotted Screw Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807
FDA Device · Class I · 2016-08-24 · Orasure Technologies - Valleylab Laparoscopic AP Argon Blunt Needle Electrode 28cm Item Code: E258328 The Valleylab Laparoscopic Handset and Electrodes are indica…
FDA Device · Class II · 2016-08-24 · Medtronic - Certain Preformance Post Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Healing Abutment Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - TI Single Vector Distractor Proximal Foot/Right
FDA Device · Class II · 2016-08-24 · Synthes Usa Products - Valleylab Laparoscopic Straight Spatula Electrode 28CM Item Code: E278028 The Valleylab Laparoscopic Handset and Electrodes are indicated f…
FDA Device · Class II · 2016-08-24 · Medtronic - GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Archiving and Communication System Used as a primary diagnostic an…
FDA Device · Class II · 2016-08-24 · Ge Healthcare It - IOL Titanium Temporary Cylinder Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - LDA Screw SBL 4mm(D) Item: SCRSBL2 Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Conical Abutment Gold Standard ZR TM Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Valleylab Laparoscopic Curved Spatula Electrode 28CM Item Code: E278128 The Valleylab Laparoscopic Handset and Electrodes are indicated for…
FDA Device · Class II · 2016-08-24 · Medtronic - Certain Gingihue Post 3.4mm(D) x 3.8mm(P) x 2mm(H) Item: IMAP32G Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - TI Single Vector Distractor Body with Left Foot/20mm
FDA Device · Class II · 2016-08-24 · Synthes Usa Products - Certain EP Twist Lock TM Coping Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Gingihue 15 Degree Pre-Angled Post Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Hospira RECEPTAL CANISTERS: 1L(1000mL), 1.5L(1500mL), 2L(2000mL) Canister, ATS, 2000, with Valve 1) List Numbers 43449-01 and 43449-11
FDA Device · Class II · 2016-08-24 · Hospira - Conical EP Pick-Up Coping (Non-Hexed) Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 4mm(H) Item: IWTH54 Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Certain Gingihue 15 degree Pre- Angled Post Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Preformance 15 degrees pre-angled post Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Certain Flat Implant Cover Screw Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Locator Replacement Males 4pk Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - TI Single Vector Distractor Body with Left Foot/30mm
FDA Device · Class II · 2016-08-24 · Synthes Usa Products - TI Single Vector Distractor Body with Right Foot/20mm
FDA Device · Class II · 2016-08-24 · Synthes Usa Products - Standard Abutment Pick -Up Coping Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Certain Cover Screw Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i - Straumann Bone Level Implant, ¿ 4.1mm RC, SLA 10mm, TiZr, NTP Article Number: 021.4510
FDA Device · Class II · 2016-08-24 · Straumann Manufacturing - Certain Micromini Flat Implant Cover Screw Dental implants
FDA Device · Class II · 2016-08-24 · Biomet 3i
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)