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.
- *** 1) Product labeled in part: 19683-28
FDA Device · Class II · 2016-07-06 · Hospira - K-wire, Smooth Double-pointed 0.8 x 90mm, a component of the METASURG Capture Screw System The K-wire is used in conjunction with the 2.0 m…
FDA Device · Class II · 2016-07-06 · Integra Lifesciences - IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Conten…
FDA Device · Class II · 2016-07-06 · Cmp Industries - Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of total homocysteine in human serum and plasma - H7575-…
FDA Device · Class II · 2016-07-06 · Medtest Holdings - Laryngo Stroboscope Product Usage Intended to provide optical visualization of, therapeutic access to, the Upper Airway and Vocal Folds
FDA Device · Class II · 2016-07-06 · Pentax Medical - MOSAIQ Oncology Information System
FDA Device · Class II · 2016-07-06 · Elekta - Ureteroscope Intended to provide optical visualization of and therapeutic access to the Urinary Track
FDA Device · Class II · 2016-07-06 · Pentax Medical - LIFEPAK CR Plus and/or LIFEPAK EXPRESS are Automatic External Defibrillator(s) and are non-wearable
FDA Device · Class II · 2016-07-06 · Physio Control - Symbiq One Channel Infuser
FDA Device · Class II · 2016-07-06 · Hospira - Colonoscope Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract
FDA Device · Class II · 2016-07-06 · Pentax Medical - LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 LEFT, A/P 62 MM, M/L 70 MM, REF 71421375 The LEGION Hinge Knee System is indicated for: 1. Rheumatoi…
FDA Device · Class II · 2016-07-06 · Smith And Nephew - LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 LEFT, A/P 54.5 MM, M/L 62 MM, REF 71421373 The LEGION Hinge Knee System is indicated for: 1. Rheumat…
FDA Device · Class II · 2016-07-06 · Smith And Nephew - LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 RIGHT, A/P 62 MM, M/L 70 MM, REF 71421365 The LEGION Hinge Knee System is indicated for: 1. Rheumato…
FDA Device · Class II · 2016-07-06 · Smith And Nephew - Brilliance iCT model #728306
FDA Device · Class II · 2016-07-06 · Philips Medical Systems Cleveland - Bronchoscope Intended to provide optical visualization of and therapeutic access to the Airway and Bronchial Tree
FDA Device · Class II · 2016-07-06 · Pentax Medical - Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereb…
FDA Device · Class II · 2016-07-06 · Integra Lifesciences - Ingenuity Core, model # 728326
FDA Device · Class II · 2016-07-06 · Philips Medical Systems Cleveland - SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography images and tomosynthes…
FDA Device · Class II · 2016-07-06 · Siemens Medical Solutions Usa - Cystoscope Intended to provide optical visualization of and therapeutic access to the Urinary Tract
FDA Device · Class II · 2016-07-06 · Pentax Medical - *** 1) Product labeled in part: List No. 14220-28
FDA Device · Class II · 2016-07-06 · Hospira - dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only Product Usage:containers for sampl…
FDA Device · Class II · 2016-07-06 · Dynarex - CENTURION Vision System
FDA Device · Class II · 2016-07-06 · Alcon Research - Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vials, Rx Only, NDC 0487-9007-60
FDA Device · Class II · 2016-07-06 · Nephron Pharmaceuticals - Universal aluminum crutch, 1 pair per case Aid the user in walking while relieving weight from one foot or leg
FDA Device · Class II · 2016-07-06 · Medical Depot - Ingenuity Core 128-Computed Tomography X-ray system Product Usage: The Ingenuity Core 128 scanner is a whole body Computed Tomography X-ray…
FDA Device · Class II · 2016-07-06 · Philips Medical Systems Cleveland - Small Bowel Scope Gastrointestinal Tract
FDA Device · Class II · 2016-07-06 · Pentax Medical - Direct Supply aluminum crutch, adult, 1 pair per case Aid the user in walking while relieving weight from one foot or leg
FDA Device · Class II · 2016-07-06 · Medical Depot - Aluminum crutch under the following labels: 1) Aluminum crutch, adult, 1 pair per case, 2) Aluminum crutch, adult, 8 pairs per case, 3) Alu…
FDA Device · Class II · 2016-07-06 · Medical Depot - IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK PF PINK-FIBERED ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325cc), Part…
FDA Device · Class II · 2016-07-06 · Cmp Industries - Intubation Scope Intended to provide optical visualization of, therapeutic access to, and use to facilitate routine or difficult tracheal i…
FDA Device · Class II · 2016-07-06 · Pentax Medical - LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 RIGHT, A/P 54.5 MM, M/L 62 MM, REF 71421363 The LEGION Hinge Knee System is indicated for: 1. Rheuma…
FDA Device · Class II · 2016-07-06 · Smith And Nephew - Gastroscope Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract
FDA Device · Class II · 2016-07-06 · Pentax Medical - *** 1) Product labeled in part: 14951-48
FDA Device · Class II · 2016-07-06 · Hospira - IMPAK ELASTIC ACRYLIC RESIN POWDER & LIQUID, SHADE TRANSPARENT, CONTENTS: 454 gm Powder + 325ml Liquid, REF 3746, Rx ONLY
FDA Device · Class II · 2016-07-06 · Cmp Industries - Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per carton, Rx Only, NDC 0487-9003-60
FDA Device · Class II · 2016-07-06 · Nephron Pharmaceuticals - Confocal GI Scope Intended to provide optical visualization of an therapeutic access to the Gastrointestinal Tract
FDA Device · Class II · 2016-07-06 · Pentax Medical - Access Free T3 Assay, Ref No. A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative…
FDA Device · Class II · 2016-07-06 · Beckman Coulter - ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx Only
FDA Device · Class II · 2016-07-06 · Cardiovascular Systems - EZ adjust aluminum crutch under the following labels: 1) EZ adjust aluminum crutch, adult, 1 pair per case, 2) EZ adjust aluminum crutch, a…
FDA Device · Class II · 2016-07-06 · Medical Depot - Ultrasound Bronchoscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Pulmonary…
FDA Device · Class II · 2016-07-06 · Pentax Medical - Choledochoscope Intended to provide optical visualization of and therapeutic access to the Biliary Tree
FDA Device · Class II · 2016-07-06 · Pentax Medical - Signmoidoscope Intended to provide optical visualization of, therapeutic access to, the Lower Gastrointestinal Tract
FDA Device · Class II · 2016-07-06 · Pentax Medical - Universal Quick Adjust under the following labels: 1) Aluminum crutch, adult, 1 pair per case, 2) Aluminum crutch, tall adult, 1 pair per c…
FDA Device · Class II · 2016-07-06 · Medical Depot - *** 1) Product labeled in part: 19734-28
FDA Device · Class II · 2016-07-06 · Hospira - LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 LEFT, A/P 58.5 MM, M/L 66 MM, REF 71421374 The LEGION Hinge Knee System is indicated for: 1. Rheumat…
FDA Device · Class II · 2016-07-06 · Smith And Nephew - Naso-Pharyngo-Laryngoscope Intended to provide optical visualization of, therapeutic access to, the Upper Airway
FDA Device · Class II · 2016-07-06 · Pentax Medical - Ultrasound Gastroscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Upper Gastr…
FDA Device · Class II · 2016-07-06 · Pentax Medical - Universal Quick Adjust under the following labels: 1) Aluminum crutch, adult, 1 pair per case, 2) Aluminum crutch, tall adult, 1 pair per c…
FDA Device · Class II · 2016-07-06 · Medical Depot - Brilliance 64, Computed Tomography X-ray system Product Usage: The Brilliance CT 64 scanner is a whole body Computed Tomography X-ray syste…
FDA Device · Class II · 2016-07-06 · Philips Medical Systems Cleveland - Ingenuity Core 128, model #728323
FDA Device · Class II · 2016-07-06 · Philips Medical Systems Cleveland - LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 RIGHT, A/P 58.5 MM, M/L 66 MM, REF 71421364 The LEGION Hinge Knee System is indicated for: 1. Rheuma…
FDA Device · Class II · 2016-07-06 · Smith And Nephew - Choledocho-Nephroscope Intended to provide optical visualization of and therapeutic access to the Abdominal Cavity
FDA Device · Class II · 2016-07-06 · Pentax Medical - Brilliance CT Big Bore Oncology, model #728243
FDA Device · Class II · 2016-07-06 · Philips Medical Systems Cleveland - Big Bore Radiology tomography X-ray system scanner, model number 728244
FDA Device · Class II · 2016-07-06 · Philips Medical Systems Cleveland - *** 1) Product labeled in part: List No. 14212-28
FDA Device · Class II · 2016-07-06 · Hospira - Dako HER2 CISH pharmDx Kit, product code: SK 109 Product Usage: For in vitro diagnostic use
FDA Device · Class II · 2016-07-06 · Dako North America - Esophagoscope Gastrointestinal Tract
FDA Device · Class II · 2016-07-06 · Pentax Medical - BIOGRAPH mCT Flow 40-4R, MATERIAL NUMBER 10529159 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Po…
FDA Device · Class II · 2016-06-29 · Siemens Medical Solutions Usa - BIOGRAPH Sys 40-3R to 40-4R, MATERIAL NUMBER 10246388 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) an…
FDA Device · Class II · 2016-06-29 · Siemens Medical Solutions Usa - BIOGRAPH 40 TruePoint w/TrueV, Material Number 10097304 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT)…
FDA Device · Class II · 2016-06-29 · Siemens Medical Solutions Usa - Biograph mCT-S(40) 4R, MATERIAL NUMBER 10248671 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Posi…
FDA Device · Class II · 2016-06-29 · Siemens Medical Solutions Usa - BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Po…
FDA Device · Class II · 2016-06-29 · Siemens Medical Solutions Usa - Biograph 6 TP 3R to 4R Upgrade, Material Number 10246387 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT)…
FDA Device · Class II · 2016-06-29 · Siemens Medical Solutions Usa - Germ Terminator, Toothbrush Steam Sterilization for Oral Health
FDA Device · Class II · 2016-06-29 · Ceg Enterprises - BIOGRAPH SYS 64-3R to 64-4R, MATERIAL NUMBER 10246389 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) an…
FDA Device · Class II · 2016-06-29 · Siemens Medical Solutions Usa - BIOGRAPH mCT Flow 64-4R, MATERIAL NUMBER 10529161 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Po…
FDA Device · Class II · 2016-06-29 · Siemens Medical Solutions Usa - BIOGRAPH 64-4R TruePoint w/TrueV, MATERIAL NUMBER 10097302 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (C…
FDA Device · Class II · 2016-06-29 · Siemens Medical Solutions Usa - SYS IVK, Bio mCT-S(40) 3R->4R Upgrade, MATERIAL NUMBER 10250743 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomograp…
FDA Device · Class II · 2016-06-29 · Siemens Medical Solutions Usa - BIOGRAPH mCT Flow Edge-4R, MATERIAL NUMBER 10528955 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and…
FDA Device · Class II · 2016-06-29 · Siemens Medical Solutions Usa - Biograph Sys 16-3R to 16-4R upgrade, MATERIAL NUMBER 10525581 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography…
FDA Device · Class II · 2016-06-29 · Siemens Medical Solutions Usa - BIOGRAPH 6 TruePoint, Material Number 10097289 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Posit…
FDA Device · Class II · 2016-06-29 · Siemens Medical Solutions Usa - Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Posi…
FDA Device · Class II · 2016-06-29 · Siemens Medical Solutions Usa - BIOGRAPH 40 - 3 Ring, Material Number 10097233 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Posit…
FDA Device · Class II · 2016-06-29 · Siemens Medical Solutions Usa - BIOGRAPH 64 - 3 Ring, Material Number 08727450 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Posit…
FDA Device · Class II · 2016-06-29 · Siemens Medical Solutions Usa - Biograph mCT-X 4R, MATERIAL NUMBER 10248670 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron…
FDA Device · Class II · 2016-06-29 · Siemens Medical Solutions Usa - SIOOA I (EP I84) Rabbit Monoclonal Antibody
FDA Device · Class II · 2016-06-29 · Cell Marque - Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version 4.4.001, Fujifilm Synapse PACS software version 4.4.…
FDA Device · Class II · 2016-06-29 · Fujifilm Medical Systems U - Crit Line in a Clip (CLiC). CliC P/N: CL 10041001 CLiC is a continuous real-time monitor for non-invasive hematocrit oxygen saturation and…
FDA Device · Class II · 2016-06-29 · Fresenius Medical Care Renal Therapies Group - Biograph mCT-S(40) 3R, MATERIAL NUMBER 10248668 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Posi…
FDA Device · Class II · 2016-06-29 · Siemens Medical Solutions Usa - EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide, Rx Only, PRB35-08-040-080
FDA Device · Class II · 2016-06-29 · Ev3 - BIOGRAPH 40 TruePoint, Material Number 10097303 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Posi…
FDA Device · Class II · 2016-06-29 · Siemens Medical Solutions Usa - BIOGRAPH mCT Flow 20-4R, MATERIAL NUMBER 10528958 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Po…
FDA Device · Class II · 2016-06-29 · Siemens Medical Solutions Usa - 6534-08N InterActive¿ Implant Open-Tray Transfer Narrow Part Number: 6534-08N Product Usage: Intended Use of Implant Direct Open Tray Trans…
FDA Device · Class II · 2016-06-29 · Implant Direct Sybron Manufacturing - Myriad handpiece Tissue morcellator
FDA Device · Class II · 2016-06-29 · Nico - Biograph mCT-S(64) 3R, MATERIAL NUMBER 10248669 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Posi…
FDA Device · Class II · 2016-06-29 · Siemens Medical Solutions Usa - Siemens Healthcare ADVIA Centaur Tnl-Ultra Assay . In-Vitro Diagnostic for quantitative determination of cardiac troponin For in vitro diag…
FDA Device · Class II · 2016-06-29 · Siemens Healthcare Diagnostics - BIOGRAPH 40-3R to 64-3R Upgrade, Material Number 10246390 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT…
FDA Device · Class II · 2016-06-29 · Siemens Medical Solutions Usa - Biograph 16 TruePoint, MATERIAL NUMBER 10249555 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Posi…
FDA Device · Class II · 2016-06-29 · Siemens Medical Solutions Usa - SYS IVK, Bio mCT-X 3R->4R Upgrade, MATERIAL NUMBER 10250745 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (…
FDA Device · Class II · 2016-06-29 · Siemens Medical Solutions Usa - BIOGRAPH mCT S(20)-4R, MATERIAL NUMBER 10534160 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Posi…
FDA Device · Class II · 2016-06-29 · Siemens Medical Solutions Usa - Biograph mCT-X 3R, MATERIAL NUMBER 10248673 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron…
FDA Device · Class II · 2016-06-29 · Siemens Medical Solutions Usa - Biograph 16 TruePoint TV, Material Number 10249556 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and P…
FDA Device · Class II · 2016-06-29 · Siemens Medical Solutions Usa - BIOGRAPH mCT Flow 64-3R, MATERIAL NUMBER 10529160 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Po…
FDA Device · Class II · 2016-06-29 · Siemens Medical Solutions Usa - BIOGRAPH mCT Flow Edge-3R, MATERIAL NUMBER 10528954 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and…
FDA Device · Class II · 2016-06-29 · Siemens Medical Solutions Usa - CytoVision Image Analysis and Capture System, an automated cell-locating device
FDA Device · Class III · 2016-06-29 · Leica Biosystems Richmond - BIOGRAPH mCT Flow 20-3R, MATERIAL NUMBER 10528956 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Po…
FDA Device · Class II · 2016-06-29 · Siemens Medical Solutions Usa - Sharpoint Polypropylene Blue Monofilament 6"/15cm 9-0 USP, Product No. J2558N
FDA Device · Class II · 2016-06-29 · Ssc Surgical Specialties - BIOGRAPH mCT Flow 40-3R, MATERIAL NUMBER 10529158 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Po…
FDA Device · Class II · 2016-06-29 · Siemens Medical Solutions Usa - Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal antigens and positive controls are used to detect antibodies in…
FDA Device · Class II · 2016-06-29 · Immuno Mycologics - BIOGRAPH 64-3R TruePoint, MATERIAL NUMBER 10097301 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and P…
FDA Device · Class II · 2016-06-29 · Siemens Medical Solutions Usa
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)