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.
- MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the MRIdian¿ System) is indicated f…
FDA Device · Class II · 2016-04-06 · Viewray - Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by comp…
FDA Device · Class II · 2016-04-06 · Siemens Medical Solutions Usa - 31" (79 cm) Appx. 3.4 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, Spiros, Bag Hanger, Item No. SL3011 sterile devices…
FDA Device · Class II · 2016-04-06 · Icu Medical - The E.CAM gamma camera system Product Usage: The E.CAM gamma camera system is a SPECT system and measures the distribution of radiopharmace…
FDA Device · Class II · 2016-04-06 · Siemens Medical Solutions Usa - Rebound Cartilage Product Usage: Rebound Cartilage is an external knee brace that provides support for knee instability due to ligament inj…
FDA Device · Class II · 2016-04-06 · Ossur H F - Vanguard XP Knee System Porous Femoral Component various sizes and orientation a total knee replacement system. prosthesis, knee, patella/f…
FDA Device · Class II · 2016-04-06 · Biomet - AXIOM Artis (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional procedures such as cardiac and neuro…
FDA Device · Class II · 2016-04-06 · Siemens Medical Solutions Usa - Unloader Custom Product Usage: Unloader Custom is an external knee braces to provide support for knee instability due to ligament injuries…
FDA Device · Class II · 2016-04-06 · Ossur H F - Estradiol II Elecsys and cobas e analyzers REF 03000079 190
FDA Device · Class II · 2016-04-06 · Roche Diagnostics Operations - Extreme Custom Product Usage: Extreme Custom is an external knee braces to provide support for knee instability due to ligament injuries an…
FDA Device · Class II · 2016-04-06 · Ossur H F - AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems…
FDA Device · Class II · 2016-04-06 · Siemens Medical Solutions Usa - Rebound Air Walker Product Usage: Rebound Air Walkers are indicated for grade 2 and grade 3 ankle sprains, to stabilize fractures, post-ope…
FDA Device · Class II · 2016-04-06 · Ossur H F - Unloader Custom Lite Product Usage: Unloader Custom Lite is an external knee braces to provide support for knee instability due to ligament…
FDA Device · Class II · 2016-04-06 · Ossur H F - Miami J Collar Product Usage: Miami J collars are applied to patients afflicted with cervical injuries to ensure immobilization
FDA Device · Class II · 2016-04-06 · Ossur H F - Cardiosave Hybrid and rescue IABP
FDA Device · Class II · 2016-04-06 · Maquet Datascope Cardiac Assist Division - The Spectra-System Dental Implant 2008 system is comprised of dental implant fixtures and prosthetic devices that compose a two-piece impla…
FDA Device · Class II · 2016-04-06 · Implant Direct Sybron Manufacturing - Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by comp…
FDA Device · Class II · 2016-04-06 · Siemens Medical Solutions Usa - The Symbia gamma camera system Product Usage: The Symbia gamma camera system is a computed tomography x-ray system which is a diagnostic x-…
FDA Device · Class II · 2016-04-06 · Siemens Medical Solutions Usa - 10mm X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System, Model Number 1400-1230
FDA Device · Class II · 2016-04-06 · Biomet Spine - Rebound Cartilage Custom Product Usage: Rebound Cartilage Custom is an external knee brace that provides support for knee instability due t…
FDA Device · Class II · 2016-04-06 · Ossur H F - Unloader XT Product Usage: Unloader XT Extreme is an external knee braces to provide support for knee instability due to ligament injuries…
FDA Device · Class II · 2016-04-06 · Ossur H F - Artis zee/zeego (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional procedures such as cardiac and n…
FDA Device · Class II · 2016-04-06 · Siemens Medical Solutions Usa - CIOS ALPHA (Image-intensified fluoroscope x-ray system) Product Usage: The Cios Alpha is a mobile X-ray system designed to provide X-ray im…
FDA Device · Class II · 2016-04-06 · Siemens Medical Solutions Usa - Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiography system developed for diagnostic imaging and interventiona…
FDA Device · Class II · 2016-04-06 · Siemens Medical Solutions Usa - Foot Switches used with the following systems: Philips Allura Xper Systems
FDA Device · Class II · 2016-04-06 · Philips Medical Systems - NecLoc Extrication Collar Product Usage: Necloc collars are applied to patients afflicted with cervical injuries to ensure immobilization
FDA Device · Class II · 2016-04-06 · Ossur H F - Rebound Diabetic Walker Product Usage: Rebound Diabetic Walkers are used for the treatment of plantar foot ulcers
FDA Device · Class II · 2016-04-06 · Ossur H F - 30" (76 cm) Appx. 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, 0.2 Micron Filter, ChemoLock, Hanger, Item No. CL352…
FDA Device · Class II · 2016-04-06 · Icu Medical - CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood gas monitor Product Usage: The CDL System 500 provides conti…
FDA Device · Class II · 2016-04-06 · Terumo Cardiovascular Systems - 30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, ChemoLock, Hanger, Item No. CL3511 ster…
FDA Device · Class II · 2016-04-06 · Icu Medical - Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector
FDA Device · Class II · 2016-04-06 · Philips Medical Systems - Estradiol III
FDA Device · Class II · 2016-04-06 · Roche Diagnostics Operations - Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by comp…
FDA Device · Class II · 2016-04-06 · Siemens Medical Solutions Usa - Back Support Suspenders Clip on Black Back Support Suspenders Sew on Black
FDA Device · Class II · 2016-04-06 · Ossur H F - Molteno3 Glaucoma Implants G-Series: GS-Single Plate 175mm2 (IOP reorder#: M3-175) GL-Single Plate 230mm2 (IOP reorder#: M3-230)
FDA Device · Class II · 2016-04-06 · Innovative Ophthalmic Products - The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit)
FDA Device · Class II · 2016-04-06 · Pmbs - 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, ChemoLock, Bag Hanger, Item No. 011-CL3511 sterile de…
FDA Device · Class II · 2016-04-06 · Icu Medical - IMCO brand Conforming Stretch Gauze Bandages, 4 x 4.1 Yds/10 cm x 3,7 cm, Reorder No. 704-IMC, Bar code 6 86864 04351 5, 96 per case (8 box…
FDA Device · Class II · 2016-04-06 · Amd Ritmed - 110" (279 cm) Appx 13.8 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, Clave, Rotating Luer, Bag Hanger, Item No. AHCL330…
FDA Device · Class II · 2016-04-06 · Icu Medical - Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by comp…
FDA Device · Class II · 2016-04-06 · Siemens Medical Solutions Usa - VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear Accelerator MHI-TM2000 Linear Accelerator System is intended for…
FDA Device · Class II · 2016-04-06 · Mitsubishi Heavy Industries Hiroshima Machinery Work - Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by comp…
FDA Device · Class II · 2016-04-06 · Siemens Medical Solutions Usa - 30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Integrated ChemoLock Drip Chamber, Spiros, Hanger, Drop-In Red Cap, Item No. CL 3011 Clerest…
FDA Device · Class II · 2016-04-06 · Icu Medical - 74" (188cm) approximately 9.0ml, 20 Drop Admin Set w/ Integrated ChemoLock Port sterile IV Administration sets are intended for the infusio…
FDA Device · Class II · 2016-04-06 · Icu Medical - Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by comp…
FDA Device · Class II · 2016-04-06 · Siemens Medical Solutions Usa - Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide
FDA Device · Class II · 2016-04-06 · Medtronic Neuromodulation - Reveal LINQ insertable Cardiac Monitor, Model LNQ11
FDA Device · Class II · 2016-04-06 · Medtronic - Papoose Infant Spine Immobilizer Item # Item Description: PA-100 Papoose PAR-100 Papoose w/replacement pads PO-100 Papoose w/o PO front POR…
FDA Device · Class II · 2016-04-06 · Ossur H F - Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by comp…
FDA Device · Class II · 2016-04-06 · Siemens Medical Solutions Usa - AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems…
FDA Device · Class II · 2016-04-06 · Siemens Medical Solutions Usa - Knee Undersleeve Gray Product Usage: Knee undersleeves are worn as an accessory for comfort under knee braces
FDA Device · Class II · 2016-04-06 · Ossur H F - MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41 Catalog No. 10638819, 10638820, 10638823, 10638824, 10638825,106…
FDA Device · Class II · 2016-04-06 · Beckman Coulter - Helios HL3T and HLT Track Mounted Dental Lights Product Usage: The product is intended for use by dental professionals to illuminate the or…
FDA Device · Class II · 2016-04-06 · Pelton And Crane Marus Dci Equipment Kavo - Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by comp…
FDA Device · Class II · 2016-04-06 · Siemens Medical Solutions Usa - Synthes Interlocking Bolt, 151 mm (General and Plastics Surgery Devices) Guide, Surgical Instrument
FDA Device · Class II · 2016-04-06 · Synthes Usa Products - system, x-ray, angiographic, model # 10094135, 10094137, 10094139, 10094141, 10280959 Artis zee/ zeego is a family of dedicated angiography…
FDA Device · Class II · 2016-04-06 · Siemens Medical Solutions Usa - Covidien Dover MIDSTREAM KIT RING CASTILE Item Code: 4090SA Castile soap towelettes are used to clean the genital area for male and female…
FDA Device · Class II · 2016-03-30 · Covidien - Instinct¿ Java¿ System (IFU reference: 046WAN0000T) . Stabilizes one or more vertebral segments from the thoracic spine to the sacrum durin…
FDA Device · Class II · 2016-03-30 · Zimmer Spine - syngo X Workplace is a medical workstation for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medic…
FDA Device · Class II · 2016-03-30 · Siemens Medical Solutions Usa - Covidien Dover PREM U/M 14FR SIL FLY Item Code: P4P14SD P400 Castile soap towelettes are used to clean the genital area for male and female…
FDA Device · Class II · 2016-03-30 · Covidien - Covidien Dover PREM U/M 14FR TMP SNS CSD Item Code: P4P14TSD P400 Castile soap towelettes are used to clean the genital area for male and f…
FDA Device · Class II · 2016-03-30 · Covidien - Covidien Dover PRECISION PRM 18FR SIL COUDE CATH SECURE Item Code: PP18CSD Castile soap towelettes are used to clean the genital area for m…
FDA Device · Class II · 2016-03-30 · Covidien - Covidien Dover 400 PREM U/M 18FR SLVR FLY Item Code: ¿¿¿ P4P18XSD Castile soap towelettes are used to clean the genital area for male and f…
FDA Device · Class II · 2016-03-30 · Covidien - Covidien Dover PREC PRM 16FR SILVER FLY TY Item Code: PP16XSD Castile soap towelettes are used to clean the genital area for male and femal…
FDA Device · Class II · 2016-03-30 · Covidien - UltraxxTM Nephrostomy Balloon Set The Ultraxx" Nephrostomy Balloon Set consists of a radiopaque balloon catheter, radiopaque sheath, and in…
FDA Device · Class II · 2016-03-30 · Cook - Covidien Dover P400 PREM U/M 18FR UL FOLY CSD Item Code: P4P18ULD Castile soap towelettes are used to clean the genital area for male and f…
FDA Device · Class II · 2016-03-30 · Covidien - Covidien Dover PREM 16FR UL LTX FOLEY TRY CSD Item Code: PP16ULD Castile soap towelettes are used to clean the genital area for male and fe…
FDA Device · Class II · 2016-03-30 · Covidien - Covidien Dover P400 PREM U/M 16FR SLVR FLY Item Code: P4P16XSD Castile soap towelettes are used to clean the genital area for male and fema…
FDA Device · Class II · 2016-03-30 · Covidien - Covidien Dover EASY CATCH MIDSTREAM KT W/CAST Item Code: 25015 Castile soap towelettes are used to clean the genital area for male and fema…
FDA Device · Class II · 2016-03-30 · Covidien - MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions anywh…
FDA Device · Class II · 2016-03-30 · Mitsubishi Heavy Industries Hiroshima Machinery Work - Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)
FDA Device · Class II · 2016-03-30 · Qig Group - Irrigation Clip 30
FDA Device · Class II · 2016-03-30 · The Anspach Effort - Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 ( 2 x 12 channel)
FDA Device · Class II · 2016-03-30 · Qig Group - Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400
FDA Device · Class II · 2016-03-30 · Qig Group - Neurotherm Curved Radiofrequency (RF) cannnula 10 cm 18 gauge, 10 mm active tip Model Number: C-1010-R-18 Product Usage: The device is a ra…
FDA Device · Class II · 2016-03-30 · Neurotherm - Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000¿ is intended for use with the ceiling-suspended tube support, high volta…
FDA Device · Class II · 2016-03-30 · Toshiba American Medical Systems - Dimension Vista LOCI Estradiol Test Code E2 Catalog Number: K6463 SMN: 10489099 Product Usage: The E2 method is an in vitro diagnostic test…
FDA Device · Class II · 2016-03-30 · Siemens Healthcare Diagnostics - Covidien Dover P400 PREM U/M 16FR TMP SNS CSD Item Code: P4P16TSD Castile soap towelettes are used to clean the genital area for male and f…
FDA Device · Class II · 2016-03-30 · Covidien - Covidien Dover P400 PREM U/M 18FR SIL FLY Item Code: P4P18SD Castile soap towelettes are used to clean the genital area for male and female…
FDA Device · Class II · 2016-03-30 · Covidien - Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set The Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set consists of a radiopaque balloon…
FDA Device · Class II · 2016-03-30 · Cook - Covidien Dover P400 PREM U/M 16FR UL FOLY CSD Item Code:P4P16ULD Castile soap towelettes are used to clean the genital area for male and fe…
FDA Device · Class II · 2016-03-30 · Covidien - da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC)Touchpad
FDA Device · Class II · 2016-03-30 · Intuitive Surgical - RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: Product Usage: Instrument providing means of positioning spherical and cylindrical len…
FDA Device · Class II · 2016-03-30 · Nidek - Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number: 10490889, 10491445, 10697757 Product Usage: For in vitro diagnostic u…
FDA Device · Class II · 2016-03-30 · Siemens Healthcare Diagnostics - Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, Size 4 -Catalog # AR-503-TTTE, Size 5 - Ca…
FDA Device · Class II · 2016-03-30 · Arthrex - Covidien Dover PRECISION PRM 16FR SIL COUDE CATH SECURE Item Code: PP16CSD Castile soap towelettes are used to clean the genital area for m…
FDA Device · Class II · 2016-03-30 · Covidien - Covidien Dover PRECSION PRM 18FR SIL FLY Item Code: PP18SD Castile soap towelettes are used to clean the genital area for male and female p…
FDA Device · Class II · 2016-03-30 · Covidien - Covidien Dover PREC PRM 14FR SILVER FLY TY Item Code: PP14XSD ¿ ¿¿ Castile soap towelettes are used to clean the genital area for male and…
FDA Device · Class II · 2016-03-30 · Covidien - Covidien Dover 4.5OZ MIDSTREAM W/CASTILE TOWL Item Code: 24015 Castile soap towelettes are used to clean the genital area for male and fema…
FDA Device · Class II · 2016-03-30 · Covidien - Covidien Dover P400 PREM UM 16FR SILV TMP CSD Item Code: P4P16XTSD Castile soap towelettes are used to clean the genital area for male and…
FDA Device · Class II · 2016-03-30 · Covidien - Covidien Dover P400 PREM U/M 16FR SIL COUDE CATH SECURE Item Code: P4P16CSD Castile soap towelettes are used to clean the genital area for…
FDA Device · Class II · 2016-03-30 · Covidien - Covidien Dover PPREM 18FR UL LTX FOLEY TRY CSD Item Code: P18ULD Castile soap towelettes are used to clean the genital area for male and fe…
FDA Device · Class II · 2016-03-30 · Covidien - Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile for use as an alternative to a face mask for achieving and maintaining control of the…
FDA Device · Class II · 2016-03-30 · Ambu - BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile in a dedicated case for steam sterilization The Adapter Kit is…
FDA Device · Class II · 2016-03-30 · Medtronic Navigation - Covidien Dover PRECSION PRM 14FR SIL FLY Item Code: ¿ PP14SD ¿¿ Castile soap towelettes are used to clean the genital area for male and fem…
FDA Device · Class II · 2016-03-30 · Covidien - IMMULITE 1000 Estradiol Test Code E2 Catalog Number: LKE21, LKE21(D), LKE25 SMN: 10381132, 10702832, 10381142 Product Usage: For in vitro d…
FDA Device · Class II · 2016-03-30 · Siemens Healthcare Diagnostics - Covidien Dover PREM U/M 14FR SLVR FLY Item Code: P4P14XSD P400 Castile soap towelettes are used to clean the genital area for male and fema…
FDA Device · Class II · 2016-03-30 · Covidien - Covidien Dover PRECSION PRM 16FR SIL FLY Item Code: PP16SD Castile soap towelettes are used to clean the genital area for male and female p…
FDA Device · Class II · 2016-03-30 · Covidien - Covidien Dover P400 UM 18FR SIL COUDE SECURE Item Code: P4P18CSDK Castile soap towelettes are used to clean the genital area for male and f…
FDA Device · Class II · 2016-03-30 · Covidien - KAMRA Inlay, ACI 7000 Corneal Inlay, Part No. 76195-01 and 76195-10 (OUS) Labeling: The KAMRA inlay is indicated for the improvement of nea…
FDA Device · Class II · 2016-03-30 · Acufocus
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)