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.
- Covidien Endo GIA Ultra Universal 12 mm XL Stapler Handle Ref: EGIAUXL Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Un…
FDA Device · Class II · 2016-02-24 · Medtronic - Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046, Expiration 10/31/2018, Product…
FDA Device · Class II · 2016-02-24 · Sorin Group Usa - Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32
FDA Device · Class II · 2016-02-24 · Carefusion 303 - MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stimulator Box) JB-116B, JB-132B (Amplifier…
FDA Device · Class II · 2016-02-24 · Nihon Kohden America - Arctic Sun 5000 and Arctic Sun 2000
FDA Device · Class II · 2016-02-17 · C R Bard - IMPLANT,TM, MTX 4.1 mm x 13 mm diameter 3.5 mm Catalog #TMM4B13 Product Usage: Zimmer Dental implant systems are designed for use in the ma…
FDA Device · Class II · 2016-02-17 · Zimmer Dental - GE Healthcare, Optima XR220amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images
FDA Device · Class II · 2016-02-17 · Ge Medical Systems - VS200 radiographic Cassette Holder or Wall Stand
FDA Device · Class II · 2016-02-17 · Del Medical - Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended for posterior, non-cervical pedicle, and non-pedicle fixation…
FDA Device · Class II · 2016-02-17 · Orthofix - Allura Xper FD OR Table, Ceiling version only
FDA Device · Class II · 2016-02-17 · Philips Electronics North America - Moog Curlin Infusion, Ambulatory Infusion Pump The Curlin Ambulatory Infusion System includes Curlin Ambulatory multi-therapy and PainSmart…
FDA Device · Class II · 2016-02-17 · Moog Medical Devices Group - Bard Distaflo Vascular Bypass Graft
FDA Device · Class II · 2016-02-17 · Bard Peripheral Vascular - RadSuite, a picture archive and communications system
FDA Device · Class II · 2016-02-17 · Merge Healthcare - Patient transport Shuttle with Trendelenburg quick adjustment function (Jupiter, Mars, Titan, TruSystem and Saturn operating table systems)
FDA Device · Class II · 2016-02-17 · Trumpf Medical Systems - Bard Distaflo Vascular Bypass Graft
FDA Device · Class II · 2016-02-17 · Bard Peripheral Vascular - Endobon-Xenograft Granules, Zimmer Biomet, Synthetic Bone Grafting Material, used in dental and/or surgical procedures
FDA Device · Class II · 2016-02-17 · Biomet France Sarl - SIGMA HP MBT Non-Keel Punch Knee Instrument
FDA Device · Class II · 2016-02-17 · Depuy Orthopaedics - Mizuho OSI Trios, Table Base
FDA Device · Class II · 2016-02-17 · Mizuho Osi - Mavig Monitor Suspension System, Model GD60, contained in the following Fluoroscopic imaging systems: Advantx LCV+, Advantx LCN+, Advantx L…
FDA Device · Class II · 2016-02-17 · Ge Medical Systems - IMPLANT,TM, MTX FULL 3.7 mm x 10 mm diameter 3.5 mm Catalog #TMTB10 Product Usage: Zimmer Dental implant systems are designed for use in th…
FDA Device · Class II · 2016-02-17 · Zimmer Dental - IMPLANT,TM, MTX 3.7 mm x 13 mm diameter 3.5 mm Catalog #TMMB13 Product Usage: Zimmer Dental implant systems are designed for use in the max…
FDA Device · Class II · 2016-02-17 · Zimmer Dental - IMPLANT,TM, MTX 4.1 mm x 11.5 mm diameter 3.5 mm Catalog #TMM4B11 Product Usage: Zimmer Dental implant systems are designed for use in the…
FDA Device · Class II · 2016-02-17 · Zimmer Dental - VS300 radiographic Cassette Holder or Wall Stand
FDA Device · Class II · 2016-02-17 · Del Medical - Philips Allura Xper FD20 Ceiling version only
FDA Device · Class II · 2016-02-17 · Philips Electronics North America - PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative -free, Non-pyrogenic, pH 7.4 For Inhalation Only Rx…
FDA Device · Class II · 2016-02-17 · Pharmacaribe - Smith & Nephew BEAVER Blade 4.0mm Part Number: 72203307 Orthopedic surgical instrument used in hip arthroscopy
FDA Device · Class II · 2016-02-17 · Smith And Nephew - INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
FDA Device · Class II · 2016-02-17 · Toshiba American Medical Systems - Reuseable rotary blade/abrader, product number 899751514
FDA Device · Class II · 2016-02-17 · Richard Wolf Medical Instruments - IMPLANT,TM, MTX FULL 3.7 mm x 13 mm diameter 3.5 mm Catalog #TMTB13 Product Usage: Zimmer Dental implant systems are designed for use in th…
FDA Device · Class II · 2016-02-17 · Zimmer Dental - IMPLANT,TM, MTX FULL 4.1 mm x 10 mm diameter 3.5 mm Catalog #TMT4B10 Product Usage: Zimmer Dental implant systems are designed for use in t…
FDA Device · Class II · 2016-02-17 · Zimmer Dental - IMPLANT,TM, MTX FULL 3.7 mm x 11.5 mm diameter 3.5 mm Catalog #TMTB11 Product Usage: Zimmer Dental implant systems are designed for use in…
FDA Device · Class II · 2016-02-17 · Zimmer Dental - T-piece Nebulizer with in-line connectors, Part number 8915-7-50
FDA Device · Class II · 2016-02-17 · Salter Labs - IMPLANT,TM, MTX FULL 3.7 mm x 16 mm diameter 3.5 mm Catalog #TMTB16 Product Usage: Zimmer Dental implant systems are designed for use in th…
FDA Device · Class II · 2016-02-17 · Zimmer Dental - IMPLANT,TM, MTX 4.1 mm x 10 mm diameter 3.5 mm Catalog #TMM4B10 Product Usage: Zimmer Dental implant systems are designed for use in the ma…
FDA Device · Class II · 2016-02-17 · Zimmer Dental - IMPLANT,TM, MTX FULL 4.1 mm x 13 mm diameter 3.5 mm Catalog #TMT4B13 Product Usage: Zimmer Dental implant systems are designed for use in t…
FDA Device · Class II · 2016-02-17 · Zimmer Dental - IMPLANT,TM, MTX 3.7 mm x 10 mm diameter 3.5 mm Catalog #TMMB10 Product Zimmer Dental implant systems are designed for use in the maxilla or…
FDA Device · Class II · 2016-02-17 · Zimmer Dental - Reuseable rotary blade/abrader, product number 899751504
FDA Device · Class II · 2016-02-17 · Richard Wolf Medical Instruments - 2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Power System (Laser Atherectomy Catheter) is a laser atherectomy de…
FDA Device · Class II · 2016-02-17 · Spectranetics - IMPLANT,TM, MTX 3.7 mm x 11.5 mm diameter 3.5 mm Catalog #TMMB11 Product Usage: Zimmer Dental implant systems are designed for use in the m…
FDA Device · Class II · 2016-02-17 · Zimmer Dental - GE Healthcare, Brivo XR285amx Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images
FDA Device · Class II · 2016-02-17 · Ge Medical Systems - GE Healthcare, Optima XR200amx, Mobile Digital Ready Radiographic System Designed to generate diagnostic radiographic images
FDA Device · Class II · 2016-02-17 · Ge Medical Systems - IMPLANT,TM, MTX FULL 4.1 mm x 11.5 mm diameter 3.5 mm Catalog #TMT4B11 Product Usage: Zimmer Dental implant systems are designed for use in…
FDA Device · Class II · 2016-02-17 · Zimmer Dental - Philips Healthcare TraumaDiagnost
FDA Device · Class II · 2016-02-17 · Philips Electronics North America - CyberKnife Robotic
FDA Device · Class II · 2016-02-17 · Accuray - Reuseable rotary blade/abrader, product number 899751305
FDA Device · Class II · 2016-02-17 · Richard Wolf Medical Instruments - MEVION S250 Radiation therapy system
FDA Device · Class II · 2016-02-17 · Mevion Medical Systems - DS/US Proton Feature with Pinnacle3 Software Version 10.0.0 and 14.0.0 Radiation Therapy Planning System Model #459800200621
FDA Device · Class II · 2016-02-10 · Philips Medical Systems - INTEGRIS V3000
FDA Device · Class II · 2016-02-10 · Philips Electronics North America - INTEGRIS BV3000 MONO
FDA Device · Class II · 2016-02-10 · Philips Electronics North America - Allura Xper FD20/20
FDA Device · Class II · 2016-02-10 · Philips Electronics North America - Panorama Patient Monitoring Network
FDA Device · Class II · 2016-02-10 · Mindray Ds Usa - ADVIA Centaur PSA Assay
FDA Device · Class II · 2016-02-10 · Siemens Healthcare Diagnostics - ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical chemistry analyzer that runs tests on serum, plasma, urine, or c…
FDA Device · Class II · 2016-02-10 · Siemens Healthcare Diagnostics - UNIQ FD
FDA Device · Class II · 2016-02-10 · Philips Electronics North America - Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily used as non-invasive homecare devices, for example, the largest…
FDA Device · Class II · 2016-02-10 · Resmed - Allura Xper FD10, FD10 C, and FD10 F
FDA Device · Class II · 2016-02-10 · Philips Electronics North America - API ZYM Bx2 (Ref 70493) Product Usage: ZYM B reagent is an additional test used for revealing the results of some miniaturized biochemical…
FDA Device · Class II · 2016-02-10 · Biomerieux - MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent pa…
FDA Device · Class II · 2016-02-10 · Owens And Minor Distribution - MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent pa…
FDA Device · Class II · 2016-02-10 · Owens And Minor Distribution - ABX PENTRA Triglycerides CP ref
FDA Device · Class II · 2016-02-10 · Horiba Instruments - Allura Xper FD10/10
FDA Device · Class II · 2016-02-10 · Philips Electronics North America - UNIQ FD OR table
FDA Device · Class II · 2016-02-10 · Philips Electronics North America - Biosure Ratchet Driver, Product No: 72201888 For delivery and placement of orthopedic screws
FDA Device · Class II · 2016-02-10 · Smith And Nephew Endoscopy Div - BacT/ALERT¿ SN, bioM¿rieux, Inc
FDA Device · Class II · 2016-02-10 · Biomerieux - Allura CV20
FDA Device · Class II · 2016-02-10 · Philips Electronics North America - INTEGRIS V5000: Model Number: 72248 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neur…
FDA Device · Class II · 2016-02-10 · Philips Electronics North America - INTEGRIS Allura 15-12 (biplane)
FDA Device · Class II · 2016-02-10 · Philips Electronics North America - Cardiovascular Allura Centron
FDA Device · Class II · 2016-02-10 · Philips Electronics North America - Emergency Transport Ventilator Oxylog 3000 Ventilator and Oxylog 3000 plus Ventilator Catalog Numbers: 2M86300/2M86965 and 5704813/5704831
FDA Device · Class I · 2016-02-10 · Draeger Medical - ABX PENTRA Uric Acid CP ref
FDA Device · Class II · 2016-02-10 · Horiba Instruments - INTEGRIS BV5000: Model Number: 72249 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neu…
FDA Device · Class II · 2016-02-10 · Philips Electronics North America - The ABX PENTRA Cholesterol CP ref
FDA Device · Class II · 2016-02-10 · Horiba Instruments - Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: 5705080
FDA Device · Class I · 2016-02-10 · Draeger Medical - AQURE System
FDA Device · Class II · 2016-02-10 · Radiometer America - Allura Xper FD20/10
FDA Device · Class II · 2016-02-10 · Philips Electronics North America - MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent pa…
FDA Device · Class II · 2016-02-10 · Owens And Minor Distribution - Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: This instrument has been designed to be used with an Olympus video…
FDA Device · Class II · 2016-02-10 · Olympus - Allura Xper FD20 OR Table
FDA Device · Class II · 2016-02-10 · Philips Electronics North America - Allura Xper FD20
FDA Device · Class II · 2016-02-10 · Philips Electronics North America - Synthes Small Electric Drive (SED). For use in general traumatology
FDA Device · Class II · 2016-02-10 · The Anspach Effort - Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F. Intravascular filters
FDA Device · Class II · 2016-02-10 · Bard Peripheral Vascular - ABX PENTRA Glucose PAP CP ref
FDA Device · Class II · 2016-02-10 · Horiba Instruments - INTEGRIS BH5000
FDA Device · Class II · 2016-02-10 · Philips Electronics North America - INTEGRIS Allura 9 (biplane)
FDA Device · Class II · 2016-02-10 · Philips Electronics North America - INTEGRIS H5000
FDA Device · Class II · 2016-02-10 · Philips Electronics North America - ABX PENTRA Enzymatic Creatinine CP ref
FDA Device · Class II · 2016-02-10 · Horiba Instruments - Allura Xper FD20/15
FDA Device · Class II · 2016-02-10 · Philips Electronics North America - INTEGRIS BN/BV3000
FDA Device · Class II · 2016-02-10 · Philips Electronics North America - ET-20 Anesthesia Extension Tubes, 2.5 ml approximately, Sterile and Disposable, Wall Medical Inc., Made in China
FDA Device · Class II · 2016-02-10 · Global Healthcare - Allura Xper FD20 Biplane OR Table
FDA Device · Class II · 2016-02-10 · Philips Electronics North America - Allura Xper FD20/20 OR Table
FDA Device · Class II · 2016-02-10 · Philips Electronics North America - Allura Xper FD20 Biplane
FDA Device · Class II · 2016-02-10 · Philips Electronics North America - HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company
FDA Device · Class II · 2016-02-10 · Instrumentation Laboratory - Allura Xper FD10 OR Table
FDA Device · Class II · 2016-02-10 · Philips Electronics North America - INTEGRIS H3000
FDA Device · Class II · 2016-02-10 · Philips Electronics North America - INTEGRIS BH3000
FDA Device · Class II · 2016-02-10 · Philips Electronics North America - BacT/ALERT¿ FA, bioM¿rieux, Inc., Product Usage: BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿ Microbial Detection System in qu…
FDA Device · Class II · 2016-02-10 · Biomerieux - ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU 014623) Automated Manifold Kits, Sterile R, Rx Only, Mad…
FDA Device · Class II · 2016-02-10 · Acist Medical Systems - Baxter, RAPIDFILL Syringe Strip, 10 ml
FDA Device · Class II · 2016-02-10 · Baxter Englewood - Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws
FDA Device · Class II · 2016-02-10 · Smith And Nephew Endoscopy Div
Other years
2026 (2,088) · 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)