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.
- Lap/Pelviscopy Pack, Kit number AMS4151, PSS3256, PSS3256(A convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - General Male Pack, Kit number AMS1580 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Basic Tray, Kit part numbers AMS1199(A and PSS1559(A convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Nasal Pack, Kit number PSS2186 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - C-Section Pack, Kit number 002643-10, 002643-9, and AMS4449 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Endoscopic Articulating Linear Cutter, ATB35
FDA Device · Class II · 2016-10-26 · Ethicon Endo Surgery - Total Hip Pack, Kit number PSS2956 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Minor Tray AMS2685 convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - Cytoplast Titanium-Reinforced Posterior Singles Membrane A temporarily implantable material (non-resorbable) for use as a space-making barr…
FDA Device · Class II · 2016-10-26 · Osteogenics Biomedical - Custom Venous Kit, TVS4024(C convenience custom kits used for general surgery in hospital operating room
FDA Device · Class II · 2016-10-26 · Windstone Medical Packaging - OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance Product Usage: The OEC Brivo Mobile C-Arm X-Ray Products are designed t…
FDA Device · Class II · 2016-10-19 · Ge Oec Medical Systems - Teleflex Percuaneous Solutions, Gripper Grasper, Ref ML003EE, Rx Only Sterile Manufactured for: Teleflex Medical, Park, NC 27709 The Percut…
FDA Device · Class II · 2016-10-19 · Teleflex Medical - Phoenix Recon Targeting Arm Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgical Instruments for the Arm Product Usage…
FDA Device · Class II · 2016-10-19 · Zimmer Biomet - Phoenix Recon Soft Tissue Sleeve Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgical Instruments for the Arm Product…
FDA Device · Class II · 2016-10-19 · Zimmer Biomet - CONCEPT HEATWAVE Electrode 130 mm x 2.3 mm diameter, REF/Catalog Number CS-023, STERILE, Rx Only Product Usage: The HeatWave Electrode is i…
FDA Device · Class II · 2016-10-19 · Conmed - Symbia T Series SPECT + CT Product Usage 1) SPECT: To Detect or image the distribution of radionuclides in the body or organ, using the fol…
FDA Device · Class II · 2016-10-19 · Siemens Medical Solutions Usa - Blood Pressure Monitor UA-767PBT-Ci for small cuff
FDA Device · Class II · 2016-10-19 · A And D Enginering - The Medix NatalCare LX Intensive Care Incubator
FDA Device · Class II · 2016-10-19 · Natus Medical - Radiation Therapy Treatment Planning System, Model 5.0
FDA Device · Class II · 2016-10-19 · Raysearch Laboratories Ab - Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X Cannula w/ Sideport
FDA Device · Class II · 2016-10-19 · Banyan Medical - The Introes Pocket Bougie is an endotracheal tube introducer
FDA Device · Class II · 2016-10-19 · Brathwaites Oliver Medical - Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, Howmedica Osteonics Corp., Mahwah, NJ, USA,…
FDA Device · Class II · 2016-10-19 · Stryker Howmedica Osteonics - The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circuit and provide complia…
FDA Device · Class III · 2016-10-19 · Circulatory Technology - Monaco RTP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy
FDA Device · Class II · 2016-10-19 · Elekta - TransMotion Medical, TMM4 Series Multi-Purpose Treatment Chair
FDA Device · Class II · 2016-10-19 · Winco Mfg - TransMotion Medical, TMM3 Series Video-Fluoroscopy Swallow Study Stretcher-Chair
FDA Device · Class II · 2016-10-19 · Winco Mfg - SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS), Siemens Material Number (SMN) 10381282 (OUS), Uni…
FDA Device · Class II · 2016-10-19 · Siemens Healthcare Diagnostics - Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000 Product Usage: The O-arm Surgical Imaging System…
FDA Device · Class II · 2016-10-19 · Medtronic Navigation Littleton - Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management sys…
FDA Device · Class II · 2016-10-19 · Fujifilm Medical Systems U - Banyan Medical 5 x 55mm Regular Pyramidal Trocar and 2x Cannula
FDA Device · Class II · 2016-10-19 · Banyan Medical - Zero-Gravity Radiation Protection System Radiology Personnel protective shield
FDA Device · Class II · 2016-10-19 · Contour Fabricators - SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number for US: L2KRM2(D), Siemens Material Number (SMN) for US: 10374…
FDA Device · Class II · 2016-10-19 · Siemens Healthcare Diagnostics - TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere¿ is indicated for radiation treatment or as a neoadjuvant to surgery or t…
FDA Device · Class II · 2016-10-19 · Biocompatibles U K - HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103
FDA Device · Class I · 2016-10-19 · Heartware - Varian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and Post Kits (PN1008016)
FDA Device · Class II · 2016-10-19 · Varian Medical Systems - Symbia S, Product Usage 1) SPECT: To Detect or image the distribution of radionuclides in the body or organ, using the following techniques…
FDA Device · Class II · 2016-10-19 · Siemens Medical Solutions Usa - BioSentry Tract Sealant System, Product Code: 768022019S
FDA Device · Class II · 2016-10-19 · Surgical Specialties Mexico - TransMotion Medical, TMM5 Series Mobile Surgical Stretcher -Chair
FDA Device · Class II · 2016-10-19 · Winco Mfg - Teleflex Percuaneous Solutions, Johans Grasper, Ref ML004EE, Rx Only Sterile Manufactured for: Teleflex Medical, Park, NC 27709 The Percuta…
FDA Device · Class II · 2016-10-19 · Teleflex Medical - V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX
FDA Device · Class II · 2016-10-19 · Cardinal Health 200 - ADVIA Centaur XPT Immunoassay System
FDA Device · Class II · 2016-10-19 · Siemens Healthcare Diagnostics - Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the b…
FDA Device · Class II · 2016-10-12 · Philips Medical Systems - Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain
FDA Device · Class II · 2016-10-12 · Ivoclar Vivadent - Dimension Vista¿ Calcium (CA) Flex¿ reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB
FDA Device · Class II · 2016-10-12 · Siemens Healthcare Diagnostics - Siemens RAPIDPoint 405 Measurement Cartridge Siemens SMN numbers: 10844812, 1028322, 10313971 , 10310469
FDA Device · Class III · 2016-10-12 · Siemens Healthcare Diagnostics - TriFoillmaging Triumph/Triumph II Research CT scanners
FDA Device · Class II · 2016-10-12 · Northridge Tri Modality Imaging - Integra Lumbar Drainage Set, REF 910120A, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary pack…
FDA Device · Class II · 2016-10-12 · Integra Lifesciences - RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0) -- Radiation Therapy Treatment Planning System RayStation is a softwa…
FDA Device · Class II · 2016-10-12 · Raysearch Laboratories Ab - Thermo Scientific QMS Everolimus Assay
FDA Device · Class II · 2016-10-12 · Microgenics - Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain
FDA Device · Class II · 2016-10-12 · Ivoclar Vivadent - Merit Inflation Syringe Kit
FDA Device · Class II · 2016-10-12 · Merit Medical Systems - Integra Ventricular Catheter Accessory Kit, REF 951303, Sterile EO, Rx only, packaged in a PVC tray, then secondary package in to Tyvek pou…
FDA Device · Class II · 2016-10-12 · Integra Lifesciences - Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner
FDA Device · Class II · 2016-10-12 · Toshiba American Medical Systems - Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by…
FDA Device · Class II · 2016-10-12 · Philips Medical Systems - Zenostar MT Color B4 60ml, art. no. 681058
FDA Device · Class II · 2016-10-12 · Ivoclar Vivadent - Zenostar MT Color A3 60ml, art. no. 681052
FDA Device · Class II · 2016-10-12 · Ivoclar Vivadent - Zenostar MT Color D2 60ml, art. no. 681063
FDA Device · Class II · 2016-10-12 · Ivoclar Vivadent - Zenostar MT Color C2 60ml art. no. 681060
FDA Device · Class II · 2016-10-12 · Ivoclar Vivadent - Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
FDA Device · Class II · 2016-10-12 · Ivoclar Vivadent - CDI¿ H/S Cuvette The intended use for the CDI¿ H IS Cuvette is as follows: The CDI¿ H/S Cuvettes are intended for use with a CDI monitor du…
FDA Device · Class III · 2016-10-12 · Terumo Cardiovascular Systems - Zenostar MT Color D4 60ml, art. no. 681065
FDA Device · Class II · 2016-10-12 · Ivoclar Vivadent - Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body…
FDA Device · Class II · 2016-10-12 · Philips Medical Systems - Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch, s…
FDA Device · Class II · 2016-10-12 · Integra Lifesciences - Zenostar MT Color A4 60ml, art. no. 681054
FDA Device · Class II · 2016-10-12 · Ivoclar Vivadent - Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
FDA Device · Class II · 2016-10-12 · Ivoclar Vivadent - ROI-A Anterior Delivery Device
FDA Device · Class II · 2016-10-12 · Ldr Spine Usa - CT3Plus (a.k.a. CT3PZ)
FDA Device · Class II · 2016-10-12 · New Star Lasers - Multix Fusion VA10 Product Usage: The Multix Fusion VA10 system is a radiographic system used in hospitals, clinics, and medical practices
FDA Device · Class II · 2016-10-12 · Siemens Medical Solutions Usa - Zenostar MT Color B1 60ml, art. no. 681055
FDA Device · Class II · 2016-10-12 · Ivoclar Vivadent - BLUE IMPERVIOUS GOWN WITH THUMBHOOKS, X-LARGE. Non-Sterile, Single Use Only, Plastic Non-Surgical Isolation Gown Non-Sterile, Single Use On…
FDA Device · Class II · 2016-10-12 · Cardinal Health - Stationary Column TruSystem 7599, Material Number 1717020 Patient positioning during surgery, ranging from anesthesia induction to actual s…
FDA Device · Class II · 2016-10-12 · Trumpf Medical Systems - MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath used to facilitate placing a catheter through the ski…
FDA Device · Class II · 2016-10-12 · Argon Medical Devices - Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner
FDA Device · Class II · 2016-10-12 · Toshiba American Medical Systems - CUSA Dissectron Fingertip Laparoscopic Cannula, REF F75221, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in Tyvek…
FDA Device · Class II · 2016-10-12 · Integra Lifesciences - Multix Fusion Stationary X-Ray System Product Usage: The Multix Fusion system is a radiographic system used in hospitals, clinics, and medi…
FDA Device · Class II · 2016-10-12 · Siemens Medical Solutions Usa - Arthrex Suture Washer
FDA Device · Class III · 2016-10-12 · Arthrex - Vanguard 360 Revision Knee System Knee prostheses
FDA Device · Class II · 2016-10-12 · Zimmer Biomet - Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is intended for use in removing arterial emboli
FDA Device · Class II · 2016-10-12 · Arrow International - Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner
FDA Device · Class II · 2016-10-12 · Toshiba American Medical Systems - 0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions
FDA Device · Class I · 2016-10-12 · Baxter Englewood - Zenostar MT Color A3.5 60ml, art. no. 681053
FDA Device · Class II · 2016-10-12 · Ivoclar Vivadent - Mobile Column TruSystem 7500, Material Number 1717023
FDA Device · Class II · 2016-10-12 · Trumpf Medical Systems - Zenostar MT Color D3 60ml, art. no. 681064
FDA Device · Class II · 2016-10-12 · Ivoclar Vivadent - Zenostar MT Color B2 60ml, art. no. 681056
FDA Device · Class II · 2016-10-12 · Ivoclar Vivadent - Integra Drainage Accessory Kits, REF 910122, Sterile EO, Rx only, packaged in one Tyvek pouch
FDA Device · Class II · 2016-10-12 · Integra Lifesciences - Operating Table TruSystem 7000 U, Material Number 1604788
FDA Device · Class II · 2016-10-12 · Trumpf Medical Systems - Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN numbers:10329756, 10341161
FDA Device · Class III · 2016-10-12 · Siemens Healthcare Diagnostics - IgE Calibrator Series
FDA Device · Class II · 2016-10-12 · Randox Laboratories - Integral Lumbar Drainage Set, REF 910420, Sterile EO, Rx only, primary packaged in a PVC blister sealed with Tyvek sheet and secondary pack…
FDA Device · Class II · 2016-10-12 · Integra Lifesciences - Zenostar MT Color B3 60ml, art. no. 681057
FDA Device · Class II · 2016-10-12 · Ivoclar Vivadent - Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the bod…
FDA Device · Class II · 2016-10-12 · Philips Medical Systems - Zenostar MT Color C4 60ml, art. no. 681062
FDA Device · Class II · 2016-10-12 · Ivoclar Vivadent - YSIO Max Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices
FDA Device · Class II · 2016-10-12 · Siemens Medical Solutions Usa - VariaBreeze
FDA Device · Class II · 2016-10-12 · New Star Lasers - Toshiba America Medical Systems, Inc . Aquilion RXL TSX-101 A/R, U CT Scanner Diagnostic imaging systems indicated to acquire and display c…
FDA Device · Class II · 2016-10-12 · Toshiba American Medical Systems - Floor Mounting Column TS 7500 U, Material Number 1730732
FDA Device · Class II · 2016-10-12 · Trumpf Medical Systems - Zenostar MT Color C3 60ml, art. no. 681061
FDA Device · Class II · 2016-10-12 · Ivoclar Vivadent - Zenostar MT Color Impulse orange, art. no. 681168
FDA Device · Class II · 2016-10-12 · Ivoclar Vivadent - Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray images
FDA Device · Class II · 2016-10-12 · Panoramic Rental - ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue
FDA Device · Class II · 2016-10-12 · New Star Lasers
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)