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.
- Product 32 consists of all product under product code: HWC and same usage: Item no: 47115401200 HERBERT BONE SCREW, 3.0MM 47115401400 HERBE…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Short Percutaneous Antenna with Thermosphere" Technology Standard Percutaneous Antenna with Thermosphere" Technology
FDA Device · Class II · 2016-03-23 · Covidien Medical Products Shanghai Manufacturing - Product 16 consists of all product under poduct code: KWY and same usage: Item no: 500103822 BIPOLAR LINER 38MM OD X 2 500103922 BIPOLAR LI…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Transport Stretcher, and Head and Neck Surgery Stretcher Non-powered stretcher
FDA Device · Class II · 2016-03-23 · Stryker Medical Division - Product 31 consists of all product under product code: KTT and same usage: Item no: 118113003 FREE-LOCK TUBE & SCP PLAT 118113502 FREE-LOCK…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 70 consists of all product under product code: JDI and same usage: Item no: 785701000 VERSYS HERITAGE FEM STEM 785701100 VERSYS HER…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 56 consists of all product under product code: HWC and same usage: Item no: 47234702032 PERI SCR 3.5MM X 32MM STE 47234702018 PERI…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - Product 51 consists of all product under product code: JWH and same usage: Item no: 598603701 NEXGEN OPTION STEMMED TIB 598603702 NEXGEN OP…
FDA Device · Class II · 2016-03-23 · Zimmer Manufacturing B V - CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator
FDA Device · Class II · 2016-03-23 · Cordis - Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E - 2-Pack Catalog Number: 04634452 SMN: 10309079 ADVIA Centaur¿ Calibrator E For i…
FDA Device · Class II · 2016-03-16 · Siemens Healthcare Diagnostics - Siemens Healthcare Diagnostic ADVIA Centaur Calibrator E- 6- Pack (Reference) Catalog Number: 04636889 SMN: 10335532 ADVIA Centaur¿ Calibra…
FDA Device · Class II · 2016-03-16 · Siemens Healthcare Diagnostics - Percutaneous Insertion Tray
FDA Device · Class I · 2016-03-16 · Arrow International Division - Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura Xper FD1O and Allura Xper FD1O/10 is intended for use in cardiova…
FDA Device · Class II · 2016-03-16 · Philips Electronics North America - ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only
FDA Device · Class II · 2016-03-16 · Tem Systems - FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon…
FDA Device · Class I · 2016-03-16 · Arrow International Division - Denali Filter-Jugular/Subclavian Delivery System Product Code: DL900J/DL950J
FDA Device · Class II · 2016-03-16 · Bard Peripheral Vascular - VITROS 250 Chemistry Systems, Catalog 8132086, Unique Device Identifier No. 10758750004409, and VITROS 250 Refurbished, Catalog 6801759, Un…
FDA Device · Class II · 2016-03-16 · Ortho Clinical Diagnostics - VITROS 350 Chemistry System, Catalog Number 6802153, Unique Device Identifier Number 10758750002054
FDA Device · Class II · 2016-03-16 · Ortho Clinical Diagnostics - Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111
FDA Device · Class II · 2016-03-16 · Conformis - UltraFlex IAB: 7.5Fr 30cc
FDA Device · Class I · 2016-03-16 · Arrow International Division - Milex Arcing Diaphragm Size 95
FDA Device · Class II · 2016-03-16 · Coopersurgical - Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, Trilogy EC, Garbin, Garbin Plus Trilogy 100, Trilogy 200, Garbin, Garbin plus provides c…
FDA Device · Class II · 2016-03-16 · Philips Respironics - Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retractor) Biomet Comprehensive Reverse Shoulder products are indica…
FDA Device · Class II · 2016-03-16 · Biomet - LightSpeed QX/I (4-slice MDAS) LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body…
FDA Device · Class II · 2016-03-16 · Ge Medical Systems - GlideScope Titanium Single-Use Video Laryngoscope
FDA Device · Class I · 2016-03-16 · Verathon - Percutaneous Insertion Tray
FDA Device · Class I · 2016-03-16 · Arrow International Division - Mobile wDR motorized portable diagnostic X-ray systems
FDA Device · Class II · 2016-03-16 · Sedecal - iChem VELOCITY Automated Urine Chemistry, Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713, 800-7…
FDA Device · Class II · 2016-03-16 · Beckman Coulter - Discovery ST, , 2339985 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray…
FDA Device · Class II · 2016-03-16 · Ge Medical Systems - LightSpeed 16 (MDAS only , , 2339985 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whol…
FDA Device · Class II · 2016-03-16 · Ge Medical Systems - LightSpeed Plus (4-slice MDAS LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body…
FDA Device · Class II · 2016-03-16 · Ge Medical Systems - MitraClip Clip Delivery System, product number MSK0101
FDA Device · Class I · 2016-03-16 · Abbott Vascular - Large Volume Paracentesis Kit is packaged in a thermaformed tray which contains slots and snap-in holders for most components
FDA Device · Class II · 2016-03-16 · Gi Supply - Stryker Position Pro Mattress
FDA Device · Class II · 2016-03-16 · Stryker Medical Division - Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, screws, and instruments for orthopedic fixation The…
FDA Device · Class II · 2016-03-16 · Biomet - Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E- 6- Pack Catalog Number: 04634762 SMN: 10321075 ADVIA Centaur¿ Calibrator E For i…
FDA Device · Class II · 2016-03-16 · Siemens Healthcare Diagnostics - TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a endontontically obturated root canal treatment
FDA Device · Class II · 2016-03-16 · Ormco Sybronendo - Super Arrow-Flex Percutaneous Sheath Introducer Sets REF CL-07035 or CL-07635 or CL-07735 or CL-07835 Super Arrow-Flex Percutaneous Sheath…
FDA Device · Class II · 2016-03-16 · Arrow International - Medtronic 0-arm 02 Imaging System Catalog Number: Bl-700-02000 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoros…
FDA Device · Class II · 2016-03-16 · Medtronic Navigation - Denali Filter-Femoral Delivery System Product Code: DL900F/DL950F
FDA Device · Class II · 2016-03-16 · Bard Peripheral Vascular - UltraFlex IAB: 7.5Fr 40cc
FDA Device · Class I · 2016-03-16 · Arrow International Division - BladderScan BVI 9600, Model Numbers: 0270-0451, 0270-0452, 0270-0754, and U270-0451
FDA Device · Class II · 2016-03-16 · Verathon - Ultra 8 IAB: 8Fr 30cc
FDA Device · Class I · 2016-03-16 · Arrow International Division - Custom Assembly, Custom FCFFM x/8.2 cm Tubing Extension, Model Number: FCA026-001, Manufactured by: Value Plastics dba Nordson MEDICAL, 805…
FDA Device · Class II · 2016-03-16 · Value Plastics - RediGuard IAB: 7Fr 30cc
FDA Device · Class I · 2016-03-16 · Arrow International Division - Discovery LS, 2286327 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Co…
FDA Device · Class II · 2016-03-16 · Ge Medical Systems - VITROS 4600 Chemistry System, Catalog Number 6802445, Unique Device Identifier Number 10758750012343
FDA Device · Class II · 2016-03-16 · Ortho Clinical Diagnostics - VITROS 5600 Chemistry System, Catalog Number 6802413, Unique Device Identifier Number 10758750002740
FDA Device · Class II · 2016-03-16 · Ortho Clinical Diagnostics - Spacelabs Healthcare Xhibit Central Station, Model 96102 is used to provide clinicians with central monitoring of patient data for those pa…
FDA Device · Class II · 2016-03-16 · Spacelabs Healthcare - BD Intelliport Medication Management System Sensor The system is indicated for use by healthcare professionals in a hospital or medical cen…
FDA Device · Class II · 2016-03-16 · Becton Dickinson And - LightSpeed Ultra (8-slice MDAS), 5120327-3 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head an…
FDA Device · Class II · 2016-03-16 · Ge Medical Systems - IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 cc), Part Number 3306, and 11 oz. size (325 cc), Part Number 3…
FDA Device · Class II · 2016-03-16 · Cmp Industries - M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093
FDA Device · Class II · 2016-03-16 · Zimmer Biomet - VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132
FDA Device · Class II · 2016-03-16 · Ortho Clinical Diagnostics - Ultra 8 IAB: 8Fr 40cc
FDA Device · Class I · 2016-03-16 · Arrow International Division - FiberOptix Ultra 8 IAB: 8Fr 40cc
FDA Device · Class I · 2016-03-16 · Arrow International Division - Columbus Revision Knee System, EnduRo Knee System Product Usage: The Columbus Revision Knee System and EnduRo Knee System are indicated for…
FDA Device · Class II · 2016-03-09 · Aesculap - Karma Flexx Wheelchair Manual Wheelchair
FDA Device · Class II · 2016-03-09 · Karman Healthcare - Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert r…
FDA Device · Class III · 2016-03-09 · Medtronic Perfusion Systems - Volcano SpinVision Sterile Equip cover II
FDA Device · Class II · 2016-03-09 · Volcano - BrightView are gamma cameras
FDA Device · Class II · 2016-03-09 · Philips Medical Systems Cleveland - Dimension Vista System B2 Microglobulin Flex reagent cartridge and urine stabilizer Catalog #K7024 SMN: 10445889 Lot #15246MA Product Usage…
FDA Device · Class II · 2016-03-09 · Siemens Healthcare Diagnostics - (Stryker) AccuPlace Round Level Needle Guide
FDA Device · Class II · 2016-03-09 · Stryker Instruments Div - SENSE Body Coil 1.5T with identification
FDA Device · Class II · 2016-03-09 · Philips Electronics North America - 50001 (Inrad) AccuPlace Drace Stereotaxic Needle Guide
FDA Device · Class II · 2016-03-09 · Stryker Instruments Div - ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast Introducer Sheath Set 7Fr/Ch(2.3mm) x 11 cm REF I…
FDA Device · Class II · 2016-03-09 · Argon Medical Devices - Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered…
FDA Device · Class II · 2016-03-09 · Convatec - Kopans Breast Lesion Localization Needle The Kopans Breast Lesion Localization Needle consists of a bevel-tip needle with centimeter markin…
FDA Device · Class II · 2016-03-09 · Cook - BrightView XCT & BrightView XCT Upgrade, gamma cameras
FDA Device · Class II · 2016-03-09 · Philips Medical Systems Cleveland - Virage OCT Spinal Fixation System
FDA Device · Class II · 2016-03-09 · Zimmer Spine - Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 6.5 Fr/Ch (2.2 mm) x 36" (91 cm), Sterile
FDA Device · Class II · 2016-03-09 · Covidien - PICC/CVC Secure Dressing Change kit, Ref: 73775, Lot 213403, Sterile Single Use, Medical Action Industries, Inc., Arden, NC. This kit is us…
FDA Device · Class II · 2016-03-09 · Medical Action Industries - NeoCoil 3.0T GEM Flex Coil
FDA Device · Class II · 2016-03-09 · Neocoil - Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 8 Fr/Ch (2.7 mm) x 20" (51 cm)
FDA Device · Class II · 2016-03-09 · Covidien - 50000 (Inrad) AccuPlace Drace Stereotaxic Needle Guide
FDA Device · Class II · 2016-03-09 · Stryker Instruments Div - BrightView X are gamma cameras
FDA Device · Class II · 2016-03-09 · Philips Medical Systems Cleveland - PINPOINT Endoscopic Fluorescence Imaging System
FDA Device · Class II · 2016-03-09 · Novadaq Technologies - Maquet Getinge Group 1180.19XO Extension Device
FDA Device · Class II · 2016-03-09 · Maquet Cardiovascular Us Sales - Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art
FDA Device · Class II · 2016-03-09 · Ivoclar Vivadent - (Stryker) AccuPlace Straight Level Needle Guide
FDA Device · Class II · 2016-03-09 · Stryker Instruments Div - Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunct…
FDA Device · Class II · 2016-03-09 · Mako Surgical - Volcano R100 Sterile Equipment Cover
FDA Device · Class II · 2016-03-09 · Volcano - EndoVive 3s Low Profile Balloon Kits Part Number: M00549410 (XMD P/N 70-0050-B22) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - EndoVive 3s Low Profile Balloon Kits Part Number: M00549380 (XMD P/N 70-0050-822) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - EndoVive 3s Low Profile Balloon Kits Part Number: M00548280 (XMD P/N 70-0050-712) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - Olympus, Model No. CF-H180AL, flexible scope, large diameter, video colonoscope
FDA Device · Class II · 2016-03-02 · Integrated Medical Systems - EndoVive 3s Low Profile Balloon Kits Part Number: M00549460 (XMD P/N 70-0050-G22) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - Olympus, Model No. CF-Q180AL, flexible scope, large diameter, video colonoscope
FDA Device · Class II · 2016-03-02 · Integrated Medical Systems - EndoVive 3s Low Profile Balloon Kits Part Number: M005489490 (XMD P/N 70-0050-524) The EndoVive 3s Low Profile Balloon is intended to provi…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - Femoral Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-c…
FDA Device · Class I · 2016-03-02 · Cook - EndoVive 3s Low Profile Balloon Kits Part Number: M00548870 (XMD P/N 70-0050-620) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - Olympus, Model No. GIF-XQ140, flexible scope, large diameter, video gastroscope
FDA Device · Class II · 2016-03-02 · Integrated Medical Systems - Stryker, T2 Guidewire, Ball-Tipped, 2.5 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments
FDA Device · Class II · 2016-03-02 · Stryker Howmedica Osteonics - EndoVive 3s Low Profile Balloon Kits Part Number: M00548770 (XMD P/N 70-0050-C18) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - EndoVive 3s Low Profile Balloon Kits Part Number: M00548360 (XMD P/N 70-0050-314) The EndoVive 3s Low Profile Balloon is intended to provid…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices - Hill-Rom Bariatric Power Recliner, Product Model # P9096 Hill-Roms 660 lb Powered Bariatric Recliner was created to provide an aestheticall…
FDA Device · Class II · 2016-03-02 · Hill Rom - Stryker, T2 Guidewire, Ball-Tipped, 3 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments
FDA Device · Class II · 2016-03-02 · Stryker Howmedica Osteonics - Single Lumen Central Venous Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated c…
FDA Device · Class I · 2016-03-02 · Cook - NKII CSTI Porous Femoral NKII NP Femoral prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer variou si…
FDA Device · Class II · 2016-03-02 · Zimmer Biomet - EndoVive 3s Low Profile Balloon Kits Part Number: MM00548410 (XMD P/N 70-0050-814) The EndoVive 3s Low Profile Balloon is intended to provi…
FDA Device · Class II · 2016-03-02 · Xeridiem Mediem Medical Devices
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