FDA Device · 2014
FDA Device recalls in 2014
RecallRadar indexes 3,059 FDA Device recall notices published in 2014. By classification: 558 Class I, 2,441 Class II, 60 Class III.
- ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 2-pack SMN 10311391 For in vitro diagnostic use in the quantitative determination of…
FDA Device · Class II · 2014-02-12 · Siemens Healthcare Diagnostics - SuperElastic Regular force NiTi lower or upper Natural arches. 0.16 size 10 or 100 count packages
FDA Device · Class II · 2014-02-12 · Highland Metals - Trifurcated Extension Set, model no
FDA Device · Class II · 2014-02-12 · Carefusion 303 - Stand-Alone Resuscitation Unit, Bag and Mask, part number M1226444, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723***ww…
FDA Device · Class II · 2014-02-12 · Ge Healthcare - Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Made in…
FDA Device · Class II · 2014-02-05 · Deroyal Industries - Vivid (tm) Endo Illuminator, 20ga, Synergetics, inc., length 7.5 ft, sterile / EO, 56.20P. Packed 12 units per box
FDA Device · Class II · 2014-02-05 · Synergetics - User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with software version 3.5.1 or lower User De…
FDA Device · Class II · 2014-02-05 · Siemens Healthcare Diagnostics - GE Healthcare Innova IGS 630
FDA Device · Class II · 2014-02-05 · Ge Healthcare - Stiff 25ga Wide Field Endo Illuminator, Synergetics, inc. length 7.5 ft, sterile / EO, 56.21.25PS. Packed 12 units per box
FDA Device · Class II · 2014-02-05 · Synergetics - Compressor Mini To provide a supply of dry, filtered compressed air for a medical respiratory ventilator or anaesthesia machine that meet t…
FDA Device · Class II · 2014-02-05 · Maquet Cardiovascular Us Sales - Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body by computer reconstruction of…
FDA Device · Class II · 2014-02-05 · Philips Medical Systems Cleveland - ACUSON SC2000 Power Input: 100-240VAC, 1600 Max 50/60Hz
FDA Device · Class II · 2014-02-05 · Siemens Medical Solutions Usa - Accuray CyberKnife Robotic Radiosurgery System
FDA Device · Class II · 2014-02-05 · Accuray - BD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit instrument, catalog 441386, available as a single or a stack conf…
FDA Device · Class II · 2014-02-05 · Becton Dickinson And - Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plastic Port/F, Product Number H965450140, Catalog Number 45-014
FDA Device · Class II · 2014-02-05 · Navilyst Medical - T3F, Free T3 Assay, REF/Catalog Number L2KF32 (200 tests), Siemens Material Number (SMN) 10381675, and REF/Catalog Number L2KF36 (600 Tests…
FDA Device · Class II · 2014-02-05 · Siemens Healthcare Diagnostics - InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regula…
FDA Device · Class II · 2014-02-05 · Philips Healthcare - 23ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.24.23P. Packed 12 units per box
FDA Device · Class II · 2014-02-05 · Synergetics - DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Shoulder Blanket w/ Straps NS, REF T655NS, Rx only, Manufacturer DeRoyal Industries, I…
FDA Device · Class II · 2014-02-05 · Deroyal Industries - KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc
FDA Device · Class II · 2014-02-05 · Carestream Health - Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device Product Code: 82-8804 Product Usage: The CODMAN CERTAS Programm…
FDA Device · Class II · 2014-02-05 · Codman And Shurtleff - S5/C5 Heart-lung machine Product Usage: The StOckert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedure…
FDA Device · Class II · 2014-02-05 · Sorin Group Deutschland - 27ga ONE-STEP (tm) Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.02.27P. Packed 12 units per box
FDA Device · Class II · 2014-02-05 · Synergetics - Radial Assist RAD BOARD, used to support the weight of a patient's arm and supplies for a medical procedure
FDA Device · Class II · 2014-02-05 · Merit Medical Systems - T3F, Free T3 Assay, REF/Catalog Number LKF31, Siemens Material Number (SMN) 10381626
FDA Device · Class II · 2014-02-05 · Siemens Healthcare Diagnostics - 23ga Wide Field Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.21.23P. Packed 12 units per box
FDA Device · Class II · 2014-02-05 · Synergetics - 25ga Wide Field Corona Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.12.23P. Packed 12 units per box
FDA Device · Class II · 2014-02-05 · Synergetics - Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw
FDA Device · Class II · 2014-02-05 · The Anspach Effort - 29ga Oshima Dual Chandelier, Synergetics, inc., length 7.5 ft, sterile / EO, 56.50.29P. Packed 12 units per box
FDA Device · Class II · 2014-02-05 · Synergetics - 25ga Awh Chandelier, Synergetics, inc., B&L Cannula Compatible, length 8.0 ft, sterile / EO, 56.52.25P. Packed 12 units per box
FDA Device · Class II · 2014-02-05 · Synergetics - Brilliance iCT, Brilliance 64 and Brilliance Big Bore The Brilliance iCT, Brilliance 64 and Brilliance Big Bore are Computed Tomography X-R…
FDA Device · Class II · 2014-02-05 · Philips Medical Systems Cleveland - Stiff 25ga Chow Illuminated Pick (Dull), Synergetics, inc., length 8.0 ft, sterile / EO, 56.07.25PS. Packed 12 units per box
FDA Device · Class II · 2014-02-05 · Synergetics - Chandelier Infusion Cannula, Synergetics, inc., 20ga, length 7.5 ft, sterile / EO, 56.30.P. Packed 12 units per box
FDA Device · Class II · 2014-02-05 · Synergetics - Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen, Germany distributed in the USA by: St…
FDA Device · Class II · 2014-02-05 · Stryker Howmedica Osteonics - Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Catheter and Accessories Product Code: 82-8805 Product Usage: The C…
FDA Device · Class II · 2014-02-05 · Codman And Shurtleff - BD BACTEC FX 40 instrument, catalog number 442296, manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152
FDA Device · Class II · 2014-02-05 · Becton Dickinson And - Simplexa Flu A/B & RSV Direct assay, Model MOL2650
FDA Device · Class II · 2014-02-05 · Focus Diagnostics - 23ga Chow Illuminated Pick, Synergetics, inc., length 7.5 ft, sterile / EO, 56.07.23P. Packed 12 units per box
FDA Device · Class II · 2014-02-05 · Synergetics - DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Foot/Ankle Blanket NS, REF T656NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200…
FDA Device · Class II · 2014-02-05 · Deroyal Industries - API NH (REF 10400) API NH is a standardized system for the identification of Neisseria, Haemophilus (and related genera) and Moraxella cath…
FDA Device · Class II · 2014-02-05 · Biomerieux France Chemin De L Or - Stiff 25ga Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.02.25PS. Packed 12 units per box
FDA Device · Class II · 2014-02-05 · Synergetics - 25ga Mid-Field Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.22.25P. Packed 12 units per box
FDA Device · Class II · 2014-02-05 · Synergetics - Endo Illuminator, Synergetics, inc., 20ga, length 7.0 ft, sterile / EO, 56.02
FDA Device · Class II · 2014-02-05 · Synergetics - Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform
FDA Device · Class II · 2014-02-05 · Zimmer Dental - 25ga Awh Chandelier, Synergetics, inc., length 8.0 ft, sterile / EO, 56.50.25P. Packed 12 units per box
FDA Device · Class II · 2014-02-05 · Synergetics - The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities ass…
FDA Device · Class III · 2014-02-05 · Ge Healthcare It - Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container
FDA Device · Class II · 2014-02-05 · Symmetry Medical Ssi - DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blanket NS, REF T652NS, Rx only, Manufacturer DeRoyal Industries, Inc. 2…
FDA Device · Class II · 2014-02-05 · Deroyal Industries - Kimberly-Clark RadiOpaque Radiofrequency Cannula, Gauge 22, Length 100 mm, Active Tip 10 mm, Distributed in the US by Kimberly-Clark,Produc…
FDA Device · Class II · 2014-02-05 · Kimberly Clark - Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: Sterile, R
FDA Device · Class II · 2014-02-05 · Boston Scientific - AnspacSingle use Sterile bone cutting burs.h REF: S-1504TD Twist Drill for 1.5mm x 4mm screw
FDA Device · Class II · 2014-02-05 · The Anspach Effort - GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850
FDA Device · Class II · 2014-02-05 · Ge Healthcare - 25ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.24.25P. Packed 12 units per box
FDA Device · Class II · 2014-02-05 · Synergetics - 25ga Awh Vivid Chandelier, Synergetics, length 7.5 ft, sterile / EO, 56.54.25P. Packed 12 units per box
FDA Device · Class II · 2014-02-05 · Synergetics - 23ga Mid-Field Endo Illuminator, Synergetics length 7.5 ft, sterile / EO, 56.22.23P. Packed 12 units per box
FDA Device · Class II · 2014-02-05 · Synergetics - ACUSON SC2000 Ultrasound System
FDA Device · Class II · 2014-02-05 · Siemens Medical Solutions Usa - Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Standard Q) is a permanently installed diagnostic x-ray system for g…
FDA Device · Class II · 2014-02-05 · Carestream Health - API Listeria (REF 10300) API Listeria is a standardized system for the identification of Listeria which uses miniaturized tests, as well as…
FDA Device · Class II · 2014-02-05 · Biomerieux France Chemin De L Or - Wide Field Endo Illuminator, Vivid (tm) Endo Illuminator, 20ga, Synergetics, inc., 20ga, length 7.5 ft, sterile / EO, 56.21P. Packed 12 uni…
FDA Device · Class II · 2014-02-05 · Synergetics - Standard tubing set, Synergetics, Inc., length 10 ft, sterile / EO, 17570
FDA Device · Class II · 2014-02-05 · Synergetics - DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blnkt NS, REF T653NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200…
FDA Device · Class II · 2014-02-05 · Deroyal Industries - Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Catheter and Accessories Product Code: 82-8803 Product Usage: The CO…
FDA Device · Class II · 2014-02-05 · Codman And Shurtleff - Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver, Product Usage: The Modular Screw Driver is used for insertin…
FDA Device · Class II · 2014-02-05 · Orthofix - 27ga ONE-STEP (tm) Awh/Tano Vivid Chandelier, Synergetics, length 8.0 ft, sterile / EO, 56.55.27P. Packed 12 units per box
FDA Device · Class II · 2014-02-05 · Synergetics - The ACUTE Innovations Modular RibLoc System (RibLoc U plus) is comprised titanium plates and screws that are used to stabilize rib fracture…
FDA Device · Class II · 2014-02-05 · Acute Innovations - 25ga Endo Illuminator, Synergetics, inc., length 7.0 ft, sterile / EO, 56.02.25 Packed 12 units per box
FDA Device · Class II · 2014-02-05 · Synergetics - ZYM B Reagent (REF 70493) ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical test included in…
FDA Device · Class II · 2014-02-05 · Biomerieux France Chemin De L Or - 23ga Endo Illuminator (Eckardt Trocar Compatible), Synergetics, inc., length 8.0 ft, sterile / EO, 56.02.23P Packed 12 units per box
FDA Device · Class II · 2014-02-05 · Synergetics - 23ga Wide Field Corona Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.12.23P. Packed 12 units per box
FDA Device · Class II · 2014-02-05 · Synergetics - CP5 centrifugal pump system Product Usage: The Stockert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for proced…
FDA Device · Class II · 2014-02-05 · Sorin Group Deutschland - Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips Healthcare, Cleveland, OH The Brilliance iCT and iCT SP are w…
FDA Device · Class II · 2014-02-05 · Philips Medical Systems Cleveland - 23ga Straight Fixed Extended Illuminated Laser Probe, Synergetics, length 7.5 ft, sterile / EO, 55.62.23P. Packed 12 units per box
FDA Device · Class II · 2014-02-05 · Synergetics - DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee Blanket w/ Straps NS, REF T654NS, Rx only, Manufacturer DeRoyal Industries, Inc.…
FDA Device · Class II · 2014-02-05 · Deroyal Industries - ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient popu…
FDA Device · Class II · 2014-02-05 · Spacelabs Healthcare - SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc
FDA Device · Class II · 2014-02-05 · Medtronic Sofamor Danek Usa - GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems
FDA Device · Class II · 2014-02-05 · Ge Healthcare - Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Unitized Bactiseal Catheter and Accessories Product Code: 82-8807 P…
FDA Device · Class II · 2014-02-05 · Codman And Shurtleff - Codman Certas Programmable Valve In Line Valve with Siphonguard, Unitized Catheter and Accessories Product Code: 82-8806 Product Usage: The…
FDA Device · Class II · 2014-02-05 · Codman And Shurtleff - "The Corona" Shielded Wide Field Endo Illuminator, Synergetics, inc. 20ga, length 7.0 ft, sterile / EO, 56.12
FDA Device · Class II · 2014-02-05 · Synergetics - Codman Certas Programmable Valve In Line Valve with Catheter and Accessories Product Code: 82-8801 Product Usage: The CODMAN CERTAS Program…
FDA Device · Class II · 2014-02-05 · Codman And Shurtleff - Codman Certas Programmable Valve In Line Valve Only Product Code: 82-8800 Product Usage: The CODMAN CERTAS Programmable Valve is an implant…
FDA Device · Class II · 2014-02-05 · Codman And Shurtleff - 23ga Chandelier Infusion Cannula, Synergetics, inc., length 8.0 ft, sterile / EO, 56.30.23P. Packed 12 units per box
FDA Device · Class II · 2014-02-05 · Synergetics - Two-Port Vitrectomy (TPV (tm)) Wide Field High Flow End Irrigator, Synergetics, inc., 19ga, length 7.0 ft, sterile / EO, 56.14
FDA Device · Class II · 2014-02-05 · Synergetics - GE Healthcare, TRAM MODULE, High-acuity patient monitoring
FDA Device · Class II · 2014-01-29 · Ge Healthcare - Oxoid Antimicrobial Susceptibility Test Discs, Cefpodoxime 10 mcg., CT1612B, packaged in cartridges of 50 discs, 5 cartridges/pack
FDA Device · Class II · 2014-01-29 · Remel - Vital Signs Anesthesia Circuits The Ventilator Circuit is intended for use as an interface between a ventilator dependent patient and a ven…
FDA Device · Class II · 2014-01-29 · Vital Signs Colorado - Composix L/P with Echo PS 6" X 8" Product Code 0144680 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile li…
FDA Device · Class II · 2014-01-29 · Davol Subs C R Bard - TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System
FDA Device · Class I · 2014-01-29 · Codman And Shurtleff - Puritan Bennett 840 Series Ventilator PB840 Operators Manual Addendum PN 066009A 09/02 The intended use of the oxygen sensor is to provide…
FDA Device · Class II · 2014-01-29 · Nellcor Puritan Bennett Dba Covidien - PRIMUS, ONCOR, ARTISTE Linac systems with component 550 TxT Treatment Table
FDA Device · Class II · 2014-01-29 · Siemens Medical Solutions Usa - XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brac…
FDA Device · Class II · 2014-01-29 · Elekta - DRX-Evolution with CSH WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator cons…
FDA Device · Class II · 2014-01-29 · Carestream Health - MRI Low Profile Single Lumen port with Open-Ended 6.6Fr Silicone Catheter
FDA Device · Class II · 2014-01-29 · Bard Access Systems - Oxoid Antimicrobial Susceptibility Test Discs, Ertapenem 10 mcg., CT1761B, packaged in cartridges of 50 discs, 5 cartridges/pack
FDA Device · Class II · 2014-01-29 · Remel - Civco Belly Board, Reusable non-sterile carbon fiber belly board with cushion, REF 125012, packaged 1 per box
FDA Device · Class II · 2014-01-29 · Civco Medical Instruments - Video Monitor Suspensions that may be on the following Fluoroscopic and Radiographic X-Ray systems: Precision 500D, Legacy, Prestilix, Moni…
FDA Device · Class II · 2014-01-29 · Ge Healthcare - Zimmer Segmental Systems
FDA Device · Class II · 2014-01-29 · Zimmer - Medrad Veris MR Monitor units The system is intended to monitor physiological parameters of patients within any healthcare environment
FDA Device · Class II · 2014-01-29 · Medrad Mr - ADAC ARGUS Gamma Camera Systems & ADAC CIRRUS Gamma Camera Systems
FDA Device · Class II · 2014-01-29 · Philips Medical Systems Cleveland - Compensator Slider Lambda 6x20 component (part number 473704-0000-000) utilized on all upright ZEISS microscopes (Axio Imager, Axio Scope
FDA Device · Class II · 2014-01-29 · Zeiss Carl
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)