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.
- ONE-PIECE LAG SCREW 11MM. Item codes starting with 00225900
FDA Device · Class II · 2014-02-26 · Zimmer - Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment shunt system is intended to shut cerebrospinal fluid from the la…
FDA Device · Class II · 2014-02-26 · Aesculap - NEXGEN OSTEOTOMY CORT BON. Item codes starting with 0052500
FDA Device · Class II · 2014-02-26 · Zimmer - SAFSITE¿ Injection Sites and IV Sets manufactured with SAFSITE¿ Injection Sites
FDA Device · Class II · 2014-02-26 · B Braun Medical - CPT 12/14 COCR (various sizes)
FDA Device · Class II · 2014-02-26 · Zimmer - MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST, THOMPSON HIP PROSTHESIS sizes 3, 4, 5, and 6, and Mod Aust…
FDA Device · Class II · 2014-02-26 · Zimmer - 12/14 COCR FEMORAL HEAD (2, 3 and 4)
FDA Device · Class II · 2014-02-26 · Zimmer - 3.5 X 10 CORT SCREW SELFT 3.5 X 12 CORT SCREW SELFT 3.5 X 14 CORT SCREW SELFT 3.5 X 16 CORT SCREW SELFT 3.5 X 18 CORT SCREW SELFT 3.5 X 20…
FDA Device · Class II · 2014-02-26 · Zimmer - GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port2 Docking Station
FDA Device · Class II · 2014-02-26 · Ge Healthcare - COMPRESSION SCREW (1/2, 1-1/2, 1-1/4, 1-3/4, 1. 2. 3/4 IN)
FDA Device · Class II · 2014-02-26 · Zimmer - M/DN HUMERAL I/M NAIL. Sizes from 6 MM to 13 MM. Codes starting with 0022541, 002542 and 0022543
FDA Device · Class II · 2014-02-26 · Zimmer - PERI SCR. 3.5MM X 10MM PERI SCR. 3.5MM X 12MM PERI SCR. 3.5MM X 14MM PERI SCR 3.5MM X 44MM STE PERI SCR. 3.5MM X 65MM PERI. SCR 4.0MM X24MM…
FDA Device · Class II · 2014-02-26 · Zimmer - External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), 2300 Riverchase Center, Birmingham, AL 3…
FDA Device · Class II · 2014-02-26 · Biohorizons Implant Systems - Invivo Corporation Expression Information Portal (Model IP5) is intended to be used as a secondary display control unit, where the device m…
FDA Device · Class II · 2014-02-26 · Invivo - NEXGEN MIS TIBIA PLATE PR NEXGEN TAPER PLUG NEXGEN PRECOAT PEG TIB PL NEXGEN MICRO ALL-POLY PAT NEXGEN ALL-POLY PATELLA, NEXGEN PRECOAT STE…
FDA Device · Class II · 2014-02-26 · Zimmer - MODULAR AUSTIN MOORE FENE. Item codes starting with 45502001, 455503001 and 455504001
FDA Device · Class II · 2014-02-26 · Zimmer - M/DN R-F IM NAIL 9MM DIA , 10 MM, 11 MM, 12 MM, 13 MM and 14 MM. Item codes starting with 0022400
FDA Device · Class II · 2014-02-26 · Zimmer - Medtronic Select CAP Arterial Cannulae
FDA Device · Class II · 2014-02-26 · Medtronic Cardiac Rhythm Disease Management - ZIMTRON 6 DEG 22 HEADS
FDA Device · Class II · 2014-02-26 · Zimmer - VERSA-FX KEYLESS 90D X 8 and X 11, VERSA-FX KEYLESS 95D X 8, X 11, and X 14, VERSA-FX KEYLESS 140D X 4 and X 5, VERSA-FX KEYLESS 135D X 4 a…
FDA Device · Class II · 2014-02-26 · Zimmer - Access 2 Immunoassay System Analyzer
FDA Device · Class II · 2014-02-26 · Beckman Coulter - 1.5 X 6 CORT SCREW HEX/SE 2.0 X 6 CORT SCREW HEX/SE 2.0 X 10 CORT SCREW CRUCI 2.0 X 12 CORT SCREW CRUCI 2.0 X 14 CORT SCREW CRUCI 2.0 X 16…
FDA Device · Class II · 2014-02-26 · Zimmer - MORPH ACCESSPRO Steerable Introducer
FDA Device · Class II · 2014-02-26 · Biocardia - Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP Arterial Cannulae
FDA Device · Class II · 2014-02-26 · Medtronic Cardiac Rhythm Disease Management - Superstand stand-up wheelchair HPS-2 A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility…
FDA Device · Class II · 2014-02-26 · The Standing - Synergy XVI XVI can incorrectly calculate the target position of the treatment table, because of an error that does not occur very frequent…
FDA Device · Class II · 2014-02-26 · Elekta - 6 DEGREE COCR FEM HEAD (various sizes) and 6 DEG UNIPOLAR FEMORAL HE
FDA Device · Class II · 2014-02-26 · Zimmer - CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes)
FDA Device · Class II · 2014-02-26 · Zimmer - Synthes Matrix Mandible Short Threaded Drill Guide intended for oral, maxillofacial surgery
FDA Device · Class II · 2014-02-26 · Synthes - FEM HD ION (various sizes)
FDA Device · Class II · 2014-02-26 · Zimmer - Medtronic Select CAP Arterial Cannulae
FDA Device · Class II · 2014-02-26 · Medtronic Cardiac Rhythm Disease Management - INTERLOCKING IM SCREW 4.5 and INTERLOCKING IM SCREW LG Some items starting with codes 0022530
FDA Device · Class II · 2014-02-26 · Zimmer - UniCel DxI 600 Access Immunoassay System Analyzer
FDA Device · Class II · 2014-02-26 · Beckman Coulter - HGP II ACETABULAR CUP BON
FDA Device · Class II · 2014-02-26 · Zimmer - MODULAR CUP NEUTRAL LINER MODULAR CUP 10 DEGREE LIN MODULAR CUP 20 DEGREE LIN MODULAR CUP 7MM OFFSET LI
FDA Device · Class II · 2014-02-26 · Zimmer - Siemens Prisma 2K Hearing Aid Product Usage: A behind the ear (BTE) hearing aid developed for pediatric patients
FDA Device · Class II · 2014-02-26 · Siemens Hearing Instruments - Bipolar liners and Multipolar cups with the following dimensions in MM (38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 53, 54, 55, 57,…
FDA Device · Class II · 2014-02-26 · Zimmer - MODULAR AUSTIN MOORE SOLI and MOORE HIP PROS REG SOLID
FDA Device · Class II · 2014-02-26 · Zimmer - TRILOGY ACET SHELL 36MM O TRILOGY ACET SHELL 38MM O TRILOGY ACET SHELL 40MM O TRILOGY ACET SHELL 42MM O TRILOGY ACET SHELL 44MM O TRILOGY A…
FDA Device · Class II · 2014-02-26 · Zimmer - 3.5 COMP PLT, 4 HOLE 3.5 COMP PLT, 5 HOLE 3.5 COMP PLT, 6 HOLE 3.5 COMP PLT, 8 HOLE 3.5 COMP PLT, 9 HOLE 3.5 COMP PLT, 10 HOLE
FDA Device · Class II · 2014-02-26 · Zimmer - Merit Medical's Custom Procedural Trays or Kits containing 1% Lidocaine HCl Injection, USP, 10 mg/mL, Lot 25-090-DK. Custom Procedural Tray…
FDA Device · Class I · 2014-02-26 · Merit Medical Systems - VERSA-FX II KEYLESS TUBE, VERSA-FX II KEYLESS SHORT, VERSA-FX II SHORT TUBE PL, VERSA-FX II STD TUBE PLAT and VERSA-FX II SUPRACONDYLR Item…
FDA Device · Class II · 2014-02-26 · Zimmer - ASIA ONE-PIECE LAG SCREW
FDA Device · Class II · 2014-02-26 · Zimmer - enGen Track System with enGen Select v5.0 with autoverification enabled Product The VITROS 5,1 FS Chemistry System with enGenTM Laboratory…
FDA Device · Class II · 2014-02-19 · Ortho Clinical Diagnostics - ***REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in dental and orthopedic applications.***STERILE Using R…
FDA Device · Class II · 2014-02-19 · Rti Surgical - GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH
FDA Device · Class II · 2014-02-19 · Philips Medical Systems Cleveland - Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a package Howmedica Osteonics Corp. 325 Corporate Drive…
FDA Device · Class II · 2014-02-19 · Stryker Howmedica Osteonics - Stryker CMF Customized Implant Kit X-Large
FDA Device · Class II · 2014-02-19 · Stryker Howmedica Osteonics - MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER W/ GEL, featuring IsoSilk(R), 5" x 98", (13cm x 249 cm), REF 3688, STERILE EO, QTY 20, Micr…
FDA Device · Class II · 2014-02-19 · Ecolab - MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688, STERILE EO, QTY 2…
FDA Device · Class II · 2014-02-19 · Ecolab - Boston Scientific, 2.5mm Coyote" OVER-THE-WIRE PTA Balloon Dilation Catheter, UPN# H74939186251210, Catalog # 39186-25121
FDA Device · Class II · 2014-02-19 · Boston Scientific - Vital CARE(TM) REPS INC. ULTRASOUND PROBE COVER, BUR HOLE COVER, 5 x 96 , REF VPC0699, STERILE EO, QTY 20, Manufactured for Vital Care Rep…
FDA Device · Class II · 2014-02-19 · Ecolab - MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER W/ GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688EU, STERILE EO, QTY 2…
FDA Device · Class II · 2014-02-19 · Ecolab - Normative Data Template CD for use with the I-Portal devices
FDA Device · Class II · 2014-02-19 · Neuro Kinetics - Horizon Medical Imaging, Picture Archive Communication System (PACS)
FDA Device · Class II · 2014-02-19 · Mckesson Information Solutions - VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chemistry Systems Product Usage: Mixing Cup Array is a disposable,…
FDA Device · Class II · 2014-02-19 · Ortho Clinical Diagnostics - MICROTEK(TM) MEDICAL BUR HOLE LATEX PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 249 cm, REF 3688UK, STERILE EO, QTY 20, Microtek Med…
FDA Device · Class II · 2014-02-19 · Ecolab - Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 Product Usage: The ADVIA Chemistry Systems models 1200, 1650, 1800 and 240…
FDA Device · Class II · 2014-02-19 · Siemens Healthcare Diagnostics - Boston Scientific, Coyote" MONORAIL" PTA Balloon Dilatation Catheter, UPN # H74939185201510, Catalogue # 39185-20151
FDA Device · Class II · 2014-02-19 · Boston Scientific - Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc., 1800 Pyramid P…
FDA Device · Class II · 2014-02-19 · Medtronic Sofamor Danek Usa - T:slim Insulin Delivery System Insulin Infusion Pump
FDA Device · Class I · 2014-02-19 · Tandem Diabetes Care - D-10 Dual Program, which contains Update Kit D-10 A1c program diskette
FDA Device · Class III · 2014-02-19 · Bio Rad Laboratories - BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided localization system for minimally invasive surgery
FDA Device · Class II · 2014-02-19 · Brainlab Ag - MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688N, QTY 100, Microtek Medical…
FDA Device · Class II · 2014-02-19 · Ecolab - 5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use
FDA Device · Class II · 2014-02-19 · Custom Medical Specialties - The UF-1000i is a fully automated urine particle analyzer intended for vitro diagnostic use in urinalysis
FDA Device · Class II · 2014-02-19 · Sysmex America - Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109
FDA Device · Class II · 2014-02-19 · Integra Lifesciences - enGen Track System with enGen Custom v3.2.2 (& below) Product The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System…
FDA Device · Class II · 2014-02-19 · Ortho Clinical Diagnostics - ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions…
FDA Device · Class III · 2014-02-12 · Horiba Instruments - Neptune 2 Rover Ultra Waste Management System
FDA Device · Class II · 2014-02-12 · Stryker Instruments Div - CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare f…
FDA Device · Class II · 2014-02-12 · Ge Healthcare - Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470, GEMINI TF PET/CT 64…
FDA Device · Class II · 2014-02-12 · Philips Medical Systems Cleveland - LOCATOR¿ Implant Attachment System
FDA Device · Class II · 2014-02-12 · Zest Anchors - IMPAX RIS QDOC 5.8
FDA Device · Class II · 2014-02-12 · Agfa - B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used for delivery of antibiotic and local anesthesia medications
FDA Device · Class II · 2014-02-12 · B Braun Medical - XiO RTP System
FDA Device · Class II · 2014-02-12 · Elekta - ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 6-pack SMN 10314977 For in vitro diagnostic use in the quantitative determination of…
FDA Device · Class II · 2014-02-12 · Siemens Healthcare Diagnostics - MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEtrack
FDA Device · Class II · 2014-02-12 · Nipro Diagnostics - Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650103
FDA Device · Class II · 2014-02-12 · Fresenius Medical Care Holdings - The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications
FDA Device · Class II · 2014-02-12 · Arjohuntleigh - The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees
FDA Device · Class II · 2014-02-12 · Ossur Americas - Medtronic Advanced Energy Aquamantys3 Pump Generator
FDA Device · Class II · 2014-02-12 · Medtronic Advanced Energy - MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEbalance
FDA Device · Class II · 2014-02-12 · Nipro Diagnostics - Panda iRes¿ Infant Warmers, part number M1112198 and Panda Freestanding Warmers, part number 2063568, labeled in part *** GE Healthcare 888…
FDA Device · Class II · 2014-02-12 · Ge Healthcare - Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -s…
FDA Device · Class II · 2014-02-12 · Itc Nexus Dx - Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic Obturators are used with the Mosaic Porcine Aortic Bioprostheses
FDA Device · Class II · 2014-02-12 · Medtronic Cardiovascular Surgery The Heart Valve Division - Stand-Alone Resuscitation Unit, Bag and Mask, Upgrade Kits, part number M1139612, labeled in part ***GE Healthcare 8880 Gorman Road Laurel,…
FDA Device · Class II · 2014-02-12 · Ge Healthcare - ***REF 186-01-08***InteGrip ACETABULAR AUGMENT***SMALL 8mm
FDA Device · Class II · 2014-02-12 · Exactech - Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems
FDA Device · Class II · 2014-02-12 · Siemens Medical Solutions Usa - Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M1223628, labeled in part ***GE Healthcare 8880 Gorman Road Laurel…
FDA Device · Class II · 2014-02-12 · Ge Healthcare - GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems
FDA Device · Class II · 2014-02-12 · Ge Healthcare - SuperElastic Regular force NiTi lower or upper Natural arches. 0.14 size 10 or 100 count packages
FDA Device · Class II · 2014-02-12 · Highland Metals - SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are sterile, individually packaged connectors
FDA Device · Class II · 2014-02-12 · Carefusion 303 - The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying temperature-controlled water through a connect…
FDA Device · Class II · 2014-02-12 · Stryker Medical Division - Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation
FDA Device · Class II · 2014-02-12 · Edwards Lifesciences - Neptune 2 Rover Ultra Waste Management System
FDA Device · Class II · 2014-02-12 · Stryker Instruments Div - Giraffe¿ Infant Warmers, part number M1118179, labeled in part *** GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com*…
FDA Device · Class II · 2014-02-12 · Ge Healthcare - 3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm Part No. 00-0903-2620 OrthoPediatrics Pediloc" Tibia Plates are indicat…
FDA Device · Class II · 2014-02-12 · Orthopediatrics - Stand-Alone Resuscitation, T-Piece, part numbers 2063771-001, 2063772-001, 2063773-001, 2063774-001, 2063775-001, M1226442, M1241420, M1241…
FDA Device · Class II · 2014-02-12 · Ge Healthcare - ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision for t…
FDA Device · Class II · 2014-02-12 · Horiba Instruments
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)