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.
- Series OEC 9800
FDA Device · Class II · 2014-11-19 · Ge Oec Medical Systems - MX 16-slice CT Scanner System and MX 16-slice CT Scanner System Phase 11 can be used as a whole body computed tomography X-ray system featu…
FDA Device · Class II · 2014-11-19 · Philips Medical Systems Cleveland - CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model: MXKPRS01 Product Usage: The CooperSurgical Milex silicon pessar…
FDA Device · Class III · 2014-11-19 · Coopersurgical - OEC¿ UroView 2800
FDA Device · Class II · 2014-11-19 · Ge Oec Medical Systems - Philips Medical Systems Allura Xper FD20C Radiological Imaging with software version R8.2.O
FDA Device · Class II · 2014-11-19 · Philips Medical Systems - ATTUNE Intuition Distal Femoral Jig
FDA Device · Class II · 2014-11-19 · Depuy Orthopaedics - Transport Rollator with Padded Seat
FDA Device · Class II · 2014-11-19 · Roscoe Medical - Discovery NM 630, dual detector free-geometry integrated nuclear imaging system
FDA Device · Class II · 2014-11-19 · Ge Healthcare - Fisher and Paykel Healthcare (FPH) IW900-Series Infant Warmer Fisher and Paykel
FDA Device · Class II · 2014-11-19 · Fisher And Paykel Healthcare - Optima NM/CT 640, Models H3100YA, H3100YC. Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging p…
FDA Device · Class II · 2014-11-19 · Ge Healthcare - Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system
FDA Device · Class II · 2014-11-19 · Ge Healthcare - OEC¿ MiniView 6800
FDA Device · Class II · 2014-11-19 · Ge Oec Medical Systems - Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous noninvasive monitoring of fun…
FDA Device · Class II · 2014-11-19 · Masimo - CooperSurgical MILEX PESSARY KITS- Hodge w/Support Folding Pessary- #1 Model: MXKPHS01 Product Usage: The CooperSurgical Milex silicon pess…
FDA Device · Class III · 2014-11-19 · Coopersurgical - Medtronic Launcher Coronary Guide Catheter
FDA Device · Class II · 2014-11-19 · Medtronic Vascular - Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Ireland) Limited, IDA Business and Technology Park, Sragh, Tullamo…
FDA Device · Class II · 2014-11-19 · Integra Lifesciences - FlexiView 8800 Digital Mobile Imaging System
FDA Device · Class II · 2014-11-19 · Ge Oec Medical Systems - Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is indicated for patients with severe knee pain and disability due to: …
FDA Device · Class II · 2014-11-19 · Zimmer - Rapid Neg Urine Combo Panel Type 1
FDA Device · Class I · 2014-11-19 · Siemens Healthcare Diagnostics - The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation
FDA Device · Class II · 2014-11-19 · Steris - Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and supplied in Tris buffered salin…
FDA Device · Class II · 2014-11-12 · Leica Microsystems - Terumo Custom Cardiovascular and Perfusion Procedure Kits Catalog Codes: Kits with a 5-digit code beginning with the digit 6: Catalog Numbe…
FDA Device · Class II · 2014-11-12 · Terumo Cardiovascular Systems - Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic fluid path) ,500 ml
FDA Device · Class I · 2014-11-12 · Baxter Healthcare - Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 Item Number: 16110 Product Usage: This is a replacement line t…
FDA Device · Class II · 2014-11-12 · Terumo Cardiovascular Systems - Siemens Calibrator E
FDA Device · Class II · 2014-11-12 · Siemens Healthcare Diagnostics - Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B14253A. Product Usage: The Access 2 Immunoassay sy…
FDA Device · Class II · 2014-11-12 · Beckman Coulter - UniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instructions for Use Part No. A93659AB. Product Usage: The DxI 600i…
FDA Device · Class II · 2014-11-12 · Beckman Coulter - Terumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The Cardioplegia Delivery Sets are indicated for delivery of cardiopleg…
FDA Device · Class II · 2014-11-12 · Terumo Cardiovascular Systems - CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01
FDA Device · Class II · 2014-11-12 · Smiths Medical Asd - Cardiopulmonary bypass connector
FDA Device · Class II · 2014-11-12 · Dokitz Novosci - Stryker SmartLife Small Aseptic Housing REF 7222-120-000 Rx Only The SmartLife" Aseptic Housings are designed to be used in conjunction wit…
FDA Device · Class II · 2014-11-12 · Stryker Instruments Div - St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
FDA Device · Class II · 2014-11-12 · St Jude Medical - Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic Sterile if package is unopened or undamaged
FDA Device · Class II · 2014-11-12 · Merit Medical Systems - Terumo Custom Cardioplegia Delivery Sets Catalog Code: 204880 Product Usage: This is a replacement line to multiple Cardioplegia Delivery S…
FDA Device · Class II · 2014-11-12 · Terumo Cardiovascular Systems - Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and Catalog Number: 6375 Product Usage: Cardioplegia Delivery System that is…
FDA Device · Class II · 2014-11-12 · Terumo Cardiovascular Systems - Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml, Admixture Products and Accessories
FDA Device · Class I · 2014-11-12 · Baxter Healthcare - Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts
FDA Device · Class I · 2014-11-12 · Trivascular - Stryker SmartLife Large Aseptic Housing REF 7126-120-000 Rx Only The SmartLife" Aseptic Housings are designed to be used in conjunction wit…
FDA Device · Class II · 2014-11-12 · Stryker Instruments Div - Straumann Bone Level Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021.4308 Product Usage: Dental implants are intende…
FDA Device · Class II · 2014-11-12 · Straumann Usa - Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product Usage: This is a Cardiopl…
FDA Device · Class II · 2014-11-12 · Terumo Cardiovascular Systems - Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone basket is a teardrop-shaped basket with the ability to capture stones b…
FDA Device · Class II · 2014-11-12 · C R Bard - Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System
FDA Device · Class II · 2014-11-12 · Cynosure - COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
FDA Device · Class II · 2014-11-12 · Iba Dosimetry - UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corru…
FDA Device · Class II · 2014-11-12 · Zimmer Surgical - Prescription eyeglass safety lenses
FDA Device · Class II · 2014-11-12 · Eyemart Express - ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Nu…
FDA Device · Class II · 2014-11-05 · Siemens Healthcare Diagnostics - HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL and 1 x 1.6 mL. A1c Calibrators (lyophilized) contain hemoglobi…
FDA Device · Class II · 2014-11-05 · Abbott Laboratories - Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400
FDA Device · Class III · 2014-11-05 · Coloplast Manufacturing Us - ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Nu…
FDA Device · Class II · 2014-11-05 · Siemens Healthcare Diagnostics - Animas Vibe Insulin Infusion Pump and System
FDA Device · Class II · 2014-11-05 · Animas - siemens Dimension¿ Phenytoin Flex¿ Reagent Cartridge The PTN method used on the Dimension¿ clinical chemistry system is an in vitro diagnos…
FDA Device · Class II · 2014-11-05 · Siemens Healthcare Diagnostics - Equate Moisture Last Multi-Purpose Solution, 2 pack, 12 fl. oz. (355 mL), Distributed by Walmart Stores, Inc
FDA Device · Class II · 2014-11-05 · Bausch And Lomb Greenville Solutions Plant - Freedom EVO-2 100 Base Unit, with Air LiHa Arms The Freedom EVO is an open automation platform product for general laboratory use
FDA Device · Class II · 2014-11-05 · Tecan Us - Spline Twist Implant, HA 3.25mmD X 15mmL
FDA Device · Class II · 2014-11-05 · Zimmer Dental - Lipase Reagent, 7D80
FDA Device · Class II · 2014-11-05 · Abbott Laboratories - Merge Healthcare, Merge Hemo Programmable diagnostic computer
FDA Device · Class II · 2014-11-05 · Merge Healthcare - TITAN Operating Room Table Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthe…
FDA Device · Class II · 2014-11-05 · Trumpf Medical Systems - IMRIS Operating Room table (ORT200 and ORT300)
FDA Device · Class II · 2014-11-05 · Imris - SAM Junctional Tourniquet (SJT) Auxiliary, Model SJT 102 and SJT 112
FDA Device · Class II · 2014-11-05 · Sam Medical Products - The GemStar Power Supply is an accessory for the GemStar Infusion Pump
FDA Device · Class I · 2014-11-05 · Hospira - Spirotome" Soft-Tissue Biopsy Needle Set
FDA Device · Class II · 2014-11-05 · Cook Medical - ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System Product Usage: The ACCU-CHEK Combo System is meant only…
FDA Device · Class II · 2014-11-05 · Roche Diagnostics Operations - Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174
FDA Device · Class II · 2014-11-05 · Coloplast Manufacturing Us - DMI Duro-Med Industries Rollator Transport Chair
FDA Device · Class II · 2014-11-05 · Briggs Medical Service D B A Mabis - Tapered Screw-Vent Implant, MTX, 4.1mmD X 10mmL X 3.5mm Platform Part No. TSV4B10 Tapered Screw-Vent Implant, MTX, 4.1mmD X 11.5mmL X 3.5mm…
FDA Device · Class II · 2014-11-05 · Zimmer Dental - Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump System OM-9000S Axius Xpose 3 Access Device XP-3000 XPOSE 4 Access De…
FDA Device · Class II · 2014-11-05 · Maquet Cardiovascular - Parker Eclipse Probe Cover, Latex Free, REF 38-01, 10 Eclipse Probe Covers, Size: 2.37/1.75"W x 9.5"L (60/44 mm x 241 mm), Lot #D424, Expir…
FDA Device · Class II · 2014-11-05 · Parker Laboratories - Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide…
FDA Device · Class I · 2014-11-05 · Nellcor Puritan Bennett Dba Covidien - The GemStar Power Supply is an accessory for the GemStar Infusion Pump
FDA Device · Class I · 2014-11-05 · Hospira - ProClear Toric contact lenses are made from a material containing 62% water and 38% omafilcon B, a random copolymer of 2-hydroxyethylmethac…
FDA Device · Class III · 2014-11-05 · Cooper Vision Caribbean - Laksell Gamma Knife Perfexion
FDA Device · Class II · 2014-11-05 · Elekta - Joerns EasyCare Bed Product Usage: The AC-powered adjustable hospital bed is a device intended for medical purposes
FDA Device · Class II · 2014-11-05 · Joerns Healthcare - ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603
FDA Device · Class II · 2014-11-05 · Biosense Webster - ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) C…
FDA Device · Class II · 2014-11-05 · Siemens Healthcare Diagnostics - Animas Vibe Insulin Infusion Pump
FDA Device · Class II · 2014-11-05 · Animas - Dimension Vista¿ HbA1c
FDA Device · Class II · 2014-11-05 · Siemens Healthcare Diagnostics - Proteus 235 Proton Therapy System for cancer treatment
FDA Device · Class II · 2014-11-05 · Ion Beam Applications - Blunt Hurd Cannula Blunt Tip 10 mm with 5 mm Reducer simplifies open laparoscopy
FDA Device · Class II · 2014-11-05 · Coopersurgical D B A Lone Star Medical Products - APTUS Ulna Shortening 2.5 Product Usage: APTUS Ulna Shortening 2.5 Plates are indicated for fractures and osteotomies, in particular for th…
FDA Device · Class II · 2014-11-05 · Medartis - Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture
FDA Device · Class II · 2014-11-05 · C P Medical - Philips Avalon Monitors with software revision J.30.58: Model Product FM20 M2702A
FDA Device · Class II · 2014-10-29 · Philips Medical Systems - e.cam line of gamma camera systems Used to detect or image the distribution of radionuclides in the body or organ
FDA Device · Class II · 2014-10-29 · Siemens Medical Solutions Usa - The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-pr…
FDA Device · Class II · 2014-10-29 · Aerogen - Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021 .5308 Dental implants are intended for…
FDA Device · Class II · 2014-10-29 · Straumann Usa - Mindray V21, Size: 515 mm X 335 mm X 685 mm, N.W.: 8 kg, G.W.: 11 kg, Qty:1 The V-Series Monitor is intended for intra hospital use under t…
FDA Device · Class II · 2014-10-29 · Mindray Ds Usa - Ultra Battery 1 Model: TA-UB1 NSN: 6515-01-592-5803 The Ultra Battery 1 (TA-UB1) is a rechargeable power source for the Thermal Angel Blood…
FDA Device · Class II · 2014-10-29 · Estill Medical Technologies - Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E1…
FDA Device · Class II · 2014-10-29 · Boston Scientific Crm - McKesson Cardiology Hemo
FDA Device · Class II · 2014-10-29 · Mckesson Information Solutions - The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures
FDA Device · Class II · 2014-10-29 · Zimmer - The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-pr…
FDA Device · Class II · 2014-10-29 · Aerogen - Bionector Needleless connector
FDA Device · Class II · 2014-10-29 · Vygon - IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog Number LKC01, SMN 10381388, IVD. For in vitro diagnostic use with the IMMULITE 10…
FDA Device · Class II · 2014-10-29 · Siemens Healthcare Diagnostics - St Jude Medical, 10F Fast-Cath Trio" Hemostasis Introducer, REF # 406308, Sterile EO. The Fast-Cath Trio" Hemostasis Introducer consists of…
FDA Device · Class II · 2014-10-29 · St Jude Medical - GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS MOLly Forceps 5mm/45cm REF 3640 -Everest BiCOAG Macro Jaw Forc…
FDA Device · Class II · 2014-10-29 · Gyrus Medical - Continuum Acetabular System Trabecular Metal Shell with Multi Holes, Porous 68mm, Prosthesis, Hip, Semi-Constrained, Metal/Polymer
FDA Device · Class II · 2014-10-29 · Zimmer - Box Label: 3 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-3KDINX . Pouch labels: Each kit contains 3 pouches. 3 mm Cueva Electrod…
FDA Device · Class II · 2014-10-29 · Ad Tech Medical Instrument - Siemens Mammomat Inspiration mammography systems
FDA Device · Class II · 2014-10-29 · Siemens Medical Solutions Usa - ADVIA Centaur¿¿ Systems HBc Total (HBcT) Kit
FDA Device · Class II · 2014-10-29 · Siemens Healthcare Diagnostics - CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle"
FDA Device · Class II · 2014-10-29 · Intra Pump Infusion Systems - ASK-05501-AFH1, Lot Number 23F13K0969 Anesthesia Conduction Catheter, Epidural Anesthesia Kit
FDA Device · Class II · 2014-10-29 · Arrow International
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)