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.
- Neodent Titamax WS Cortical Implant ¿4.0 x 5 mm (Endosseous dental implant) Article Number: 109.604 Dental implants are intended for surgic…
FDA Device · Class II · 2014-12-31 · Instradent Usa - KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.0 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway manage…
FDA Device · Class I · 2014-12-31 · Halyard Health - KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.0 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway manage…
FDA Device · Class I · 2014-12-31 · Halyard Health - RTH8 Rotor, P/N X01-005847-001
FDA Device · Class II · 2014-12-31 · Iris Diagnostics - DPM 6 Patient Monitor and DPM 7 Patient Monitor
FDA Device · Class II · 2014-12-31 · Mindray Ds Usa - Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in the pro…
FDA Device · Class II · 2014-12-31 · Illumina - Trilogy¿ Fiber Metal Acetabular Shell Size 54 mm OD The Trilogy Acetabular System is indicated for either cemented or uncemented use in ske…
FDA Device · Class II · 2014-12-31 · Zimmer Manufacturing B V - ADULT Radiotranslucent Electrode, Part number T100LO-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical H…
FDA Device · Class I · 2014-12-31 · Heart Sync - Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594 Spring-Loaded Drill/Awl Sleeve Intended to stabilize cervical…
FDA Device · Class II · 2014-12-31 · Ebi - Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data
FDA Device · Class II · 2014-12-31 · Ge Healthcare It - Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Yellow, Baxter Healthcare Corporation, 14445 Grasslands Dr. Eng…
FDA Device · Class II · 2014-12-31 · Baxter Englewood - KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.5 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway manage…
FDA Device · Class I · 2014-12-31 · Halyard Health - STERRAD 100NX, Product Code 10144 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose…
FDA Device · Class II · 2014-12-31 · Advanced Sterilization Products - ADULT/CHILD Radiotransparent Electrode, Part number C100AC-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Med…
FDA Device · Class I · 2014-12-31 · Heart Sync - GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 300/350 Control Series with dryer --- Class II, exempt from 5…
FDA Device · Class II · 2014-12-31 · Getinge Disinfection Ab - Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Xi 4000 Surgical Systems
FDA Device · Class II · 2014-12-31 · Intuitive Surgical - ADVIA Centaur XP Immunoassay System (including refurbished) Professional use in a laboratory for in vitro diagnostic tests
FDA Device · Class II · 2014-12-31 · Siemens Healthcare Diagnostics - Bausch & Lomb Stellaris PC w/ Laser Upgrade BL1433 (Stellaris PC w v3 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhance…
FDA Device · Class II · 2014-12-31 · Bausch And Lomb - Lite DM (Lite Data Manager) Software Version(s): Versions 2.0.0.19 and lower Product Model #: D00A00224D The Lite DM (Lite Data Manager) is…
FDA Device · Class II · 2014-12-31 · Horiba Instruments - Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Si 3000 Surgical Systems
FDA Device · Class II · 2014-12-31 · Intuitive Surgical - adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment room 4: I2C is used with a charged particle or photon radiation therapy system for loc…
FDA Device · Class II · 2014-12-31 · Ion Beam Applications - KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.5 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway manage…
FDA Device · Class I · 2014-12-31 · Halyard Health - Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Software) with BL2272 (Laser Upgrade kit) Stellaris PC Vision Enhanc…
FDA Device · Class II · 2014-12-31 · Bausch And Lomb - NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5 Femoral Size Green / CH Zimmer U.K. Ltd., SN3 4FP, U…
FDA Device · Class II · 2014-12-31 · Zimmer Trabecular Metal Technology - ADULT Radiotransparent Electrode, Part number C100-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical Hea…
FDA Device · Class I · 2014-12-31 · Heart Sync - KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 9.0 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway manage…
FDA Device · Class I · 2014-12-31 · Halyard Health - ADULT Radiotranslucent Electrode, Part number T100-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical Hea…
FDA Device · Class I · 2014-12-31 · Heart Sync - Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system
FDA Device · Class II · 2014-12-31 · Natus Medical - HemoCue¿ Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and the…
FDA Device · Class II · 2014-12-31 · Radiometer America - Cyberonics VNS Therapy AspireHC, Model 105 Generator
FDA Device · Class II · 2014-12-31 · Cyberonics - ADVIA Centaur (including refurbished) Professional use in a laboratory for in vitro diagnostic tests
FDA Device · Class II · 2014-12-31 · Siemens Healthcare Diagnostics - STERRAD 50, Product Code 10114
FDA Device · Class II · 2014-12-31 · Advanced Sterilization Products - VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro diagnostic use only
FDA Device · Class II · 2014-12-31 · Ortho Clinical Diagnostics - ADULT/CHILD Radiotranslucent Electrode, Part number T100AC-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Med…
FDA Device · Class I · 2014-12-31 · Heart Sync - HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company
FDA Device · Class II · 2014-12-31 · Instrumentation Laboratory - STERRAD 200, Product Code 10118 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose s…
FDA Device · Class II · 2014-12-31 · Advanced Sterilization Products - Component- Dianz Capacitor used in PerfectO2 Oxygen Concentrator, packaged one unit per box
FDA Device · Class II · 2014-12-31 · Invacare - Persona Cemented Tibial Broach Inserter/Extractor
FDA Device · Class II · 2014-12-31 · Zimmer - GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes
FDA Device · Class I · 2014-12-31 · Leonhard Lang - Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated Rochester, NY
FDA Device · Class II · 2014-12-31 · Bausch And Lomb - Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform
FDA Device · Class III · 2014-12-31 · Illumina - Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating
FDA Device · Class II · 2014-12-31 · Maquet Cardiovascular Us Sales - UniStrip1, Blood Glucose Test Strips, 50 count box
FDA Device · Class II · 2014-12-31 · Unistrip Technologies - STERRAD NX, Product Code 10133 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose st…
FDA Device · Class II · 2014-12-31 · Advanced Sterilization Products - STERRAD 100S, Product Code 10113
FDA Device · Class II · 2014-12-31 · Advanced Sterilization Products - UroSeal Adjustable Endoscopic Valve
FDA Device · Class II · 2014-12-31 · Us Endoscopy Group - Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System: An in vitro diagnostic device intended to duplic…
FDA Device · Class II · 2014-12-31 · Siemens Healthcare Diagnostics - PKG, 5MM INSERT, MINI METZENBAUM SCISSORS, CURVED, 45CM, P/N 0250080574 Laparoscopic Manual Instruments are intended for cutting, holding,…
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - PKG, BIPOLAR FORCEPS, MICRO TIP, 33CM, P/N 0250080122 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manip…
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - EPIQ 7 Ultrasound System, EPIQ 7 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected
FDA Device · Class II · 2014-12-24 · Philips Ultrasound - PKG, 3MM INSERT, FUNDUS GRASPER, 29CM, P/N 0250282050 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manip…
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - PKG, METZENBAUM SCISSORS, CURVED, LONG, P/N 0250080025
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - PKG, ASPIRATION NEEDLE, 45 CM, P/N 0250080703 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating…
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - PKG, 3MM INSERT, BIOPSY PUNCH, 29CM, P/N 0250282060 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipul…
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - PKG, BABY METZENBAUM SCISSORS, CURVED, P/N 0250080028
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - PKG, SCHERTEL FORCEPS, FENESTRATED, P/N 0250080312
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer
FDA Device · Class II · 2014-12-24 · Carestream Health - AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS Monarc C Subfascial Hammock with Tensioning Suture REF 72404195…
FDA Device · Class II · 2014-12-24 · American Medical Systems - PKG, 5MM X 45CM INSERT, JOHANN FORCEPS, P/N 0250080764 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and mani…
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - 33CM DORSEY GRASPER FORCEPS, P/N 0250080319
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - PKG, KELLY FORCEPS, CURVED LEFT, P/N 0250080283
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - PKG,5MM 45CM INSERT,PERFORATOR, P/N 0250080578S1 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulati…
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - PKG, BABCOCK FORCEPS, PADDLE, P/N 0250080250
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - PKG, 3MM INSERT, BIOPSY FORCEPS, 20CM, P/N 0250282012 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manip…
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - PKG, 3MM INSERT, BULLET FORCEPS, 29CM, P/N 0250282057 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manip…
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - PKG, 10MM CLIP APPLYING FORCEPS, P/N 0250080558
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - PKG, 5MM PEEK HANDLE, 45CM, P/N 0250181164 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of…
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - PKG, 3MM INSERT, BULLET FORCEPS, 20CM, P/N 0250282010 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manip…
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - PKG, TROCAR, 8MM, PYRAMIDAL TIP, P/N 0250080155
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - PKG, BIPOLAR FORCEPS, FENESTRATED 45CM, P/N 0250080113
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - Q-Station Quantification Software
FDA Device · Class II · 2014-12-24 · Philips Ultrasound - PKG, 3MM PEEK MONOPOLAR HANDLE, P/N 0250282045 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating…
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - Ceramic Femoral Head
FDA Device · Class II · 2014-12-24 · Depuy Orthopaedics - PKG, 5MM X 45CM INSERT, RIGHT ANGLE DISSECTOR, LONG JAW, P/N 0250080761 Laparoscopic Manual Instruments are intended for cutting, holding,…
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - PKG, BULLET FORCEPS, TAPERED, SERRATED, SPOON, P/N 0250080041
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - PKG, CANNULA 5.5MM AUTOMATIC VALVE STOP COCK W/O TROCAR, P/N 0250080171
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - PKG, GRASPER FORCEPS, DELICATE, FENESTRATED, P/N 0250080322
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - PKG, 3MM INSERT, METZENBAUM, CURVED, LONG SCISSORS, 29CM, P/N 0250282047 Laparoscopic Manual Instruments are intended for cutting, holding,…
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - PKG, 5MM ROTATING HANDLE, W/RATCHET, INSULATED SHAFT 45CM LENGTH, P/N 0250080596 Laparoscopic Manual Instruments are intended for cutting,…
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - PKG, ROTATING HANDLE, RATCHET, INSULATED SHAFT, P/N 0250080231
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - AdVance"Male Sling System, REF 720088-01 & AdVance" XP Male Sling System REF 720163-01 (not commercially available in the US) The AdVance M…
FDA Device · Class II · 2014-12-24 · American Medical Systems - PKG, PORTIO ACORN SMALL ONLY, P/N 0250080139
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - PKG, HASSON CANNULA, 5.5MM, AUTOMATIC VALVE, STOP COCK, P/N 0250080176
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - PKG, ALLIS FORCEPS, P/N 0250080240
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - PKG, OP-VIOPSY FORCEPS, SPOON JAW, P/N 0250080246
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - PKG, ATRAUMATIC FORCEPS, DOUBLE ACTION, P/N 0250080311
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - PKG, 5MM INSULATED SHAFT 33CM, FOR BIPOLAR FORCEPS, P/N 0250080371
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - PKG, 3MM INSERT, STRAIGHT NEEDLEHOLDER, 20CM, P/N 0250282014 Laparoscopic Manual Instruments are intended for cutting, holding, grasping an…
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - PKG, 5MM INSERT, RIGHT ANGLE FORCEP, 45CM P/N 0250080729 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and ma…
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - PKG, NEEDLE HOLDER, CURVED LEFT, P/N 0250080341
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - PKG, 5MM INSERT, BOWEL GRASPER FORCEPS, 45CM, P/N 0250080587 Laparoscopic Manual Instruments are intended for cutting, holding, grasping an…
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - PKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080123 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and man…
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - Innova IGS 540 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy f…
FDA Device · Class II · 2014-12-24 · Ge Healthcare - PKG, MICRO SCISSORS, STRAIGHT, P/N 0250080029
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - PKG, 5MM INSERT, HOOK SCISSORS, 45CM, P/N 0250080573 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipu…
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - PKG, ROTATING HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080234
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - PKG, 5MM INSULATED SHAFT 45CM, FOR BIPOLAR FORCEPS, P/N 0250080370
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - PKG, 5MM ROTATING HANDLE, INSULATED SHAFT/ HANDLE 45CM LENGTH, P/N 0250080595 Laparoscopic Manual Instruments are intended for cutting, hol…
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - PKG, CANNULA, 11MM, AUTOMATIC VALVE STOP COCK, W/O TROCAR, P/N 0250080174
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy - PKG, 5MM INSERT, ENDO METZENBAUM SCISSORS, CURVED 45CM, P/N 0250080575 Laparoscopic Manual Instruments are intended for cutting, holding, g…
FDA Device · Class II · 2014-12-24 · Stryker Endoscopy
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)