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.
- SIMVIEW NT and SIMVIEW NT with IDI: October 01, 2012 Siemens ceased Simview distribution
FDA Device · Class II · 2014-01-29 · Siemens Medical Solutions Usa - Puritan Bennett 700 Series Ventilators (PB740 and PB760) PB700 Series Operators Manual: PN 10066984 & PN G-061874-00 and PB700 Series Serv…
FDA Device · Class II · 2014-01-29 · Nellcor Puritan Bennett Dba Covidien - VITROS Chemistry Products COCM Reagent
FDA Device · Class II · 2014-01-29 · Ortho Clinical Diagnostics - SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patient…
FDA Device · Class II · 2014-01-29 · Ge Healthcare - Pulmonary Hemi-Artery SG Used in heart surgery
FDA Device · Class II · 2014-01-29 · Cryolife - Computed Tomography X-Ray System (Brilliance CT Big Bore Oncology & Brilliance CT Big Bore Radiology) Distributed by Philips Healthcare Sys…
FDA Device · Class II · 2014-01-29 · Philips Medical Systems Cleveland - Oxoid Antimicrobial Susceptibility Test Discs, Ampicillin 10 mcg., CT0003B, packaged in cartridges of 50 discs, 5 cartridges/pack
FDA Device · Class II · 2014-01-29 · Remel - Civco Belly Board MRI, Reusable non-sterile glass fiber belly board with cushion, REF 126000, packaged 1 per box
FDA Device · Class II · 2014-01-29 · Civco Medical Instruments - UP & UP kids' power toothbrush
FDA Device · Class II · 2014-01-29 · Ranir - TopCare Clifford THE BIG RED DOG power toothbrush for kids!
FDA Device · Class II · 2014-01-29 · Ranir - 1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in pa…
FDA Device · Class II · 2014-01-29 · Ziemer Usa - AMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravascular administration set
FDA Device · Class II · 2014-01-29 · Churchill Medical Systems - Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems
FDA Device · Class II · 2014-01-29 · Siemens Healthcare Diagnostics - GE Healthcare, Dash 3000, Dash 4000 and Dash 5000
FDA Device · Class II · 2014-01-29 · Ge Healthcare - Dimension Vista Cyclosporine Flex reagent cartridge an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in…
FDA Device · Class II · 2014-01-29 · Siemens Healthcare Diagnostics - ABL90 FLEX Analyzer Radiometer Medical ApS, ¿kandevej 21 Br¿nsh¿j, Denmark A portable, automated analyzer that measures pH, blood gases, el…
FDA Device · Class II · 2014-01-29 · Radiometer America - Titanium Single Lumen Low-Profile port, with Pre-Attached open-Ended Silicone 6.6Fr Catheter
FDA Device · Class II · 2014-01-29 · Bard Access Systems - DRX-Evolution with FF WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator conso…
FDA Device · Class II · 2014-01-29 · Carestream Health - DR 7500 with FF WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, ov…
FDA Device · Class II · 2014-01-29 · Carestream Health - ORCHESTRA/ORCHESTRA PLUS Programmer
FDA Device · Class II · 2014-01-29 · Sorin Group Italia S R L - Oxoid Antimicrobial Susceptibility Test Discs, Norfloxacin 10 mcg., CT0434B, packaged in cartridges of 50 discs, 5 cartridges/pack
FDA Device · Class II · 2014-01-29 · Remel - Composix L/P with Echo PS 10" X 13" Product Code 0144113 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile…
FDA Device · Class II · 2014-01-29 · Davol Subs C R Bard - Zimmer Segmental Systems
FDA Device · Class II · 2014-01-29 · Zimmer - Siemens CentraLink" Data Management System V14.0.4, V14.0.5 or V14.0.8 The CentraLink system software is a network solution provider and mu…
FDA Device · Class II · 2014-01-29 · Siemens Healthcare Diagnostics - TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of T…
FDA Device · Class I · 2014-01-29 · Codman And Shurtleff - BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/kit
FDA Device · Class II · 2014-01-29 · Becton Dickinson And - MCA7-06SD - 0.6MM Diamond Ball, 7.3CM. All lots are included in recall
FDA Device · Class II · 2014-01-22 · The Anspach Effort - MCA5-06SD - 0.6MM Diamond Ball, 5.6CM. All lots are included in recall
FDA Device · Class II · 2014-01-22 · The Anspach Effort - Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System with stopcock and in-line connectors Sterile fluid path packaging Product Cod…
FDA Device · Class II · 2014-01-22 · Atrium Medical - MCA7-15SD - 1.5MM Diamond Ball, 7.3CM. All lots are included in recall
FDA Device · Class II · 2014-01-22 · The Anspach Effort - Micro Curved Attachment (MCA) Cutting Burr, DFU 18-0001
FDA Device · Class II · 2014-01-22 · The Anspach Effort - Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain
FDA Device · Class II · 2014-01-22 · Atrium Medical - Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with in-line connectors Product Code: 3650-100
FDA Device · Class II · 2014-01-22 · Atrium Medical - TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN): M00561411
FDA Device · Class II · 2014-01-22 · Boston Scientific - MCA5-05SD - 0.5 MM Diamond Ball, 5.6CM. All lots are included in recall
FDA Device · Class II · 2014-01-22 · The Anspach Effort - Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock Blood Recovery System
FDA Device · Class II · 2014-01-22 · Atrium Medical - MCA5-2SD - 2MM Diamond Ball, 5.6CM. All lots are included in recall
FDA Device · Class II · 2014-01-22 · The Anspach Effort - Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock and in-line connectors Pro…
FDA Device · Class II · 2014-01-22 · Atrium Medical - Locking Cortical Screw 3.5mmX38mm REF 8161-35-038
FDA Device · Class II · 2014-01-22 · Biomet - Anspach Carbide Cutting Burrs & Drums: 2MM Carbide Fluted Ball, Extended part # S-2B-C and 7MM Carbide Fluted Ball part # S-7B-C Anspach cu…
FDA Device · Class II · 2014-01-22 · The Anspach Effort - MCA7-07SD - 0.7MM Diamond Ball, 7.3CM. All lots are included in recall
FDA Device · Class II · 2014-01-22 · The Anspach Effort - Arena-L 38x28Trial Head I 10¿ Lordotic
FDA Device · Class II · 2014-01-22 · Spinefrontier - Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above UPN: M00547100 The Extractor Pro XL Retrieval Balloon C…
FDA Device · Class II · 2014-01-22 · Boston Scientific - pO2 D999 membrane units
FDA Device · Class II · 2014-01-22 · Radiometer America - Anspach Carbide Cutting Burrs: 1.5MMx7.5MM Cylindrical Carbide Drum part # S-15DRMC-L, 1MM Carbide Fluted ball, Extended part # S-1B-C, 1MM…
FDA Device · Class II · 2014-01-22 · The Anspach Effort - Oxoid Antimicrobial Susceptibility Testing Disc, MEM10, REF: CT0774B, 10 mcg meropenem, Packed in packs containing 5 cartridges per pack, 5…
FDA Device · Class II · 2014-01-22 · Remel - Merge Mammo is a multi-modality, vendor-neutral digital mammography workstation that enables imaging centers to use a single workstation to…
FDA Device · Class II · 2014-01-22 · Ge Healthcare It - MCA7-2SD - 2MM Diamond Ball, 7.3CM. All lots are included in recall
FDA Device · Class II · 2014-01-22 · The Anspach Effort - MCA7-15SB - 1.5MM Fluted Ball, 7.3CM. All lots are included in recall
FDA Device · Class II · 2014-01-22 · The Anspach Effort - Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures
FDA Device · Class II · 2014-01-22 · The Anspach Effort - TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 5 configuration) Universal Product Number (UPN):M00561421
FDA Device · Class II · 2014-01-22 · Boston Scientific - MCA7-2SB - 2MM Fluted Ball, 7.3CM. All lots are included in recall
FDA Device · Class II · 2014-01-22 · The Anspach Effort - TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 10 configuration) Intended to be used in flexible endoscopes as a retrieval device for…
FDA Device · Class II · 2014-01-22 · Boston Scientific - Arena-L Trial Handle
FDA Device · Class II · 2014-01-22 · Spinefrontier - Palacos¿ R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin), 40.8 g Methyl Acrylate Copolymer, 20 ml Methyl Methacrylate Monomer…
FDA Device · Class II · 2014-01-22 · Zimmer - MCA7-08SD - 0.8MM Diamond Ball, 7.3CM. All lots are included in recall
FDA Device · Class II · 2014-01-22 · The Anspach Effort - MCA5-1SB - 1MM Fluted Ball, 5.6CM. All lots are included in recall
FDA Device · Class II · 2014-01-22 · The Anspach Effort - King Systems KLTSD414 Quantity, 5 PER CASE KING LTSD KIT SIZE 4 King LT(S)-DTM supraglottic airway Identification Part Number(s): KLTSD414…
FDA Device · Class II · 2014-01-22 · King Systems - MCA7-1SD - 1MM Diamond Ball, 7.3CM. All lots are included in recall
FDA Device · Class II · 2014-01-22 · The Anspach Effort - MCA5-08SD - 0.8MM Diamond Ball, 5.6CM. All lots are included in recall
FDA Device · Class II · 2014-01-22 · The Anspach Effort - MCA7-05SD - 0.5MM Diamond Ball, 7.3CM. All lots are included in recall
FDA Device · Class II · 2014-01-22 · The Anspach Effort - Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock and in-line connectors
FDA Device · Class II · 2014-01-22 · Atrium Medical - STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System is a general purpose, low temperature sterilizer w…
FDA Device · Class II · 2014-01-22 · Advanced Sterilization Products - Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml) Manufactured by: Lab Vision Corporation, Fremont, CA Thermo Fis…
FDA Device · Class II · 2014-01-22 · Lab Vision - Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock
FDA Device · Class II · 2014-01-22 · Atrium Medical - MCA5-15SB - 1.5MM Fluted Ball, 5.6CM. All lots are included in recall
FDA Device · Class II · 2014-01-22 · The Anspach Effort - Weck, Electrosurgical Coagulation Suction Tube 8 (20.0cm), 11 French, with Stylet, Teleflex Medical, Research Triangle, NC 27709
FDA Device · Class II · 2014-01-22 · Teleflex Medical - TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 10 configuration) Universal Product Number (UPN):M00561412
FDA Device · Class II · 2014-01-22 · Boston Scientific - Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips
FDA Device · Class II · 2014-01-22 · The Anspach Effort - Anspach Carbide Cutting Burrs & Drums: 1.5MM x 7.5MM Cylindrical Carbide Drum part # S-15DRMC Anspach cutting burrs are intended for cuttin…
FDA Device · Class II · 2014-01-22 · The Anspach Effort - Consult Diagnostics¿ Eon Calcium Reagent For In-Vitro Diagnostic Use PN: 1429 For the quantitative measurement of calcium in plasma and ser…
FDA Device · Class II · 2014-01-22 · Vital Diagnostics - Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Above UPN: M00547110
FDA Device · Class II · 2014-01-22 · Boston Scientific - MCA5-1SD - 1MM Diamond Ball, 5.6CM. All lots are included in recall
FDA Device · Class II · 2014-01-22 · The Anspach Effort - BD Interlink threaded lock cannula This is a locking blunt plastic cannula specifically designed for IV connection to an Interlink¿ injecti…
FDA Device · Class II · 2014-01-22 · Becton Dickinson And - Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only MIA16 attachments are intended for use with Motor Systems for cutting and shap…
FDA Device · Class II · 2014-01-22 · The Anspach Effort - Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use
FDA Device · Class II · 2014-01-22 · Vital Diagnostics - Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Below UPN :M00547140
FDA Device · Class II · 2014-01-22 · Boston Scientific - GE Healthcare Carescape Patient Data Module The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic p…
FDA Device · Class II · 2014-01-22 · Ge Healthcare - Arena-L 35x26 Trial Head I 10¿ Lordotic
FDA Device · Class II · 2014-01-22 · Spinefrontier - Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with Prefilled Air Leak Monitor
FDA Device · Class II · 2014-01-22 · Atrium Medical - STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Sterilization System is a general purpose, low temperature steriliz…
FDA Device · Class II · 2014-01-22 · Advanced Sterilization Products - TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN): M00561410
FDA Device · Class II · 2014-01-22 · Boston Scientific - Weck, Electrosurgical Coagulation Suction Tube 6 (15.2cm), 11 French, with Stylet, Teleflex Medical, Research Triangle, NC 2770
FDA Device · Class II · 2014-01-22 · Teleflex Medical - Draeger Infinity Acute Care System Monitoring Solution
FDA Device · Class II · 2014-01-22 · Draeger Medical Systems - MCA5-15SD - 1.5MM Diamond Ball, 5.6CM. All lots are included in recall
FDA Device · Class II · 2014-01-22 · The Anspach Effort - Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain Dual patient lines
FDA Device · Class II · 2014-01-22 · Atrium Medical - MCA5-07SD - 0.7MM Diamond Ball, 5.6CM. All lots are included in recall
FDA Device · Class II · 2014-01-22 · The Anspach Effort - TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN):M00561420
FDA Device · Class II · 2014-01-22 · Boston Scientific - STERRAD 50 Sterilization System, Product Code: 10050 The STERRAD 50 Sterilization System is a general purpose, low temperature sterilizer w…
FDA Device · Class II · 2014-01-22 · Advanced Sterilization Products - MCA7-1SB - 1MM Fluted Ball, 7.3CM. All lots are included in recall
FDA Device · Class II · 2014-01-22 · The Anspach Effort - Leica BIOSYSTEMS
FDA Device · Class II · 2014-01-22 · Leica Biosystems Newcastle - Anspach Carbide Cutting Burrs: 2MM Carbide Fluted Ball, Standard, 8 Flutes - part #QD8-2SB-C-8F, 4MM Carbide Fluted Ball, 10 Flutes - part…
FDA Device · Class II · 2014-01-22 · The Anspach Effort - MCA5-2SB - 2MM Fluted Ball, 5.6CM. All lots are included in recall
FDA Device · Class II · 2014-01-22 · The Anspach Effort - GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems
FDA Device · Class II · 2014-01-22 · Ge Healthcare - Imagecast PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses…
FDA Device · Class II · 2014-01-22 · Ge Healthcare It - Centricity PACS System versions 3.X and higher and 4.X and higher Product Usage: The Centricity PACS Workstation is intended for use as a p…
FDA Device · Class II · 2014-01-22 · Ge Healthcare It - SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module)
FDA Device · Class II · 2014-01-15 · Ge Healthcare - Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #11 Blade Manufactured for: Ansell Sandel Medical…
FDA Device · Class II · 2014-01-15 · Ansell Sandel Medical Industries - 6" (15 cm) Appx 0.37 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. K7096-001 The ICU Needleles…
FDA Device · Class II · 2014-01-15 · Icu Medical - 78" Ext Set w/Check Valve, CLAVE¿ Clear, Remv 2 Gang 4-Way Stopcocks, NanoClave¿, NanoClave¿ T-Connector, 4 Clamps, Rotating Luer, 3 Ext, P…
FDA Device · Class II · 2014-01-15 · Icu Medical
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)