FDA Device · 2015
FDA Device recalls in 2015
RecallRadar indexes 2,495 FDA Device recall notices published in 2015. By classification: 77 Class I, 2,300 Class II, 118 Class III.
- MicroCutter Xchange 30 Blue Curved Tip Cartridge
FDA Device · Class II · 2015-12-30 · Cardica - 12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP, PSD-6MTDBO300, PSD-10PPX, PSD-10MOX, 60960D, 61127D, DCC-81205-5, IMCA-10M5
FDA Device · Class III · 2015-12-30 · Ameditech - Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests WW. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility o…
FDA Device · Class I · 2015-12-30 · Biomerieux - Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number (SMN) 10445729, IVD. --- CLASSIFICATION NAME: Test, Qualit…
FDA Device · Class II · 2015-12-30 · Siemens Healthcare Diagnostics - iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016
FDA Device · Class III · 2015-12-30 · Ameditech - Vancomycin Screen Agar
FDA Device · Class II · 2015-12-30 · Becton Dickinson And - ImmuTest Cup 7-panel w/ Adulteration, Item No. IMCA-7P
FDA Device · Class III · 2015-12-30 · Ameditech - DA-2006P - Defibrillator / Pacer Analyzer
FDA Device · Class III · 2015-12-30 · Bc Group International - Dressol-X, Radiopaque D-502, NDC 11004-502-40, Dental Use Only, Active Ingredients: A.S.A. (Acetylsalicylic Acid) + Eugenol
FDA Device · Class II · 2015-12-30 · Rainbow Specialty And Health Products - Brilliance iCT SP Computed Tomography X-ray system
FDA Device · Class II · 2015-12-30 · Philips Medical Systems Cleveland - Alaris EtCO2 Module, Model 8300
FDA Device · Class II · 2015-12-30 · Carefusion 303 - ProScreen 6 Panel Dip Drug Screen, Item No. PSD-6BUPO3
FDA Device · Class III · 2015-12-30 · Ameditech - Immutest 11 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-11OP
FDA Device · Class III · 2015-12-30 · Ameditech - ProScreen 10 Panel Dip Card w/Adult, Item No. PSDA-10MO, PSDA-10MMO300, PSDA-10PPX, PSDA-10BUP, PSD-12BUP, PSD-10M, PSCupA-6MB-W, PSCup-10M…
FDA Device · Class III · 2015-12-30 · Ameditech - Ingenuity Core Computed Tomography X-ray system
FDA Device · Class II · 2015-12-30 · Philips Medical Systems Cleveland - Reagent Management System (RMS) Dimension RxL Max w/o HM Product Usage: The Reagent Management System (RMS) is a module for use with the Di…
FDA Device · Class II · 2015-12-30 · Siemens Healthcare Diagnostics - DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, Item No. 30600D
FDA Device · Class III · 2015-12-30 · Ameditech - CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12, DCC-81205-5
FDA Device · Class III · 2015-12-30 · Ameditech - Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray system and allows a technician to take a general digi…
FDA Device · Class II · 2015-12-30 · Shimadzu Medical Systems - ProScreen 6 Panel Dip Card, Item No. PSCuPSD-6BUP300, PSD-6MTDBO300, PSD-6BUPO, PSD-6MBO, PSD-6MB
FDA Device · Class III · 2015-12-30 · Ameditech - ProScreen 12 Panel Cup w/Adult., Item No. PSCupA-12M
FDA Device · Class III · 2015-12-30 · Ameditech - ProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P, PSDA-8MBO300
FDA Device · Class III · 2015-12-30 · Ameditech - ProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P, PSDA-8MBO300
FDA Device · Class III · 2015-12-30 · Ameditech - Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Single Trigger Handpiece
FDA Device · Class II · 2015-12-30 · Zimmer - BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes
FDA Device · Class II · 2015-12-30 · Becton Dickinson And - Alaris Pump SmartSite Infusion Set, Model No. 2420-0500
FDA Device · Class II · 2015-12-30 · Carefusion 303 - ProScreen CLIA Wvd 12 Panel Cup w/Adult., Item No. PSCupA-12M-W
FDA Device · Class III · 2015-12-30 · Ameditech - Enterococcus Screen Agar QUAD Plate
FDA Device · Class II · 2015-12-30 · Becton Dickinson And - Hook Blade, Angled
FDA Device · Class II · 2015-12-30 · Instratek - Reagent Management System (RMS) Dimension RxL Max HM STM Product Usage: The Reagent Management System (RMS) is a module for use with the Di…
FDA Device · Class II · 2015-12-30 · Siemens Healthcare Diagnostics - ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU
FDA Device · Class III · 2015-12-30 · Ameditech - 11 Panel Card (OPI 300) w/Adult, Item No. 71125AA
FDA Device · Class III · 2015-12-30 · Ameditech - Immutest 12 Panel Cup w/Adulteration, Item No. IMCA-11OP
FDA Device · Class III · 2015-12-30 · Ameditech - Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5
FDA Device · Class III · 2015-12-30 · Ameditech - Cardinal Health Tiny Toes
FDA Device · Class II · 2015-12-30 · Philips Electronics North America - Etest¿ Piperacillin/tazobactam (4 ug/mL) PTc0.016-256-pack of 30 tests WW Etest¿ is a quantitative technique for determining the antimicrob…
FDA Device · Class I · 2015-12-30 · Biomerieux - DrugSmart Cup THC/COC/AMP//MET/OPI2/BZO, Item No. 60600D
FDA Device · Class III · 2015-12-30 · Ameditech - ProScreen CLIA Waived Cup with 8 Drug, Item No. PSCup-8P-W
FDA Device · Class III · 2015-12-30 · Ameditech - Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU
FDA Device · Class III · 2015-12-30 · Ameditech - ImmuTest 12 Panel Dip Card, Item No. IMD-12MO3
FDA Device · Class III · 2015-12-30 · Ameditech - ProScreen CLIA Waived Cup 6 Drugs w/Adul, Item No. PSCupA-6MB-W
FDA Device · Class III · 2015-12-30 · Ameditech - ProScreen 5 Panel Dip Card w/Adult, Item No. PSDA-5MB300
FDA Device · Class III · 2015-12-30 · Ameditech - ProScreen 8 Panel Dip Card, Item No. PSD-8P
FDA Device · Class III · 2015-12-30 · Ameditech - Zimmer Oscillating Flat - TS ST Hub
FDA Device · Class II · 2015-12-30 · Synvasive Technology - ProScreen 12 Drug Cup w/Adulteration, Item No. PSCupA-12TBU
FDA Device · Class III · 2015-12-30 · Ameditech - iCup DX 12 Panel w/ Adulterant, Item No. I-DXA-1127-023
FDA Device · Class III · 2015-12-30 · Ameditech - Boston Scientific, Chariot ST-CCV Guiding Sheath, Sterilized using ethylene oxide: Product Description Material Number (UPN) Guiding Sheath…
FDA Device · Class I · 2015-12-30 · Boston Scientific - DrugSmart 11 Test Cup, Item No. 61127D
FDA Device · Class III · 2015-12-30 · Ameditech - ProScreen 10 Panel Cup, Item No. PSCup-10M
FDA Device · Class III · 2015-12-30 · Ameditech - ProScreen 6 Panel Cassette w/Adult (AU), Item No. PSPA-6MBAU
FDA Device · Class III · 2015-12-30 · Ameditech - Reagent Management System (RMS) Dimension EXL with LM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimen…
FDA Device · Class II · 2015-12-30 · Siemens Healthcare Diagnostics - 1 Step 12 Panel Cup, Item No. NBCA-12M-W
FDA Device · Class III · 2015-12-30 · Ameditech - Black Mamba Suture Passer
FDA Device · Class II · 2015-12-30 · Biomet - IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 OUS
FDA Device · Class II · 2015-12-30 · Boston Scientific - Brilliance 64 Computed Tomography X-ray system
FDA Device · Class II · 2015-12-30 · Philips Medical Systems Cleveland - RealityCHECK Tilt Cup 12 Panel + Adult, Item No. RC12TCA
FDA Device · Class III · 2015-12-30 · Ameditech - ProScreen 7 Panel Dip Card, Item No. PSD-7MPB, PSD-7MO, PSD-7M
FDA Device · Class III · 2015-12-30 · Ameditech - ProScreen 6 Panel Dip Card w/Adult (AU), Item No. PSDA-6MBAU
FDA Device · Class III · 2015-12-30 · Ameditech - MAGNETOM systems, magnetic resonance diagnostic devices (MRDD)
FDA Device · Class II · 2015-12-30 · Siemens Medical Solutions Usa - Artis systems with large display from Siemens Medical Solutions USA, Inc
FDA Device · Class II · 2015-12-30 · Siemens Medical Solutions Usa - Immutest Cup CLIA Waived w/Adulteration, Item No. IMCA-7MT-W
FDA Device · Class III · 2015-12-30 · Ameditech - Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part Number: 9000-3002 The component in question…
FDA Device · Class II · 2015-12-30 · Arthrosurface - Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Double Trigger Handpiece
FDA Device · Class II · 2015-12-30 · Zimmer - Brilliance iCT Computed Tomography X-ray system
FDA Device · Class II · 2015-12-30 · Philips Medical Systems Cleveland - MicroCutter Xchange 30 Blue Cartridge, FG-025320
FDA Device · Class II · 2015-12-30 · Cardica - Flexible Bone Awl
FDA Device · Class II · 2015-12-30 · Aesculap - EDI BZO Uncut Sheet - Cup*, Item No. 160170
FDA Device · Class III · 2015-12-30 · Ameditech - ProScreen CLIA Waived Cup with 6 Drugs, Item No. PSCup-6BO-W
FDA Device · Class III · 2015-12-30 · Ameditech - THERMO FISHER 8 DRUG CASSETTE, Item No. MTPA-8MBAU
FDA Device · Class III · 2015-12-30 · Ameditech - Flexible Drill
FDA Device · Class II · 2015-12-30 · Aesculap - DrugSmart Dip AMP/OPI2/COC/THC/BZO Test, Item No. 30520D
FDA Device · Class III · 2015-12-30 · Ameditech - iCup DX 11 Panel w/ Adulterant, Item No. I-DXA-1117-131
FDA Device · Class III · 2015-12-30 · Ameditech - iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013
FDA Device · Class III · 2015-12-30 · Ameditech - ProScreen 10 Panel Dip Card, Item No. PSD-10MOX, PSD-10MOB, PSD-10MMO300
FDA Device · Class III · 2015-12-30 · Ameditech - A.L.P.S. 4.0mm Cancellous Locking Screws intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconst…
FDA Device · Class II · 2015-12-30 · Biomet - Label reading in part as: "NexGen System, Complete Knee Solution
FDA Device · Class II · 2015-12-30 · Zimmer Manufacturing B V - IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10
FDA Device · Class II · 2015-12-30 · Boston Scientific - Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-W
FDA Device · Class III · 2015-12-30 · Ameditech - Tray Set containing multiple instruments and may contain the flexible bone awl, flexible drill and/or flexible screw driver in varying amou…
FDA Device · Class II · 2015-12-30 · Aesculap - Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests US. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility o…
FDA Device · Class I · 2015-12-30 · Biomerieux - DrugSmart Cup 10, Item No. 61093D-3C, 61085D, 61015D
FDA Device · Class III · 2015-12-30 · Ameditech - Reagent Management System (RMS) Dimension EXL with LM STM Product Usage: The Reagent Management System (RMS) is a module for use with the D…
FDA Device · Class II · 2015-12-30 · Siemens Healthcare Diagnostics - 11 Panel Dip Card (OPI 300) w/Adult, Item No. 11125AA
FDA Device · Class III · 2015-12-30 · Ameditech - Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only, Active Ingredients: Eugenol Oil
FDA Device · Class II · 2015-12-30 · Rainbow Specialty And Health Products - Synaptive Medical BrightMatter Navigator System (Guide System)
FDA Device · Class II · 2015-12-30 · Synaptive Medical - DrugCheck Waived 12 Panel Cup w/Adult, Item No. DCC-81205-5
FDA Device · Class III · 2015-12-30 · Ameditech - 10-Panel Pipette Drug Screen, Item No. PSP-10M
FDA Device · Class III · 2015-12-30 · Ameditech - FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fastidious bacteria broth for the enriched cultivation of Neisseria sp…
FDA Device · Class II · 2015-12-30 · Hardy Diagnostics - Flexible Screw Driver SJ706R
FDA Device · Class II · 2015-12-30 · Aesculap - Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700
FDA Device · Class II · 2015-12-30 · Airways Development - Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35
FDA Device · Class II · 2015-12-30 · Terumo Medical - Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator
FDA Device · Class I · 2015-12-30 · Draeger Medical - ProScreen 10 Drug Panel Cassette Test, Item No. PSP-10PPX
FDA Device · Class III · 2015-12-30 · Ameditech - Ingenuity Core 128 Computed Tomography X-ray system
FDA Device · Class II · 2015-12-30 · Philips Medical Systems Cleveland - ProScreen 5 Panel Dip Card, Item No. PSD-12BUP
FDA Device · Class III · 2015-12-30 · Ameditech - Aegis Torque Handle CATALOG NO. : 2871-10-800
FDA Device · Class II · 2015-12-30 · Depuy Spine - Syngo Imaging XS is a Picture Archiving and Communication System (PACS)
FDA Device · Class II · 2015-12-30 · Siemens Medical Solutions Usa - Green Mamba Suture Passer
FDA Device · Class II · 2015-12-30 · Biomet - DrugSmart 10 Test Cup (PCP & OXY), Item No. 61020D
FDA Device · Class III · 2015-12-30 · Ameditech - ProScProScreen 10 Panel Cup with Adulterants, Item No. PSCupA-10AM
FDA Device · Class III · 2015-12-30 · Ameditech
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)