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.
- PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable Implant, Model No. 8044M0K5. An injectable implant u…
FDA Device · Class II · 2015-12-09 · Merz North America - Copper NiTi Preformed Archwires
FDA Device · Class II · 2015-12-09 · Ormco Sybronendo - Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delivery tubing
FDA Device · Class II · 2015-12-09 · Quest Medical - Philips Healthcare INTEGRIS cardio system Model : 722121 Product Usage: The Allura Xper series is intended for use in cardiovascular and va…
FDA Device · Class II · 2015-12-09 · Philips Medical Systems - Philips Healthcare Xper vascular system Model : 722124 Product Usage: The Allura Xper series is intended for use in cardiovascular and vasc…
FDA Device · Class II · 2015-12-09 · Philips Medical Systems - Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile
FDA Device · Class II · 2015-12-09 · Stryker Howmedica Osteonics - IOL Master 500: Software versions 7.5 and 7.7
FDA Device · Class II · 2015-12-09 · Carl Zeiss Meditec Ag - ProTrack Microcatheter
FDA Device · Class II · 2015-12-09 · Baylis Medical - SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System
FDA Device · Class II · 2015-12-02 · Pega Medical - NxStage System One S Cycler - Model no
FDA Device · Class II · 2015-12-02 · Nxstage Medical - Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric IOL
FDA Device · Class I · 2015-12-02 · Alcon Research - Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool
FDA Device · Class II · 2015-12-02 · Medtronic Sofamor Danek Usa Dallas Distribution - Dimension Vista System (MG)
FDA Device · Class II · 2015-12-02 · Siemens Healthcare Diagnostics - NxStage System One S Cycler - Model no
FDA Device · Class II · 2015-12-02 · Nxstage Medical - rainbow Reusable Sensors
FDA Device · Class II · 2015-12-02 · Masimo - Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10)
FDA Device · Class II · 2015-12-02 · Leica Microsystems - Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Pre-Curved Shaft and Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number…
FDA Device · Class II · 2015-12-02 · Covidien - Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145046C The Pal…
FDA Device · Class II · 2015-12-02 · Covidien - NxStage System One S Cycler -High Permeability Hemodialysis System Model no
FDA Device · Class II · 2015-12-02 · Nxstage Medical - Thermo Scientific p21 WF1 Ab-3 (DCS-60.2) 1 ml (0.4mg/ml): Product code: MS-230-P and MS-230P0
FDA Device · Class III · 2015-12-02 · Lab Vision - Syngo Imaging VB36D_HF02
FDA Device · Class II · 2015-12-02 · Siemens Medical Solutions Usa - Philips HeartStart MRx Monitor/Defibrillator
FDA Device · Class II · 2015-12-02 · Philips Electronics North America - ADVIA Chemistry Hemoglobin A1c_3, A1c_3M Reagent kits
FDA Device · Class II · 2015-12-02 · Siemens Healthcare Diagnostics - Palindrome Precision Chronic Catheter Kit Symmetrical Tip 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145017P The Palindrome chronic cathet…
FDA Device · Class II · 2015-12-02 · Covidien - CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG Controls are intended to va…
FDA Device · Class III · 2015-12-02 · Biochemical Diagnostics - NxStage System One S Cycler (High Permeability Hemodialysis System) Model no
FDA Device · Class II · 2015-12-02 · Nxstage Medical - Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi View software option
FDA Device · Class II · 2015-12-02 · Philips Medical Systems - 2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm
FDA Device · Class II · 2015-12-02 · Synthes Usa Products - BD CD64 APC-R700
FDA Device · Class II · 2015-12-02 · Becton Dickinson And Bd Biosciences - Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042 The Palindrome ch…
FDA Device · Class II · 2015-12-02 · Covidien - Palindrome Precision Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042P The Pal…
FDA Device · Class II · 2015-12-02 · Covidien - NxStage System One S Cycler (High Permeability Hemodialysis System) Model no
FDA Device · Class II · 2015-12-02 · Nxstage Medical - Taut Intraducers 10/BX7.5 FR 3.5, Product Code PI-93
FDA Device · Class II · 2015-11-25 · Teleflex Medical - DrugSmart 11 Test Cup, Item No. 61127D
FDA Device · Class II · 2015-11-25 · Ameditech - Neptune Plus, HEMOSTASIS PAD WITH ANTIMICROBIAL BARRIER, For hemostasis following needle/sheath removal, Part number 8870-03
FDA Device · Class II · 2015-11-25 · Tz Medical - Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101
FDA Device · Class II · 2015-11-25 · Fresenius Medical Care Renal Therapies Group - Prism Medical P-300 Portable Consumer Lift
FDA Device · Class II · 2015-11-25 · Ergosafe Products Dba Prism Medical - Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106
FDA Device · Class II · 2015-11-25 · Cyberonics - 12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP These Drugs of Abuse Tests are one-step immunoassays for the qualitative dete…
FDA Device · Class II · 2015-11-25 · Ameditech - DrugCheck Waived 12 Panel Cup w/Adult, Item No. DCC-81205-5 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detect…
FDA Device · Class II · 2015-11-25 · Ameditech - 11 Panel Cup (OPI2000) w/Adult, Item No. 71125AA2K
FDA Device · Class II · 2015-11-25 · Ameditech - DrugSmart 10 Test Cup (PCP & MDMA), Item No. 61055D
FDA Device · Class II · 2015-11-25 · Ameditech - DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, Item No. 30600D
FDA Device · Class II · 2015-11-25 · Ameditech - Inspiration Ventilator System, i Series and LS 12.1 LCD. The Inspiration 7i / 5i Ventilator System is to be used by healthcare professional…
FDA Device · Class I · 2015-11-25 · Event Medical - Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analy…
FDA Device · Class II · 2015-11-25 · Roche Diagnostics Operations - Fresenius 132 Gallon Dry Acid Dissolution Unit, P/N 160147
FDA Device · Class II · 2015-11-25 · Fresenius Medical Care Renal Therapies Group - iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013
FDA Device · Class II · 2015-11-25 · Ameditech - Easy Dial Oxygen Regulator, 168708D and 168715D. Eight liter from .0.25 to 8 liters, 15 liter from 0.5 liter to 15 liters of oxygen per min…
FDA Device · Class II · 2015-11-25 · Precision Medical - IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects certain demographic information (Patient…
FDA Device · Class II · 2015-11-25 · Agfa Healthcare - Hill-Rom 100 Low Bed (GPAC) AC Powered adjustable hospital bed
FDA Device · Class II · 2015-11-25 · Hill Rom - The Drug Detection Agency 6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUP These Drugs of Abuse Tests are one-step immunoassa…
FDA Device · Class II · 2015-11-25 · Ameditech - 10-Panel Pipette Drug Screen, Item No. PSP-10M These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multip…
FDA Device · Class II · 2015-11-25 · Ameditech - CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx…
FDA Device · Class II · 2015-11-25 · Civco Medical Instruments - CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs 610-1215, 610-1234, 610-1235, 610-1236
FDA Device · Class II · 2015-11-25 · Civco Medical Instruments - MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx
FDA Device · Class II · 2015-11-25 · Astora - 1 Step 12 Panel Cup, Item No. NBCA-12M-W These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple dru…
FDA Device · Class II · 2015-11-25 · Ameditech - Synthes Application Instrument for Sternal ZIPFIX. Indications for use include primary or secondary closure/repair of the sternum following…
FDA Device · Class II · 2015-11-25 · Synthes Usa Products - Fresenius Modified Mixer Motor (for 132 Gallon Dissolution Units), P/N 160075
FDA Device · Class II · 2015-11-25 · Fresenius Medical Care Renal Therapies Group - CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 674-030, 67…
FDA Device · Class II · 2015-11-25 · Civco Medical Instruments - 11 Panel Dip Card (OPI 2000), Item No. 11125AA2K
FDA Device · Class II · 2015-11-25 · Ameditech - Prism Medical C-300 Consumer Ceiling Lift
FDA Device · Class II · 2015-11-25 · Ergosafe Products Dba Prism Medical - Premier Clia Waived 12 panel Tilt Cup, Item No. C12APC These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection o…
FDA Device · Class II · 2015-11-25 · Ameditech - EDI BZO UNCUT SHEET-CARD, Item No. 100170 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple dr…
FDA Device · Class II · 2015-11-25 · Ameditech - ECG Electrodes: 50007 Stablebase SBW55 50675 Stablebase SBW55-15 58051 Skintact W-60 50547 Stablebase SBT60 Only OUS: 50476 Skintac…
FDA Device · Class II · 2015-11-25 · Leonhard Lang Medizintechnik - ArcPoint Labs 10 Panel Dip Screen (OXY), Item No. APD-10MO These Drugs of Abuse Tests are one-step immunoassays for the qualitative detecti…
FDA Device · Class II · 2015-11-25 · Ameditech - HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery
FDA Device · Class II · 2015-11-25 · Ethicon Endo Surgery - SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate, Part number 8870-07
FDA Device · Class II · 2015-11-25 · Tz Medical - ECG Out Cable,for use with a Philips ALS monitor/ defibrillator and bedside monitor for Synchronized cardioversion and Transcutaneous pacing
FDA Device · Class II · 2015-11-25 · Philips Electronics North America - Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5
FDA Device · Class II · 2015-11-25 · Ameditech - CIVCO Sales Demo Kit
FDA Device · Class II · 2015-11-25 · Civco Medical Instruments - CIVCO Biopsy Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 10787043, 1100190…
FDA Device · Class II · 2015-11-25 · Civco Medical Instruments - Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip System intended for use during total hip arthro…
FDA Device · Class II · 2015-11-25 · Stryker Howmedica Osteonics - Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult r…
FDA Device · Class III · 2015-11-25 · Baxter Healthcare - GMK Hinge knee prosthesis
FDA Device · Class II · 2015-11-25 · Medacta Usa - THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU, MTPA-8MBAU These Drugs of Abuse Tests are one-step immunoassays for the qualitative det…
FDA Device · Class II · 2015-11-25 · Ameditech - BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cranial ENT version 2.1, and Spine and Trauma 3D ve…
FDA Device · Class II · 2015-11-25 · Brainlab Ag - DrugCheck Pipette 10 Drug Test, Item No. 41025 DC These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of mul…
FDA Device · Class II · 2015-11-25 · Ameditech - CLIA RDTC 12-Panel Cup and CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12 These Drugs of Abuse Tests are one-step immunoass…
FDA Device · Class II · 2015-11-25 · Ameditech - Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU These Drugs of Abuse Tests are one-step immunoassays for the qualitative dete…
FDA Device · Class II · 2015-11-25 · Ameditech - ProScreen 10 Drug Panel Cassette Test, Item No. CPSP-10PPX
FDA Device · Class II · 2015-11-25 · Ameditech - GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR system is an open, whole body scanner for use as a diagnostic imag…
FDA Device · Class II · 2015-11-18 · Ge Healthcare - Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis component
FDA Device · Class II · 2015-11-18 · Stryker Howmedica Osteonics - Stryker Radius 5.5 to 3.5 Rod to Red Connector, REF 48664530
FDA Device · Class II · 2015-11-18 · Stryker Spine - miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-BT miraDry bioTip and accessories
FDA Device · Class II · 2015-11-18 · Miramar Labs - Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use
FDA Device · Class II · 2015-11-18 · Cook - Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/PLATE 231mm 6HOLES/5.0mm ROD/17HOLES. Orthopedic implant
FDA Device · Class II · 2015-11-18 · Synthes Usa Products - GE Healthcare, Discovery MR750w 3.0T. Product Usage: The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima M…
FDA Device · Class II · 2015-11-18 · Ge Healthcare - DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630, Lot Nos: 2016-09EE: TOTAL KNEE A & B,…
FDA Device · Class II · 2015-11-18 · Deroyal Industries - GE Healthcare, SIGNA HDxt 3.0T. Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scan…
FDA Device · Class II · 2015-11-18 · Ge Healthcare - GE Healthcare, SIGNA Excite 3.0T. MR System for use as a diagnostic imaging device
FDA Device · Class II · 2015-11-18 · Ge Healthcare - Myelo-Nate CSF Sampling Kit, Neonatal/Pediatric cerebralspinal fluid sampling sterile tray, including a lumbar puncture needle, four collec…
FDA Device · Class II · 2015-11-18 · Utah Medical Products - GE Healthcare, SIGNA 3.0T. Product Usage: Magnetic resonance system for diagnostic imaging
FDA Device · Class II · 2015-11-18 · Ge Healthcare - Maquet Getinge Group, Universal Frame for Positioning Patients (1007.24XX) Manufacturer: Maquet GmbH, Germany The MAQUET Adjustable Positio…
FDA Device · Class II · 2015-11-18 · Maquet Cardiovascular Us Sales - Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Sterilized using Ethylene Oxide
FDA Device · Class II · 2015-11-18 · Medtronic Perfusion Systems - Stryker Orthopaedics, MIS MODULAR DISTAL CAPTURE TRIATHLON MIS INSTRUMENTS, REF 6541-5-723, Lot AdminECR19205, Non-Sterile, The Triathlon M…
FDA Device · Class II · 2015-11-18 · Stryker Howmedica Osteonics - MODULARIS VARIOSTAR
FDA Device · Class II · 2015-11-18 · Siemens Medical Solutions Usa - MILEX PESSARY KIT
FDA Device · Class III · 2015-11-18 · Coopersurgical - Maquet Getinge Group, Adjustable Positioning Elements (1007.28A0) Manufacturer: Maquet GmbH, Germany
FDA Device · Class II · 2015-11-18 · Maquet Cardiovascular Us Sales - Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic
FDA Device · Class II · 2015-11-18 · Focus Diagnostics - R¿sch Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip, Sterile, Rx only, Teleflex Medical
FDA Device · Class II · 2015-11-18 · Teleflex Medical
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