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.
- BZO Strip Dip Card (300ng/ml)*, Item No. 100170
FDA Device · Class III · 2015-12-30 · Ameditech - ProScreen 9 Panel Cup w/Adulterants, Item No. PSCUPA-9BO300
FDA Device · Class III · 2015-12-30 · Ameditech - VAPR¿ TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028)
FDA Device · Class II · 2015-12-30 · Depuy Mitek A Johnson And Johnson - IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-8 Material Number: M004PM4500N40
FDA Device · Class II · 2015-12-30 · Boston Scientific - 6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUP
FDA Device · Class III · 2015-12-30 · Ameditech - Etest¿ PIP/TAZO/CON-4 PTC 256 -pack of 30 tests US. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of…
FDA Device · Class I · 2015-12-30 · Biomerieux - IntellaTip MiFi XP Asymmetric (N4) Curve, 7/110/2.5/8-8 OUS
FDA Device · Class II · 2015-12-30 · Boston Scientific - DrugSmart 9 Test Cup (BUP), Item No. 60960D
FDA Device · Class III · 2015-12-30 · Ameditech - ProScreen 12 Panel Dip Card, Item No. PSD-12BUP
FDA Device · Class III · 2015-12-30 · Ameditech - Ingenuity CT Computed Tomography X-ray system
FDA Device · Class II · 2015-12-30 · Philips Medical Systems Cleveland - iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142
FDA Device · Class III · 2015-12-30 · Ameditech - THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU
FDA Device · Class III · 2015-12-30 · Ameditech - ProScreen Cup CLIA with 6 Panel Drug, Item No. PSCup-6MB-W
FDA Device · Class III · 2015-12-30 · Ameditech - DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D DrugSmart 12 Test Cup (Multi/Single/BUP), Item No. 61205D
FDA Device · Class III · 2015-12-30 · Ameditech - MYLA CLINIC PATCH 3.2.0 CD Product Usage: MYLA is a computer application ( Middleware ) based on Web 2.0 technology which: Interfaces betwe…
FDA Device · Class II · 2015-12-23 · Biomerieux - Cournand Modified 2-PC 19G, 5.4cm or (Guidewire Introducer Needle) 20 units per case The Stryker Guidewire Introducer Needles are designed…
FDA Device · Class II · 2015-12-23 · Stryker Instruments Div - OmniPod¿, Insulin Management System (OUS) Catalog Number: 14810 Product Usage: The OmnniPod¿ Insulin Management System is intended for subc…
FDA Device · Class I · 2015-12-23 · Insulet - Unolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use, Non-injectable needle, Single use, non-injection needle
FDA Device · Class II · 2015-12-23 · Myco Medical Supplies - Digital Temple Thermometer labeled under: Bestmed, Good Neighbor (Amerisource Bergen), Kroger, Medline, Meijer, Premier Value, Safeway, Lif…
FDA Device · Class II · 2015-12-23 · Bestmed - Perseus A500 Anesthesia Workstation, MK06000
FDA Device · Class I · 2015-12-23 · Draeger Medical - UniCel DxH 800 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 629029, B24465, B24802 The UniCel DxH 800/DxH 600 analy…
FDA Device · Class II · 2015-12-23 · Beckman Coulter - MYLA MASTER DVD V4.0 CLI Product Usage: MYLA is a computer application ( Middleware ) based on Web 2.0 technology which: Interfaces between…
FDA Device · Class II · 2015-12-23 · Biomerieux - Philips Healthcare Ingenuity Core Computed Tomography X-ray system
FDA Device · Class II · 2015-12-23 · Philips Electronics North America - MYLA MASTER DVD V4.1 CLI Product Usage: MYLA is a computer application ( Middleware ) based on Web 2.0 technology which: Interfaces between…
FDA Device · Class II · 2015-12-23 · Biomerieux - MiniMed 620G, 3.0mL mg/dL, Model No. MMT-1710 The MiniMed 620G and MiniMed 640G insulin pump systems are indicated for the continuous deliv…
FDA Device · Class II · 2015-12-23 · Medtronic Minimed - UniCel DxH 600 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 775222 The UniCel DxH 800/DxH 600 analyzers are quantit…
FDA Device · Class II · 2015-12-23 · Beckman Coulter - Philips Healthcare Ingenuity Core 128 Computed Tomography X-ray system
FDA Device · Class II · 2015-12-23 · Philips Electronics North America - Catalog No. INF0020-A EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector (spike…
FDA Device · Class II · 2015-12-23 · Moog Medical Devices Group - Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B packaged in packs of 5 cartridges - 50 disc/cartridge
FDA Device · Class II · 2015-12-23 · Remel - Philips Healthcare Brilliance 64 Computed Tomography X-ray system
FDA Device · Class II · 2015-12-23 · Philips Electronics North America - OmniPod¿, Insulin Management System (US) Catalog Number: PODZXP420 Product Usage: The OmnniPod¿ Insulin Management System is intended for s…
FDA Device · Class I · 2015-12-23 · Insulet - MOSAIQ Oncology Information System
FDA Device · Class II · 2015-12-23 · Elekta - Intravascular (IV) Administration Sets, Model No. 54IV12, 54IV22, 54IV32, MK2450, 54IV42, MK132, MK2156, MK2270, MK2292, MK2300, MK2374, MK…
FDA Device · Class II · 2015-12-23 · Edwards Lifesciences - Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT, ED-410XU, ED-450XL, and ED…
FDA Device · Class II · 2015-12-23 · Fujifilm Medical Systems U - GE Healthcare Optima CL323i Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in g…
FDA Device · Class II · 2015-12-23 · Ge Medical Systems - GE Healthcare Optima IGS 320
FDA Device · Class II · 2015-12-23 · Ge Medical Systems - MYLA CLI V3.X TO V4.1 DL380 SERVER Product Usage: MYLA is a computer application ( Middleware ) based on Web 2.0 technology which: Interfac…
FDA Device · Class II · 2015-12-23 · Biomerieux - GlideScope Video Laryngoscope (GVL), Part Number GVL 3 - 0574-0007
FDA Device · Class II · 2015-12-23 · Verathon - MYLA CLI V3.X TO V4.1 ML350 SERVER Product Usage: MYLA is a computer application ( Middleware ) based on Web 2.0 technology which: Interfac…
FDA Device · Class II · 2015-12-23 · Biomerieux - MYLA MASTER DVD 3.2 CLI DL380 Product Usage: MYLA is a computer application ( Middleware ) based on Web 2.0 technology which: Interfaces be…
FDA Device · Class II · 2015-12-23 · Biomerieux - UniCel DxH 600 Coulter Cellular Analysis System, Software Version 1.1.1.0, Part No. B23858 The DxH Slidemaker Stainer is a fully automated…
FDA Device · Class II · 2015-12-23 · Beckman Coulter - VentriClear¿ II Ventricular Drainage Catheter Set
FDA Device · Class II · 2015-12-23 · Cook - GlideScope AVL Video Laryngoscope (AVL), Part Number AVL 3- 0574-0115
FDA Device · Class II · 2015-12-23 · Verathon - MYLA CLINIC PATCH 3.3.0 CD Product Usage: MYLA is a computer application ( Middleware ) based on Web 2.0 technology which: Interfaces betwe…
FDA Device · Class II · 2015-12-23 · Biomerieux - Philips Healthcare Ingenuity CT Computed Tomography X-ray system
FDA Device · Class II · 2015-12-23 · Philips Electronics North America - MiniMed 640G, 3.0mL mmol/L, 3.0mL mg/dL, Model No. MMT-1711 and MMT-1712 The MiniMed 620G and MiniMed 640G insulin pump systems are indicat…
FDA Device · Class II · 2015-12-23 · Medtronic Minimed - AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W) x 1.5cm (H), RH-7413-10, Sterilized by Gamma Radiation, Rx…
FDA Device · Class II · 2015-12-23 · Summit Medical - Hudson RCI Adult Universal Ventilator Circuit, Duel Heated Limb and Hudson RCI Adult Heated Wire Circuit Kit with Column
FDA Device · Class II · 2015-12-23 · Teleflex Medical - One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube
FDA Device · Class II · 2015-12-16 · Boston Scientific - GE Healthcare, Revolution CT Scanners
FDA Device · Class II · 2015-12-16 · Ge Medical Systems - Brilliance 64 Computed Tomography X-Ray System, Model number 728231, running version 2.6.0. Intended to produce cross-sectional images of t…
FDA Device · Class II · 2015-12-16 · Philips Medical Systems Cleveland - LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601-38
FDA Device · Class II · 2015-12-16 · Lemaitre Vascular - Persona EM Distal Rod, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-002-00, part of the Persona…
FDA Device · Class II · 2015-12-16 · Zimmer - Thin-Flex Venous Cannula, Model Number:TF292902A
FDA Device · Class II · 2015-12-16 · Edwards Lifesciences - AMS 4674 Custom Pack
FDA Device · Class II · 2015-12-16 · Windstone Medical Packaging - The eCareManager system
FDA Device · Class II · 2015-12-16 · Visicu - LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654-78
FDA Device · Class II · 2015-12-16 · Lemaitre Vascular - Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243. software version 2.0 The products are intended t…
FDA Device · Class II · 2015-12-16 · Philips Medical Systems Cleveland - LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651-34
FDA Device · Class II · 2015-12-16 · Lemaitre Vascular - LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38
FDA Device · Class II · 2015-12-16 · Lemaitre Vascular - LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 40 cm, Model e1651-84
FDA Device · Class II · 2015-12-16 · Lemaitre Vascular - LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model e1801-26
FDA Device · Class II · 2015-12-16 · Lemaitre Vascular - LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654-48
FDA Device · Class II · 2015-12-16 · Lemaitre Vascular - IBS - Osteosynthesis screws for bone fixation Model S25 ST014
FDA Device · Class II · 2015-12-16 · In2bones Sas - Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, RIGHT - 62 MM, STERILE R, Rx only, REF Numbers: 71863114 Bone fixa…
FDA Device · Class II · 2015-12-16 · Smith And Nephew - Olympus ENDOEYE HD II Video Telescopes
FDA Device · Class II · 2015-12-16 · Olympus - RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant
FDA Device · Class II · 2015-12-16 · Biohorizons Implant Systems - DGDE, DirectGuide Drill Extender
FDA Device · Class II · 2015-12-16 · Implant Direct Sybron Manufacturing - Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only
FDA Device · Class II · 2015-12-16 · Sterilmed - Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA 420MM/Right Sterile (The TFN-ADVANCED Proximal Femoral Nailing System…
FDA Device · Class II · 2015-12-16 · Synthes Usa Products - Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size Aerosol Generator SPAG-2 6000 is a pneumatic flow system indicat…
FDA Device · Class II · 2015-12-16 · Valeant Pharmaceuticals North America - Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue: 866023 IntelliVue Info Center iX 866024…
FDA Device · Class II · 2015-12-16 · Philips Medical Systems - Persona EM Proximal Tube, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-001-00, part of the Pers…
FDA Device · Class II · 2015-12-16 · Zimmer - AMS 4675 Angio Pack
FDA Device · Class II · 2015-12-16 · Windstone Medical Packaging - Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT - 62 MM, STERILE R, Rx only, REF Numbers: 71863110 Bone fixat…
FDA Device · Class II · 2015-12-16 · Smith And Nephew - The "Pacifier Activated Lullaby" (PAL) System composed of three major components: 1) the PAL Player Module (aka Player Unit), 2) the PAL Pa…
FDA Device · Class II · 2015-12-16 · Powers Medical Devices - LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64
FDA Device · Class II · 2015-12-16 · Lemaitre Vascular - LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68
FDA Device · Class II · 2015-12-16 · Lemaitre Vascular - LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601-48
FDA Device · Class II · 2015-12-16 · Lemaitre Vascular - LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and e1654-88
FDA Device · Class II · 2015-12-16 · Lemaitre Vascular - LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601-58
FDA Device · Class II · 2015-12-16 · Lemaitre Vascular - LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 6F, 80 cm, Model 1601-68
FDA Device · Class II · 2015-12-16 · Lemaitre Vascular - DeRoyal sterile custom surgical kits: 1) Emergency CABG Pack Pgybk, ref 89-7859.01 2) Emergency CABG Pack Pgybk, ref 89-7859.02 3) Open Hea…
FDA Device · Class II · 2015-12-09 · Deroyal Industries - Philips Healthcare Allure BiPlane Series: Model 722013 Allura Xper FD20 BIPLANE R7.6 722013 Allura Xper FD20 BIPLANE R7.7 722013 Allura Xpe…
FDA Device · Class II · 2015-12-09 · Philips Medical Systems - IOL Master 5.5: Software versions 7.5 and 7.7
FDA Device · Class II · 2015-12-09 · Carl Zeiss Meditec Ag - U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387
FDA Device · Class II · 2015-12-09 · Procedure Products - Philips Healthcare Xper vascular systems R7.6 Model : 722134 Product Usage: The Allura Xper series is intended for use in cardiovascular an…
FDA Device · Class II · 2015-12-09 · Philips Medical Systems - Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost
FDA Device · Class II · 2015-12-09 · Philips Medical Systems - Patient Support Material Number: 9890 010 87431, used with:EasyDiagnost
FDA Device · Class II · 2015-12-09 · Philips Medical Systems - Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker
FDA Device · Class II · 2015-12-09 · Medtronic - Philips Healthcare Xper cardio systems Model : 722123 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascu…
FDA Device · Class II · 2015-12-09 · Philips Medical Systems - Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 & 2) 60-9500-INT. Thermal Ligation and Cutting Energy Source
FDA Device · Class II · 2015-12-09 · Conmed - Philips Healthcare Allura Xper Series: Allura Xper FD10 Allura Xper FD10/10 Allura Xper FD20 Allura Xper FD21 Allura Xper FD22 Allura Xper…
FDA Device · Class II · 2015-12-09 · Philips Medical Systems - HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only
FDA Device · Class II · 2015-12-09 · Deroyal Industries - Philips Healthcare INTEGRIS H5000F/Allura 9F Model : 722017 Product Usage: The Allura Xper series is intended for use in cardiovascular and…
FDA Device · Class II · 2015-12-09 · Philips Medical Systems - Philips Healthcare INTEGRIS vascular System Model : 722122 Product Usage: The Allura Xper series is intended for use in cardiovascular and…
FDA Device · Class II · 2015-12-09 · Philips Medical Systems - PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in surgical reconstructions as a space occ…
FDA Device · Class II · 2015-12-09 · Merz North America - Two-stage and three-stage I.V. poles are shipped as an optional accessory to a bed or stretcher
FDA Device · Class II · 2015-12-09 · Stryker Medical Division - Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the correction of moderate to seve…
FDA Device · Class II · 2015-12-09 · Merz North America - Philips Healthcare Xper cardio systems R7.6 Model : 722133 Product Usage: The Allura Xper series is intended for use in cardiovascular and…
FDA Device · Class II · 2015-12-09 · Philips Medical Systems
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