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.
- Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0. Usage:RF Remote Transmitter
FDA Device · Class II · 2015-01-21 · St Jude Medical Cardiac Rhythm Management Division - Infinite 200PRO The Tecan Infinite 200 is a multifunctional microplate reader with injector option
FDA Device · Class III · 2015-01-21 · Tecan Us - Infinite 200 The Tecan Infinite 200 is a multifunctional microplate reader with injector option
FDA Device · Class III · 2015-01-21 · Tecan Us - Various Brilliance and Ingenuity Computed Tomography X-ray systems
FDA Device · Class II · 2015-01-21 · Philips Medical Systems Cleveland - VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho Clinical Diagnostics
FDA Device · Class II · 2015-01-21 · Ortho Clinical Diagnostics - Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102
FDA Device · Class II · 2015-01-21 · Biomet Spine - Siemens Linear Accelerator: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIUS HI, Mevatron M2/Pr…
FDA Device · Class II · 2015-01-21 · Siemens Medical Solutions Usa - The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing
FDA Device · Class II · 2015-01-21 · Abbott Molecular - EXp Tibial Insert
FDA Device · Class II · 2015-01-21 · Stelkast - Lotus TAVR 27mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System
FDA Device · Class I · 2015-01-21 · Boston Scientific - GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product Used for general surgical applications and musculoskeletal procedures to visualize
FDA Device · Class II · 2015-01-21 · Ge Oec Medical Systems - Civco, MTSR02 Shoulder Retractor with Sherpa Wrist Loops Kit with Base, Non-sterile re-usable wool wrist strap, REF: 20SR02SUB2, Rx Only, T…
FDA Device · Class II · 2015-01-21 · Med Tec - HeartStart MRx Monitor/Defibrillator
FDA Device · Class II · 2015-01-21 · Philips Medical Systems - The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in knee replacement procedures
FDA Device · Class II · 2015-01-21 · Depuy Orthopaedics - iPlan RT is a radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiat…
FDA Device · Class II · 2015-01-21 · Brainlab Ag - CDC Anaerobe 5% Sheep Blood Agar CDC Anaerobe 5% Sheep Blood Agar is an enriched, nonselective culture medium particularly useful or the is…
FDA Device · Class II · 2015-01-21 · Becton Dickinson And - Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204 Timberline Anchored Lateral Variable Retrac…
FDA Device · Class II · 2015-01-21 · Biomet Spine - Civco, MTSR03 Shoulder Retractor with Wrist Loops Kit with Base, plus two pairs of wrist loops (nylon and sherpa), Non-sterile re-usable wo…
FDA Device · Class II · 2015-01-21 · Med Tec - Labeled in part: I Color Complete / Crazy Lens, blister packing, 14.5mm, (Additional colors include: #003 White out, #005 Yellow out, #020…
FDA Device · Class II · 2015-01-21 · Intertrade Imports - TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Trypticase Soy Agar with 5% Sheep Blood is used for the growth of…
FDA Device · Class II · 2015-01-21 · Becton Dickinson And - ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x in specific configurations: The CentraLink system software is…
FDA Device · Class II · 2015-01-21 · Siemens Healthcare Diagnostics - Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since launch in 2003)
FDA Device · Class II · 2015-01-21 · Phadia Us - Philips Expression MR200 MRI Patient Monitoring System
FDA Device · Class II · 2015-01-21 · Invivo - The SurgiCounter Charging Cradle Product Usage: SurgiCounter Charging Cradles are designed to be used with the SurgiCounter and are part of…
FDA Device · Class II · 2015-01-21 · Stryker Instruments Div - Malleable C- Retractor, Part Number 397.232, used to provide retraction of the soft tissues during use of trocar instrumentation
FDA Device · Class II · 2015-01-21 · Synthes - GE Healthcare, Proteus XR/a with wall stand model number 600-0301
FDA Device · Class II · 2015-01-21 · Ge Healthcare - Lotus TAVR 25mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System
FDA Device · Class I · 2015-01-21 · Boston Scientific - Fixed Tibial bearing ATTUNE INTUITION Impactor The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement proce…
FDA Device · Class II · 2015-01-14 · Depuy Orthopaedics - Femoral Impactor ATTUNE INTUITION Impactor
FDA Device · Class II · 2015-01-14 · Depuy Orthopaedics - The Siemens Symbia S series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnos…
FDA Device · Class II · 2015-01-14 · Siemens Medical Solutions Usa - McKesson Cardiology ECG Management It is a software application designed to import, display, store, analyze, distribute and manage informat…
FDA Device · Class II · 2015-01-14 · Mckesson Israel - Synthes Small Electric Drive (SED), part number: 05.001.175: The Small Electric Drive is designed for use in general traumatology, especial…
FDA Device · Class II · 2015-01-14 · Synthes Usa Products - Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws
FDA Device · Class II · 2015-01-14 · Ebi - Rotating Tibial Platform ATTUNE INTUITION Impactor
FDA Device · Class II · 2015-01-14 · Depuy Orthopaedics - Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03
FDA Device · Class II · 2015-01-14 · Exactech - Cable remote control JUX Material, no.1307315, Serial number: to (incl.) 101287649
FDA Device · Class II · 2015-01-14 · Trumpf Medical Systems - IR remote control JUPITER / TS7500, Material no.1601927, Serial number: to (incl.) 102222333
FDA Device · Class II · 2015-01-14 · Trumpf Medical Systems - Harmony¿ vLED Surgical Lighting System, one unit packaged per box The Harmony¿ vLED Surgical Lighting System is a variable pattern, variabl…
FDA Device · Class II · 2015-01-14 · Steris - Pacemaker Tray (Cardiovascular Surgical Instruments convenience kit)
FDA Device · Class II · 2015-01-14 · Centurion Medical Products - Cable remote control JUPITER / TS7500, Material no.1601926, Serial number: to (incl.) 101465919
FDA Device · Class II · 2015-01-14 · Trumpf Medical Systems - Cervical Extension Machine for Physical Therapy
FDA Device · Class II · 2015-01-14 · Medx Holdings - Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle, Model Numbers: 2090-0027 Needle (bullet-tip), 11 gauge x 4 inch 2090-0028 Need…
FDA Device · Class II · 2015-01-14 · Orthovita - AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before an…
FDA Device · Class II · 2015-01-14 · Vision Rt - I.M. Hole Locator Instrument
FDA Device · Class II · 2015-01-14 · Depuy Orthopaedics - Cable remote control JUPITER, Material no. 4544119, Serial number: to (incl.) 102284378
FDA Device · Class II · 2015-01-14 · Trumpf Medical Systems - HomeChoice Automated PD system and HomeChoice Pro Automated PD system Baxter's HomeChoice and HomeChoice Pro APD systems are designed to pr…
FDA Device · Class II · 2015-01-14 · Baxter Healthcare - ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL)
FDA Device · Class II · 2015-01-14 · Horiba Instruments - Lumbar Extension Machine for Physical Therapy
FDA Device · Class II · 2015-01-14 · Medx Holdings - CSA Medical truFreeze System
FDA Device · Class II · 2015-01-14 · Csa Medical - INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing System - 0200432 Alere INRatio 2 PT/INR Home Monitoring System - 0…
FDA Device · Class I · 2015-01-14 · Alere San Diego - Chest Tube Tray (Cardiovascular Surgical Instruments convenience kit)
FDA Device · Class II · 2015-01-14 · Centurion Medical Products - (R)IR remote control JUPITER, Material no.1219656, Serial number: to (incl.) 102317869
FDA Device · Class II · 2015-01-14 · Trumpf Medical Systems - Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 This device is intended to be used with autogenous bone graft
FDA Device · Class II · 2015-01-14 · Spinal Elements - Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated peritoneal dialysis
FDA Device · Class II · 2015-01-14 · Baxter Healthcare - e.cam -emission computed tomography system Used to detect or image the distribution of radionuclides in the body or organ, using the follow…
FDA Device · Class II · 2015-01-14 · Siemens Medical Solutions Usa - IS3000 Vision Side Cart (VSC) used in conjunction with the da Vinci Si Surgical System IS3000
FDA Device · Class II · 2015-01-14 · Intuitive Surgical - Cable remote control JUPITER U, Material no.4500119, Serial number: to (incl.) 102306915
FDA Device · Class II · 2015-01-14 · Trumpf Medical Systems - (R)Cable remote control JUPITER, Material no.1219655, Serial number: to (incl.) 101998119
FDA Device · Class II · 2015-01-14 · Trumpf Medical Systems - IIR remote control JUPITER, Material no.4544120, Serial number: to (incl.) 102006720
FDA Device · Class II · 2015-01-14 · Trumpf Medical Systems - INRatio Monitors - 0100004 Alere INRatio PT/INR System Professional - 0100007 INRatio Prothrombin Time (PT) Monitoring System - 0100137 Ale…
FDA Device · Class I · 2015-01-14 · Alere San Diego - Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle- Model Numbers: 2110-0505 Beveled Needle, 11 gauge x 4 inch 2110-0524 Bevel…
FDA Device · Class II · 2015-01-14 · Orthovita - The Symbia Intevo Excel is a non-diagnostic SPECT ICT system with CT support for only attenuation correction and anatomical localization
FDA Device · Class II · 2015-01-14 · Siemens Medical Solutions Usa - Nerve Block Tray (Nerve Block convenience kit)
FDA Device · Class II · 2015-01-14 · Centurion Medical Products - Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 Product usage: in vitro diagnostic product for the calibration of Myoglobin (MYO…
FDA Device · Class II · 2015-01-14 · Siemens Healthcare Diagnostics - IR remote control JUC, BUTTON, Material no.1239824, Serial number: to (incl.) 100139854
FDA Device · Class II · 2015-01-14 · Trumpf Medical Systems - CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured for: KCI USA, Inc
FDA Device · Class II · 2015-01-14 · Kci Usa - IR remote control JUPITER U, Material no. 4500120, Serial number: to (incl.) 102306940
FDA Device · Class II · 2015-01-14 · Trumpf Medical Systems - Diagnostic Imaging Tray (General Surgery convenience kit)
FDA Device · Class II · 2015-01-14 · Centurion Medical Products - The Siemens Symbia T series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnos…
FDA Device · Class II · 2015-01-14 · Siemens Medical Solutions Usa - Cable remote control JUC, BUTTON, Material no.1239823, Serial number: to (incl.) 100143048
FDA Device · Class II · 2015-01-14 · Trumpf Medical Systems - Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional - 0100071 Alere INRatio PT/INR Test Strips, Box of 12 - 0100139…
FDA Device · Class I · 2015-01-14 · Alere San Diego - IR remote control JUX, Material no.1307314, Serial number: to (incl.) 102338310 Patient positioning during surgery, ranging from anesthesia…
FDA Device · Class II · 2015-01-14 · Trumpf Medical Systems - ACCU-CHEK Tender I 13/110 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of…
FDA Device · Class II · 2015-01-07 · Roche Diagnostics Operations - ACCU-CHEK Tender I 13/80 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of t…
FDA Device · Class II · 2015-01-07 · Roche Diagnostics Operations - Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use during cardiovascular to create and maintain, monit…
FDA Device · Class II · 2015-01-07 · Perouse Medical - Hypodermic Needle Pro¿ Edge" Safety Device with Syringe 20G x1 5mL Luer lock syringe
FDA Device · Class II · 2015-01-07 · Smiths Medical Asd - Hypodermic Needle Pro¿ Edge" Safety Device 20G x1
FDA Device · Class II · 2015-01-07 · Smiths Medical Asd - ev3, Prot¿g¿ Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, Rx only
FDA Device · Class II · 2015-01-07 · Ev3 - Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joint (SUJ)mechanical clamp that secures the SUJ to the catheter…
FDA Device · Class II · 2015-01-07 · Hansen Medical - ACCU-CHEK Tender I 17/80 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of t…
FDA Device · Class II · 2015-01-07 · Roche Diagnostics Operations - ACCU-CHEK Tender II 17/60 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surfac…
FDA Device · Class II · 2015-01-07 · Roche Diagnostics Operations - ACCU-CHEK Tender II 13/110 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surfa…
FDA Device · Class II · 2015-01-07 · Roche Diagnostics Operations - ACCU-CHEK Tender II 13/80 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surfac…
FDA Device · Class II · 2015-01-07 · Roche Diagnostics Operations - ACCU-CHEK Tender II 17/110 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surfa…
FDA Device · Class II · 2015-01-07 · Roche Diagnostics Operations - ACCU-CHEK Tender II 17/80 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surfac…
FDA Device · Class II · 2015-01-07 · Roche Diagnostics Operations - Hypodermic Needle Pro¿ Edge" Safety Device with Syringe 20G x1 10mL Luer lock syringe
FDA Device · Class II · 2015-01-07 · Smiths Medical Asd - Osteobond Bone Cement Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants
FDA Device · Class II · 2015-01-07 · Zimmer - ACCU-CHEK Tender I 17/60 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of t…
FDA Device · Class II · 2015-01-07 · Roche Diagnostics Operations - SenSmart, Regional Oximetry EQUANOX Classic Plus Adult/Pediatric Sensor > 40 kg., Model 8003CA (REF 9824-001, 3-Wavelength), 8004CA (REF 97…
FDA Device · Class II · 2015-01-07 · Nonin Medical - Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches Product Usage: Cryogenic probe for cardiac ablation su…
FDA Device · Class II · 2015-01-07 · Atricure - ACCU-CHEK¿ Tender I 13/60 10 pieces Product Usage: Usage: Intended for the infusion and/or injection of fluids into the body below the surf…
FDA Device · Class II · 2015-01-07 · Roche Diagnostics Operations - Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphoplasty or other interventional kyphoplasty or ot…
FDA Device · Class II · 2015-01-07 · Perouse Medical - ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx only
FDA Device · Class II · 2015-01-07 · Ev3 - ACCU-CHEK Tender II 13/60 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surfac…
FDA Device · Class II · 2015-01-07 · Roche Diagnostics Operations - ACCU-CHEK Tender I 17/110 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of…
FDA Device · Class II · 2015-01-07 · Roche Diagnostics Operations
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