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.
- Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222 The ReNew Fenestrated Grasper Forceps Tips are in…
FDA Device · Class II · 2014-05-28 · Microline Surgical - Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a multiple-lumen catheter that permits venous access to…
FDA Device · Class II · 2014-05-28 · Arrow International - Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical device
FDA Device · Class II · 2014-05-28 · Heraeus Kulzer - JK Bariatric Beds, True Air Technologies, Inc
FDA Device · Class II · 2014-05-28 · Scm True Air Technologies - syngo Imaging XS Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, commun…
FDA Device · Class II · 2014-05-28 · Siemens Medical Solutions Usa - MAMMOMAT Inspiration
FDA Device · Class II · 2014-05-28 · Siemens Medical Solutions Usa - Anspach Irrigation Clip 40 Product Usage: Irrigation clips provide a method of supplying controlled, cooling irrigation during cutting, sha…
FDA Device · Class II · 2014-05-28 · The Anspach Effort - Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump
FDA Device · Class I · 2014-05-28 · Maquet Datascope Cardiac Assist Division - CDI Blood Parameter Monitoring System
FDA Device · Class II · 2014-05-28 · Terumo Cardiovascular Systems - SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket
FDA Device · Class II · 2014-05-28 · Smiths Medical Asd - LATEX-FREE
FDA Device · Class II · 2014-05-28 · Hospira - SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0. SoftMic is a laboratory information system to be used in medical results…
FDA Device · Class II · 2014-05-21 · Scc Soft Computer - Recalled product is a component of the Newport Medical Instruments e360 Ventilator: single board computer, part number SBC2105A. Intended t…
FDA Device · Class II · 2014-05-21 · Nellcor Puritan Bennett Dba Covidien - DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, storing, and alarming…
FDA Device · Class II · 2014-05-21 · Mindray Ds Usa - NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020
FDA Device · Class II · 2014-05-21 · Blue Belt Technologies Mn - MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The MedStream programmable pump is intended for the intrathecal delivery…
FDA Device · Class II · 2014-05-21 · Codman And Shurtleff - HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-cardiac transplantation in…
FDA Device · Class II · 2014-05-21 · Heartware - Tennis Elbow Support, Neoprene***LATEX FREE" Product Usage: Provides compression and warmth for mild to moderate elbow strains and sprains
FDA Device · Class II · 2014-05-21 · Zimmer - ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062
FDA Device · Class II · 2014-05-21 · Biomet - Ultrasound USB needles, with 30 degree bevel, packaged individually, 10 needles/box, item number REF USB050-22
FDA Device · Class II · 2014-05-21 · Rm Temena - MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 The MedStream programmable pump is intended for the intrathecal delivery…
FDA Device · Class II · 2014-05-21 · Codman And Shurtleff - Coaxial Micro-Introducer Kit
FDA Device · Class II · 2014-05-21 · Greatbatch Medical - Fresenius 2008T Hemodialysis Machine with Revision K Actuator Test Boards and also sold as replacement parts for use with Fresenius 2008-Se…
FDA Device · Class II · 2014-05-21 · Fresenius Medical Care Holdings - Revision K Actuator Test Boards sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@ho…
FDA Device · Class II · 2014-05-21 · Fresenius Medical Care Holdings - Enaly 1000 BT-12 Ozone Generator, Model # 1000BT-12 The 1000BT-12 ozone generator is capable of delivering up to 1gram of ozone per hour fr…
FDA Device · Class II · 2014-05-21 · William C Domb D M D A Professional - DROP LOK" Knee Brace***LATEX FREE" Product Usage: Used in the treatment, support, and rehabilitation of many types of knee injuries or foll…
FDA Device · Class II · 2014-05-21 · Zimmer - Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay Until" Option and "Multidose" Feature The Alaris…
FDA Device · Class I · 2014-05-21 · Carefusion 303 - Mucus Specimen Trap 40 cc, Specimen Trap 40 cc with additional transport cap
FDA Device · Class II · 2014-05-21 · Medline Industries - McKesson Radiology-PACS. McKesson Radiology is a medical image and information application that is intended to receive, transmit, store, re…
FDA Device · Class II · 2014-05-21 · Mckesson Medical Immaging - ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Meters
FDA Device · Class II · 2014-05-21 · Roche Diagnostics Operations - ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length
FDA Device · Class II · 2014-05-21 · The Anspach Effort - Cartilage Knee Brace***LATEX FREE" Product Usage: Used in the treatment and support of many types of knee injuries or following surgical an…
FDA Device · Class II · 2014-05-21 · Zimmer - InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110
FDA Device · Class II · 2014-05-21 · Intervalve - ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition),…
FDA Device · Class I · 2014-05-21 · Baxter Englewood - Hinged Knee Support***LATEX FREE" Product Usage: Provide added lateral stability and allows the knee to tolerate more strenuous activity du…
FDA Device · Class II · 2014-05-21 · Zimmer - PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total kn…
FDA Device · Class II · 2014-05-21 · Ortho Development - Ultrasound needles, 22G (0.7 mm) x 50mm, packaged individually, 10 needles/box, item number REF USC050-22
FDA Device · Class II · 2014-05-21 · Rm Temena - Syngo Dynamics v9.5 system
FDA Device · Class II · 2014-05-21 · Siemens Medical Solutions Usa - RAPIDFILL Syringe Strip, For use with RAPIDFILL Automated Syringe Filler (ASF): H93890200 RAPIDFILL Syringe Strip, White
FDA Device · Class II · 2014-05-21 · Baxter Englewood - TX1 Tissue Removal System
FDA Device · Class II · 2014-05-14 · Tenex Health - Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel Suture, Nonabsorbable Surgical Suture, U.S.P. Used for…
FDA Device · Class II · 2014-05-14 · Teleflex Medical - Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, 10 fl.oz., Sterile
FDA Device · Class II · 2014-05-14 · Bausch And Lomb Greenville Solutions Plant - Giraffe¿ Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their…
FDA Device · Class II · 2014-05-14 · Ge Healthcare - Panda¿ iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on th…
FDA Device · Class II · 2014-05-14 · Ge Healthcare - Teleflex Medical, Research Triangle Park, NC, Braided Polyester Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA
FDA Device · Class II · 2014-05-14 · Teleflex Medical - CLINITEK Status+ Analyzer (portable urine chemistry analyzer)
FDA Device · Class III · 2014-05-14 · Siemens Healthcare Diagnostics - RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 799, 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered…
FDA Device · Class II · 2014-05-14 · Med Mizer - Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f
FDA Device · Class II · 2014-05-14 · Shimadzu Medical Systems - Siemens ADVIA Centaur Folate Cat No. 06891541 SMN 10325366 (500 tests) Cat No. 06367974 SMN 10310308 (100 tests) Cat No. 00203473 SMN 10331…
FDA Device · Class II · 2014-05-14 · Siemens Healthcare Diagnostics - INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS delivery system delivers INOMAX (nitric…
FDA Device · Class II · 2014-05-14 · Ino Therapeutics Dba Ikaria - Medtronic SynchroMed¿ II Implantable Drug Infusion Pump, Model 8637-20, 8637-40
FDA Device · Class II · 2014-05-14 · Medtronic Neuromodulation - Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Programmable Infusion Pumps
FDA Device · Class II · 2014-05-14 · Medtronic Neuromodulation - Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture, Sterile, Rx Only, Teleflex Me…
FDA Device · Class II · 2014-05-14 · Teleflex Medical - 12-Instrument Sterilization Tray
FDA Device · Class II · 2014-05-14 · Stryker Endoscopy - RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 762 ( 76 " bed w/ 2 motors)
FDA Device · Class II · 2014-05-14 · Med Mizer - Alere INRatio2 PT/INR Professional Test Strips, Model Number: 99008G2. The Alere INRatio2 PT/INR Monitoring System (Professional Use), cons…
FDA Device · Class I · 2014-05-14 · Alere San Diego - Mar Cor Purification, Central Water Platform (CWP), 102, 104 and 106
FDA Device · Class II · 2014-05-14 · Mar Cor Purification - Joseph Lamelas Atrial Lift System, Model Number MI-ALS-001
FDA Device · Class II · 2014-05-14 · Biorep Technologies - Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM part manufactured by a third party supplier
FDA Device · Class II · 2014-05-14 · Ge Healthcare - Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests), Bio-Rad Laboratories, Inc. in vitro…
FDA Device · Class II · 2014-05-14 · Bio Rad Laboratories - SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in spinal fusion surgery
FDA Device · Class II · 2014-05-14 · Spinefrontier - RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 801, 802, 803, 803A: 80 " bed with 1, 2, or 3, motors and autocontour 120 V,…
FDA Device · Class II · 2014-05-14 · Med Mizer - Nonabsorbable Surgical Suture, U.S.P., Sterile - Do Not Resterilize, Deknatel
FDA Device · Class II · 2014-05-14 · Teleflex Medical - Panda¿ Freestanding Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate ba…
FDA Device · Class II · 2014-05-14 · Ge Healthcare - Panda¿ Wall-Mount Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate base…
FDA Device · Class II · 2014-05-14 · Ge Healthcare - Alere Triage BNP Test for the Beckman Coulter Access Family of Immunoassay Systems, Model Number 98200, Lot Numbers: 329599, 331265
FDA Device · Class II · 2014-05-14 · Alere San Diego - ADVIA Centaur XP Immunoassay system, an automated in vitro diagnostic analyzer
FDA Device · Class II · 2014-05-14 · Siemens Healthcare Diagnostics - AlloFuse DBM Putty 5cc, Catalog No. 90038005 AlloFuse is indicated for orthopedic applications as filler for gaps or voids that are not int…
FDA Device · Class II · 2014-05-14 · Allosource - Deknatel Teleflex Medical Silk Black Braided Silk Suture Nonabsorbable Surgical Suture U.S.P. Indicated for use in soft tissue approximation
FDA Device · Class II · 2014-05-14 · Teleflex Medical - Bard Fixt Suture Braided Polyester, Rx Only, Teleflex Medical, Research Triangle Park, NC USA Assembled in Mexico
FDA Device · Class II · 2014-05-14 · Teleflex Medical - Teleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA
FDA Device · Class II · 2014-05-14 · Teleflex Medical - Hospira Acclaim Encore Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell components and entera…
FDA Device · Class I · 2014-05-07 · Hospira - Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Aluminum Applicator Swab, .025 and .035 in Diameter, all lots, 100 per pack Fisher…
FDA Device · Class II · 2014-05-07 · Fisher Scientific - Anti EpCam PE - Analyte Specific Reagent
FDA Device · Class II · 2014-05-07 · Bd Biosciences Systems And Reagents - Dekna-lok, 1 x 17.78 cm, Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture USP, Rx Only, Sterile
FDA Device · Class II · 2014-05-07 · Teleflex Medical - The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . 2.0 mm x 850mm SS Cable/Sleeve
FDA Device · Class II · 2014-05-07 · Acumed - VITROS Chemistry Products Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD --- Ortho-Clinical Diagnostics, Inc
FDA Device · Class II · 2014-05-07 · Ortho Clinical Diagnostics - Integra CUSA Excel Disposable Wrench
FDA Device · Class II · 2014-05-07 · Integra Lifesciences - VITROS Chemistry Products FS Diluent Pack 3, REF 680 1754, 3 x 45 mL, (D1)/15 mL (D2), IVD --- Ortho-Clinical Diagnostics, Inc
FDA Device · Class II · 2014-05-07 · Ortho Clinical Diagnostics - IMMULITE/IMMULITE 1000 Systems Androstenedione (Test Code AND), REF LKAO1, SMN 10381158, IVD, 100 test kit size --- Siemens Healthcare Diag…
FDA Device · Class II · 2014-05-07 · Siemens Healthcare Diagnostics - GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advantage Workstation]. M…
FDA Device · Class II · 2014-05-07 · Ge Healthcare - Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent
FDA Device · Class II · 2014-05-07 · Alfa Wassermann - Medtronic, External neurostimulator, ENS (37021) & ENS (37022)
FDA Device · Class II · 2014-05-07 · Medtronic Neuromodulation - IMMULITE 2000/2000 XPi Systems Androstenedione (Test Code AND), REF L2KAO2, SMN 10381188, IVD, 200 test kit size --- Siemens Healthcare Dia…
FDA Device · Class II · 2014-05-07 · Siemens Healthcare Diagnostics - Medtronic neurostimulators
FDA Device · Class II · 2014-05-07 · Medtronic Neuromodulation - GE Healthcare Discovery MR450, Discovery MR750, Optima MR450w, Optima MR450w equipped with the GEM option, Discovery MR750w, and Discovery…
FDA Device · Class II · 2014-05-07 · Ge Healthcare - ExacTrac 6.0 is a patient positioning and monitoring system
FDA Device · Class II · 2014-05-07 · Brainlab Ag - HexaPOD evo RT Couchtop
FDA Device · Class II · 2014-05-07 · Elekta - Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent
FDA Device · Class II · 2014-05-07 · Alfa Wassermann - PolypVac 3.5mm Microdebrider
FDA Device · Class III · 2014-05-07 · Laurimed - CAPIO, Monodeck, Violet Monofilament Polydioxanone Suture, 1 x 48 inches (122cm) Absorbable Surgical Suture, Rx Only, Teleflex Medical
FDA Device · Class II · 2014-05-07 · Teleflex Medical - IMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE, REF L2KIE2, SMN 10380873, and L2KIE6, SMN 10380872, IVD --- Siemens Healthcare Diag…
FDA Device · Class II · 2014-05-07 · Siemens Healthcare Diagnostics - Abbott Acclaim Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids…
FDA Device · Class I · 2014-05-07 · Hospira - GemStar Docking Station, used with GemStar infusion pump, in combination with other GemStar accessories such as the GemStar Lock Box and pa…
FDA Device · Class I · 2014-05-07 · Hospira - Medtronic Activa RC (37612), Activa PC (37601), Activa SC (37602), Activa SC (37603), Activa PC+S (37604), Multi-program Rechargeable Neuro…
FDA Device · Class II · 2014-05-07 · Medtronic Neuromodulation - The Acumed Tension Band Pin is a fixation pin which is .0625" in diameter and is available in lengths between 35mm and 90mm
FDA Device · Class II · 2014-05-07 · Acumed - IMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD --- Siemens Healthcare Diagnostics Products Ltd
FDA Device · Class II · 2014-05-07 · Siemens Healthcare Diagnostics - Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic) Philips Medical System, Cleveland, OH 44143
FDA Device · Class II · 2014-05-07 · Philips Medical Systems Cleveland - Amo-O Herbal Stimulator, 2 fl. oz
FDA Device · Class II · 2014-04-30 · Altasource - Monodek Violet Synthetic Absorbable Surgical Sutures, MF 0 TC43/HR26 48
FDA Device · Class II · 2014-04-30 · Teleflex Medical
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