FDA Device · 2013
FDA Device recalls in 2013
RecallRadar indexes 2,249 FDA Device recall notices published in 2013. By classification: 177 Class I, 1,944 Class II, 128 Class III.
- Microscan Synergies Plus Negative Urine Combo 2 Product Usage: MicroScan¿ Synergies plus¿ Panels &
FDA Device · Class I · 2013-09-18 · Siemens Healthcare Diagnostics - StaXx¿ IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar
FDA Device · Class II · 2013-09-18 · Spine Wave - Tempa DOT Single-Use Clinical Thermometer Medical Indicators Made in U.S.A. by Medical Indicators, Inc. 16 Thomas J Rhodes Industrial Drive…
FDA Device · Class II · 2013-09-18 · Medical Indicators - Outlook ES pump is intended for use with B. Braun Medical Inc
FDA Device · Class II · 2013-09-18 · B Braun Medical - Microscan Synergies Plus Negative Breakpoint Combo 7 Product Usage: MicroScan¿ Synergies plus¿ Panels &
FDA Device · Class I · 2013-09-18 · Siemens Healthcare Diagnostics - MicroscanrapID/S panels NC3.11 Sold in Japan only
FDA Device · Class I · 2013-09-18 · Siemens Healthcare Diagnostics - Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill Product ID: 8881570121 Product Usage: Both 0.9% Sodium Chloride…
FDA Device · Class II · 2013-09-18 · Covidien - Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 3 mL Fill Product ID: 8881570123 Product Usage: Both 0.9% Sodium Chloride F…
FDA Device · Class II · 2013-09-18 · Covidien - Baxa Vial Adapter, 14mm - Luer Lock, Order No. REF: 90, Quantity: 50 each, Single Use
FDA Device · Class II · 2013-09-18 · Baxa - Outlook ES pump is intended for use with B. Braun Medical Inc
FDA Device · Class II · 2013-09-18 · B Braun Medical - ADVIA Centaur Folate (2500 tests), REF SMN 10340209, Cat No. 09132781 In vitro diagnostic use in the quantitative determination of folate i…
FDA Device · Class II · 2013-09-18 · Siemens Healthcare Diagnostics - Microscan rapID/S panels NC3.33 Sold in Japan only
FDA Device · Class I · 2013-09-18 · Siemens Healthcare Diagnostics - ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/USUAL NAME: ADVIA Chemistry A1c_3 Calibrators Shipping or unit p…
FDA Device · Class II · 2013-09-11 · Siemens Healthcare Diagnostics - LeGoo¿ Endovascular Occlusion Gel-0.5 mL LeGoo with 3 Cannula Pouch Product Number: CS-50 LeGoo is a water-soluble, biocompatible polymer w…
FDA Device · Class II · 2013-09-11 · Genzyme A Sanofi - CONFIDENCE SPINAL CEMENT SYSTEM 11CC PLUS KIT, Product Code: 2839-10-000 The CONFIDENCE Spinal Cement System is intended for percutaneous d…
FDA Device · Class II · 2013-09-11 · Depuy Spine - LeGoo Endovascular Occlusion Gel 1.0 mL Product Number: LG100IT LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensiti…
FDA Device · Class II · 2013-09-11 · Genzyme A Sanofi - CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 The CONFIDENCE Spinal Cement System is intended for percutaneous deliver…
FDA Device · Class II · 2013-09-11 · Depuy Spine - LeGoo Internal Vessel Occluder 5mL Product Number: 10-0500 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive pr…
FDA Device · Class II · 2013-09-11 · Genzyme A Sanofi - Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irradiation: The Peripheral Cutting Balloon Catheters are indicated…
FDA Device · Class II · 2013-09-11 · Boston Scientific - LeGoo Internal Vessel Occluder 2.5mL Product Number: 10-0250 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive…
FDA Device · Class II · 2013-09-11 · Genzyme A Sanofi - LeGoo¿ Endovascular Occlusion Gel- 0.5 mL LeGoo with 3 Cannula Pouch Product Number: LG50 LeGoo is a water-soluble, biocompatible polymer w…
FDA Device · Class II · 2013-09-11 · Genzyme A Sanofi - LeGoo¿ Endovascular Occlusion Gel-0.25 mL LeGoo with 3 Cannula Pouch Product Number: CS-25 LeGoo is a water-soluble, biocompatible polymer…
FDA Device · Class II · 2013-09-11 · Genzyme A Sanofi - LeGoo¿ Endovascular Occlusion Gel- 1.0 mL LeGoo with 3 Cannula Pouch Product Number: LG100 LeGoo is a water-soluble, biocompatible polymer…
FDA Device · Class II · 2013-09-11 · Genzyme A Sanofi - LeGoo Internal Vessel Occluder 1mL Product Number: 10-0100 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive pr…
FDA Device · Class II · 2013-09-11 · Genzyme A Sanofi - LeGoo Internal Vessel Occluder 10mL Product Number: 10-1000 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive p…
FDA Device · Class II · 2013-09-11 · Genzyme A Sanofi - Boston Scientific, FlextomeTM Cutting BalloonTM, Sterilized using irradiation: 1) 4.00mm x 15mm FlextomeTM Cutting BalloonTM MonorailTM Mic…
FDA Device · Class II · 2013-09-11 · Boston Scientific - LeGoo¿ Endovascular Occlusion Gel-2.5 mL LeGoo with 1 Cannula Pouch Product Number: LG250 LeGoo is a water-soluble, biocompatible polymer w…
FDA Device · Class II · 2013-09-11 · Genzyme A Sanofi - LeGoo Internal Vessel Occluder .25mL Product Number: 10-0025 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive…
FDA Device · Class II · 2013-09-11 · Genzyme A Sanofi - LeGoo¿ Endovascular Occlusion Gel-2.5 mL LeGoo w/ no Cannula Product Number: PV-250 LeGoo is a water-soluble, biocompatible polymer with re…
FDA Device · Class II · 2013-09-11 · Genzyme A Sanofi - LeGoo Internal Vessel Occluder .5mL Product Number: 10-0050 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive p…
FDA Device · Class II · 2013-09-11 · Genzyme A Sanofi - CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of…
FDA Device · Class II · 2013-09-11 · Depuy Spine - Kirschner-Wire (K-Wire), packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit
FDA Device · Class II · 2013-09-11 · Microaire Surgical Instruments - LeGoo¿ Endovascular Occlusion Gel-1.0 mL LeGoo with 3 Cannula Pouch Product Number: CS-100 LeGoo is a water-soluble, biocompatible polymer…
FDA Device · Class II · 2013-09-11 · Genzyme A Sanofi - Steinmann Pin, packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit
FDA Device · Class II · 2013-09-11 · Microaire Surgical Instruments - LeGoo¿ Endovascular Occlusion Gel- 1.0 mL LeGoo w/ no Cannula Product Number: PV-100 LeGoo is a water-soluble, biocompatible polymer with r…
FDA Device · Class II · 2013-09-11 · Genzyme A Sanofi - WASP (Walk Away Specimen Process)
FDA Device · Class III · 2013-09-11 · Copan Italia - LeGoo Endovascular Occlusion Gel 2.5 mL Product Number: LG250IT LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensiti…
FDA Device · Class II · 2013-09-11 · Genzyme A Sanofi - SC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-tra…
FDA Device · Class II · 2013-09-11 · Stelkast - LeGoo¿ Endovascular Occlusion Gel-0.5 mL LeGoo w/ no Cannula Product Number: PV-50 LeGoo is a water-soluble, biocompatible polymer with rev…
FDA Device · Class II · 2013-09-11 · Genzyme A Sanofi - LeGoo Endovascular Occlusion Gel 0.5 mL Product Number: LG50IT LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitiv…
FDA Device · Class II · 2013-09-11 · Genzyme A Sanofi - DMLC IV-ERGO - Beam shaping block for Radiation Therapy
FDA Device · Class II · 2013-09-11 · Elekta - PRIMUS, ONCOR, ARTISTE Linac systems with component Tabletop, 550TxT, TT-A s/n 1001-1233 and Tabletop 550TxT, TT-S s/n 1001-1083
FDA Device · Class II · 2013-09-04 · Siemens Medical Solutions Usa - TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/18, Stem size 003, prox
FDA Device · Class II · 2013-09-04 · Waldemar Link And Kg Hq - 00 4309-049-00 Trabecular Metal Reverse Shoulder Glenosphere Distractor Rx, Non sterile (sterilize before use) The Glenosphere Distractor m…
FDA Device · Class II · 2013-09-04 · Zimmer - SARKEN STAT! 1- Panel Test Kit-mAMP Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing)
FDA Device · Class II · 2013-09-04 · Sarken - Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT0036B, packaged in cartridges of 50 discs, 5 cartridges/pack
FDA Device · Class III · 2013-09-04 · Remel - Free Lock Femoral Hip Fixation System Compression Lag Screw . Several lengths (55 to 150 mm) and diameters (12.7 and 15. 8 mm)
FDA Device · Class II · 2013-09-04 · Zimmer - Philips Easy Upgrade DR, Code No: 712086 This system is used for making X-Ray exposures for diagnostics
FDA Device · Class II · 2013-09-04 · Philips Healthcare - ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM DISTAL MEDIAL HUMERAL LOCKING PLATE, SHORT RIGHT 11 HOLES 178 MM LENGTH STERILE RX ONLY Product U…
FDA Device · Class II · 2013-09-04 · Zimmer - SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M). Use to aspirate bone morrow
FDA Device · Class II · 2013-09-04 · Spinenet - Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Dispense with software versions 3.5.1 and 3.6. In vitro diagnostic…
FDA Device · Class II · 2013-09-04 · Siemens Healthcare Diagnostics - SARKEN STAT! 1- Panel Test Kit-COC Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing)
FDA Device · Class II · 2013-09-04 · Sarken - 3M ESPE Unitek Primary Stainless Steel Crowns (First Primary UL4), Product code 902150 (Kit- 112 crowns/kit) and 900114 (Refill- 5 crowns/b…
FDA Device · Class II · 2013-09-04 · 3m 3m Espe Dental Products - TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/16, Stem size 002, prox
FDA Device · Class II · 2013-09-04 · Waldemar Link And Kg Hq - PrepStain Tecan US-I. For use in the screening and detection of cervical cancer
FDA Device · Class II · 2013-09-04 · Becton Dickinson And - TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/25, Stem size S-6, prox
FDA Device · Class II · 2013-09-04 · Waldemar Link And Kg Hq - VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short low profiles, several holes/length combinations (2/54, 3/70,…
FDA Device · Class II · 2013-09-04 · Zimmer - Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm
FDA Device · Class II · 2013-09-04 · Alphatec Spine - SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing)
FDA Device · Class II · 2013-09-04 · Sarken - E-Z Clean¿ Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to 07/2018
FDA Device · Class II · 2013-09-04 · Megadyne Medical Products - TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/18, Stem size 03, prox
FDA Device · Class II · 2013-09-04 · Waldemar Link And Kg Hq - Medtronic Custom Perfusion System with Carmeda BioActive Surface
FDA Device · Class II · 2013-09-04 · Medtronic Cardiac Rhythm Disease Management - GE Ultrasound ViewPoint 6. Product Usage: ViewPoint is intended to be used in medical practices and in clinical departments and serves the…
FDA Device · Class II · 2013-09-04 · Ge Healthcare - TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/20, Stem size 04, prox
FDA Device · Class II · 2013-09-04 · Waldemar Link And Kg Hq - Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000
FDA Device · Class II · 2013-09-04 · Respironics California - OLA Buffer For Laboratory Use
FDA Device · Class III · 2013-09-04 · Celera - TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/25, Stem size 06, prox
FDA Device · Class II · 2013-09-04 · Waldemar Link And Kg Hq - TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/12, Stem size 0, prox
FDA Device · Class II · 2013-09-04 · Waldemar Link And Kg Hq - BRAINLAB
FDA Device · Class II · 2013-09-04 · Brainlab Ag - ACCU-CHECK FastClix Lancing Device
FDA Device · Class II · 2013-09-04 · Roche Diagnostics Operations - Axiom Artis systems
FDA Device · Class II · 2013-09-04 · Siemens Medical Solutions Usa - TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/22, Stem size S-5, prox
FDA Device · Class II · 2013-09-04 · Waldemar Link And Kg Hq - GE Healthcare, Dash 3000, Dash 4000 and Dash 5000
FDA Device · Class II · 2013-09-04 · Ge Healthcare - Stryker Part Numbers 79-43903 (3cc), 79-43905 (5cc), 79-43910 (10 cc), 79-43915 (15cc), 397003 (3cc), 397005 (5cc), 397010 (10 cc), 397015…
FDA Device · Class II · 2013-09-04 · Stryker Craniomaxillofacial Division - PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers, Catalog Numbers LKPS1, LKPS5 and LKPTS1(D)
FDA Device · Class II · 2013-09-04 · Siemens Healthcare Diagnostics - Free Lock Femoral Hip Fixation System Compression Tube/Plate, different length (59, 75, 91, 107, 123 mm), holes (2, 3, 4, 5, 6) and degree…
FDA Device · Class II · 2013-09-04 · Zimmer - SpineNet Anterior Cervical Cage, Lordotic, Peek (originally submitted as Daytona Anterior Cervical Cage) Product Usage: Is indicated for us…
FDA Device · Class II · 2013-09-04 · Spinenet - HSV 2 Primers, Catalog #18081020
FDA Device · Class II · 2013-09-04 · Life Technologies - TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/12, Stem size S-0, prox
FDA Device · Class II · 2013-09-04 · Waldemar Link And Kg Hq - VERSA-FX FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW, several length (55 mm to 155 mm), diameters (12.7 mm and 15.8 mm) and short thread,…
FDA Device · Class II · 2013-09-04 · Zimmer - SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patient…
FDA Device · Class II · 2013-09-04 · Ge Healthcare - ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . The ADVIA 120 is a hematology system that utilizes the principle…
FDA Device · Class II · 2013-09-04 · Siemens Healthcare Diagnostics - DeRoyal Insufflation Tubing sets: 1) REF 28-0206 Insufflation Tubing, Laparoscopic Rx Only 2) REF 28-0214 Hi-Flow Insufflation Tubing Rx On…
FDA Device · Class II · 2013-09-04 · Deroyal Industries - Mc Kesson Anesthesia-Rx Model Number 8.0.2 & 8.0.1 with RapiDispense Product Usage: Automated anesthesia cart that monitors and controls th…
FDA Device · Class II · 2013-09-04 · Mckesson Technologies - TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/14, Stem size 01, prox
FDA Device · Class II · 2013-09-04 · Waldemar Link And Kg Hq - SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing)
FDA Device · Class II · 2013-09-04 · Sarken - SARKEN STAT! 1- Panel Test Kit-OPI Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing)
FDA Device · Class II · 2013-09-04 · Sarken - Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS, N750-BMKXT-FS, N750-BMKLT-FS, N750-DIS-FS, N750-DISXT-FS. Product Usage: Usage…
FDA Device · Class II · 2013-09-04 · Ventana Medical Systems - PrepStain AG. For use in the screening and detection of cervical cancer
FDA Device · Class II · 2013-09-04 · Becton Dickinson And - TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/18, Stem size S-3, prox
FDA Device · Class II · 2013-09-04 · Waldemar Link And Kg Hq - TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/12, Stem size 00, prox
FDA Device · Class II · 2013-09-04 · Waldemar Link And Kg Hq - Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age…
FDA Device · Class II · 2013-09-04 · Micro Therapeutics - TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/16, Stem size S-2, prox
FDA Device · Class II · 2013-09-04 · Waldemar Link And Kg Hq - VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short - low profile, different hole/length combinations (4/86, 5/1…
FDA Device · Class II · 2013-09-04 · Zimmer - TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/22, Stem size 005, prox
FDA Device · Class II · 2013-09-04 · Waldemar Link And Kg Hq - Stryker 1) Asnis III Cannulated Screw REF 604640 4.0x40mm TL 13.5mm 2) Asnis III Cannulated Screw REF 604642S 4.0x42mm TL 14mm, sterile Pro…
FDA Device · Class II · 2013-09-04 · Stryker Howmedica Osteonics - TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/14, Stem size 001, prox
FDA Device · Class II · 2013-09-04 · Waldemar Link And Kg Hq - Medtronic Custom Perfusion System
FDA Device · Class II · 2013-09-04 · Medtronic Cardiac Rhythm Disease Management - NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software…
FDA Device · Class II · 2013-09-04 · Nidek - Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm Synthes VA-LCP Distal Radius System is inte…
FDA Device · Class II · 2013-09-04 · Synthes Usa Products
Other years
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