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.
- SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B
FDA Device · Class II · 2013-04-10 · Siemens Medical Solutions Usa - Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50
FDA Device · Class II · 2013-04-10 · Polymedco - Dual Tip Marker, Sterile Product Usage: A writing instrument intended to mark paper and plastic items around the sterile field during surge…
FDA Device · Class III · 2013-04-10 · Viscot Medical - SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B
FDA Device · Class II · 2013-04-10 · Siemens Medical Solutions Usa - Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR. For the rapid, qualitative detection of human hemoglobin in feces
FDA Device · Class II · 2013-04-10 · Polymedco - Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiographic Balloon Catheter
FDA Device · Class II · 2013-04-10 · Arrow International - LeMaitre Stent Guide: 1102-00 (100 strips)
FDA Device · Class II · 2013-04-10 · Lemaitre Vascular - Z-800 Volumetric Infusion System
FDA Device · Class II · 2013-04-10 · Zyno Medical - Siemens Dimension(R) EXL(TM) 200 (Siemens Material Number 10636929)
FDA Device · Class III · 2013-04-10 · Siemens Healthcare Diagnostics - Integra Ojemann Cortical Stimulator
FDA Device · Class II · 2013-04-10 · Integra Burlington Ma - LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Procedure, a thin, low-voltage electrified wire loop is used to cut out ab…
FDA Device · Class II · 2013-04-10 · Cooper Surgical - SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B
FDA Device · Class II · 2013-04-10 · Siemens Medical Solutions Usa - Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems
FDA Device · Class II · 2013-04-10 · Philips Medical Systems Cleveland - Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number 05232732001
FDA Device · Class II · 2013-04-10 · Roche Diagnostics Operations - SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B
FDA Device · Class II · 2013-04-10 · Siemens Medical Solutions Usa - Access 2 Immunoassay System
FDA Device · Class II · 2013-04-10 · Beckman Coulter - Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61) The Phosphorus (PHOS) method used on the Dimension(R) clinical chem…
FDA Device · Class II · 2013-04-10 · Siemens Healthcare Diagnostics - Siemens Dimension(R) EXL(TM) LM STM (Siemens Material Number 106393377)
FDA Device · Class III · 2013-04-10 · Siemens Healthcare Diagnostics - ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management System consists of the IM2 Data Manager Software, Desktop Compute…
FDA Device · Class III · 2013-04-10 · Horiba Instruments - Zimmer NexPosure, retractor portals of the NexPosure MIS Access System, Part Numbers or REF numbers: N1830R80-100, N1830R80-090¿, N1830R80-…
FDA Device · Class II · 2013-04-10 · Zimmer - Smiths Medical, BCI¿ Remote Alarm Cable (Normally Open & Normally Closed), Reorder Numbers: WW3398NO & WW3398NC. For use with respiration c…
FDA Device · Class I · 2013-04-10 · Smiths Medical Asd - STERRAD 200 Sterilization System, P/N 10201 Product Usage: The STERRAD 200 Sterilization System is a general purpose, low temperature steri…
FDA Device · Class II · 2013-04-10 · Advanced Sterilization Products - Glow 'N Tell 20 cm Tape: 1100-00 (100 strips)
FDA Device · Class II · 2013-04-10 · Lemaitre Vascular - SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B
FDA Device · Class II · 2013-04-10 · Siemens Medical Solutions Usa - SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B
FDA Device · Class II · 2013-04-10 · Siemens Medical Solutions Usa - Access Immunoassay System
FDA Device · Class II · 2013-04-10 · Beckman Coulter - Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treat…
FDA Device · Class I · 2013-04-10 · Animas - STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature s…
FDA Device · Class II · 2013-04-10 · Advanced Sterilization Products - Medtronic Prostiva RF Therapy Generator
FDA Device · Class II · 2013-04-10 · Medtronic Neuromodulation - SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B
FDA Device · Class II · 2013-04-10 · Siemens Medical Solutions Usa - Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890)
FDA Device · Class III · 2013-04-10 · Siemens Healthcare Diagnostics - SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B
FDA Device · Class II · 2013-04-10 · Siemens Medical Solutions Usa - UniCel DxC 600i Synchron Access Clinical System
FDA Device · Class II · 2013-04-10 · Beckman Coulter - BD Vacutainer C&S Transfer Straw Kit C&S Preservative Plus Urine Tube. 4.0 ml, 13 X 75 mm STERILE REF 364953
FDA Device · Class III · 2013-04-10 · Becton Dickinson And - Synchron LXi 725 Clinical System
FDA Device · Class II · 2013-04-10 · Beckman Coulter - SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B
FDA Device · Class II · 2013-04-10 · Siemens Medical Solutions Usa - Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500
FDA Device · Class II · 2013-04-03 · Smiths Medical Asd - Needle Counters with Blade Disarmer
FDA Device · Class II · 2013-04-03 · Cardinal Health - VITEK 2 XL computer system when equipped with the following Hewlett-Packard PC models: (1) rp5700, Cat. #W0452
FDA Device · Class II · 2013-04-03 · Biomerieux - Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.…
FDA Device · Class II · 2013-04-03 · Vital Images - VITEK 2 Compact computer system when equipped with the following Hewlett-Packard PC models: (1) dc7100 8-port, Cat. #W0441
FDA Device · Class II · 2013-04-03 · Biomerieux - Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay…
FDA Device · Class II · 2013-04-03 · Genetic Testing Institute - STERRAD 200 System Carriage, P/N 10208
FDA Device · Class II · 2013-04-03 · Advanced Sterilization Products - Toshiba Infinix-i X-Ray System
FDA Device · Class II · 2013-04-03 · Toshiba American Medical Systems - Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk
FDA Device · Class III · 2013-04-03 · Carefusion 213 - Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 in conjunction with specific technical configuration Angiograph…
FDA Device · Class II · 2013-04-03 · Siemens Medical Solutions Usa - KIMGUARD Container Filters, 7.5in (19cm), Round and 9in
FDA Device · Class II · 2013-04-03 · Kimberly Clark - Needle Counters
FDA Device · Class II · 2013-04-03 · Cardinal Health - Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm
FDA Device · Class III · 2013-04-03 · Cooper Surgical - BS-200 Chemistry Analyzer Designed for clinical laboratory use
FDA Device · Class II · 2013-04-03 · Mindray Ds Usa D B A Mindray North America - Needle Counters with Blade Disarmer
FDA Device · Class II · 2013-04-03 · Cardinal Health - Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also known as the Anterior Column Retractor Set) The Synthes Dens ins…
FDA Device · Class II · 2013-04-03 · Synthes Usa Hq - Pyxis Anesthesia System Model 2000 (PAS 2000) Product Usage: The PAS 2000 is an anesthesia medication dispensing device that provides medic…
FDA Device · Class II · 2013-04-03 · Carefusion - Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contraception
FDA Device · Class II · 2013-04-03 · Cooper Surgical - Cooper Surgical Gellhorn Flexible Pessary -2 3/4", 70mm
FDA Device · Class III · 2013-04-03 · Cooper Surgical - Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit
FDA Device · Class II · 2013-04-03 · Orthohelix Surgical Designs - Needle Counters with Blade Disarmer
FDA Device · Class II · 2013-04-03 · Cardinal Health - Cooper Surgical Cube Pessary 1 5/8"", 41mm
FDA Device · Class III · 2013-04-03 · Cooper Surgical - Cooper Surgical Incontinence Dish w/ Support Pessary #0, 55mm
FDA Device · Class III · 2013-04-03 · Cooper Surgical - Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed
FDA Device · Class II · 2013-04-03 · Siemens Medical Solutions Usa - Needle Counters with Blade Disarmer
FDA Device · Class II · 2013-04-03 · Cardinal Health - Needle Counters
FDA Device · Class II · 2013-04-03 · Cardinal Health - Cooper Surgical Incontinence Dish w/ Support Pessary #5, 80mm
FDA Device · Class III · 2013-04-03 · Cooper Surgical - Cooper Surgical Incontinence Dish Folding Pessary #0, 55mm
FDA Device · Class III · 2013-04-03 · Cooper Surgical - Needle Counters
FDA Device · Class II · 2013-04-03 · Cardinal Health - BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR Cartridges, GeneOhm Sciences Canada, Inc. 2555 bo…
FDA Device · Class II · 2013-04-03 · Becton Dickinson And - 20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is intended to be used as an interface cable between the LASSO…
FDA Device · Class II · 2013-04-03 · Biosense Webster - Cooper Surgical Cube Pessary w/Drainage Holes #0"1", 25mm
FDA Device · Class III · 2013-04-03 · Cooper Surgical - Cooper Surgical Incontinence Ring Flexible Pessary #4, 2 3/4", 70mm
FDA Device · Class III · 2013-04-03 · Cooper Surgical - Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in vitro diagnostic product for the calibration of the A…
FDA Device · Class III · 2013-04-03 · Siemens Healthcare Diagnostics - VITEK 2 60 computer system when equipped with the following Hewlett-Packard PC models: (1) rp5700, Cat. #W0452
FDA Device · Class II · 2013-04-03 · Biomerieux - Cooper Surgical Gellhorn Flexible Pessary 3", 76mm
FDA Device · Class III · 2013-04-03 · Cooper Surgical - Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. Intended to facilitate catheter placement and exchange during…
FDA Device · Class II · 2013-04-03 · Medtronic Cardiac Rhythm Disease Management - Needle Counters with Blade Disarmer
FDA Device · Class II · 2013-04-03 · Cardinal Health - Needle Counters
FDA Device · Class II · 2013-04-03 · Cardinal Health - Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W. Sterile using ethylene oxide
FDA Device · Class II · 2013-04-03 · Medtronic Cardiac Rhythm Disease Management - Microbiologics KWIK-QC SLIDES ( KWIK-QC Acid Fast Stain Slides and KWIK-QC Mycobacterium Slides)
FDA Device · Class II · 2013-04-03 · Microbiologics - ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Qualitative Confirmatory Assay, List Number 4P54 The ARCHITECT HBsA…
FDA Device · Class II · 2013-04-03 · Abbott Laboratories - bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028
FDA Device · Class II · 2013-04-03 · Biomerieux - DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000
FDA Device · Class II · 2013-03-27 · Depuy Spine - Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508
FDA Device · Class II · 2013-03-27 · Exactech - DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000
FDA Device · Class II · 2013-03-27 · Depuy Spine - Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiopulmonary bypass
FDA Device · Class I · 2013-03-27 · Vascular Solutions - Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators
FDA Device · Class II · 2013-03-27 · Boston Scientific Crm - INTIO Inc., ClearStart-SVM Segmentation and Volumetric Measurement System, Users Manual
FDA Device · Class II · 2013-03-27 · Intio - Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fracture Table Orthopedic Leg Holders, non-invasive medical devices de…
FDA Device · Class II · 2013-03-27 · Allen Medical Systems - Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107)
FDA Device · Class II · 2013-03-27 · Siemens Healthcare Diagnostics - Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431
FDA Device · Class II · 2013-03-27 · Synthes Usa Hq - 20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) u…
FDA Device · Class III · 2013-03-27 · Volk Optical - CR MD1.0 General Set, x-ray imager image plate
FDA Device · Class II · 2013-03-27 · Agfa - Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques: Sigma HP Instruments Classic Surgical Technique,0612-89-510 Sigma HP I…
FDA Device · Class II · 2013-03-27 · Depuy Orthopaedics - ReClaim Reamer Extension
FDA Device · Class II · 2013-03-27 · Depuy Orthopaedics - Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number 101-00006 - Non-Sterile
FDA Device · Class II · 2013-03-27 · Extremity Medical - Sterile Access & Return Line Set, 36" Length, Part # UM-872-36
FDA Device · Class II · 2013-03-27 · Molded Products - Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II Absorber contained in Service Kits Part Num…
FDA Device · Class I · 2013-03-27 · Del Mar Reynolds Medical - Howmedica Osteonics Corp
FDA Device · Class II · 2013-03-27 · Stryker Howmedica Osteonics - PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework
FDA Device · Class II · 2013-03-27 · Keystone Dental - DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT Catalog Number: 283907000
FDA Device · Class II · 2013-03-27 · Depuy Spine - DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000
FDA Device · Class II · 2013-03-27 · Depuy Spine - Creatinine, Part Numbers OSR6178, OSR6678 Product Usage: System reagent for the quantitative determination of Creatinine in human serum and…
FDA Device · Class II · 2013-03-27 · Beckman Coulter
Other years
2026 (2,024) · 2025 (2,908) · 2024 (3,393) · 2023 (2,477) · 2022 (2,191) · 2021 (2,303) · 2020 (3,055) · 2019 (2,801) · 2018 (3,757) · 2017 (2,615) · 2016 (3,246) · 2015 (2,495) · 2014 (3,059) · 2013 (2,249) · 2012 (1,310)