FDA Device · 2018
FDA Device recalls in 2018
RecallRadar indexes 3,757 FDA Device recall notices published in 2018. By classification: 136 Class I, 3,529 Class II, 92 Class III.
- Manuka Honey Wound Gel Catalogue No: 716597 Product Usage: Helps maintain a moist wound environment which has shown to be conducive to woun…
FDA Device · Class II · 2018-05-16 · Integra Lifesciences - IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative MRI systems are traditional MRI systems that have been suspended on…
FDA Device · Class II · 2018-05-16 · Deerfield Imaging - Dimension Alanine Aminotransferase (ALTI) assay
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - Gentle Threads, Interference Screw
FDA Device · Class II · 2018-05-16 · Zimmer Biomet - Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid…
FDA Device · Class II · 2018-05-16 · Cook - AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor, monometer Product Usage: The…
FDA Device · Class I · 2018-05-16 · Vyaire Medical - BARD¿ BrachySource¿ Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-co…
FDA Device · Class II · 2018-05-16 · Bard Brachytherapy - Dimension Vista Ammonia (AMM) assay (Product Number: K3119/10711992) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - Fabius GS Premium, anesthesia machine, catalog no. 8607000 Product Usage: The products are inhalation anesthesia machines for use in operat…
FDA Device · Class I · 2018-05-16 · Draeger Medical - AirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, PEEP valve Product Usage: The AirLife Resuscitation devices are ma…
FDA Device · Class I · 2018-05-16 · Vyaire Medical - Dimension Creatine Kinase MB (MBI) assay (Product Number: DF32/10464510) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - Straumann¿ Emdogain 0.3 ml Multipack USA. Enamel Matrix Derivative
FDA Device · Class II · 2018-05-16 · Straumann Manufacturing - Jasper Vektor, Class II Correction Appliance, Part No. 610-533 used for correcting class 2 malocclusions by applying light forces on the te…
FDA Device · Class II · 2018-05-16 · Tp Orthodontics - AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resus…
FDA Device · Class I · 2018-05-16 · Vyaire Medical - BEQ-TOP 38900 ECC PACK, Custom Tubing Kit, Catalog No. 701056368
FDA Device · Class II · 2018-05-16 · Datascope - Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX Product Usage: The Baxter Sigma Spectrum Infusion Pump wi…
FDA Device · Class II · 2018-05-16 · Baxter Healthcare - AirLife Resuscitation, Broselow Hinkle Kit Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used…
FDA Device · Class I · 2018-05-16 · Vyaire Medical - IMMULITE ¿ /IMMULITE ¿ 1000 BR-MA (CA15-3)
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - BEQ-TOP 5210 ECC Set - Respiratory, Custom Tubing Kit, Catalog No. 701055604R01
FDA Device · Class II · 2018-05-16 · Datascope - BEQ-T 25502 1/4 Better Bladder , Custom Tubing Kit, Catalog No. 709000434
FDA Device · Class II · 2018-05-16 · Datascope - AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, filter Product Usage: The AirLife Resus…
FDA Device · Class I · 2018-05-16 · Vyaire Medical - Dimension Vista Alanine Aminotransferase (ALTI) assay
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - Capio SLIM Box 5, Model #M0068318261
FDA Device · Class II · 2018-05-16 · Boston Scientific - POWERPORT ClearVUE isp with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter, REF 5668362
FDA Device · Class II · 2018-05-16 · Bard Peripheral Vascular - AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer Product Usage: The AirLife Resuscitation devices are manual resusc…
FDA Device · Class I · 2018-05-16 · Vyaire Medical - Thumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog No. 15370 Product Usage: The device is used to perform Cardiopulmonary Resusci…
FDA Device · Class III · 2018-05-16 · Michigan Instruments - ADVIA Centaur¿ Cyclosporine
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - Jasper Vektor, Class II Correction Appliance, Part No. 610-527 used for correcting class 2 malocclusions by applying light forces on the te…
FDA Device · Class II · 2018-05-16 · Tp Orthodontics - Capio SLIM Suture Capturing Device, Model #M0068318250
FDA Device · Class II · 2018-05-16 · Boston Scientific - Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRE Product Usage: The Baxter Sigma Spectrum Infusion Pump…
FDA Device · Class II · 2018-05-16 · Baxter Healthcare - AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, manometer, pressure-relief valve, PEEP valve Product Usage: The AirLife…
FDA Device · Class I · 2018-05-16 · Vyaire Medical - Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User Interface Module (Part Numbe…
FDA Device · Class II · 2018-05-16 · Icu Medical - Dimension Vista Creatine Kinase MB (MBI) assay
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - Syngo.plaza software Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communi…
FDA Device · Class II · 2018-05-16 · Siemens Medical Solutions Usa - Wet-Field Hemostatic Eraser Bipolar 25G, fine tip, straight, 5/SP
FDA Device · Class II · 2018-05-16 · Beaver Visitec International - BO-TOP 20705 SMALL PATIENT 1/4, Catalog No. 701053486
FDA Device · Class II · 2018-05-16 · Datascope - POWERPORT ClearVUE isp Implantable Port With Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Ki…
FDA Device · Class II · 2018-05-16 · Bard Peripheral Vascular - IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Gastrin
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, PEEP valve Product Usage: The AirLife R…
FDA Device · Class I · 2018-05-16 · Vyaire Medical - Jasper Vektor, Class II Correction Appliance, Part No. 610-527R used for correcting class 2 malocclusions by applying light forces on the t…
FDA Device · Class II · 2018-05-16 · Tp Orthodontics - AirLife Resuscitation, Pediatric, with mask, 28inch large bore tubing, pressure-relief valve Product Usage: The AirLife Resuscitation devic…
FDA Device · Class I · 2018-05-16 · Vyaire Medical - BEQ-TOP 27610 ECC PACK 3/8, Custom Tubing Kit, Catalog No. 701065622
FDA Device · Class II · 2018-05-16 · Datascope - AirLife Resuscitation, Broselow Hinkle Kit Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used…
FDA Device · Class I · 2018-05-16 · Vyaire Medical - POWERPORT ClearVUE Slim with Smooth Septum, 8F ChronoFlex, Polyurethane Catheter with Open Suture Holes, REF 1678301
FDA Device · Class II · 2018-05-16 · Bard Peripheral Vascular - ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detection of heparin-dependent antibodies, whether the isotype i…
FDA Device · Class II · 2018-05-16 · Hyphen Biomed - POWERPORT ClearVUE Slim with Smooth Septum, 6F ChronoFlex Silk, Polyurethane Catheter, REF 5676300
FDA Device · Class II · 2018-05-16 · Bard Peripheral Vascular - PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PICCs into the vascular system
FDA Device · Class II · 2018-05-16 · Vygon U - AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, Broselow Product Usage: The AirLife Resusc…
FDA Device · Class I · 2018-05-16 · Vyaire Medical - Jasper Vektor, Class II Correction Appliance, Part No. 610-500 used for correcting class 2 malocclusions by applying light forces on the te…
FDA Device · Class II · 2018-05-16 · Tp Orthodontics - Jasper Vektor, Class II Correction Appliance, Part No. 610-536R used for correcting class 2 malocclusions by applying light forces on the t…
FDA Device · Class II · 2018-05-16 · Tp Orthodontics - BEQ-T 9410 Lurie Chldns Small 1/4, Custom Tubing Kit, Catalog No. 709000430
FDA Device · Class II · 2018-05-16 · Datascope - ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee
FDA Device · Class II · 2018-05-16 · Depuy Orthopaedics - POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter, REF 1666362
FDA Device · Class II · 2018-05-16 · Bard Peripheral Vascular - IMMULITE ¿ /IMMULITE ¿ 1000 Vitamin B12
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - ADVIA Centaur¿ Folate (FOL)
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - BEQ-TOP 40700 HUNTINGTON, Catalog No. 701062899
FDA Device · Class II · 2018-05-16 · Datascope - Jasper Vektor, Class II Correction Appliance, Part No. 610-530L used for correcting class 2 malocclusions by applying light forces on the t…
FDA Device · Class II · 2018-05-16 · Tp Orthodontics - Dimension Thyroxine (T4) assay (Product Number: DF65/10444908) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - Dimension¿ Thyroid Stimulating Hormone (TSHL) Flex¿ reagent cartridge
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - Gentle Threads, Interference Screw
FDA Device · Class II · 2018-05-16 · Zimmer Biomet - Dimension Vista¿ Cardiac Troponin I (CTNI) Flex¿ reagent cartridge
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXR Product Usage: The Baxter Sigma Spectrum Infusion Pump w…
FDA Device · Class II · 2018-05-16 · Baxter Healthcare - AirLife Resuscitation, Infant, with mask, 40 inch oxygen reservoir tubing, pressure-relief valve, CO2 detector, manometer Product Usage: Th…
FDA Device · Class I · 2018-05-16 · Vyaire Medical - BEQ-TOP 24500 ADULT ECC, Custom Tubing Kit, Catalog No. 701050253
FDA Device · Class II · 2018-05-16 · Datascope - Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy f…
FDA Device · Class II · 2018-05-16 · Zimmer Biomet - BEQ-TOP 25500 ECC 3/8 w/QiD, Custom Tubing Kit, Catalog No. 701052461
FDA Device · Class II · 2018-05-16 · Datascope - Syva Emit 2000 Tacrolimus Assay (Product Number: 8R019UL/10445397) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - Syva¿ EMIT¿ II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10481483
FDA Device · Class III · 2018-05-16 · Siemens Healthcare Diagnostics - BEQ-TOP 33500 3/8" ECC PACK, Catalog No. 701053752
FDA Device · Class II · 2018-05-16 · Datascope - Retractor f/Sciatic Nerve Long
FDA Device · Class II · 2018-05-16 · Synthes Usa Products - ReNew Endocut Scissor Disposable Tip, Catalog Number: 3142, UDI: 00811099012115 The ReNew single patient use disposable tips are to be used…
FDA Device · Class II · 2018-05-16 · Microline Surgical - Straumann¿ Emdogain 015, USA. Enamel Matrix Derivative
FDA Device · Class II · 2018-05-16 · Straumann Manufacturing - Dimension Glucose (GLUC) assay (Product Number: DF40/10444973) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
FDA Device · Class II · 2018-05-16 · Siemens Healthcare Diagnostics - 6381 M-1 Cot Fastener, catalog no. 6381000000
FDA Device · Class II · 2018-05-09 · Stryker Medical Division - MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumo…
FDA Device · Class II · 2018-05-09 · Hitachi Medical System Operations Group - SOMATOM Sensation 10 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data
FDA Device · Class II · 2018-05-09 · Siemens Medical Solutions Usa - SOMATOM Emotion 6 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data
FDA Device · Class II · 2018-05-09 · Siemens Medical Solutions Usa - Beijing Syntech Laser Nice Station Light Based Platform surgical lasers
FDA Device · Class II · 2018-05-09 · Beijing Syntech Laser - HYPOTHERMIA MITTS Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), TM7006 (b) Elasto-Gel(TM), TM7006LV (c) El…
FDA Device · Class II · 2018-05-09 · Southwest Technologies - StoneBreaker Single Use Probe, Catalog numbers: SBP-010500
FDA Device · Class II · 2018-05-09 · Cook - Beijing Syntech Laser APOLLO V+ Medical Platform surgical lasers
FDA Device · Class II · 2018-05-09 · Beijing Syntech Laser - SOMATOM Perspective Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data
FDA Device · Class II · 2018-05-09 · Siemens Medical Solutions Usa - Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector 708037 As a multifunctional universal imaging application system, General R…
FDA Device · Class II · 2018-05-09 · Philips Medical Systems Nederlands - MultiDiagnostic-Eleva with Flat Detector 708038 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiog…
FDA Device · Class II · 2018-05-09 · Philips Medical Systems Nederlands - AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is intended to let allow the management of analytical devices and o…
FDA Device · Class II · 2018-05-09 · Radiometer Medical Aps - 6376 M-1 Cot Fastener, catalog no. 6376000000
FDA Device · Class II · 2018-05-09 · Stryker Medical Division - HYPOTHERMIA CAP Supportive in Cancer, packaged under the following brands: (a) Elasto-Gel(TM), CAP610 (b) Elasto-Gel(TM), CAP610LV (c) Elas…
FDA Device · Class II · 2018-05-09 · Southwest Technologies - MultiDim Eleva 708032 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can…
FDA Device · Class II · 2018-05-09 · Philips Medical Systems Nederlands - SOMATOM Emotion (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data
FDA Device · Class II · 2018-05-09 · Siemens Medical Solutions Usa - Cobas b 221<4>Roche OMNI S4 system
FDA Device · Class II · 2018-05-09 · Roche Diagnostics - Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical specimens
FDA Device · Class II · 2018-05-09 · Siemens Healthcare Diagnostics - Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023, SMN # 10445160 The CA method is an in vitro diagnostic test f…
FDA Device · Class II · 2018-05-09 · Siemens Healthcare Diagnostics - Miriam Capsule Endoscope System
FDA Device · Class II · 2018-05-09 · Intromedic - cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S Analyzer is a fully automated cr…
FDA Device · Class II · 2018-05-09 · Roche Diagnostics - Modular Head Component, Biomet Hip System
FDA Device · Class II · 2018-05-09 · Zimmer Biomet - SOMATOM Perspective 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data
FDA Device · Class II · 2018-05-09 · Siemens Medical Solutions Usa - SOMATOM Emotion 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data
FDA Device · Class II · 2018-05-09 · Siemens Medical Solutions Usa - Beijing Syntech Laser UL Station surgical lasers
FDA Device · Class II · 2018-05-09 · Beijing Syntech Laser - SOMATOM Sensation 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data
FDA Device · Class II · 2018-05-09 · Siemens Medical Solutions Usa - SOMATOM Scope Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data
FDA Device · Class II · 2018-05-09 · Siemens Medical Solutions Usa
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)