FDA Device · 2019
FDA Device recalls in 2019
RecallRadar indexes 2,801 FDA Device recall notices published in 2019. By classification: 369 Class I, 2,343 Class II, 89 Class III.
- SenTec Membrane Changer (reloadable) [9 pcs] - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tensio…
FDA Device · Class II · 2019-08-14 · Sentec Ag - Philips EPIQ and Affiniti Ultrasound Systems with software version 4.0: Models EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIZ C…
FDA Device · Class II · 2019-08-14 · Philips Ultrasound - CIRCUMCISION TRAY Kit Code: CIT2650H - Product Usage: Kit is used for performing circumcision procedures on newborns
FDA Device · Class II · 2019-08-14 · Centurion Medical Products - ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs)
FDA Device · Class I · 2019-08-14 · St Jude Medical - SenTec Standard Starter Set with and without Service Gas (2 changers each) - Product Usage: Is indicated for continuous, non-invasive monit…
FDA Device · Class II · 2019-08-14 · Sentec Ag - 14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061425 Product Usage: An aid for introducing a hemod…
FDA Device · Class II · 2019-08-14 · Medical Components - iCT SP Model # 728311, computed tomography x-ray system
FDA Device · Class II · 2019-08-14 · Philips Medical Systems Cleveland - VITROS 250 Chemistry System, clinical chemistry analyzer
FDA Device · Class II · 2019-08-14 · Ortho Clinical Diagnostics - HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument
FDA Device · Class II · 2019-08-14 · Hycor Biomedical - NEONATAL PICC INSERTION TRAY Kit Code: CVI2310 - Product Usage: Kit is used for Peripheral Central Line Insertion procedures on newborns
FDA Device · Class II · 2019-08-14 · Centurion Medical Products - CIRCUMCISION TRAY Kit Code: CIT2245 - Product Usage: Kit is used for performing circumcision procedures on newborns
FDA Device · Class II · 2019-08-14 · Centurion Medical Products - Lidar System for Erosion Flume Application Class 1 Laser Product Product Usage: Product is installed and fixed above a dynamic indoor flume…
FDA Device · Class II · 2019-08-14 · Astra - Vereos PET/CT Model # 882446, computed tomography x-ray system
FDA Device · Class II · 2019-08-14 · Philips Medical Systems Cleveland - VITROS 350 Chemistry System, clinical chemistry analyzer
FDA Device · Class II · 2019-08-14 · Ortho Clinical Diagnostics - ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: 05414734507615
FDA Device · Class I · 2019-08-14 · St Jude Medical - Logolas Laser Projection Series
FDA Device · Class II · 2019-08-14 · Gk Photonics - iCT, Model # 728306, computed tomography x-ray system
FDA Device · Class II · 2019-08-14 · Philips Medical Systems Cleveland - LSB Style Anchor Bolt
FDA Device · Class II · 2019-08-14 · Ad Tech Medical Instrument - Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulating tissue during general surgery, neuros…
FDA Device · Class II · 2019-08-14 · Integra Lifesciences - Maxim Laser Projection Series
FDA Device · Class II · 2019-08-14 · Gk Photonics - Lantis system (pre-2003), Model #5835991 - Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver treatment to t…
FDA Device · Class II · 2019-08-14 · Siemens Medical Solutions Usa - The Alinity ci-series System Control Modules which are configured with Alinity c Processing Modules
FDA Device · Class II · 2019-08-14 · Abbott And Kg - VITROS 250AT Chemistry System, clinical chemistry analyzer
FDA Device · Class II · 2019-08-14 · Ortho Clinical Diagnostics - ClubMax Laser Projection Series
FDA Device · Class II · 2019-08-14 · Gk Photonics - Lantis 6.1 Commander, Model # 5493072 - Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver treatment to the…
FDA Device · Class II · 2019-08-14 · Siemens Medical Solutions Usa - VITROS 5,1 FS Chemistry System, clinical chemistry analyzer
FDA Device · Class II · 2019-08-14 · Ortho Clinical Diagnostics - LVAD DRESSING SYSTEM W/BIOPATCHKit Code: DM700 - Product Usage: Kit is used for Left Ventricular Assist Device Dressing System for general…
FDA Device · Class II · 2019-08-14 · Centurion Medical Products - DRIVELINE MANAGEMENT SYSTEM 1 DAILY Kit Code: DT18440A - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for ge…
FDA Device · Class II · 2019-08-14 · Centurion Medical Products - VITROS 250 Chemistry System, clinical chemistry analyzer
FDA Device · Class II · 2019-08-14 · Ortho Clinical Diagnostics - PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 1710 Product Usage: PTS Panels Lipid Panel test strips measure t…
FDA Device · Class III · 2019-08-14 · Polymer Technology Systems - Ingenuity CT, Model # 728326, computed tomography x-ray system
FDA Device · Class II · 2019-08-14 · Philips Medical Systems Cleveland - LACERATION TRAY Kit Code: SUT18370 - Product Usage: Kit is used for laceration repairs for general population
FDA Device · Class II · 2019-08-14 · Centurion Medical Products - Toothete Oral Care Sodium Bicarbonate Mouthpaste, Net Wt. 1/3 oz/ 9g, included in Independent Care System
FDA Device · Class II · 2019-08-14 · Sage Products - CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IIAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an…
FDA Device · Class II · 2019-08-14 · Biomet 3i - VITROS 5600 Integrated System, clinical chemistry analyzer
FDA Device · Class II · 2019-08-14 · Ortho Clinical Diagnostics - EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF numbers 12GV Upright (V…
FDA Device · Class II · 2019-08-14 · Bard Peripheral Vascular - Assayed Bovine Multi-Sera Level 1, Model No. AL1027
FDA Device · Class III · 2019-08-14 · Randox Laboratories - 14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061424 Product Usage: An aid for introducing a hemod…
FDA Device · Class II · 2019-08-14 · Medical Components - Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use, in the quality cont…
FDA Device · Class II · 2019-08-14 · Randox Laboratories - Ingenuity Core128 Model # 728323, computed tomography x-ray system
FDA Device · Class II · 2019-08-14 · Philips Medical Systems Cleveland - Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.5g, For single use only, Part Number 20116 - Product Usage…
FDA Device · Class II · 2019-08-14 · Geistlich Pharma North America - Endoscopic Cleaning Brushes sold in various Endoscopy Kits - Product Usage: The brushes are used to help clean out the endoscopes in betwee…
FDA Device · Class II · 2019-08-14 · Medline Industries - EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton, single use, Rx, catalog/REF number 7G - REF ECP017G…
FDA Device · Class II · 2019-08-14 · Bard Peripheral Vascular - Regard ¿ custom surgical pack labeled as "LAP - FLOL LADY OF ANGELS" including recalled Stryker part numbers 0620 040 660 Pneumosure High F…
FDA Device · Class II · 2019-08-14 · Roi Consolidated Service Center Csc - Workstation, G2, Configured (P/N 000-0241)
FDA Device · Class II · 2019-08-14 · Intellijoint Surgical - MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the following implant types: a. Mil000 CONCERTO PIN +FLEX28
FDA Device · Class II · 2019-08-14 · Med El Elektromedizinische Gereate - DRIVELINE MANAGEMENT TRAY Kit Code: DT17780B - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general pati…
FDA Device · Class II · 2019-08-14 · Centurion Medical Products - Frontal Quick Drop OR Apron, Product Number 601, Part Numbers ECRE601A, ECRE601B, ECRE601C, ECRE601XLM, RE601*M, RE601C, RE601D, RE601XXLM…
FDA Device · Class II · 2019-08-07 · Burlington Medical - Half Apron, Product Number Half Apron, Part Numbers REHALF*, REHALF3 Product Usage: Products are designed to protect healthcare workers aga…
FDA Device · Class II · 2019-08-07 · Burlington Medical - Frontal Stretch Buckle Closure Apron, Product Number A-10, Part Numbers REA10A, REA10B, REA10C, REA10*F, REA10*M, UEA10*M Product Usage: Pr…
FDA Device · Class II · 2019-08-07 · Burlington Medical - Thyroid Collar Oversize, Product Number TS3, Part Numbers RBTS3-R, RETS3-R, RLTS3-R, RLTS3-SEP, RLTS3-T2T Product Usage: Products are desig…
FDA Device · Class II · 2019-08-07 · Burlington Medical - Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
FDA Device · Class II · 2019-08-07 · Elekta - Thyroid Collar, Velcro Closure, Product Number TS2, Part Numbers RBTS2-R, RETS2-R, RLTS2PED, RLTS2-R, RLTS2-SEP, RLTS2-T2T, SBTS2-R, SETS2-…
FDA Device · Class II · 2019-08-07 · Burlington Medical - Peak Vest, Single Item, Product Number PVest, Part Numbers REPVEST*M, SEPVESTE, SEPVEST*F Product Usage: Products are designed to protect h…
FDA Device · Class II · 2019-08-07 · Burlington Medical - Hood, Product Number Hood, Part Numbers HOOD1, HOOD2 Product Usage: Products are designed to protect healthcare workers against scatter (se…
FDA Device · Class II · 2019-08-07 · Burlington Medical - Front/Back Apron with Stretch Velcro Closure, Product Number EURO, Part Numbers ECSEEUROA, ECSEEUROB, ECSEEUROC, ECSEEUROXLM, REEURO*F, REE…
FDA Device · Class II · 2019-08-07 · Burlington Medical - Porta Shield, Product Number Porta Shield, Part Numbers PTS2, PTS3, PTS4 Product Usage: Products are designed to protect healthcare workers…
FDA Device · Class II · 2019-08-07 · Burlington Medical - Kilt, Single Item, Product Number Kilt, Part Numbers ECREKILTF, ECREKILTXLF, REKILTA, REKILTB, REKILTXLF, REKILTXLM, REKILT*M, SEKILTB, SEK…
FDA Device · Class II · 2019-08-07 · Burlington Medical - Terumo Capiox NX19 Oxygenator With Reservoir (West Orientation) P/N: 3CX*NX19RW
FDA Device · Class II · 2019-08-07 · Terumo Cardiovascular Systems - 1 pc Full Wrap Support Belt Apron, Product Number F111, Part Numbers MTREF111*F, MTREF111E, MTREF111F, REF111*F, REF111*M, REF111B, REF111E…
FDA Device · Class II · 2019-08-07 · Burlington Medical - Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, Rx Only Product Usage: The Assurance¿ Nasal Alar SpO2 Sensor is indicated for single p…
FDA Device · Class II · 2019-08-07 · Xhale Assurance - Sheridan Endotracheal Tube contained inside Centurion kit code TC7855
FDA Device · Class I · 2019-08-07 · Centurion Medical Products - AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The Agfa s DR 800 system is indicated for performing dynam…
FDA Device · Class II · 2019-08-07 · Agfa N V - Acuject Variable Injection Needle
FDA Device · Class II · 2019-08-07 · Wilson Cook Medical - Frontal Apron with Quick Drop Velcro Closure (no elastic), Product Number 401, Part Numbers RE401*M Product Usage: Products are designed to…
FDA Device · Class II · 2019-08-07 · Burlington Medical - Overlap Vest, Single Item, Product Number FVest, Part Numbers REFVEST*F, REFVEST*M, REFVESTE, REFVESTXLM, SEFVEST*F, SEFVEST*M
FDA Device · Class II · 2019-08-07 · Burlington Medical - Frontal Support Belt Apron, Product Number F-15, Part Numbers REF15*F, REF15*M, REF15B, REF15XLM Product Usage: Products are designed to pr…
FDA Device · Class II · 2019-08-07 · Burlington Medical - Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P
FDA Device · Class II · 2019-08-07 · Encore Medical - GE Senographe Pristina - Product Usage: Senographe Pristina generates digital mammographic images that can be used for screening and in the…
FDA Device · Class II · 2019-08-07 · Ge Healthcare - Filter-Tips, 1500 ul (1024 tips/kitbox), REF 997024- REF: 997024 IVD: Used with the QIAGEN QIAsymphony SP/AS Instruments (REF 9001297 and 9…
FDA Device · Class I · 2019-08-07 · Qiagen Sciences - A&E Medical Corp
FDA Device · Class II · 2019-08-07 · Alto Development - Sleeve, Product Number Sleeve, Part Numbers RESL, SL 3 L, SL 3 M, SL 3 S, L 3 X, SL 3 XS, UESL Product Usage: Products are designed to prot…
FDA Device · Class II · 2019-08-07 · Burlington Medical - Inovo Single Luman Conserver Product Usage: This device is intended to regulate the flow of oxygen from an oxygen tank and only deliver oxy…
FDA Device · Class II · 2019-08-07 · Inovo - Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test for the measurement of cardiac troponin I in hepar…
FDA Device · Class II · 2019-08-07 · Siemens Healthcare Diagnostics - Rusch EasyCath Kit
FDA Device · Class II · 2019-08-07 · Teleflex Medical - Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE
FDA Device · Class II · 2019-08-07 · Terumo Cardiovascular Systems - 2 pc Full Wrap Vest & Kilt Back-Saver , Product Number PVK, Part Numbers REPVK*F, REPVK*M, REPVKE, REPVKF, REPVKXLM, SEPVK*F, SEPVK*M, SEPV…
FDA Device · Class II · 2019-08-07 · Burlington Medical - Terumo Capiox NX19 Oxygenator (East Orientation), P/N: CXOT280 Exported only to Japan for inclusion into convenience kits that are sold onl…
FDA Device · Class II · 2019-08-07 · Terumo Cardiovascular Systems - 2 pc Full Overlap Vest & Kilt, Single Item, Product Number FVK, Part Numbers REFVK*F, REFVK*M, REFVKB, REFVKD, REFVKE, REFVKF, SEFVK*F, SEF…
FDA Device · Class II · 2019-08-07 · Burlington Medical - 1 pc Full Wrap Back Relief Apron, Product Number B52 Front & Back Apron, Part Numbers SEB52*F, UEB52*M Product Usage: Products are designed…
FDA Device · Class II · 2019-08-07 · Burlington Medical - Maximum Pelvic Trainer (MPT)
FDA Device · Class II · 2019-08-07 · Ralston Group - Thyroid Collar, Buckle Closure, Product Number TS4, Part Numbers RBTS4-R, RBTS4-T2T, RETS4-R, RLTS4-R, RLTS4-SEP, RLTS4-T2T, SBTS4-R, SETS4…
FDA Device · Class II · 2019-08-07 · Burlington Medical - Cap, Product Number Cap, Part Numbers CAP1, CAP2 Product Usage: Products are designed to protect healthcare workers against scatter (second…
FDA Device · Class II · 2019-08-07 · Burlington Medical - Terumo Capiox NX19 Oxygenator (West Orientation P/N:CXOT281 Exported only to Japan for inclusion into convenience kits that are sold only w…
FDA Device · Class II · 2019-08-07 · Terumo Cardiovascular Systems - Frontal Apron Velcro Closure, Product Number F-17, Part Numbers REF17A, REF17B, REF17C, REF17D, REF17*F, REF17*M, REF17XLF, REF17XLM, REF17…
FDA Device · Class II · 2019-08-07 · Burlington Medical - 2 pc Full Wrap Vest & Kilt, Product Number VK, Part Numbers ECREVKA, ECREVKB, ECREVKC, ECREVKXLM, ECSEVKA, ECSEVKB, ECSEVKC, ECSEVKXLM, REV…
FDA Device · Class II · 2019-08-07 · Burlington Medical - Thyroid Collar, Magnetic Closure, Product Number TS5, Part Numbers RBTS5-R, RBTS5-T2T, RLTS5-R, RLTS5-T2T, SLTS5-R Product Usage: Products…
FDA Device · Class II · 2019-08-07 · Burlington Medical - Azurion lnterventional Fluoroscopic X-ray System, with software version 1.2
FDA Device · Class II · 2019-08-07 · Philips Medical Systems Nederlands - Vest, Single Item, Product Number Vest, Part Numbers ECREVESTD, ECREVESTF, ECREVESTXLF, REVEST*M, REVESTB, REVESTC, SEVEST*F, SEVEST*M, SEV…
FDA Device · Class II · 2019-08-07 · Burlington Medical - AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid Factor IgM ELISA is intended to be utilized as either a manu…
FDA Device · Class II · 2019-08-07 · Hycor Biomedical - GE Pristina Serena - Product Usage: Pristina Serena is an optional accessory of Senographe Pristina intended to provide accurate location o…
FDA Device · Class II · 2019-08-07 · Ge Healthcare - Transferrin is an in vitro diagnostic assay for the quantitative determination of transferrin in human serum or plasma
FDA Device · Class II · 2019-07-31 · Abbott Laboratories - 3mL Luer-Lok Syringe, Catalog Number 309657, UDI 30382903096573
FDA Device · Class II · 2019-07-31 · Becton Dickinson And - AXIOM Artis dBC, Model Number 7728392
FDA Device · Class II · 2019-07-31 · Siemens Medical Solutions Usa - Spacelabs Healthcare Smart Disclosure System, Model 92810, a component of the Intesys Clinical Suite (ICS) G2
FDA Device · Class II · 2019-07-31 · Spacelabs Healthcare - MOOG Curlin Infusion Administration Set, REF 340-4130-V, Non-DEHP Tubing with Non-Vented Bag Spike and Vented 0.2 Micron Filter with add-on…
FDA Device · Class II · 2019-07-31 · Zevex Dba Moog Medical Devices Group - Monoject Standard Hypodermic Needle, 18 G x 1-1/2" Item code: 8881200078
FDA Device · Class II · 2019-07-31 · Cardinal Health 200 - Monoject" 201 Vet Pak Hypodermic Needle, 16 ga x 1-1/2 Item code: 8881201654
FDA Device · Class II · 2019-07-31 · Cardinal Health 200 - Immunoglobulin M is an in vitro diagnostic assay for the quantitative determination of immunoglobulin M in human serum or plasma
FDA Device · Class II · 2019-07-31 · Abbott Laboratories - Monoject Standard Hypodermic Needle, 27 G x 1-1/4" Item code: 8881200508
FDA Device · Class II · 2019-07-31 · Cardinal Health 200
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)