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.
- OviTex 2S Reinforced BioScaffold 16x20cm, Part Number F10258-1620G
FDA Device · Class II · 2018-11-21 · Aroa Biosurgery - OviTex Reinforced BioScaffold 18x22cm, Part Number F10254-1822G
FDA Device · Class II · 2018-11-21 · Aroa Biosurgery - Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388
FDA Device · Class II · 2018-11-21 · Invivo - OviTex 1S Reinforced BioScaffold 6x10cm, Part Number F10256-0610G
FDA Device · Class II · 2018-11-21 · Aroa Biosurgery - Affixus Hip Fracture Nail 125 Deg 10x165mm, Item Number 816710165 The Affixus Hip Fracture Nail System, comprised of short and long nails,…
FDA Device · Class II · 2018-11-21 · Zimmer Biomet - Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20) Product Usage: The PCOPM15 and PCOPM20 reorder codes are circular in…
FDA Device · Class II · 2018-11-21 · Covidien - OviTex 1S Reinforced BioScaffold 4x8cm, Part Number F10256-0408G
FDA Device · Class II · 2018-11-21 · Aroa Biosurgery - Heron toilet and bath chair Model 880505-01 & 880505-11
FDA Device · Class II · 2018-11-21 · R82 A S - Affixus Hip Fracture Nail Left 130 Deg 11x300mm, Item Number 814611300 The Affixus Hip Fracture Nail System, comprised of short and long na…
FDA Device · Class II · 2018-11-21 · Zimmer Biomet - OviTex 1S Reinforced BioScaffold 10x20cm, Part Number F10256-1020G
FDA Device · Class II · 2018-11-21 · Aroa Biosurgery - bioM¿rieux NucliSENS easyMAG Lysis Buffer ref. 280134
FDA Device · Class II · 2018-11-21 · Biomerieux - Arrow AGB+ Multi-Lumen CVC Kit, 7 Fr., 3 Lumen, 20cm catheter length, .025 inch dia. spring-wire guide, Product Code CDC-45703-B1A - Produc…
FDA Device · Class II · 2018-11-21 · Arrow International - ARTIS Q.zen biplane with Material 10848355 - a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system develop…
FDA Device · Class II · 2018-11-21 · Siemens Medical Solutions Usa - Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the c…
FDA Device · Class II · 2018-11-21 · Stryker Sustainability Solutions - OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G
FDA Device · Class II · 2018-11-21 · Aroa Biosurgery - ARTIS zee biplane systems with Material 10094141- a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system de…
FDA Device · Class II · 2018-11-21 · Siemens Medical Solutions Usa - Aisys CS2 Anesthesia System
FDA Device · Class II · 2018-11-21 · Ge Healthcare - Aisys Anesthesia System
FDA Device · Class II · 2018-11-21 · Ge Healthcare - Touchscreen display kit
FDA Device · Class II · 2018-11-21 · Ge Healthcare - Affixus Hip Fracture Nail 130 Deg 10x165mm, Item Number 816810165 The Affixus Hip Fracture Nail System, comprised of short and long nails,…
FDA Device · Class II · 2018-11-21 · Zimmer Biomet - OviTex 2S Reinforced BioScaffold 6x10cm, Part Number F10258-0610G
FDA Device · Class II · 2018-11-21 · Aroa Biosurgery - OviTex Reinforced BioScaffold 10x20cm, Part Number F10254-1020G
FDA Device · Class II · 2018-11-21 · Aroa Biosurgery - Dimension Vista Lipase Flex Reagent Cartridge, Model Number 10461745 Product Usage: Dimension Vista - The LIPL method is an in vitro diagno…
FDA Device · Class II · 2018-11-21 · Siemens Healthcare Diagnostics - GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System
FDA Device · Class I · 2018-11-21 · Ge Healthcare - OviTex Reinforced BioScaffold 20x20cm, Part Number F10254-2020G
FDA Device · Class II · 2018-11-21 · Aroa Biosurgery - OviTex Reinforced BioScaffold 10x12cm, Part Number F10254-1012G
FDA Device · Class II · 2018-11-21 · Aroa Biosurgery - INFUSE Bone Graft X SMALL KIT REF 7510100
FDA Device · Class II · 2018-11-21 · Medtronic Sofamor Danek Usa - RadPRO(R) Mobile 40kW Digital X-Ray System - Model: SM-40HF-B-D-C Product Usage: Instrument is used to take diagnostic radiographic exposur…
FDA Device · Class II · 2018-11-21 · Virtual Imaging - OviTex Reinforced BioScaffold 4x8cm, Part Number F10254-0408G
FDA Device · Class II · 2018-11-21 · Aroa Biosurgery - OviTex 1S Reinforced BioScaffold 10x12cm, Part Number F10256-1012G
FDA Device · Class II · 2018-11-21 · Aroa Biosurgery - 3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack
FDA Device · Class II · 2018-11-21 · Arthrex - -Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray¿ Meningitis/Encephalitis (ME) Panel REF RFIT-ASY-0118 30 For FilmArray systems LOT KIT UDI (…
FDA Device · Class II · 2018-11-21 · Biofire Diagnostics - OviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822G
FDA Device · Class II · 2018-11-21 · Aroa Biosurgery - OviTex 2S Reinforced BioScaffold 10x20cm, Part Number F10258-1020G
FDA Device · Class II · 2018-11-21 · Aroa Biosurgery - VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro diagnostic test for the sim…
FDA Device · Class II · 2018-11-21 · Luminex - OviTex 2S Reinforced BioScaffold 20x20cm, Part Number F10258-2020G
FDA Device · Class II · 2018-11-21 · Aroa Biosurgery - Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml EMP160ECO-US-5 (GTIN:5060358120367) Product Usage: Tissue Retrieval sac ma…
FDA Device · Class II · 2018-11-21 · Espiner Medical - AIA-900 Analyzer, Product code 022930, 022930R
FDA Device · Class II · 2018-11-21 · Tosoh Bioscience - BioMend Extend, REF# 0142Z, Synthetic bone grafting material
FDA Device · Class III · 2018-11-21 · Collagen Matrix - OviTex 1S Reinforced BioScaffold 18x22cm, Part Number F10256-1822G
FDA Device · Class II · 2018-11-21 · Aroa Biosurgery - Affixus Hip Fracture Nail 125 Deg 12x165mm, Item Number 816712165 The Affixus Hip Fracture Nail System, comprised of short and long nails,…
FDA Device · Class II · 2018-11-21 · Zimmer Biomet - GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System
FDA Device · Class I · 2018-11-21 · Ge Healthcare - GE Healthcare Millennium MC
FDA Device · Class I · 2018-11-21 · Ge Healthcare - Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Delivery System, Lens Model PCB00, Sterile, Rx - Product Usage: T…
FDA Device · Class II · 2018-11-21 · Johnson And Johnson Surgical Vision - Neodent¿ GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prosthetic components to be installed onto GM im…
FDA Device · Class II · 2018-11-21 · Straumann Manufacturing - OviTex 1S Reinforced BioScaffold 20x20cm, Part Number F10256-2020G
FDA Device · Class II · 2018-11-21 · Aroa Biosurgery - The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Device · Class II · 2018-11-21 · Stryker Medical Division - OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G
FDA Device · Class II · 2018-11-21 · Aroa Biosurgery - Affixus Hip Fracture Nail Left Deg 9x300mm, Item Number 814609300 The Affixus Hip Fracture Nail System, comprised of short and long nails,…
FDA Device · Class II · 2018-11-21 · Zimmer Biomet - ARTIS Q biplane with Material 10848282- - a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed…
FDA Device · Class II · 2018-11-21 · Siemens Medical Solutions Usa - OviTex Reinforced BioScaffold 6x10cm, Part Number F10254-0610G
FDA Device · Class II · 2018-11-21 · Aroa Biosurgery - DT Medi Tech Hintermann Series Talar Implant LEFT-SIZE 4 Part Number: 302114 components are prostheses for a mobile bearing ankle joint
FDA Device · Class II · 2018-11-14 · Dt Medtech - REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 Product Usage: The OriGen RDLC catheter is in…
FDA Device · Class I · 2018-11-14 · Origen Biomedical - Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images (including mammograms) and data from…
FDA Device · Class II · 2018-11-14 · Ge Healthcare - Medtronic CareLink 2090 Programmer
FDA Device · Class II · 2018-11-14 · Medtronic Cardiac Rhythm And Heart Failure Crhf - FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) Instructions for Use (IFU's) only
FDA Device · Class II · 2018-11-14 · Integrity Implants - Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1040-12 Used for the re-attachment of the bone…
FDA Device · Class II · 2018-11-14 · Zimmer Biomet - Endoform Dermal Template 2x2, SKU 529311 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extrace…
FDA Device · Class II · 2018-11-14 · Aroa Biosurgery - Dimension Thermal Chamber Motor Cable located in the following models: Model/UDI Number: Dimension¿ EXL 200 00630414593579
FDA Device · Class II · 2018-11-14 · Siemens Healthcare Diagnostics - Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp Ref Number: 75-1040 Used for the re-attachment of the bone flap after a…
FDA Device · Class II · 2018-11-14 · Zimmer Biomet - Centricity Universal Viewer with PACS-IW foundation 6.0.x displays medical images (including mammograms) and data from various imaging sour…
FDA Device · Class II · 2018-11-14 · Ge Healthcare - Liquid Cardiac Control, CQ5051
FDA Device · Class II · 2018-11-14 · Randox Laboratories - Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1030-12 Used for the re-attachment of the bone…
FDA Device · Class II · 2018-11-14 · Zimmer Biomet - Biomet Microfixation RapidFlap System 12mm SpinDown Clamp, sterile Ref Number: 75-1020 Used for the re-attachment of the bone flap after a…
FDA Device · Class II · 2018-11-14 · Zimmer Biomet - Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4" X 5", 10 Pads, Catalogue number SNS58315
FDA Device · Class II · 2018-11-14 · Safe N Simple - TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart
FDA Device · Class I · 2018-11-14 · Oscor - Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray system: OARM BI70002000 SYS IMAGING 02 Model: BI70002000 OAR…
FDA Device · Class II · 2018-11-14 · Medtronic Navigation Littleton - VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489 For in vitro diagnostic use only For the quantitative…
FDA Device · Class II · 2018-11-14 · Ortho Clinical Diagnostics - Medtronic CareLink Encore 29901 Programmer
FDA Device · Class II · 2018-11-14 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp Ref Number: 75-1030 Used for the re-attachment of the bone flap after a…
FDA Device · Class II · 2018-11-14 · Zimmer Biomet - Biomet Microfixation RapidFlap System, 12MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1020-12 Used for the re-attachment of the bone…
FDA Device · Class II · 2018-11-14 · Zimmer Biomet - Liquid Cardiac Control, CQ5053
FDA Device · Class II · 2018-11-14 · Randox Laboratories - Endoform Dermal Template 4x5, SKU 529313 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extrace…
FDA Device · Class II · 2018-11-14 · Aroa Biosurgery - Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product Usage: For the calibration of Pointe Scientific s…
FDA Device · Class III · 2018-11-14 · Medtest Holdings - Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER, 4" X 5", 12 Pads, Catalogue number SNS58345
FDA Device · Class II · 2018-11-14 · Safe N Simple - Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm, REF 7650-2038A - Product Usage: Howmedica Osteonics Corp. (S…
FDA Device · Class II · 2018-11-14 · Howmedica Osteonics - DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components are prostheses for a mobile bearing ankle joint
FDA Device · Class II · 2018-11-14 · Dt Medtech - EZ1 Advanced XL, Model Number: 9001492, GTIN: 04053228010760 Product Usage: The EZ1 Advanced XL is designed to perform automated isolation…
FDA Device · Class II · 2018-11-14 · Qiagen Sciences - CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are indicated for treatment planning and image guided stereotactic radiosur…
FDA Device · Class II · 2018-11-14 · Accuray - PCEA Kit ASV Yellow Stripe Microbore, Catalog Number 10800177 Product Usage: PCEA Administration Set
FDA Device · Class II · 2018-11-14 · Becton Dickinson And - BD NEXIVA Closed IV Catheter System Dual Port 18GA 1.25 IN (BD Nexiva Catheter), Catalog Number 383539 Product Usage: BD Nexiva Closed IV C…
FDA Device · Class II · 2018-11-14 · Becton Dickinson And - R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971
FDA Device · Class III · 2018-11-14 · R And D Systems - Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, in…
FDA Device · Class II · 2018-11-14 · Cordis - Liquid Cardiac Control, CQ5052
FDA Device · Class II · 2018-11-14 · Randox Laboratories - Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 10011301…
FDA Device · Class II · 2018-11-14 · Carefusion 303 - ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catalog Number: P2845B Dental Posts are implanted into teeth for dental re…
FDA Device · Class II · 2018-11-14 · Coltene Whaledent - StageOne Hip, Models 431207 & 431209Usage: Product Usage: The single-use cement spacer molds are sterile disposables made of medical grade…
FDA Device · Class II · 2018-11-14 · Zimmer Biomet - Endoform Dermal Template 2x2, SKU 529312 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extrace…
FDA Device · Class II · 2018-11-14 · Aroa Biosurgery - CoaguChek¿ XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160
FDA Device · Class I · 2018-11-14 · Roche Diagnostics - PCEA ASV Yellow Microbore, Catalog Numbers 30893, 30893-07 Product Usage: PCEA Administration Set
FDA Device · Class II · 2018-11-14 · Becton Dickinson And - Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usage: The Philips Vereos PET/CT system is a diagnostic imaging device…
FDA Device · Class II · 2018-11-07 · Philips Medical Systems Cleveland - Cardiosave Hybrid IABP, Part Number 0998-00-0800-53
FDA Device · Class I · 2018-11-07 · Maquet Datascope Cardiac Assist Division - Zilver 635 Biliary Stent 4mm x 80mm, Catalog Number: ZIB6-80-4.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for p…
FDA Device · Class II · 2018-11-07 · Cook Medical - Zilver 518 Biliary Stent 4mm x 80mm, Catalog Number: ZIB5-125-4.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for…
FDA Device · Class II · 2018-11-07 · Cook Medical - Zilver 635 Biliary Stent 14mm x 80mm, Catalog Number: ZIB6-80-14.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for…
FDA Device · Class II · 2018-11-07 · Cook Medical - Zilver 635 Biliary Stent 14mm x 80mm, Catalog Number: ZIB6-125-14.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended fo…
FDA Device · Class II · 2018-11-07 · Cook Medical - Ingenuity CT (Model No. 728326), software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectiona…
FDA Device · Class II · 2018-11-07 · Philips Medical Systems Cleveland - Roche Diagnostics URISYS 1100 Urine Analyzer Part Number: 03617556001 Product Usage: The URISYS 1100 Urine Analyzer is a reflectance photom…
FDA Device · Class II · 2018-11-07 · Roche Diagnostics - Brilliance Big Bore Radiology CT (Model No. 728244) software version 4.2.0 Product Usage: Computed Tomography X-ray systems intended to pro…
FDA Device · Class II · 2018-11-07 · Philips Medical Systems Cleveland - Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media used with supplements as a selective and differential medium…
FDA Device · Class III · 2018-11-07 · Acumedia Manufacturers
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)