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.
- Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 2.4 mm Diameter, 70 cm Length Item Number: 47-2490-098-01 Product Usage: A single use s…
FDA Device · Class II · 2018-12-12 · Zimmer Biomet - Optional MDRC-1119 Front Cover Attachment Kit for review display monitors
FDA Device · Class II · 2018-12-12 · Barco N V - Brilliance 6 Slice (Air), Model 728256 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the b…
FDA Device · Class II · 2018-12-12 · Philips Medical Systems Cleveland - Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Smooth, 2.4 mm Diameter, 70 cm Length Item Number: 00-2255-025-00 Product Usage:…
FDA Device · Class II · 2018-12-12 · Zimmer Biomet - Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number: 00-2228-024-00 Product Usage:…
FDA Device · Class II · 2018-12-12 · Zimmer Biomet - Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 2.4 mm Diameter, 100 cm Length Item Number: 47-2237-033-00 Product Usage: A single u…
FDA Device · Class II · 2018-12-12 · Zimmer Biomet - Zimmer Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item Number: 47-2255-008-01 Product Usage: A single use surgical inst…
FDA Device · Class II · 2018-12-12 · Zimmer Biomet - Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 3.0 mm Diameter, 70 cm Length Item Number: 47-2490-098-00 Product Usage: A single use s…
FDA Device · Class II · 2018-12-12 · Zimmer Biomet - Thermacare HeatWraps Menstrual a) UPC 0573302002 b) UPC 0573302044 Product Usage: Provides heat therapy for temporary relief of minor menst…
FDA Device · Class II · 2018-12-12 · Pfizer - Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077
FDA Device · Class II · 2018-12-12 · Capintec - Brilliance 16 Slice (Air), Model 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the…
FDA Device · Class II · 2018-12-12 · Philips Medical Systems Cleveland - Invacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P The intended use of a Non-AC-Powered patient lift is to lift and…
FDA Device · Class II · 2018-12-12 · Invacare - Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme Control Cat
FDA Device · Class III · 2018-12-12 · Helena Laboratories - Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Bullet Tip, 2.4 mm Diameter, 70 cm Length Item Number: 00-2255-026-00 Product Usa…
FDA Device · Class II · 2018-12-12 · Zimmer Biomet - Biomet 20mm Compress Device Short Anchor Plug With Drill Set / With Pin Inserter Ion Implant Item number: 178562 Product Usage: 1. Correcti…
FDA Device · Class II · 2018-12-12 · Zimmer Biomet - Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128
FDA Device · Class II · 2018-12-12 · Atrium Medical - Brilliance 16 Slice (Power), Model 728240 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of th…
FDA Device · Class II · 2018-12-12 · Philips Medical Systems Cleveland - Thermacare Muscle Pain Therapy HeatWraps: a) UPC 0573301314 b) UPC 0573301303 Product Usage: Provides heat therapy for temporary relief of…
FDA Device · Class II · 2018-12-12 · Pfizer - Brilliance 40, Model 728235 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by comp…
FDA Device · Class II · 2018-12-12 · Philips Medical Systems Cleveland - GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (single pack) b) 2083208-001 (box of ten singles) The C…
FDA Device · Class I · 2018-12-12 · Ge Healthcare - Thermacare HEATWRAPS JOINT PAIN THERAPY, 8 HEATWRAPS
FDA Device · Class II · 2018-12-12 · Pfizer - Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 3.0 mm Diameter, 100 cm Length Item Number: 47-2490-097-00 Product Usage: A single use…
FDA Device · Class II · 2018-12-12 · Zimmer Biomet - Captus 700 Thyroid Uptake System, Model # 5430-3137 and 5430-3138
FDA Device · Class II · 2018-12-12 · Capintec - Artis Zee and Zeego, model no. 10272462 AXIOM Artis zee/Zeego is a family of dedicated angiography systems developed for single and biplane…
FDA Device · Class II · 2018-12-12 · Siemens Medical Solutions Usa - Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 2.4 mm Diameter, 100 cm Length Item Number: 47-2490-097-01 Product Usage: A single use…
FDA Device · Class II · 2018-12-12 · Zimmer Biomet - STEPHANIX D2RS Digital Dynamic Remote Systemhttp://cts.fda.gov/division-tracking/images/trash.png Product The D2RS Digital Dynamic Remote S…
FDA Device · Class II · 2018-12-12 · Stephanix - Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number: 00-2228-024-00 Product Usage:…
FDA Device · Class II · 2018-12-12 · Zimmer Biomet - Brilliance 10 Slice (Air), Model 728251 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the…
FDA Device · Class II · 2018-12-12 · Philips Medical Systems Cleveland - Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY
FDA Device · Class II · 2018-12-12 · Helena Laboratories - Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 3.0 mm Diameter, 100 cm Length Item Number: 47-2237-037-00 Product Usage: A single u…
FDA Device · Class II · 2018-12-12 · Zimmer Biomet - NEOCONNECT, Enteral Extension with ENFit connector, REF EXT-60NC The NeoMed NeoConnect Enteral Only Extension Set is intended for use as an…
FDA Device · Class III · 2018-12-12 · Neomed - Brilliance 64, Model 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by comp…
FDA Device · Class II · 2018-12-12 · Philips Medical Systems Cleveland - Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item Number: 47-2237-038-00 Product Usag…
FDA Device · Class II · 2018-12-12 · Zimmer Biomet - AIA-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated Immunoassay Analyzer is for use in vitro diagnostic to provide te…
FDA Device · Class II · 2018-12-12 · Tosoh Bioscience - Zimmer Humeral Guide Wire - Ball Tip, 2.4 mm Diameter, 70 cm Length Item Number: 47-2255-008-00 Product Usage: A single use surgical instru…
FDA Device · Class II · 2018-12-12 · Zimmer Biomet - QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO 11000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055207 The membr…
FDA Device · Class I · 2018-12-05 · Maquet Cardiovascular Us Sales - NxStage PureFlow B Solution-RFP-RFP-454, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal re…
FDA Device · Class II · 2018-12-05 · Nxstage Medical - Dash 4000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients
FDA Device · Class II · 2018-12-05 · Ge Healthcare - BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2 Product Usage: BrightMatter Guide can navigate a third-party…
FDA Device · Class I · 2018-12-05 · Synaptive Medical - Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA06100 Product Usage: Recommended for use in catheterization for angiography of c…
FDA Device · Class II · 2018-12-05 · Numed - PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow Tube Set is a single use sterile tube set used in combination wit…
FDA Device · Class II · 2018-12-05 · Wom World - Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars12x100mm - Product Usage: Physical Product Descriptio…
FDA Device · Class II · 2018-12-05 · Stryker Sustainability Solutions - Solar 8000M Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients
FDA Device · Class II · 2018-12-05 · Ge Healthcare - QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055120 The me…
FDA Device · Class I · 2018-12-05 · Maquet Cardiovascular Us Sales - AIA-900 Automated Immunoassay Analyzer, product code 022930 /022930R Product Usage: The AIA-900 is capable of performing three methods of i…
FDA Device · Class II · 2018-12-05 · Tosoh Bioscience - Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialysis
FDA Device · Class III · 2018-12-05 · Fresenius Medical Care Renal Therapies Group - NxStage PureFlow B Solution-RFP-404, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replac…
FDA Device · Class II · 2018-12-05 · Nxstage Medical - NxStage PureFlow B Solution-RFP-402, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replac…
FDA Device · Class II · 2018-12-05 · Nxstage Medical - Solar 8000i Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients
FDA Device · Class II · 2018-12-05 · Ge Healthcare - NxStage PureFlow B Solution-RFP-401, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replac…
FDA Device · Class II · 2018-12-05 · Nxstage Medical - Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hemodialysis
FDA Device · Class III · 2018-12-05 · Fresenius Medical Care Renal Therapies Group - Medex High Pressure Stopcock used to control the direction of IV fluid flow
FDA Device · Class II · 2018-12-05 · Smiths Medical Asd - NxStage PureFlow B Solution-RFP-403, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replac…
FDA Device · Class II · 2018-12-05 · Nxstage Medical - NxStage PureFlow B Solution-RFP-400, Premixed Dialysate for Hemodialysis
FDA Device · Class II · 2018-12-05 · Nxstage Medical - PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1.0 with Hot Fix 2 Software intended to identify compounds in human samples b…
FDA Device · Class II · 2018-12-05 · Perkinelmer Health Sciences Canada - HemoTrol Level 2- In Vitro Diagnostic Hematology quality control mixture Catalogue number: 171.002.002 Eurotrol HemoLin is an assayed hemog…
FDA Device · Class II · 2018-12-05 · Eurotrol - HemoTrol Level 3- In Vitro Diagnostic Hematology quality control mixture
FDA Device · Class II · 2018-12-05 · Eurotrol - NxStage PureFlow B Solution-RFP-RFP-456, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal re…
FDA Device · Class II · 2018-12-05 · Nxstage Medical - NxStage PureFlow B Solution-RFP-406, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replac…
FDA Device · Class II · 2018-12-05 · Nxstage Medical - Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis
FDA Device · Class III · 2018-12-05 · Fresenius Medical Care Renal Therapies Group - Solar 9500 Information Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients
FDA Device · Class II · 2018-12-05 · Ge Healthcare - Dash 5000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients
FDA Device · Class II · 2018-12-05 · Ge Healthcare - Dash 3000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients
FDA Device · Class II · 2018-12-05 · Ge Healthcare - Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge, an in vitro diagnostic test for the quantitative measurement of lactate…
FDA Device · Class II · 2018-12-05 · Siemens Healthcare Diagnostics - Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA05100 Product Usage: Recommended for use in catheterization for angiography of c…
FDA Device · Class II · 2018-12-05 · Numed - BD Vacutainer Urine Collection Cups, Cat
FDA Device · Class II · 2018-11-28 · Becton Dickinson And - VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27
FDA Device · Class II · 2018-11-28 · Ortho Clinical Diagnostics - Insulia Diabetes Management Companion
FDA Device · Class II · 2018-11-28 · Voluntis - Tosoh AIA-900 immunoassay Analyzer
FDA Device · Class II · 2018-11-28 · Tosoh Bioscience - Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators an…
FDA Device · Class II · 2018-11-28 · The Binding Site Group - PremierPro Aluminum Adjustable Walker
FDA Device · Class II · 2018-11-28 · Svs - 1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 MPL With MXP Software BECKMAN COULTER flow cytometer for in vitro d…
FDA Device · Class I · 2018-11-28 · Beckman Coulter - Giraffe OmniBed Carestation
FDA Device · Class II · 2018-11-28 · Ge Healthcare - DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision OMX SR Imaging System is a piece of laboratory equipment for super…
FDA Device · Class II · 2018-11-28 · Ge Healthcare Biosciences - Panda Wall Mount warmer
FDA Device · Class II · 2018-11-28 · Ge Healthcare - Minicon Clinical Sample Concentrators for In Vitro Diagnostic Use 9031 (Model: Minicon B-15) & 9051 (Model: Minicon CS-15) Minicon concentr…
FDA Device · Class II · 2018-11-28 · Merck Millipore - Panda iRes Infant Radiant Warmer
FDA Device · Class II · 2018-11-28 · Ge Healthcare - KIT URIN CUP 16X100 8.0 CONI UA YEL, Cat
FDA Device · Class II · 2018-11-28 · Becton Dickinson And - Panda Freestanding Warmer
FDA Device · Class II · 2018-11-28 · Ge Healthcare - LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10
FDA Device · Class II · 2018-11-28 · Lemaitre Vascular - KIT URIN CUP PLC 16X100 10.0 UA YEL, Cat
FDA Device · Class II · 2018-11-28 · Becton Dickinson And - Giraffe Incubator Carestation
FDA Device · Class II · 2018-11-28 · Ge Healthcare - Giraffe Warmer
FDA Device · Class II · 2018-11-28 · Ge Healthcare - The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System The S-ICD System is intende…
FDA Device · Class II · 2018-11-28 · Boston Scientific - Sedecal NOVA FA DR System. for diagnostic radiography
FDA Device · Class II · 2018-11-28 · Sedecal - COULTER EPICS XL Flow Cytometer COULTER EPICS XL-MCL Flow Cytometer SYSTEM II Software
FDA Device · Class I · 2018-11-28 · Beckman Coulter - AIA-2000 Analyzer, Model Nos
FDA Device · Class II · 2018-11-28 · Tosoh Bioscience - Irrisept OR, Finished Bottle Assembly 450 ml STEP 1
FDA Device · Class II · 2018-11-28 · Medex Cardio Pulmonary D B A Smiths Medical - Ascom Telligence Nurse Call System
FDA Device · Class II · 2018-11-28 · Ascom Us - Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126
FDA Device · Class II · 2018-11-28 · Zimmer Biomet - BD Vacutainer Specimen Collection Cups, Cat
FDA Device · Class II · 2018-11-28 · Becton Dickinson And - Vanguard Knee System -PS Open Box Femoral Right, 65 mm Item Number:183108
FDA Device · Class II · 2018-11-28 · Zimmer Biomet - The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Device · Class II · 2018-11-21 · Stryker Medical Division - Affixus Hip Fracture Nail Left 125 Deg 11x300mm, Item Number 814411300 The Affixus Hip Fracture Nail System, comprised of short and long na…
FDA Device · Class II · 2018-11-21 · Zimmer Biomet - Affixus Hip Fracture Nail Left 125 Deg 9x165mm, Item Number 816709165 The Affixus Hip Fracture Nail System, comprised of short and long nai…
FDA Device · Class II · 2018-11-21 · Zimmer Biomet - Powdered Surgical Gloves, labeled as: a. Baxter and Ansell brand Powdered Surgical Gloves b. Powdered Surgical Gloves included in ACS surgi…
FDA Device · Class II · 2018-11-21 · American Contract Systems - OviTex 1S Reinforced BioScaffold 16x20cm, Part Number F10256-1620G
FDA Device · Class II · 2018-11-21 · Aroa Biosurgery - Dimension Lipase Flex Reagent Cartridge, Model Number 10460277 Product Usage: Dimension - The LIPL method is an in vitro diagnostic test fo…
FDA Device · Class II · 2018-11-21 · Siemens Healthcare Diagnostics - OviTex Reinforced BioScaffold 16x20cm, Part Number F10254-1620G
FDA Device · Class II · 2018-11-21 · Aroa Biosurgery - Affixus Hip Fracture Nail 130 Deg 12x165mm, Item Number 816812165 The Affixus Hip Fracture Nail System, comprised of short and long nails,…
FDA Device · Class II · 2018-11-21 · Zimmer Biomet
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)