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.
- Affixus Hip Fracture Nail, LH 125 DEG 9MM X 440MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, RH 125 DEG 11MM X 440MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, RH 125 DEG 11MM X 460MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, RH 130 DEG 11MM X 360MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, LH 125 DEG 11MM X 320MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, RH 130 DEG 9MM X 320MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591
FDA Device · Class II · 2018-02-07 · Alere San Diego - Affixus Hip Fracture Nail, LH 130 DEG 11MM X 400MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, RH 130 DEG 9MM X 340MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers Device is an endodontic root canal plugger
FDA Device · Class II · 2018-02-07 · Ormco Sybronendo - SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE This product line is intended for use in orthopaedic surgery (large an…
FDA Device · Class II · 2018-02-07 · Microaire Surgical Instruments - Affixus Hip Fracture Nail, RH 125 DEG 9MM X 420MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, RH 125 DEG 9MM X 320MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 - Elecsys 2010 analyzer (d…
FDA Device · Class II · 2018-02-07 · Roche Diagnostics - Affixus Hip Fracture Nail, RH 130 DEG 9MM X 440MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Hemofiltration Standard Pack including BC 60 Plus-T 8036
FDA Device · Class II · 2018-02-07 · Maquet - Affixus Hip Fracture Nail, RH 130 DEG 13MM X 280MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, LH 125 DEG 9MM X 380MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, 125 DEG 9MM X 180MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Affixus Hip Fracture Nail, RH 130 DEG 9MM X 260MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930
FDA Device · Class II · 2018-02-07 · Tosoh Bioscience - MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets
FDA Device · Class II · 2018-02-07 · Stryker Medical Division - Affixus Hip Fracture Nail, RH 130 DEG 9MM X 300MM
FDA Device · Class II · 2018-02-07 · Zimmer Biomet - GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 The CARESCAPE Central Station is intended to collect information from…
FDA Device · Class II · 2018-02-07 · Ge Medical Systems Information Technologies - BD MAXTM Vaginal Panel
FDA Device · Class II · 2018-01-31 · Becton Dickinson And - BD MAX" UVE Specimen Collection Kit
FDA Device · Class II · 2018-01-31 · Becton Dickinson And - Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tomography X-ray systems
FDA Device · Class II · 2018-01-31 · Philips Medical Systems Cleveland - Brilliance iCT - Model 728306 Computed Tomography X-ray systems
FDA Device · Class II · 2018-01-31 · Philips Medical Systems Cleveland - smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STOUT STRAIGHT PLA…
FDA Device · Class II · 2018-01-31 · Smith And Nephew - CP5 Centrifugal Pump, made up of the drive unit, the emergency system and the pump control panel
FDA Device · Class II · 2018-01-31 · Sorin Group Deutschland - MARS Treatment Kit, Use only with MARS(R) Monitor 1TC, GAMBRO, Product Code 800541
FDA Device · Class II · 2018-01-31 · Baxter Healthcare - TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE
FDA Device · Class II · 2018-01-31 · Somatex Medical Technologies - Radial Osteotome Blade, REF 71369314
FDA Device · Class II · 2018-01-31 · Smith And Nephew - smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx only, (01)00885556456446(10), (11)…
FDA Device · Class II · 2018-01-31 · Smith And Nephew - PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S
FDA Device · Class II · 2018-01-31 · Inovo - daVinci X EndoWrist(R) Stapler 45, REF 470298 Product Usage: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads, and other Sta…
FDA Device · Class II · 2018-01-31 · Intuitive Surgical - BD MAX" CT/GC/TV. Catalog Number(s): 443824,442970,443590 (RUO).for collection and transport of vaginal and endocervical swab specimens, in…
FDA Device · Class II · 2018-01-31 · Becton Dickinson And - OSCILLATING SAW ATTACHMENT Surgical instrument motors and accessories/attachments are intended for use during surgical procedures to cut ha…
FDA Device · Class II · 2018-01-31 · The Anspach Effort - smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STRAIGHT PLATE, 8…
FDA Device · Class II · 2018-01-31 · Smith And Nephew - Infant AirLife single-limb, continuous-flow circuit (Model AH132) containing AirLife Humidification Chamber, Model Number AH290
FDA Device · Class I · 2018-01-31 · Vyaire Medical - MyCareLink Smart Patient Monitors
FDA Device · Class II · 2018-01-31 · Medtronic Cardiac Rhythm And Heart Failure - Infant AirLife Dual-,limb, dual-heat, high-flow circuit (Model AH265) with AirLife Humidification Chamber, Model Number AH290
FDA Device · Class I · 2018-01-31 · Vyaire Medical - Adult AirLife dual-limb, dual-heat circuit (Model AH280) with AirLife Humidification Chamber, Model Number AH290
FDA Device · Class I · 2018-01-31 · Vyaire Medical - Measurement Specialties Reusable Temperature Probe Autoclavable
FDA Device · Class II · 2018-01-31 · Measurement Specialties - Adult Air-Life single-limb circuit (Model AH202) with AirLife Humidification Chamber, Model Number AH290
FDA Device · Class I · 2018-01-31 · Vyaire Medical - Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401
FDA Device · Class II · 2018-01-31 · Smith And Nephew - MyCareLink Patient Monitors
FDA Device · Class II · 2018-01-31 · Medtronic Cardiac Rhythm And Heart Failure - Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Communication System (PACS) intended to display, process, read, rep…
FDA Device · Class II · 2018-01-31 · Siemens Medical Solutions Usa - ACCOLADE MRI SR Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplicare Povidone Iodine P…
FDA Device · Class II · 2018-01-24 · Deroyal Industries - ALTRUA 2 DR Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - ACCOLADE EL DR Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Com…
FDA Device · Class II · 2018-01-24 · Roche Diagnostics - ACCOLADE MRI DR Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - Intellicuff Standalone (PN 951001) Used to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tu…
FDA Device · Class II · 2018-01-24 · Hamilton Medical - Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter
FDA Device · Class II · 2018-01-24 · Stryker Neurovascular - Affirm Lateral Arm Upright Biopsy Accessory
FDA Device · Class II · 2018-01-24 · Hologic - Brilliance 64, (Code 728231) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at…
FDA Device · Class II · 2018-01-24 · Philips Medical Systems Cleveland - ALTRUA 2 SR Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (…
FDA Device · Class II · 2018-01-24 · Fujifilm Medical Systems U - ESSENTIO MRI EL DR Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - PROPONENT MRI Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 16 MM, REF TRY-PS-40 16-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Pla…
FDA Device · Class II · 2018-01-24 · Spineart - PROPONENT SR Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - PriMatrix¿ is an acellular dermal tissue matrix derived from fetal bovine dermis
FDA Device · Class II · 2018-01-24 · Tei Biosciences - ACCOLADE MRI EL DR Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles
FDA Device · Class II · 2018-01-24 · Owen Mumford Usa - VISIONIST X4 CRT-P Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles
FDA Device · Class II · 2018-01-24 · Owen Mumford Usa - TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 12 MM, REF TRY-PS-40 12-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Pla…
FDA Device · Class II · 2018-01-24 · Spineart - TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 14 MM, REF TRY-PS-45 14-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Pla…
FDA Device · Class II · 2018-01-24 · Spineart - ACCOLADE SR Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - RayStation Product Usage: is a software system designed for treatment planning and analysis of radiation therapy
FDA Device · Class II · 2018-01-24 · Raysearch Laboratories Ab - TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 18 MM, REF TRY-PS-45 18-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Pla…
FDA Device · Class II · 2018-01-24 · Spineart - Small Particle Aerosol Generator Model SPAG-2 6000 Series (SPAG-2)
FDA Device · Class II · 2018-01-24 · Valeant Pharmacueticals International - Brilliance iCT Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different ang…
FDA Device · Class II · 2018-01-24 · Philips Medical Systems Cleveland - PROPONENT VDD SL Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - Persona Partial Knee System, Size 8, Finishing Guide
FDA Device · Class II · 2018-01-24 · Zimmer Biomet - PROPONENT EL DR Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01
FDA Device · Class II · 2018-01-24 · Zoll Manufacturing - Aspire HD Plus (FDR MS-2500), also known as Aspire HD Plus F and Aspire HD-s (FDR MS-2000), also known as Aspire HD Plus S). Mammography ma…
FDA Device · Class II · 2018-01-24 · Fujifilm Medical Systems U - ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units of Philips sync cables model M1783A and M5526A as well as Philips…
FDA Device · Class II · 2018-01-24 · Philips Electronics North America - Ingenuity Core 128, (Code 728323) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data tak…
FDA Device · Class II · 2018-01-24 · Philips Medical Systems Cleveland - Ingenuity Core, (Code 728321) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken a…
FDA Device · Class II · 2018-01-24 · Philips Medical Systems Cleveland - PROPONENT DR Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - ESSENTIO MRI SR Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 16 MM, REF TRY-PS-45 16-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Pla…
FDA Device · Class II · 2018-01-24 · Spineart - ESSENTIO DR Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - ALTRUA 2 EL DR Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - ESSENTIO SR Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - ESSENTIO MRI DR Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 14 MM, REF TRY-PS-40 14-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Pla…
FDA Device · Class II · 2018-01-24 · Spineart - VISIONIST CRT-P Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R
FDA Device · Class II · 2018-01-24 · Medtronic Sofamor Danek Usa - ESSENTIO EL DR Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - ACCOLADE DR Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 12 MM, REF TRY-PS-45 12-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Pla…
FDA Device · Class II · 2018-01-24 · Spineart - Phadia 1000 Instrument, Article Number 12-3800-01
FDA Device · Class II · 2018-01-24 · Phadia Us - VALITUDE CRT-P Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific - VALITUDE X4 CRT-P Pacemaker
FDA Device · Class II · 2018-01-24 · Boston Scientific
Other years
2026 (2,088) · 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)