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.
- Hitachi Oasis MRI system Product Usage: Hitachi MR system is an imaging device and is intended to provide the physician with physiological…
FDA Device · Class II · 2018-07-25 · Hitachi Medical Systems America - PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
FDA Device · Class II · 2018-07-25 · Ethicon - Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm Vascular/Medium, Item Code SIG30AVM
FDA Device · Class II · 2018-07-25 · Covidien Medtronic - PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
FDA Device · Class II · 2018-07-25 · Ethicon - ADVANSYS TTC, Model Numbers: 181011S, 181012S, 181013S, 181014S, 181001S, 181002S, 181003S & 181004S
FDA Device · Class II · 2018-07-25 · Newdeal - Proteus 235, Universal Nozzle with snout 300x400
FDA Device · Class II · 2018-07-25 · Ion Beam Applications - Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Double Spike and no Probe, Ref ASC1221, packaged 1/box, 12 boxes/case,…
FDA Device · Class II · 2018-07-25 · Cardinal Health 200 - PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
FDA Device · Class II · 2018-07-25 · Ethicon - PROLENE SUTURE 24"(60CM) 7-0 BLUE, D8881
FDA Device · Class II · 2018-07-25 · Ethicon - Hydroline Trumpet Valve, Trumpet Valve, No Probe, Double Spike, Ref ASU1221, packaged 1/box, 12 boxes/case, single use, RX, Sterile
FDA Device · Class II · 2018-07-25 · Cardinal Health 200 - Hydroline Trumpet Valve, Trumpet Valve, 5mm x 28cm Probe, Single Spike, Ref ASU1210, packaged 1/box, 12 boxes/case, single use, RX, Sterile…
FDA Device · Class II · 2018-07-25 · Cardinal Health 200 - Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Single Spike and no Probe, Ref ASC1220, packaged 1/box, 12 boxes/case,…
FDA Device · Class II · 2018-07-25 · Cardinal Health 200 - Endo GIA 45 mm Extra Thick Black Articulating Reload with Tri-Staple Technology, Item Code EGIA45AXT
FDA Device · Class II · 2018-07-25 · Covidien Medtronic - Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part Number 9735559, Visualase¿ Cooled Laser Applicator System 3mm Tip
FDA Device · Class II · 2018-07-25 · Medtronic Navigation - MED-RX, Ref 54-1650R 5Fr X 16 inch (40cm) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Connector,…
FDA Device · Class II · 2018-07-25 · Canadian Hospital Specialties - PROLENE SUTURE BLUE 48" 4-0 D/A SH-1, D9746
FDA Device · Class II · 2018-07-25 · Ethicon - AesDex, LLC Cardica C-Port Flex-A PLUS Distal Anastomosis System, Catalog Number: FG-000150 The Cardica C-Port Flex-A PLUS Distal Anastomos…
FDA Device · Class II · 2018-07-25 · Aesdex - T2100 Micro flex Drive Treadmill, powered Product Usage: Powered exercise equipment consist of powered devices intended for medical purpose…
FDA Device · Class II · 2018-07-25 · Ge Medical Systems Ultrasound And Primary Care Diagnostics Ll - VOLISTA StandOP Surgical Light, ARD568811961 VLT600DF AIM STP
FDA Device · Class II · 2018-07-25 · Maquet Sas - PROLENE SUTURE 4-36"(90CM) 4-0 BLUE, D5988
FDA Device · Class II · 2018-07-25 · Ethicon - Fx SOLUTIONS OFFSET HEAD CoCr 50x20, REF 106-5000 Product Usage: Device is designed to produce and deliver proton beam for the treatment of…
FDA Device · Class II · 2018-07-25 · Fx Solutions - Hydroline Trumpet Valve with Pulse Wave Cassette, Cassette Trumpet Valve with Bariatric Probe, Double Spike, Ref ABP1201, packaged 1/box, 1…
FDA Device · Class II · 2018-07-25 · Cardinal Health 200 - Endo GIA 60 mm Articulating Medium/Thick Reload with Tri-StapleTechnology, Item Code EGIA60AMT
FDA Device · Class II · 2018-07-25 · Covidien Medtronic - Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system , Item Code EGIA30CTAV
FDA Device · Class II · 2018-07-25 · Covidien Medtronic - Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
FDA Device · Class II · 2018-07-25 · Edwards Lifesciences - AdvanDx QuickFISH Slides, a component of the QuickFish BC Fixation Kit - BC, REF QFFIXBC1-25, Catalog Number: CS012 Control slides included…
FDA Device · Class II · 2018-07-25 · Opgen - Endo GIA 45mm Gray Articulating Vascular Reload with Tri-Staple Technology, Item Code EGIA45AV
FDA Device · Class II · 2018-07-25 · Covidien Medtronic - Endo GIA 45mm Curved Tip Articulating Vascular/Medium Reload with Tri-Staple Technology, Item Code EGIA45CTAVM
FDA Device · Class II · 2018-07-25 · Covidien Medtronic - Endo GIA 60 mm Extra Thick Black Articulating Reload with Tri-Staple Technology, Item Code EGIA60AXT
FDA Device · Class II · 2018-07-25 · Covidien Medtronic - t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware version: 004722, Firmware, Fuel Gauge, Binary Rev B
FDA Device · Class II · 2018-07-25 · Tandem Diabetes Care - PROLENE SUTURE 36"(90CM) 4-0 BLUE, D9067
FDA Device · Class II · 2018-07-25 · Ethicon - PROLENE SUTURE 4-36" (90CM) 3-0 BLUE, D6416
FDA Device · Class II · 2018-07-25 · Ethicon - Large QWIX, Model Numbers: 111740S, 111745S, 111750S, 111755S, 111760S, 111765S, 111770S, 111775S, 111780S, 111785S, 111790S, 111795S, 1118…
FDA Device · Class II · 2018-07-25 · Newdeal - PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
FDA Device · Class II · 2018-07-25 · Ethicon - Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system 30 mm Vascular/Medium, Item Code SIG30ACTAVM
FDA Device · Class II · 2018-07-25 · Covidien Medtronic - Discovery IGS 730 Interventional Fluoroscopic X-ray Systems
FDA Device · Class II · 2018-07-18 · Ge Medical Systems Scs - Femoral Nail, RIGHT T2 GTN ¿14x460 mm, Product Number 18511446S
FDA Device · Class II · 2018-07-18 · Stryker - BioMerieux mini VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV) is an automat…
FDA Device · Class II · 2018-07-18 · Biomerieux - FDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZER, NSN: 6530-01-641-4641 Product Usage: The Fort Defiance Industries Auto…
FDA Device · Class II · 2018-07-18 · Fort Defiance Industries - Femoral Nail, LEFT T2 GTN ¿12x360 mm, Product Number 18501236S
FDA Device · Class II · 2018-07-18 · Stryker - VPS TipTracker Stylet Accessory, REF RHY-177-TTSAP Product Usage: To provide real time tip location information of a central venous cathete…
FDA Device · Class II · 2018-07-18 · Arrow International - BARD MYPICC Kit, REF CK000095B, 5F French Size, packaged 5 kits/case, Sterile, RX, For use in vascular access procedures
FDA Device · Class II · 2018-07-18 · Medline Industries - VPS Rhythm ECG Accessory Pack, REF RHY-100-ECGO Product Usage: To provide real time tip location information of a central venous catheter b…
FDA Device · Class II · 2018-07-18 · Arrow International - Percepta CRT-P MRI SureScan, REF W1TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization the…
FDA Device · Class II · 2018-07-18 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Ankle Arthrodesis Nail, right T2 Ankle ¿11x300mm, Product Number 18191130S
FDA Device · Class II · 2018-07-18 · Stryker - LigaSure" Exact Dissector Nano Coated 20.6mm-21cm Product Usage: A bipolar electrosurgical instrument intended for use in open surgical pro…
FDA Device · Class II · 2018-07-18 · Covidien - Hyalomatrix, Product nos. 651105, 651103, 651104, and 651301 Product Usage: Hyalomatrix is a bi-layered, sterile, flexible, and comfortable…
FDA Device · Class II · 2018-07-18 · Anika Therapeutics - Elecsys Vitamin D total II, Vitamin D Test System, Material number 07464215160 Product Usage: This assay is intended for the quantitative d…
FDA Device · Class II · 2018-07-18 · Roche Diagnostics - Femoral Nail, A/R T2 Femur ¿10x340 mm, Product Number 18251034S
FDA Device · Class II · 2018-07-18 · Stryker - Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153V…
FDA Device · Class II · 2018-07-18 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153AT…
FDA Device · Class II · 2018-07-18 · Medtronic Cardiac Rhythm And Heart Failure Crhf - BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235, 920654335A, and 920674235A. (The differences in the reor…
FDA Device · Class II · 2018-07-18 · Smiths Medical Asd - Medtronic EnTrust Dual Chamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154AT…
FDA Device · Class II · 2018-07-18 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Medtronic EnTrust Escudo D144DRG (OUS distribution) Product Usage: The implantable cardioverter defibrillator is intended to provide ventri…
FDA Device · Class II · 2018-07-18 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154V…
FDA Device · Class II · 2018-07-18 · Medtronic Cardiac Rhythm And Heart Failure Crhf - PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient treatment options
FDA Device · Class II · 2018-07-18 · Dako North America - Vacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-ISU) Product Usage: The vacuum regulator is intended to be used in a medical fa…
FDA Device · Class II · 2018-07-18 · Ohio Medical - Medtronic EnTrust Escudo D144VRC (OUS distribution) Product Usage: The implantable cardioverter defibrillator is intended to provide ventri…
FDA Device · Class II · 2018-07-18 · Medtronic Cardiac Rhythm And Heart Failure Crhf - AperFix AM Femoral Implant, Model numbers CM-2409 (9mm x 24 mm) and CM-2410 (10 mm x 24 mm)
FDA Device · Class II · 2018-07-18 · Cayenne Medical - Femoral Nail, A/R T2 Femur ¿10x320 mm, Product Number 18251032S
FDA Device · Class II · 2018-07-18 · Stryker - Percepta Quad CRT-P MRI SureScan, REF W4TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronizatio…
FDA Device · Class II · 2018-07-18 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Femoral Nail, LEFT T2 GTN ¿14x300 mm, Product Number 18501430S
FDA Device · Class II · 2018-07-18 · Stryker - Discovery IGS 740 Interventional Fluoroscopic X-ray Systems
FDA Device · Class II · 2018-07-18 · Ge Medical Systems Scs - VPS Rhythm ECG Accessory Pack with Johans Adapter, REF RHY-100-ECGJ Product Usage: To provide real time tip location information of a centr…
FDA Device · Class II · 2018-07-18 · Arrow International - Tibial Nail, Standard T2 Tibia ¿12x315 mm, Product Number 18221231S
FDA Device · Class II · 2018-07-18 · Stryker - Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems
FDA Device · Class II · 2018-07-18 · Ge Medical Systems Scs - NOVAPLUS(R) Pregnancy Cassette Device with Droppers, Urine hCG Pregnancy Cassette, Cat
FDA Device · Class II · 2018-07-18 · Ekla - Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronizatio…
FDA Device · Class II · 2018-07-18 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The CrAg Lateral Flow Assay is an immunochromatographic t…
FDA Device · Class II · 2018-07-18 · Immuno Mycologics - Ankle Arthrodesis Nail, right T2 Ankle ¿10x300mm, Product Number 18191030S
FDA Device · Class II · 2018-07-18 · Stryker - da Vinci Xi EndoWrist Stapler 45 Reload Green, Model 48445G-03, 12 reloads/box
FDA Device · Class II · 2018-07-18 · Intuitive Surgical - Femoral Nail, LEFT T2 GTN ¿10x360 mm, Product Number 18501036S
FDA Device · Class II · 2018-07-18 · Stryker - Femoral Nail, A/R, R1500 T2 Femur ¿12x360 mm, Product Number 18281236S
FDA Device · Class II · 2018-07-18 · Stryker - Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Catheter, catalog numbers D135303 and D135304
FDA Device · Class II · 2018-07-18 · Stryker Sustainability Solutions - Femoral Nail, A/R T2 Femur ¿12x360 mm, Product Number 18251236S
FDA Device · Class II · 2018-07-18 · Stryker - BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*) Product Usage: the Quality Control VIDAS (QCV) is an automated te…
FDA Device · Class II · 2018-07-18 · Biomerieux - Femoral Nail, A/R, R1500 T2 Femur ¿12x300 mm, Product Number 18281230S
FDA Device · Class II · 2018-07-18 · Stryker - da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box
FDA Device · Class II · 2018-07-18 · Intuitive Surgical - Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003 Product Usage: The Reliance 1227 Cart and Utensil Washer/Disi…
FDA Device · Class II · 2018-07-18 · Steris - Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A device designed to produce and deliver a proton beam for the treatment of…
FDA Device · Class II · 2018-07-18 · Ion Beam Applications - Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization the…
FDA Device · Class II · 2018-07-18 · Medtronic Cardiac Rhythm And Heart Failure Crhf - Femoral Nail, A/R, R1500 T2 Femur ¿10x320 mm, Product Number 18281032S
FDA Device · Class II · 2018-07-18 · Stryker - Femoral Nail, A/R T2 Femur ¿15x240 mm, Product Number 18251524S
FDA Device · Class II · 2018-07-18 · Stryker - Elecsys Vitamin D total II, Vitamin D Test System, Material number 07028148190 Product Usage: This assay is intended for the quantitative d…
FDA Device · Class II · 2018-07-18 · Roche Diagnostics - Peripherally Inserted Midline Catheter Kit with Placement Wire, REF MK-02031-TW Product Usage: To provide real time tip location informatio…
FDA Device · Class II · 2018-07-18 · Arrow International - Femoral Nail, A/R, R1500 T2 Femur ¿12x380 mm, Product Number 18281238S
FDA Device · Class II · 2018-07-18 · Stryker - Femoral Nail, RIGHT T2 GTN ¿9x320 mm, Product Number 18510932S
FDA Device · Class II · 2018-07-18 · Stryker - microTargeting" Drive System Distributed by Medtronic, Product Number FC1006
FDA Device · Class II · 2018-07-11 · Fhc - Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 11
FDA Device · Class II · 2018-07-11 · Zimmer Biomet - Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 16.25
FDA Device · Class II · 2018-07-11 · Zimmer Biomet - Ratcheting Cannulated Driver Handle, Catalog #: 210-00-004, Rx Only, Non Sterile
FDA Device · Class II · 2018-07-11 · Trilliant Surgical - microTargeting" Lead Adapter for microTargeting" Drive, Product Number 66-CN-DB
FDA Device · Class II · 2018-07-11 · Fhc - Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model 3650) is a portable, external device used to support the implanted de…
FDA Device · Class II · 2018-07-11 · St Jude Medical - Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 17.5
FDA Device · Class II · 2018-07-11 · Zimmer Biomet - microTargeting" Drive System, Product Number 66-ZD-MD-01
FDA Device · Class II · 2018-07-11 · Fhc - Vulcan Fast Red Chromogen Kit 2, part of an immunohistochemistry (IHC) procedure using an alkaline phosphatase (AP) detection system
FDA Device · Class II · 2018-07-11 · Biocare Medical - LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-144
FDA Device · Class II · 2018-07-11 · Howmedica Osteonics - LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-336
FDA Device · Class II · 2018-07-11 · Howmedica Osteonics - VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic
FDA Device · Class II · 2018-07-11 · Ortho Clinical Diagnostics - LFIT Anatomic CoCr Femoral Heads, 6260-9-036
FDA Device · Class II · 2018-07-11 · Howmedica Osteonics
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)