FDA Device · 2015
FDA Device recalls in 2015
RecallRadar indexes 2,495 FDA Device recall notices published in 2015. By classification: 77 Class I, 2,300 Class II, 118 Class III.
- Allofix Insertion Kit, 2.0 mm, Single Drill, Product Usage: MTF Surgical Instruments are designed for the specific needs of the orthopedic…
FDA Device · Class II · 2015-07-22 · Musculoskeletal Transplant Foundation - Apex ARC Hip Stem, HA Coated, Size 5
FDA Device · Class II · 2015-07-22 · Omnilife Science - Sorin Stockert Heater-Cooler 3T, 240 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours
FDA Device · Class II · 2015-07-22 · Sorin Group Usa - RadiForce GX540, 5MP Monochrome LCD Monitor, Part Code No. 0FTD1826A5, 0FTD1826B5, 0FTD1826C5, UPC 690592034752
FDA Device · Class II · 2015-07-22 · Eizo - Etac Supporter toilet armrest Etac Supporter toilet armrests are foldable and have comfortable rounded grips for the hands
FDA Device · Class II · 2015-07-22 · Etac Supply Center Ab - Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm)
FDA Device · Class II · 2015-07-22 · Synthes - Alere i flu, Alere i, Alere Influenza A & B
FDA Device · Class II · 2015-07-22 · Alere Scarborough - Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval Kit, Article No. 37508 (Article No. 37882 was ass…
FDA Device · Class II · 2015-07-22 · Nobel Biocare Usa - Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA)
FDA Device · Class II · 2015-07-22 · Synthes Usa Products - Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System
FDA Device · Class II · 2015-07-22 · Nidek - RadiForce RX650, 6MP Color LCD Monitor, Part Code No. 0FTD1957A5, 0FTD195B5, UPC 690592037203
FDA Device · Class II · 2015-07-22 · Eizo - Exactech Ambassador Cervical Plate System The Exactech Ambassador Cervical Place System is intended for anterior cervical fixation (C2-T1)…
FDA Device · Class II · 2015-07-22 · Exactech - Sorin Stockert Heater-Cooler 3T, 127 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours
FDA Device · Class II · 2015-07-22 · Sorin Group Usa - Oxford Femoral Drill Guide Lateral IM Adapter Product Usage: Drill guide
FDA Device · Class II · 2015-07-22 · Biomet - BD Flow Cytometers
FDA Device · Class III · 2015-07-22 · Bd Biosciences Systems And Reagents - TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX
FDA Device · Class II · 2015-07-15 · Synthes - Knee Arthro Pack and Knee Arthro Pack II - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Plastic Pack and Plastic HNP Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - ComboMap Intravascular Flow and Pressure System
FDA Device · Class II · 2015-07-15 · Volcano - Lipo/Buttocks Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Lima Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless
FDA Device · Class I · 2015-07-15 · Covidien Formerly Nellcor Puritan Bennett - Block Versions Used by Dental Offices often referred to as chairside milling: Lava Ultimate Restorative for CEREC, Compatible with Sirona…
FDA Device · Class II · 2015-07-15 · 3m Health Care Business - Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile
FDA Device · Class II · 2015-07-15 · Rti Surgical Dba Pioneer Surgical Technology - Suction Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Pediatric Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Shoulder Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp
FDA Device · Class III · 2015-07-15 · Volk Optical - Neurosurgery Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Gyn Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff
FDA Device · Class I · 2015-07-15 · Covidien Formerly Nellcor Puritan Bennett - Surgical Pack and General Surgery Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Eye Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Bariatric Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Arthroscopy Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Vasc Custom Kit - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Mississippi Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Vein Pack, Vein Treatment II Pack, Vein Brunswick Pack, Vein No Lidocaine Pack, Vein Ablation Pack - contains Devon Light Glove Used during…
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Blepharoplasty Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - PowerPICC SOLO Catheter with Tip Location System (TLS) Stylet 4F Nurse Full Tray with Microintroducer (with Lidocain) The PowerPICC Solo ca…
FDA Device · Class III · 2015-07-15 · Bard Access Systems - Face Neck Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch
FDA Device · Class II · 2015-07-15 · Integra Lifesciences D B A Integra Pain Management - Tummy Tuck Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Upper Extremity Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Phleb Pack and Laser Phleb Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Advanced Vein Care - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Nakoma-SL Anterior Cervical Plating System's Variable Single Barrel Drill Guide Product Usage: The Nakoma-SL ACP System is intended for ant…
FDA Device · Class II · 2015-07-15 · Alliance Partners - Open Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Hand Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Vein & Vascular Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Philips GoSafe Communicator 7000L Personal emergency response system
FDA Device · Class II · 2015-07-15 · Lifeline Systems - Abdominal Pack and Abdom Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Vaginal Rejuvenation Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Standard Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Cysto Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30) a measuring exercise equipment device designed to provide active and passiv…
FDA Device · Class II · 2015-07-15 · Bte Technologies - Skin and Vein Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Head & Neck Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410
FDA Device · Class II · 2015-07-15 · Allergan - PowerPICC SOLO Catheter with Sherlock 3CG (TPS) Stylet 5F Maximal Barrier Tray with Microintroducer The PowerPICC Solo catheters are intend…
FDA Device · Class III · 2015-07-15 · Bard Access Systems - Laser Evlt Pack and Laser One Leg Evlt - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Face Lift Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Hand Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Glaucoma Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Stradi 4500 - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - ACL Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Face Lift Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible illumination of the…
FDA Device · Class II · 2015-07-15 · Maquet Cardiovascular Us Sales - General Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Lipo Pack, Liposuction Expended Pack, and Liposuction Tray - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System software version 3.6.1. In vit…
FDA Device · Class II · 2015-07-15 · Siemens Healthcare Diagnostics - Minor Pack and Minor Pack II Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - PowerPICC SOLO2 Catheter 4F Maximal Barrier Tray with Microintroducer (Single-Lumen) (Sherlock) The PowerPICC Solo catheters are intended f…
FDA Device · Class III · 2015-07-15 · Bard Access Systems - Custom Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - DND Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Breast Augmentation Pack and Breast Augmentation Expanded Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Endovenous Kit, Endo Pack and Endovenous Laser Kit - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Set Up Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Orthopedic Split Drape Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure System
FDA Device · Class II · 2015-07-15 · Volcano - ENT Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - A.L.P.S. Foot Locking Calcaneus Plate,Small-Right
FDA Device · Class II · 2015-07-15 · Biomet - Breast Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System
FDA Device · Class II · 2015-07-15 · Volcano - PowerPICC SOLO Catheter with Sherlock 3CG TPS Stylet 4F Maximal Barrier Tray with Microintroducer The PowerPICC Solo catheters are intended…
FDA Device · Class III · 2015-07-15 · Bard Access Systems - Podiatry Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Basic Pack - contains Devon Light Glove Used during surgery
FDA Device · Class II · 2015-07-15 · Stradis Healthcare - Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062
FDA Device · Class II · 2015-07-08 · Covidien - Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050
FDA Device · Class II · 2015-07-08 · Covidien - Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064P
FDA Device · Class II · 2015-07-08 · Covidien - GE Healthcare Innova IGS 620
FDA Device · Class II · 2015-07-08 · Ge Healthcare - Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341 08(17)191218(10)200827
FDA Device · Class II · 2015-07-08 · Rti Surgical Dba Pioneer Surgical Technology - SOMATOM Emotion 16
FDA Device · Class II · 2015-07-08 · Siemens Medical Solutions Usa - Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063
FDA Device · Class II · 2015-07-08 · Covidien - Infinite 200 in vitro diagnostic
FDA Device · Class II · 2015-07-08 · Tecan Us - Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 44cm Item Code: 8888146144P
FDA Device · Class II · 2015-07-08 · Covidien - GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Systems
FDA Device · Class II · 2015-07-08 · Ge Healthcare - Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145057CP
FDA Device · Class II · 2015-07-08 · Covidien - Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128459P
FDA Device · Class II · 2015-07-08 · Covidien - Hamilton Medical Infant Flow Sensor, single use, (1.88m), Part number 155500
FDA Device · Class II · 2015-07-08 · Hamilton Medical
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)