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.
- Boston Scientific, WATCHMAN Access System Access Sheath with Dilator, 14F Single curve( M635TU10060, TU1006) , 14F Double curve (M635TU2006…
FDA Device · Class II · 2015-09-23 · Boston Scientific - Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components of the Syn…
FDA Device · Class I · 2015-09-23 · Syncardia Systems - Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems
FDA Device · Class II · 2015-09-23 · Intuitive Surgical - Sony LMD-1951MD, Sony LMD1951MD/BS, Sony LMD-1951MC (Foreign) 19 inch medical grade liquid crystal display (LCD) Medical Monitors with ligh…
FDA Device · Class II · 2015-09-23 · Sony Medical Systems - Voyant Open Fusion Device Models: EB040 and EB040+ Product Usage: The Applied Voyant Open Fusion Device is designed for use with the Voyant…
FDA Device · Class II · 2015-09-23 · Applied Medical Resources - NICO Myriad Console Model number NN-7000 The Myriad System is a surgical system specifically designed for morcellation of soft tissue
FDA Device · Class II · 2015-09-23 · Nico - XGAUZE Trauma Dressing, catalog number FIN-0002-01
FDA Device · Class II · 2015-09-23 · Revmedx - MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml
FDA Device · Class II · 2015-09-23 · Medtestdx - The Leica ASP200S/ASP300S Tissue Processor
FDA Device · Class III · 2015-09-23 · Leica Microsystems - UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous dental implant to support a prosthetic device in a partially or c…
FDA Device · Class II · 2015-09-23 · Biomet 3i - CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices
FDA Device · Class II · 2015-09-23 · Advanced Sterilization Products - Maryland Dissector
FDA Device · Class II · 2015-09-16 · Intuitive Surgical - 2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit, Model Number 310-30-003, Lot Number TSL002605, NON-STERILE. For use with the Gridlock Plati…
FDA Device · Class II · 2015-09-16 · Trilliant Surgical - Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING DYSPLASIA CUP W/IMPACTOR, REF Numbers: 74120246 (46 MM), 74122248 (48 MM), 74120250 (50 MM),…
FDA Device · Class II · 2015-09-16 · Smith And Nephew - CDI 500 Blood Parameter Monitoring System
FDA Device · Class II · 2015-09-16 · Terumo Cardiovascular Systems - Crocodile Grasper
FDA Device · Class II · 2015-09-16 · Intuitive Surgical - MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconcentrators)
FDA Device · Class II · 2015-09-16 · Medtronic Perfusion Systems - Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System
FDA Device · Class II · 2015-09-16 · Biomet Spine - Needle Driver
FDA Device · Class II · 2015-09-16 · Intuitive Surgical - Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Intended to be used for monitoring, displayin…
FDA Device · Class II · 2015-09-16 · Mindray Ds Usa - Fundus Grasper
FDA Device · Class II · 2015-09-16 · Intuitive Surgical - Cadiere Forceps
FDA Device · Class II · 2015-09-16 · Intuitive Surgical - MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS. Enables the perfusionist to manage the patient's hematocrit and fluid status
FDA Device · Class II · 2015-09-16 · Medtronic Perfusion Systems - Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050 and 14-525057, reusable devices distribut…
FDA Device · Class II · 2015-09-16 · Biomet Spine - ADVIA Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent
FDA Device · Class II · 2015-09-16 · Siemens Healthcare Diagnostics - Medium -Large Clip Applier
FDA Device · Class II · 2015-09-16 · Intuitive Surgical - Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVLS) for pressure monitoring and intravenous fluid administration
FDA Device · Class II · 2015-09-16 · Elcam Medical - Maryland Bipolar Forceps
FDA Device · Class II · 2015-09-16 · Intuitive Surgical - Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only, REF Numbers: 74121138 (38 MM), 74123140 (40 MM), 74121142…
FDA Device · Class II · 2015-09-16 · Smith And Nephew - Elcam Medical MANI 3G Plate BLS RAD B.BRAUN
FDA Device · Class II · 2015-09-16 · Elcam Medical - Dimension¿ CREA (Creatinine) and Dimension Vista¿ CREA (Creatinine)
FDA Device · Class II · 2015-09-16 · Siemens Healthcare Diagnostics - OmniPod¿ Insulin Management System
FDA Device · Class I · 2015-09-16 · Insulet - Fenestrated Bipolar Forceps
FDA Device · Class II · 2015-09-16 · Intuitive Surgical - Curved Needle Driver
FDA Device · Class II · 2015-09-16 · Intuitive Surgical - Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING ACETABULAR CUP W/IMPACTOR, REF Numbers: 74120144 (44 MM), 74120146 (46 MM), 74122146 (46 MM)…
FDA Device · Class II · 2015-09-16 · Smith And Nephew - OmniPod¿ Insulin Management System
FDA Device · Class I · 2015-09-16 · Insulet - DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use
FDA Device · Class II · 2015-09-16 · Derma Pen - KimVent* Turbo-Cleaning Closed Suction System for Adults, 10 F, T-Piece (Product Code 227105) A tracheobronchial suction catheter is a devi…
FDA Device · Class II · 2015-09-09 · Halyard Health - RAPIDPoint 500 Blood Gas Analyzer, Siemens Material Numbers (SMN):10492730, 10696855, 10696857, 10697306 This system tests blood gases, ele…
FDA Device · Class II · 2015-09-09 · Siemens Healthcare Diagnostics - CARPAL TUNEL LARGE SURGICAL PACK, 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound heali…
FDA Device · Class II · 2015-09-09 · Customed - UNIVERSAL DRAINAGE TRAY CUSTOMED 20/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound heali…
FDA Device · Class II · 2015-09-09 · Customed - ANGIOGRAPHY PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture remova…
FDA Device · Class II · 2015-09-09 · Customed - ARTHROSCOPY PK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals…
FDA Device · Class II · 2015-09-09 · Customed - C-SECTION SURGICAL PACK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture…
FDA Device · Class II · 2015-09-09 · Customed - ARTHROSCOPY PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture remova…
FDA Device · Class II · 2015-09-09 · Customed - ANGIODRAPE PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals,…
FDA Device · Class II · 2015-09-09 · Customed - OPHTHALMIC PACK 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removal…
FDA Device · Class II · 2015-09-09 · Customed - LAMINECTOMY PACK 3/C Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removal…
FDA Device · Class II · 2015-09-09 · Customed - NovaPlus Trach Care* Closed Suction System for Adults, Clear T-Piece MDI Adapter, 14F (Product Code 2V220158) A tracheobronchial suction…
FDA Device · Class II · 2015-09-09 · Halyard Health - Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC -- Product Usage: to measure flow intra-operatively
FDA Device · Class II · 2015-09-09 · Transonic Systems - LAPAROSCOPY PACK 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture remova…
FDA Device · Class II · 2015-09-09 · Customed - LAPAROSCOPY PK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals…
FDA Device · Class II · 2015-09-09 · Customed - BREAST PACK-BOD 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removal…
FDA Device · Class II · 2015-09-09 · Customed - GOWN COOL IMPEV. XLGE BREATHABLE 24/CS CUSTOMED Used by medical staff to perform surgical procedures and patient care procedures such as wo…
FDA Device · Class II · 2015-09-09 · Customed - SHOULDER PACK 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals,…
FDA Device · Class II · 2015-09-09 · Customed - UROLOGY PK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, ir…
FDA Device · Class II · 2015-09-09 · Customed - GOWN SURG. POLY REINF. XL XLONG 40/CS CUSTOMED Used by medical staff to perform surgical procedures and patient care procedures such as wou…
FDA Device · Class II · 2015-09-09 · Customed - PERI GYN PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals,…
FDA Device · Class II · 2015-09-09 · Customed - ARTHROSCOPY PK CS/4 Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals…
FDA Device · Class II · 2015-09-09 · Customed - LEGGINGS W/7" CUFF 30" x 42" 30/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing,…
FDA Device · Class II · 2015-09-09 · Customed - ANGIOGRAPHY PACK CUSTOMED 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, sutu…
FDA Device · Class II · 2015-09-09 · Customed - KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 2271418) A tracheobronchial suction catheter is a de…
FDA Device · Class II · 2015-09-09 · Halyard Health - LAPAROSCOPY-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, sutur…
FDA Device · Class II · 2015-09-09 · Customed - Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to measure flow intra-operatively
FDA Device · Class II · 2015-09-09 · Transonic Systems - Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each of Level 1, Level 2 and Level 3)
FDA Device · Class II · 2015-09-09 · Pointe Scientific - Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60
FDA Device · Class II · 2015-09-09 · Physician Engineered Products - ENDOVENOUS CUSTOM PACK 5/CS CUSTOMED Used by medical staff to perform surgical procedures and patient care procedures such as wound healing…
FDA Device · Class II · 2015-09-09 · Customed - SHOULDER PACK (I) (2) 6/CS CUSTOMED Used by medical staff to perform surgical procedures and patient care procedures such as wound healing,…
FDA Device · Class II · 2015-09-09 · Customed - LAPAROSCOPY CHOLE 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture remov…
FDA Device · Class II · 2015-09-09 · Customed - MINOR PROCEDURE PACK 40/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture r…
FDA Device · Class II · 2015-09-09 · Customed - CESAREAN PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals,…
FDA Device · Class II · 2015-09-09 · Customed - Vision RingLoc Shell 50 mm Size 23
FDA Device · Class II · 2015-09-09 · Biomet - UTILITY DRAPE END PRODUCT 50PK/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, s…
FDA Device · Class II · 2015-09-09 · Customed - HIP AND KNEE REPLACEMENT 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, sutur…
FDA Device · Class II · 2015-09-09 · Customed - LAPAROS.CHOLE 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals,…
FDA Device · Class II · 2015-09-09 · Customed - BREAST PACK-TPSC 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture remova…
FDA Device · Class II · 2015-09-09 · Customed - cobas Liat Analyzer, for in vitro diagnostic use
FDA Device · Class II · 2015-09-09 · Roche Molecular Systems - SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021
FDA Device · Class II · 2015-09-09 · Limacorporate S P A - LAPAROSCOPY-COLORECTAL SURGICAL PACK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound he…
FDA Device · Class II · 2015-09-09 · Customed - MAJOR LAPAROTOMY PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture rem…
FDA Device · Class II · 2015-09-09 · Customed - Syngo.plaza
FDA Device · Class II · 2015-09-09 · Siemens Medical Solutions Usa - Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety Components, 13.5 Fr x 24 cm Item Code: 8888211…
FDA Device · Class II · 2015-09-09 · Covidien - LAPAROTOMY PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals,…
FDA Device · Class II · 2015-09-09 · Customed - Transonic Flow Probe, 3 mm, Catalog Number HQC3MP -- Product Usage: to measure flow intra-operatively
FDA Device · Class II · 2015-09-09 · Transonic Systems - LAPAROSCOPY PACK 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture remova…
FDA Device · Class II · 2015-09-09 · Customed - LAPAROTOMY PACK CUSTOMED 7/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, sutur…
FDA Device · Class II · 2015-09-09 · Customed - KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DT, T-Piece (Product Code 220569) A tracheobronchial suction catheter is a device…
FDA Device · Class II · 2015-09-09 · Halyard Health - SHOULDER PACK CUSTOMED 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture…
FDA Device · Class II · 2015-09-09 · Customed - ANGIOGRAPHY PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals…
FDA Device · Class II · 2015-09-09 · Customed - FEMORAL PACK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals,…
FDA Device · Class II · 2015-09-09 · Customed - Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- Product Usage: to measure flow intra-operatively
FDA Device · Class II · 2015-09-09 · Transonic Systems - HAIR RESTORATION PACK-THR 12/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, sut…
FDA Device · Class II · 2015-09-09 · Customed - O.B. PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrig…
FDA Device · Class II · 2015-09-09 · Customed - Mahurkar" Elite Acute Dual Lumen Catheter Tray, Straight Extensions with IC* Safety Components, 12 Fr x 20 cm Item Code:8888221420 Product…
FDA Device · Class II · 2015-09-09 · Covidien - GOWN IMPERVIOUS EXTRA LONG 24/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, su…
FDA Device · Class II · 2015-09-09 · Customed - GAUZE SPONGE 4"X4" 16 PLY XRD 1280/CS (STERILE) Used by medical staff to perform surgical procedures and patient care procedures such as wo…
FDA Device · Class II · 2015-09-09 · Customed - UMBILICAL VESSEL CATHETER KIT CUSTOMED 8/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound…
FDA Device · Class II · 2015-09-09 · Customed - Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to measure flow intra-operatively
FDA Device · Class II · 2015-09-09 · Transonic Systems - PERI GYN PACK 10/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals…
FDA Device · Class II · 2015-09-09 · Customed - ORTHOPEDIC PACK BASIC 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture r…
FDA Device · Class II · 2015-09-09 · Customed
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)