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.
- KimVent* Closed Suction Systems for Adults, 14 F, Qwik Clip (Product Code 2273) A tracheobronchial suction catheter is a device that is att…
FDA Device · Class II · 2015-09-09 · Halyard Health - Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV -- Product Usage: to measure flow intra-operatively
FDA Device · Class II · 2015-09-09 · Transonic Systems - KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE (Product Code 227)
FDA Device · Class II · 2015-09-09 · Halyard Health - NovaPlus Trach Care* Closed Suction System for Adults, T-Piece, Directional Tip, 14F (Product Code 2V22059) A tracheobronchial suction cath…
FDA Device · Class II · 2015-09-09 · Halyard Health - CYSTO TUR 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 - KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DSE, MDI (Product 8224)
FDA Device · Class II · 2015-09-09 · Halyard Health - LABOR & DELIVERY 4/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 OB 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 - MINOR PACK 4/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 - OBSTETRICAL SURGICAL PACK 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 - FIRMap 60mm Catheter
FDA Device · Class III · 2015-09-09 · Abbott Electrophysiology - Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12 Fr x 20 cm Item Code: 8888222420 Product Us…
FDA Device · Class II · 2015-09-09 · Covidien - GAUZE SPONGE 2"X2" 8PLY COTTON 1500PK/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound hea…
FDA Device · Class II · 2015-09-09 · Customed - KimVent* Closed Suction System for Adults, 14 F, DSE (Product Code 2210)
FDA Device · Class II · 2015-09-09 · Halyard Health - VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemist…
FDA Device · Class II · 2015-09-09 · Ortho Clinical Diagnostics - MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16cm, Curved Extensions, PASS Tray Item Code: 8888103002HP Product Usage:…
FDA Device · Class II · 2015-09-09 · Covidien - O.B. PACK HOSPITAL 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture remo…
FDA Device · Class II · 2015-09-09 · Customed - UROLOGY 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 - HIP ORTHO. PACK 3/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 - PEDIATRIC LAP PACK 8/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture remo…
FDA Device · Class II · 2015-09-09 · Customed - MINOR LAP. PACK 5/CS REV. Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture re…
FDA Device · Class II · 2015-09-09 · Customed - KimVent* Closed Suction System for Adults, 12 F, T-Piece (Product Code 2155)
FDA Device · Class II · 2015-09-09 · Halyard Health - MAYO STAND COVER W/CSR WRAP 30/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 - CrossCHECK Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-L3008
FDA Device · Class II · 2015-09-09 · Wright Medical Technology - PERY-GYN SURGICAL PACK 6/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 - CYSTO TUR PACK BASIC 8/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture re…
FDA Device · Class II · 2015-09-09 · Customed - PERI GYN PACK CS/6 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 - URETHRAL CATHETER TRAY CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healin…
FDA Device · Class II · 2015-09-09 · Customed - FOLEY CATHETER KIT II 16FR. CUSTOMED 20/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound h…
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 - ANGIOGRAPHY 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 - KimVent* Closed Suction System for Neonates/Pediatrics, 6 F, Elbow (Product Code 206)
FDA Device · Class II · 2015-09-09 · Halyard Health - CESAREAN 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 - 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 - Monoject 0.9% Saline Flush Prefill Double Pouch Item Code: 8881570129 Product Usage: Sterile Delivery are indicated for use in flushing com…
FDA Device · Class II · 2015-09-09 · Covidien - Contour Next Control Solution for Contour Next Blood Glucose Test System
FDA Device · Class II · 2015-09-09 · Bayer Healthcare - CURATION KIT 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 - UNIVERSAL 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 - SURG GOWN POLYREINF LGE CUSTOM 28/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 - LAPAROTOMY BASIC PACK 10/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 - HIGADO Y PANCREA 2/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 - 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 - KimVent* Closed Suction System for Adults, 14 F, Elbow, D-Tip (Product Code 2219) A tracheobronchial suction catheter is a device that is a…
FDA Device · Class II · 2015-09-09 · Halyard Health - REEMPLAZO DE RODILLA Y CADERA 2/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 - Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to measure flow intra-operatively
FDA Device · Class II · 2015-09-09 · Transonic Systems - LAPAROTOMY PACK 4/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 - KimVent* Closed Suction System for Adults, 12 F, Elbow (Product Code 216)
FDA Device · Class II · 2015-09-09 · Halyard Health - PREMIUM ARTHROSCOPY PK CUSTOMED 5/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 - TRACHEOTOMY CARE KIT CUSTOMED 50/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 - UROLOGY CUSTOMED PACK 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 - SHOULDER ARTHROSCOPY PACK 3/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 - FEMORAL 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 - Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip, Product Code 50614
FDA Device · Class II · 2015-09-09 · C R Bard - Access Thyroglobulin Assay
FDA Device · Class II · 2015-09-09 · Beckman Coulter - CENTRAL LINE FULL BODY DRAPE CUSTOMED 28/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound…
FDA Device · Class II · 2015-09-09 · Customed - O.R. TOWELS 25/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 - KimVent* Multi-Access Port Replacement Catheter for Adults,Tracheostomy, 14 F (Product Code 2401453-5) A tracheobronchial suction catheter…
FDA Device · Class II · 2015-09-09 · Halyard Health - KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Y-Adapter (Product Code 195)
FDA Device · Class II · 2015-09-09 · Halyard Health - EAR PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irri…
FDA Device · Class II · 2015-09-09 · Customed - KimVent* Closed Suction System for Adults, 12 F, T-Piece,12 in Tracheostomy (Product Code 215135)
FDA Device · Class II · 2015-09-09 · Halyard Health - Mahurkar Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety Components, 13.5 FR x 13.5 cm Item Code: 8888135137…
FDA Device · Class II · 2015-09-09 · Covidien - KimVent* Wet Pak* Closed Suction System for Adults, 14 F, Elbow (Product Code 2276)
FDA Device · Class II · 2015-09-09 · Halyard Health - LAPAROSCOPY 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 - WOUND CLOSURE TRAY II CUSTOMED 50/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 - Arrow International, Inc
FDA Device · Class II · 2015-09-09 · Arrow International - Transonic Flow Probe, 2 mm, Catalog Number HQC2MP -- Product Usage: to measure flow intra-operatively
FDA Device · Class II · 2015-09-09 · Transonic Systems - O.B. PACK 4/CS REV. 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 - NovaPlus Trach Care* Closed Suction System for Adults, T-Piece, 14F (Product Code 2V220135)
FDA Device · Class II · 2015-09-09 · Halyard Health - EENT PACK I (1) 10/CS CUSTOMED 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* Multi-Access Port Closed Suction System for Adults,Tracheostomy, DSY, MDI, 14 F (Product Code 240438-5) A tracheobronchial suction…
FDA Device · Class II · 2015-09-09 · Halyard Health - FOLEY CATH KIT 16FR. W/FOLEY S SENSOR 20/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound…
FDA Device · Class II · 2015-09-09 · Customed - (1) (2) 10/CS CUSTOMED 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 - LAPAROTOMY SURGICAL PACK 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 - TUMMY TUCK & BREAST PACK-RFMHI 6/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 - BASIC PACK W/OUT GOWN 11/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 - LABOR & DELIVERY 4/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 - Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12.5 Fr x 13 cm Item Code: 8888233413 Produc…
FDA Device · Class II · 2015-09-09 · Covidien - TUMMY TUCK PACK-FJG 6/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 - MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test
FDA Device · Class II · 2015-09-09 · Diagnostic Hybrids - Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test
FDA Device · Class II · 2015-09-09 · Neuro Kinetics - Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak¿ Preconnect System Item Code:PM20022
FDA Device · Class II · 2015-09-09 · Covidien - NovaPlus Trach Care* Closed Suction System for Adults, Double Swivel Elbow, 14F (Product Code 2V2210) A tracheobronchial suction catheter i…
FDA Device · Class II · 2015-09-09 · Halyard Health - E.N.T. PK 7/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irr…
FDA Device · Class II · 2015-09-09 · Customed - NEURO PACK 2/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 - PERY GYN PACK CUSTOMED 10/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 - Mahurkar Acute Dual Lumen Catheter Tray, High Flow¿ Pre-Curved with IC* Safety Components, 13.5 FR x 13.5 cm Item Code: 8888135139 Product…
FDA Device · Class II · 2015-09-09 · Covidien - KimVent* Multi-Access Port Closed Suction System for Adults, Endotracheal, DSY, 14 F (Product Code 24014-5) A tracheobronchial suction cath…
FDA Device · Class II · 2015-09-09 · Halyard Health - ARTHROSCOPY PK L/F 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture remo…
FDA Device · Class II · 2015-09-09 · Customed - FEMORAL ANGIOGRAPHY PACK 4/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 - WOUND MANAGEMENT TRAY II 30/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 - MediTrace Cadence Adult Zoll, Preconnect Defibrillation Electrode, Nonsterile Item Code:22770PC
FDA Device · Class II · 2015-09-09 · Covidien - KimVent* Wet Pak* Closed Suction System for Pediatrics, 10 F, Y Adapter (Product Code 8281) A tracheobronchial suction catheter is a device…
FDA Device · Class II · 2015-09-09 · Halyard Health - cobas b 123 Fluid Pack COOX REF 05169992001 200 Product Usage: The cobas b 123 POC system is a fully automated POC system for whole blood i…
FDA Device · Class II · 2015-09-02 · Roche Diagnostics Operations - CAPD Solution Transfer Set with Locking Connector
FDA Device · Class II · 2015-09-02 · Baxter Healthcare - Otto Bock Healthcare Products GmbH Genium X3 Model Number: 3B5-2, Manufacturer Otto Bock Healthcare Products GmbH. Intended to be used sole…
FDA Device · Class II · 2015-09-02 · Otto Bock Healthcare Product - Carepak Sheer Adhesive Bandages 50 Sterile Bandages Assorted Sizes
FDA Device · Class II · 2015-09-02 · Aso - Offset Femoral Alignment Guide 4mm x 6¿
FDA Device · Class II · 2015-09-02 · Omnilife Science - 0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution
FDA Device · Class II · 2015-09-02 · Mrp - Central Line >34 Weeks Kit . Cardiology department
FDA Device · Class II · 2015-09-02 · Medline Industries - Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile
FDA Device · Class II · 2015-09-02 · Tornier
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)