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.
- Gown, surgical 30/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 - UROLOGY SURGICAL PACK 6/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 - SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425
FDA Device · Class II · 2015-09-09 · Limacorporate S P A - KimVent* Wet Pak* Closed Suction System for Adults, 14 F, T-Piece (Product Code 22056)
FDA Device · Class II · 2015-09-09 · Halyard Health - SUCTION CATHETER 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 - SHOULDER ARTHROSCOPY PACK 2/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 - INCISION AND DRAINAGE TRAY 50/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 - ARTHROSCOPY SURGICAL PACK 4/C 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 - SKIN STAPLE REMOVER KIT 80/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 - Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Pre-Curved with IC* Safety Components, 13.5 Fr x 20 cm Item Code: 8888213420 Produ…
FDA Device · Class II · 2015-09-09 · Covidien - PLASTIC SURGERY PACK 5/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 - MAHURKAR"* 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Curved Extensions, PASS Tray Item Code: 8888103003HP Product Usag…
FDA Device · Class II · 2015-09-09 · Covidien - KimVent* Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 22108)
FDA Device · Class II · 2015-09-09 · Halyard Health - KNEE ARTHROSCOPY 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 - OPEN HEART TRAY 1/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 - Panoramic X-ray Model PC-1000 The PC-1000 will enable the user to take panoramic x-ray images
FDA Device · Class II · 2015-09-09 · Panoramic Rental - PREMIUM O.B. PACK CUSTOMED 5/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 - 7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONLY
FDA Device · Class II · 2015-09-09 · Trilliant Surgical - OPEN HEART TRAY 1/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 - Neptune 2 Waste Management System Docking Station (120V and 230V), New and Refurbished Product Usage: The Stryker Docking Station (Docker)…
FDA Device · Class II · 2015-09-09 · Stryker Instruments Div - COULTER ISOTON 4 Diluent, Catalog No. 8547148
FDA Device · Class II · 2015-09-09 · Beckman Coulter - FACE PACK FJG 8/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 - FACE LIFT 4/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 - CESAREAN PACK 2/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 - VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports
FDA Device · Class II · 2015-09-09 · Synthes Usa Products - EXTREMITY ARM PACK 4/CS HOSP. DR. CENTER Used by medical staff to perform surgical procedures and patient care procedures such as wound hea…
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 - Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- Product Usage: to measure flow intra-operatively
FDA Device · Class II · 2015-09-09 · Transonic Systems - D & C LAPAROSCOPY PK 4/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 - SHOULDER 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 - CESAREAN PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, i…
FDA Device · Class II · 2015-09-09 · Customed - UROLOGY 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 - LAPAROSCOPY PACK 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 - MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Straight Extensions, PASS Tray Item Code: 8888104003HP Product Usag…
FDA Device · Class II · 2015-09-09 · Covidien - 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 - SUTURE REMOVAL KIT CUSTOMED 100/CS Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigat…
FDA Device · Class II · 2015-09-09 · Customed - LAP-CHOLECYSTECTOMY SURGICAL PACK 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 - Volcano Pioneer Plus Re-Entry Catheter
FDA Device · Class II · 2015-09-09 · Volcano - KimVent* Multi-Access Port Replacement Catheter for Adults, Endotracheal,16 F (Product Code 240165-5) A tracheobronchial suction catheter i…
FDA Device · Class II · 2015-09-09 · Halyard Health - MAJOR LAP 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 - OB PACK CS/4 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 - LAPAROSC 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 - KimVent* Closed Suction System for Adults, 14 F, T-Piece, MDI (Product Code 8308) A tracheobronchial suction catheter is a device that is a…
FDA Device · Class II · 2015-09-09 · Halyard Health - KimVent* Closed Suction System for Adults, 14 F, D-Tip, T-Piece (Product Code 22059)
FDA Device · Class II · 2015-09-09 · Halyard Health - GENERAL MINOR PK 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 - 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 Neonates/Pediatrics, 5 F, Manifold (Product Code 201) A tracheobronchial suction catheter is a device th…
FDA Device · Class II · 2015-09-09 · Halyard Health - COULTER LH Series Diluent, Catalog No. 8547194, Product Labeling A40192-AD. The diluent provides the ability to analyze portions of the dil…
FDA Device · Class II · 2015-09-09 · Beckman Coulter - FOLEY CATHETER KIT II 18 FR 20/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 - DRESSING CHANGE CUSTOMED 50/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 - GAUZE 2" X 2" PRODUCTION ONLY 1500PK/CS CUSTOMED Used by medical staff to perform surgical procedures and patient care procedures such as w…
FDA Device · Class II · 2015-09-09 · Customed - NEURO SPINE 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 - IRRIGATION TRAY W/BULB SYRINGE CUSTOMED 50/CS Used by medical staff to perform patient care procedures such as wound healing, suture remova…
FDA Device · Class II · 2015-09-09 · Customed - LAPAROTOMY 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 - EXTREMITY 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 - PREMIUM CESAREAN PACK 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 - LAPAROSC. OB GYN PK 5/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 - LAPAROTOMY PACK CS/6 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 - Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems
FDA Device · Class II · 2015-09-09 · Philips Medical Systems Cleveland - KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece (Product Code 22705)
FDA Device · Class II · 2015-09-09 · Halyard Health - FANFOLD DRAPE 44"X58 60/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 - CATARACT 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 - GAUZE SPONGES 2"x2" 4 PLY ST 2/PK 1500PK/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound…
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 20 cm Item Code: 8888233420 Produc…
FDA Device · Class II · 2015-09-09 · Covidien - MINOR LACERATION TRAY 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 - da Vinci Xi Surgical System P4 software;with Xi Stapler
FDA Device · Class II · 2015-09-09 · Intuitive Surgical - LAPAROSCOPY GYN PK CS/4 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 - KimVent* Closed Suction System for Adults, 14 F, DSE, DT (Product Code 22109) A tracheobronchial suction catheter is a device that is attac…
FDA Device · Class II · 2015-09-09 · Halyard Health - WOUND MANAG.TRAY 24/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 - KimVent* Closed Suction System for Adults, 14 F, MDI, T-Piece, 12 in Tracheostomy (Product Code 2201358)
FDA Device · Class II · 2015-09-09 · Halyard Health - GAUZE SPONGE 4"X4" 16 PLY SOFT 1280/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 - NEURO PACK 3/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 - 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 - C-SECTION PK 2/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 - OPEN HEART TRAY CUSTOMED 1/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 - GOWN POLYREINF XLGE TOWEL/W 24/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 - Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to measure flow intra-operatively
FDA Device · Class II · 2015-09-09 · Transonic Systems - LUMBAR PACK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, i…
FDA Device · Class II · 2015-09-09 · Customed - CESAREAN 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 - MINOR LAPAROTOMY PK 5/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 - PLASTIC SURGERY PACK 5/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 - IMPLANTE DE ORTHOPEDIA 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 - O.B. PACK 5/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 - MediTrace Cadence Adult Multi-Function Defibrillation Electrodes Item Code:22550PC
FDA Device · Class II · 2015-09-09 · Covidien - ANGIODRAPE PACK DAMAS 6/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 - Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12 Fr x 16 cm Item Code: 8888222416 Product Us…
FDA Device · Class II · 2015-09-09 · Covidien - PREMIUM LAPAROTOMY PK CUSTOMED 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 - WOUND CLOSURE TRAY I 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 - WOUND MANAGEMENT CUSTOMED 20/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 - SURGICAL PACK 20/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 - BASIC PACK 8/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 - FACE PACK MRT 8/CS CUSTOMED 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 - RETINA PACK 7/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, i…
FDA Device · Class II · 2015-09-09 · Customed - CrossCHECK Non-Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-N3008
FDA Device · Class II · 2015-09-09 · Wright Medical Technology - OPEN HEART PACK 1/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 - LITHOTOMY PACK 10/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 - CYSTO TUR PACK CUSTOMED 10/CS REV. C 10/13 NON STERILE Used by medical staff to perform surgical procedures and patient care procedures suc…
FDA Device · Class II · 2015-09-09 · Customed - NovaPlus Trach Care* Closed Suction System for Adults, Double Swivel Elbow, Directional Tip, 14F (Product Code 2V22109) A tracheobronchial…
FDA Device · Class II · 2015-09-09 · Halyard Health - 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 - ORTHO-IMPLANT SURGICAL PACK, 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
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)