FDA Device · 2016
FDA Device recalls in 2016
RecallRadar indexes 3,246 FDA Device recall notices published in 2016. By classification: 116 Class I, 3,050 Class II, 80 Class III.
- TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 10 LEFT, STERILE R, REF 12 000 006, S&N 7500261, Smith & Nephew Orthopaedics AG…
FDA Device · Class II · 2016-04-27 · Smith And Nephew - TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12 000 026, S&N 7500281, Smith & Nephew Orthopaedics AG…
FDA Device · Class II · 2016-04-27 · Smith And Nephew - TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12 000 0012, S&N 7500267, Smith & Nephew Orthopaedics A…
FDA Device · Class II · 2016-04-27 · Smith And Nephew - CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates sensor data and provides reports of continuou…
FDA Device · Class II · 2016-04-27 · Medtronic Minimed - VariAx Compression Plating System
FDA Device · Class II · 2016-04-27 · Stryker Howmedica Osteonics - Leica Microsystems (Schweiz) Ag. The common name of the device is surgical microscope
FDA Device · Class II · 2016-04-27 · Leica Microsystems - Catalog Number: 900277 SUCTION CATHETER TRAY 14FR WITH SODIUM CHLORIDE 0.9% IRRIGATION Used by medical staff to perform surgical procedures…
FDA Device · Class II · 2016-04-20 · Customed - Diana Automated Compounding System, Diana V1.3, Item No. CH5300, CH5300R The Diana is an automated compounding device for the accurate, saf…
FDA Device · Class II · 2016-04-20 · Icu Medical - Diana Automated Compounding System, Diana Onco 3xx, Item No. ASN303 The Diana is an automated compounding device for the accurate, safe and…
FDA Device · Class II · 2016-04-20 · Icu Medical - Catalog Number: 900742A CARPAL TUNEL LARGE SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures s…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 9002614 HIP AND KNEE REPLACEMENT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care proced…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 900521 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, X-LARGE Used by medical staff to perform surgical…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 9002469 BASIC SURGICAL PACK IV Used by medical staff to perform surgical procedures and patient care procedures such as wou…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 900176 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wo…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 900410 CESAREAN SECTION SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such…
FDA Device · Class II · 2016-04-20 · Customed - Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black
FDA Device · Class I · 2016-04-20 · Dexcom - Catalog Number: 9003190 SURG GOWN SMS AMMI IV FULL Used by medical staff to perform surgical procedures and patient care procedures such as…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 900740A ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as…
FDA Device · Class II · 2016-04-20 · Customed - Diana Automated Compounding System, Diana Onco Plus 1.2, Item No. ASN222, ASN222-GST, ASN222-R The Diana is an automated compounding device…
FDA Device · Class II · 2016-04-20 · Icu Medical - Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o
FDA Device · Class II · 2016-04-20 · Merit Medical Systems - Catalog Number: 900169 UNIVERSAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wou…
FDA Device · Class II · 2016-04-20 · Customed - RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver
FDA Device · Class II · 2016-04-20 · Rti Surgical Dba Pioneer Surgical Technology - Catalog Number: 900540 WOUND MANAGEMENT TRAY III Used by medical staff to perform surgical procedures and patient care procedures such as w…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 9001521 UROLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as woun…
FDA Device · Class II · 2016-04-20 · Customed - Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black
FDA Device · Class I · 2016-04-20 · Dexcom - Catalog Number: 9002123 KNEE ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures suc…
FDA Device · Class II · 2016-04-20 · Customed - Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT22608 Receiver (mg/dL), Black (pediatrics)
FDA Device · Class I · 2016-04-20 · Dexcom - Dexcom G4 PLATINUM (Professional) Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black
FDA Device · Class I · 2016-04-20 · Dexcom - Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator
FDA Device · Class II · 2016-04-20 · Maquet Cardiovascular Us Sales - Catalog Number: 900450 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wo…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 9001771 MAYO STAND COVER STERILE Used by medical staff to perform surgical procedures and patient care procedures such as w…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 900921A C-SECTION SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wo…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 900997 PERI-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as woun…
FDA Device · Class II · 2016-04-20 · Customed - X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical Navigation System is a computerized navigational system intended t…
FDA Device · Class II · 2016-04-20 · X Nav Technologies - Dexcom G5 Mobile Receiver Receiver Part Number: MT22719 Receiver (mg/dL), Black
FDA Device · Class I · 2016-04-20 · Dexcom - Catalog Number: 9002193 SHOULDER ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 900032 UNIVERSAL DRAINAGE TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wou…
FDA Device · Class II · 2016-04-20 · Customed - Diana Automated Compounding System, Diana Onco Plus 1.3, Item No. ASN223 The Diana is an automated compounding device for the accurate, saf…
FDA Device · Class II · 2016-04-20 · Icu Medical - Catalog Number: 900164 FEMORAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 9002830 ORTHOPEDIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as w…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 9001933 OPHTALMIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wo…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 9001294 PREMIUM CESAREAN PACK Used by medical staff to perform surgical procedures and patient care procedures such as woun…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 9001198 WOUND MANAGE II Used by medical staff to perform surgical procedures and patient care procedures such as wound heal…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 900028 LAPAROSCOPY SURGICAL PACK
FDA Device · Class II · 2016-04-20 · Customed - Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX
FDA Device · Class II · 2016-04-20 · Neurotherm - EPIQ DIAGNOSTIC ULTRASOUND SYSTEM, Model EPIQ 5C, EPIC 5G, EPIQ 5W, EPIQ 7C, EPIC 7GC, and EPIQ 7W. Diagnostic Ultrasound System for ultras…
FDA Device · Class II · 2016-04-20 · Philips Ultrasound - Catalog Number: 900944 CATARACT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as woun…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 900548A PERY-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wou…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 9002609 ARTHOSCOPY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound heal…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 9002511 MINOR SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound…
FDA Device · Class II · 2016-04-20 · Customed - SOMATOM Definition AS, a family of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray tr…
FDA Device · Class II · 2016-04-20 · Siemens Medical Solutions Usa - Catalog Number: 900484 LAPAROSCOPIC GYNECOLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedur…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 900946 STRABISMUS SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wo…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 900403 CESAREAN SECTION SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such…
FDA Device · Class II · 2016-04-20 · Customed - USE (Ebony) PTA .014" rapid exchange (RX) Peripheral Dilatation Catheter
FDA Device · Class II · 2016-04-20 · Us Endovascular - Catalog Number: 9002726 HIP AND KNEE REPLACEMENT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care proced…
FDA Device · Class II · 2016-04-20 · Customed - Brilliance iCT Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ra…
FDA Device · Class II · 2016-04-20 · Philips Medical Systems Cleveland - Catalog Number: 9002618 OPEN HEART SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as w…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 9001966 LIVER & PANCREAS SURGERY Used by medical staff to perform surgical procedures and patient care procedures such as w…
FDA Device · Class II · 2016-04-20 · Customed - Ingenuity Core 128 Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of…
FDA Device · Class II · 2016-04-20 · Philips Medical Systems Cleveland - Catalog Number: 9001091 PERY-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wou…
FDA Device · Class II · 2016-04-20 · Customed - BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management System is intended for monitoring and controlling patient temperat…
FDA Device · Class II · 2016-04-20 · C R Bard - Ingenuity Core Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ra…
FDA Device · Class II · 2016-04-20 · Philips Medical Systems Cleveland - Catalog Number: 900345 BASIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound h…
FDA Device · Class II · 2016-04-20 · Customed - AMT G-Jet¿ Low-Profile Transgastric-Jejunal Feeding Device 14F 1.5cm 45cm SINGLE USE ONLY Rx ONLY STERILE. For use in patients who cannot a…
FDA Device · Class II · 2016-04-20 · Applied Medical Technology - Catalog Number: 900629 STERILE OR CLOTH TOWEL BLUE Used by medical staff to perform surgical procedures and patient care procedures such as…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 9002256 NEUROSURGERY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound he…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 900110 TRACHEOSTOMY CARE KIT WITH TRACH TUBE HOLDER FOR ADULT Used by medical staff to perform surgical procedures and pati…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 9001062 ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 900419 LABOR & DELIVERY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 9002516 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as w…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 9001771 MAYO STAND COVER STERILE Used by medical staff to perform surgical procedures and patient care procedures such as w…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 900012 OB SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound heal…
FDA Device · Class II · 2016-04-20 · Customed - Bard TruGuide Disposable Coaxial Biopsy Needle Product Usage: The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guid…
FDA Device · Class II · 2016-04-20 · Bard Peripheral Vascular - SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNT…
FDA Device · Class II · 2016-04-20 · Synthes Usa Products - Cygnus Medical First StepBedside ADDWATER Kit,non-sterile
FDA Device · Class III · 2016-04-20 · Cygnus Medical - Catalog Number: 9002167 LITHOTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wo…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 900010 SUTURE REMOVAL KIT Used by medical staff to perform surgical procedures and patient care procedures such as wound he…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 900486 LAPAROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as w…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 9001300 NEURO-SPINE SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 900281A LAPAROTOMY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound heal…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 9001298 PREMIUM ARTHROSCOPY PACK Used by medical staff to perform surgical procedures and patient care procedures such as w…
FDA Device · Class II · 2016-04-20 · Customed - da Vinci S Surgical System (IS4000) user manual English and OUS. Product Usage: The Intuitive Surgical Endoscope Instrument Control System…
FDA Device · Class II · 2016-04-20 · Intuitive Surgical - Catalog Number: 900020 IRRIGATION TRAY WITH IRRIGATION BULB SYRINGE Used by medical staff to perform surgical procedures and patient care p…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 900052 MINOR PROCEDURE SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 900982 ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as w…
FDA Device · Class II · 2016-04-20 · Customed - Boston Scientific, PT Graphix Magnet J-TIP Guidewire with ICE Hydrophilic Coating, Sterile EO, UPN H7491490201MJ2 (Carton Label) ,H74914902…
FDA Device · Class II · 2016-04-20 · Boston Scientific - Catalog Number: 900618A LAPAROSCOPY-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 900774 INCISION AND DRAINAGE TRAY Used by medical staff to perform surgical procedures and patient care procedures such as…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 900741A ORTHO-IMPLANT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such a…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 900168 LABOR & DELIVERY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 9001408 UMBILICAL VESSEL CATHETER KIT Used by medical staff to perform surgical procedures and patient care procedures such…
FDA Device · Class II · 2016-04-20 · Customed - Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics)
FDA Device · Class I · 2016-04-20 · Dexcom - Diana Automated Compounding System, Final Assembly, Diana Onco Plus, Item No. CH5000, CH5000R The Diana is an automated compounding device…
FDA Device · Class II · 2016-04-20 · Icu Medical - The Concerto Basic Shower Trolley is intended for assisted hygiene care, especially showering and bathing of residents in care environments…
FDA Device · Class II · 2016-04-20 · Arjo - Catalog Number: 9001460 REYITO PLUS UROLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 9001154 WOUND MANAGEMENT TRAY Used by medical staff to perform surgical procedures and patient care procedures such as woun…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 900796 FEMORAL ANGIOGRAPHY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures s…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 9001538 DRESSING CHANGE TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound…
FDA Device · Class II · 2016-04-20 · Customed - Catalog Number: 9001780 OPHTHALMIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as w…
FDA Device · Class II · 2016-04-20 · 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)