FDA Device · 2014

FDA Device recalls in 2014

RecallRadar indexes 3,059 FDA Device recall notices published in 2014. By classification: 558 Class I, 2,441 Class II, 60 Class III.

• 5X300 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number IS3000
  FDA Device · Class II · 2014-04-16 · Intuitive Surgical
• 7mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) 10 FR Drain Kit 3/4 Fluted with Trocar and 100ml S-Vac…
  FDA Device · Class II · 2014-04-16 · Aspen Surgical Products
• Oxycodone Test Card
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• 7mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case) Intended for closed wound suction drainage
  FDA Device · Class II · 2014-04-16 · Aspen Surgical Products
• Fecal Occult Blood Test Card
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Cardiac Panel Test Card (Whole Blood)
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• EDDP Test Card
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Alcohol Test, Urine
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Smiths Medical HOTLINE¿ Fluid Warming Set L-80
  FDA Device · Class II · 2014-04-16 · Smiths Medical Asd
• H. Pylori Ab Test Card-Serum
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Dengue IgG/IgM
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• 7mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
  FDA Device · Class II · 2014-04-16 · Aspen Surgical Products
• Myoglobin Test Card (Serum)
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Malaria pf/pan Antigen Test Card
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Philips HeartStart XL+ Defibrillator/Monitor with system software version B.00.00 or B.00.01 installed Model: 861290, automatic external de…
  FDA Device · Class II · 2014-04-16 · Philips Medical Systems
• Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415
  FDA Device · Class II · 2014-04-16 · Breg
• Playtex Nurser Deluxe Double Electric Breast Pump, Model X06578AO, powered by a 12V DC power supply, Model SY-12120, which is included with…
  FDA Device · Class II · 2014-04-16 · Energizer Personal Care
• Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110
  FDA Device · Class II · 2014-04-16 · Pega Medical
• Malaria pf Antigen Test Card
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Fecal Occult Blood Test Strip
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• K2 (synthetic Marijuana) Test card
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Ketamine Test Card
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Propoxyphene Test Strip
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Cardiac Panel Test (Serum)
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• 15FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System, Sterile (10/case) Intended for closed wound suction drain…
  FDA Device · Class II · 2014-04-16 · Aspen Surgical Products
• Saber 100ml Infection Control PVC Bulb with 150ml 3C System, Sterile (10/case) Intended to provide manual suction and collection of fluids…
  FDA Device · Class II · 2014-04-16 · Aspen Surgical Products
• Methylphenidate Test Card
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down
  FDA Device · Class II · 2014-04-16 · Remington Medical
• 10mm Drain Kit Flat Full Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
  FDA Device · Class II · 2014-04-16 · Aspen Surgical Products
• Syphilis Test Card Whole Blood(Serum) LumiQuick, Santa Clara, CA 95054
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Adeno/Rota Combo Test Card
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• 10FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System, Sterile (10/case) Intended for closed wound suction drain…
  FDA Device · Class II · 2014-04-16 · Aspen Surgical Products
• Reusable latex breathing bags with multiple part numbers and sold as part of test lung part number and reusable anaesthesia sets
  FDA Device · Class II · 2014-04-16 · Draeger Medical
• 10mm Drain Kit Flat 3/4 Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
  FDA Device · Class II · 2014-04-16 · Aspen Surgical Products
• Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator
  FDA Device · Class I · 2014-04-16 · Draeger Medical Systems
• Troponin I test Card (Whole Blood)
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• K2 (synthetic Marijuana) Test Strip
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• 15FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage
  FDA Device · Class II · 2014-04-16 · Aspen Surgical Products
• Drugs of Abuse Panel Test Device
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• 10mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
  FDA Device · Class II · 2014-04-16 · Aspen Surgical Products
• Ketamine Strip
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Salmonella typhi Antigen Test Card
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• THC Strip
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Morphine Test Card (300)
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Methylphenidate Test Strip
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• H. Pylori Antigen Test Card LumiQuick, Santa Clara, CA 95054
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Clonazepam Test Card
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• PSA Test Card (Whole Blood)
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Strep A Test Card
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Oxycodone Strip
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Syphilis Test Strip (Serum) LumiQuick, Santa Clara, CA 95054
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• 19FR Drain Kit Flat Full Perforated with Trocar, Saber 100ml Bulb and 3CSystem, Sterile (10/case) Intended for closed wound suction drainage
  FDA Device · Class II · 2014-04-16 · Aspen Surgical Products
• Dengue NS1 Ag/IgG/M Ab Duo Test Card
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Troponin I test Card (serum)
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Myoglobin Test Card (Whole Blood)
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• 5X300 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number IS3000
  FDA Device · Class II · 2014-04-16 · Intuitive Surgical
• Barbiturate Test Card
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Fentanyl Test Card
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• 10FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage
  FDA Device · Class II · 2014-04-16 · Aspen Surgical Products
• MDMA/Ecstasy Test Card
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• PCP Test Card
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Benzodiazepine Test Card
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Amphetamine Test Card
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Benzodiazepine Strip
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Rickettsia IgG/IgM Test Card LumiQuick, Santa Clara, CA 95054
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Methamphetamine Strip
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Tramadol Test Card
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Tramadol Strip
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Malaria pf Antigen Test Card
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• 5X250 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number IS3000
  FDA Device · Class II · 2014-04-16 · Intuitive Surgical
• Methadone Test Card
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• Salmonella typhi/paratyphi Antigen Test
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• MDMA/Ecstasy Strip
  FDA Device · Class II · 2014-04-16 · Lumiquick Diagnostics
• 19FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage
  FDA Device · Class II · 2014-04-16 · Aspen Surgical Products
• RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0
  FDA Device · Class II · 2014-04-09 · Raysearch Laboratories Ab
• IMMULITE 2000
  FDA Device · Class II · 2014-04-09 · Siemens Medical Solutions Diagnostics
• 5/10 mm Weck Vista Universal Cannula, Catalog No. 405910RC
  FDA Device · Class II · 2014-04-09 · Teleflex Medical
• AOA Distalizer Lock Nut Screw, found in products listed as: Distal Jet, Spring Jet, Mesial Jet, and Uprighter Jet
  FDA Device · Class II · 2014-04-09 · Allesee Orthodontic Appliances
• 3M" Steri-Vac" Gas Sterilizer/Aerators, Model #'s 4XL,5XL, 8XL The 3M" Steri-Vac" Gas Sterilizer/Aerator is a compact unit designed to ster…
  FDA Device · Class II · 2014-04-09 · 3m Health Care Business
• Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500), Evita V500 and /or Babylog VN500 Venti…
  FDA Device · Class I · 2014-04-09 · Draeger Medical Systems
• RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
  FDA Device · Class II · 2014-04-09 · Raysearch Laboratories Ab
• Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended…
  FDA Device · Class II · 2014-04-09 · Elekta
• Citation TMZF HA 132 degrees Neck Angle, V40 Hip Stem - Right Size #3: catalog # 6265-5113 , Left Size #4: catalog #6265-5104 , and Right S…
  FDA Device · Class II · 2014-04-09 · Stryker Howmedica Osteonics
• Pressure Monitoring Tubing, PM6006
  FDA Device · Class II · 2014-04-09 · Merit Medical Systems
• Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO
  FDA Device · Class II · 2014-04-09 · Merit Medical Systems
• Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449-6212, Lot Number 121359169
  FDA Device · Class II · 2014-04-09 · Ormco Sybronendo
• Siemens Medical Solutions, ACUSON P300 Ultrasound system with P300 PA 230E cardiac probe (Esaote product 7348)
  FDA Device · Class II · 2014-04-09 · Siemens Medical Solutions Usa
• Weck Vista Universal Laparoscopic Port, Size 5/10mm x 100mm, Catalog No. 405910, Weck Vista Universal Laparoscopic Port, Size 5/10/12mm x 1…
  FDA Device · Class II · 2014-04-09 · Teleflex Medical
• 5/10 mm Weck Vista Optical Bladeless Laparoscopic Access Port, Catalog No. 405910R
  FDA Device · Class II · 2014-04-09 · Teleflex Medical
• 5/10/12 mm x 100mm Weck Vista Universal Cone Open Access, Catalog No. 405933
  FDA Device · Class II · 2014-04-09 · Teleflex Medical
• Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version 02.10.02.00 or Higher, automated exte…
  FDA Device · Class II · 2014-04-09 · Zoll Medical
• Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0
  FDA Device · Class II · 2014-04-09 · Philips Medical Systems Cleveland
• Infantino Squeeze & Teethe Monkey, "Go Gaga Squeeze & Teether Coco the Monkey". Non-Fluid Filled Teething Ring
  FDA Device · Class II · 2014-04-09 · Infantino
• 10mm Weck Vista Cannula-only, Catalog No. 405910C, 12mm Weck Vista Cannula-only, Catalog No. 405912C. An endoscope and accessories is a dev…
  FDA Device · Class II · 2014-04-09 · Teleflex Medical
• 5/10 Weck Vista Universal Balloon Open Access Port - Standard Length (70mm), Catalog No. 410944, 5/10 Weck Vista Universal Balloon Open Acc…
  FDA Device · Class II · 2014-04-09 · Teleflex Medical
• TDWorkstation version 11.01.A or higher
  FDA Device · Class III · 2014-04-09 · Technidata
• Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Catalog/Part Number: 03111873180 as a part of the following systems…
  FDA Device · Class II · 2014-04-09 · Roche Diagnostics Operations
• Artis Zee Angiographic x-ray systems
  FDA Device · Class II · 2014-04-09 · Siemens Medical Solutions Usa
• Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon Inc., Johnson & Johnson Medical GmbH, used for the repair of hernias…
  FDA Device · Class II · 2014-04-09 · Ethicon
• Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number 081351013
  FDA Device · Class II · 2014-04-09 · Ormco Sybronendo

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)