Medical Devices

2019 Medical Device Recalls

The list below contains recalls that were issued in 2019.

2019 Recalls

Device NameDate
Cook Medical Inc. Recalls Transseptal Needle Due to Risk of Detached Plastic Fragments 03/18/19
RVO 2.0, Inc. Recalls Raindrop Near Vision Inlay Due to Risk of Increased Risk of Corneal Haze 03/05/19
Physio-Control Recalls LIFEPAK15 Monitor/Defibrillator Due to Risk of Device "Lockup" (Freezing) 02/27/19
ICU Medical Recalls ChemoLock Vial Spike (20mm) Due to Risk of Detached Plastic Particles 02/22/19
Medtronic, Inc. Recalls Dual Chamber Implantable Pulse Generators (IPGs) Due to Possible Circuit Error 02/15/19
Edwards Lifesciences Recalls Swan-Ganz Thermodilution Catheter Due to Incorrect Assembly Causing Reversal of Lumens 02/05/19
Medex Cardio-Pulmonary, doing business as Smiths Medical, Recalls Sterile Saline and Sterile Water for Inhalation Due to Potential Exposure to Infectious Agents as a Result of Leaking Containers 02/04/19
West Pharmaceutical Services Inc. Recalls Vial2Bag Fluid Transfer Systems Due to Potential Malfunctions 02/01/19
Terrific Care, LLC. / Medex Supply Recalls CoaguChek XS PT Test Strips Used to Monitor Blood Thinner Warfarin Due to Inaccurate Test Results 02/01/19
Draeger Medical Recalls Breathing Circuits and Anesthesia Sets 01/25/19
Medtronic Recalls Synergy Cranial Software and Stealth Station S7 Cranial Software Due to Inaccuracies Displayed During Surgical Procedures 01/08/19

Page Last Updated: 03/18/2019
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English