Medical Devices
Patient Alerts (Devices)
A Patient Alert was an important message to the health care community describing a risk associated with the use of a medical device and providing recommendations to avoid or reduce the risk. They were published until 2010 when they were replaced with Safety Communications.
Please see the Safety Communication section for the most current Medical Device Safety information.
Also available: information on recalls and additional FDA safety information from MedWatch.
The following documents have been designated "Archived" because they were released over 2 years ago or because they have been updated with new information.
List of Patient Alerts
List of Patient Alerts in descending date order
Advice for Patients: Ear Candles
02/18/2010Advice for Patients: Serious Complications with Negative Pressure Wound Therapy Devices
11/13/2009Advice for Patients: Serious Errors with Certain Blood Glucose Monitoring Test Strips
08/13/2009Advice for Patients: Denture Cleansers
02/25/2008Advice for Patients with Cochlear Implants: New Information on Meningitis Risk
10/10/2007Advice for Patients: Possible Burns or Fires from Heating Pads Manufactured by HoMedics, Inc.
07/12/2007Advice for Patients With Soft Contact Lenses: Acanthamoeba Keratitis Infections Related to Complete® MoisturePlus Multi Purpose Contact Lens Solution
05/31/2007Preliminary Advice for Patients*: Possible Contamination and Malfunction of Heart Valves and Valve Conduits, Annuloplasty Rings, Surgical Grafts, Meshes and Other Medical Devices Manufactured by Shelhigh, Inc.
04/19/2007Preliminary Advice for Patients*: Possible Contamination and Malfunction of Heart Valves and Valve Conduits, Annuloplasty Rings, Surgical Grafts, Meshes and Other Medical Devices Manufactured by Shelhigh, Inc. (archived)
04/18/2007Advice for Patients: Change in Daylight Saving Time May Affect Your Medical Equipment in an Unpredictable Way
03/01/2007Advice for Patients With Soft Contact Lenses: New Information on Risk of Serious Fungal Infection
04/10/2006Advice for Patients With Cochlear Implants: New Information on Meningitis Risk (2nd advisory)
02/06/2006Advice for Patients With Cochlear Implants: New Information on Meningitis Risk (1st advisory)
02/06/2006Advice for Patients with ENTERYX® for Gastroesophageal Reflux Disease
10/14/2005Advice for Patients with ENTERYX® for Gastroesophageal Reflux Disease (1st advisory)
10/14/2005Fetal Keepsake Videos
08/30/2005Advice for Patients with VENTAK PRIZM® 2 DR and CONTAK RENEWAL® Implantable Cardioverter Defibrillators
07/14/2005Advice for Patients with VENTAK PRIZM® 2 DR and CONTAK RENEWAL® Implantable Cardioverter Defibrillators (1st advisory)
07/14/2005Pre-loaded syringes manufactured by IV Flush, LLC and distributed by Pinnacle Medical Supply should NOT be used because of possible contamination
02/08/2005TMJ Implants- A Consumer Informational Update
04/01/2001Tampons and Asbestos, Dioxin, & Toxic Shock Syndrome
07/23/1999