Drug Safety Alerts

Dexcom Glucose Systems Receivers Class I Recall

4/11/2016


On April 11, 2016, the FDA issued a MedWatch regarding a Class I Recall on continuous glucose monitoring systems manufactured by Dexcom. This recall was issued because the audible alarm may not activate in the receiver piece when hypoglycemia or hyperglycemia are detected. Relying on this product for notification of low or high blood sugar could result in serious adverse consequences, including death as the auditory alarm may not sound and users might not be notified of low or high blood sugar.

A complete list of the affected products and lot numbers is provided here:

CVS/caremark Response: Because of this action, CVS/caremark is sending letters to members who received this product through CVS/caremark Mail Service Pharmacy and their physicians.

For more information about this recall, please contact Dexcom at 1-844-607-8398 or visit https://www.dexcom-notification.com/cgm. You may also contact the FDA consumer inquiry line at 1‑888‑INFO-FDA (1‑888-463-6332) or visit their web site at https://www.fda.gov.