Abbott Diabetes Care, Inc. FreeStyle CoPilot Web Based Data Management System, and FreeStyle CoPilot Health Management System,Versions 1 and 2. Web-based software system, no packaging. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
FreeStyle CoPilot Web Based Data Management System, and FreeStyle CoPilot Health Management System,Versions 1 and 2. Web-based software system, no packaging.
Brand
Abbott Diabetes Care, Inc.
Lot Codes / Batch Numbers
N/A. Product is a software package.
Products Sold
N/A. Product is a software package.
Abbott Diabetes Care, Inc. is recalling FreeStyle CoPilot Web Based Data Management System, and FreeStyle CoPilot Health Management System,V due to Downloadable software obtained from the firm's website displays user data (including but not limited to insulin levels and pump statistics data) in a . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Downloadable software obtained from the firm's website displays user data (including but not limited to insulin levels and pump statistics data) in a matter that may be misinterpreted and result in mistreatment of therapy.
Recommended Action
Per FDA guidance
On 8/30/05, the firm initiated the recall and its notification was via web postings and phone calls requesting discontinuation of the FreeStyle CoPilot from the website. A follow-up letter will be sent to registered users advising them of the issues and instructing them to not use CoPilot.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
OR
Page updated: Jan 10, 2026