Dana Diabecare USA LLC DANA Diabecare II insulin pumps Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
DANA Diabecare II insulin pumps
Brand
Dana Diabecare USA LLC
Lot Codes / Batch Numbers
Serial numbers: AEE001FC ¿ AEE039FC, AEE041FC, AEE043FC ¿ AEE048FC, AEE083FC ¿ AEE132FC
Products Sold
Serial numbers: AEE001FC ¿ AEE039FC, AEE041FC, AEE043FC ¿ AEE048FC, AEE083FC ¿ AEE132FC
Dana Diabecare USA LLC is recalling DANA Diabecare II insulin pumps due to There is a switch malfunction that that may cause the unit not to respond when command key is depressed.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a switch malfunction that that may cause the unit not to respond when command key is depressed.
Recommended Action
Per FDA guidance
An email was sent to the sales representatives requesting the return of the pumps. The patients were contacted by telephone and letters requesting the return of the pumps.
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
AZ, FL, MD, MI, PA, TN, WV, WI
Page updated: Jan 10, 2026