Roche Diagnostics Corp. Disetronic D-TRONplus Insulin Pump Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Disetronic D-TRONplus Insulin Pump
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
all units.
Products Sold
all units.
Roche Diagnostics Corp. is recalling Disetronic D-TRONplus Insulin Pump due to Lack of assurance of reliability and notice to D-tron+ users to examine pump keys for punctures, not to use pumps with punctured keys near water, and . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of assurance of reliability and notice to D-tron+ users to examine pump keys for punctures, not to use pumps with punctured keys near water, and to alert users to the possibility of a sticking piston rod.
Recommended Action
Per FDA guidance
An urgent product correction and removal letter dated 7/24/03 was issued to each pump user informing of potential problems with the pump and instructing them how to proceed if they wish to discontinue use of the pump, have it replaced, or have questions regarding the pump.
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 noticePage updated: Jan 10, 2026