Tandem Insulin Infusion Pump
Tandem is recalling insulin infusion pumps in Czech Republic and Slovakia due to user guide translation errors that could cause unintended insulin delivery.
If you own a Tandem insulin infusion pump and received a Czech language user guide, contact Tandem Diabetes Care immediately for a corrected guide. Do not follow the infusion set connection instructions in the affected Czech guide; instead, confirm that the infusion set is not connected to your body before use.
Why it was recalled
The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infusion set is connected to the body, when it should instead direct users to confirm that the infusion set is not connected to the body. Following this instruction could result in unintended insulin delivery, potentially leading to a hypoglycemic event.
How to identify it
Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current insulin infusion…
Official source
Editorial summary by Recall Canary · last updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification