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.
Recall at a glance
- Quantity recalled
- 1,380 units
Why it was recalled
Tandem Diabetes Care is recalling Tandem insulin infusion pumps distributed in Czech Republic and Slovakia due to translation errors in the Czech language user guide. The guide incorrectly instructs users to verify that the infusion set is connected to the body when it should direct users to confirm the infusion set is not connected, which could result in unintended insulin delivery and hypoglycemic events.
Is mine affected?
This recall covers the product below. If you have it, yours is affected.
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 pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient).
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Editorial summary by Recall Canary · summary updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification