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).

Recall Insight

This FDA Devices action (record #Z-1636-2026) was formally reported on April 1, 2026, with the manufacturer initiating the action on January 30, 2026. It is classified under Moderate severity (Class II), with a current status of Ongoing. Tandem Diabetes Care, Inc. is listed as the recalling firm, operating out of San Diego, CA. Federal records list the affected scope as 1,380 units.

The documented reason for this recall is: 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 d… Distribution data in the federal record shows the product reached: International distribution in the countries of Czech Republic, Slovakia.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.