Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utili... — FDA record Z-1636-2026

What the record says

Product

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).

Reason

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.

Classification

Class II

Recalling firm

Tandem Diabetes Care, Inc.

Quantity

1,380 units

Agency-reported status

Ongoing

Source record identifier

Z-1636-2026

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

International distribution in the countries of Czech Republic, Slovakia.

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Report date

Apr 1, 2026

Recall initiation date

Jan 30, 2026

Center classification date

Mar 25, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.