FDA Device recall Z-1636-2026

Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin

• FDA Device
• Class II
• ongoing
• Published 2026-04-01

On 2026-04-01 the FDA classified a Class II recall of Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin by Tandem Diabetes Care, citing 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 connecte….

Read the official FDA Device notice

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.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1636-2026%22

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