Recall Z-1636-2026— Tandem Diabetes Care, Inc.
Class II · Ongoing
Class II FDA medical device recall by Tandem Diabetes Care, Inc., initiated 2026-01-30. It names 5 FDA 510(k) clearances: K250792, K250798, K243823 and 2 more. 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..
- Recalling firm
- Tandem Diabetes Care, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-01-30
- Firm location
- San Diego, CA, United States
510(k) clearances named in this recall
5 on FDA's record- K250792 — t:slim X2 insulin pump with interoperable technology
- K250798 — Control-IQ+ technology
- K243823 — Control-IQ+ technology
- K232380 — t:slim X2 Insulin Pump with Interoperable Technology
- K232382 — Control-IQ Technology
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.