Tandem Diabetes Care, Inc. recalls Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery
- Recalling company
- Tandem Diabetes Care, Inc.
- 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 – may cause temporary or medically reversible health consequences
- Recall date
- Jan 30, 2026
- Reported
- Apr 1, 2026
- Distribution
- International distribution in the countries of Czech Republic, Slovakia.
- Status
- Ongoing
- Quantity
- 1,380 units
- Lot / codes
- Version 7.8.1/ UDI: (01)008500066132625
- Company location
- San Diego, CA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1636-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1636-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.