FDA recall, , Moderate risk
Tandem Pumps
Tandem pumps have a Czech user guide with translation errors that could lead to unintended insulin delivery and a hypoglycemic event.
Summary by Recall Canary from the FDA notice
What happened
Tandem Diabetes Care, Inc., of San Diego, California, recalled 1,380 units of its Tandem pumps, which are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The recall began January 30, 2026, and was added to the FDA's Enforcement Report on March 25, 2026.
The Czech language user guide contained multiple translation errors; the most significant error 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.
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. The desired timing and quantity of insulin delivery is programmed by the user. The recall involves international distribution in the countries of Czech Republic and Slovakia.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
Product details
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 details
- Company began the recall
- Sold in
International distribution in the countries of Czech Republic, Slovakia.
- Company
- Tandem Diabetes Care, Inc.San Diego, California
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98478
- Recall number
- Z-1636-2026
- Quantity recalled
- 1,380 units
All recalls from Tandem Diabetes Care, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
