Tandem Diabetes Care, Inc. 2025-10-01 Health serious FDA
Health · FDA · Recall #FDA-Z-2621-2025
t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app) Recall
Issued October 1, 2025 · Tandem Diabetes Care, Inc.
In October 2025, Tandem Diabetes Care, Inc. recalled the t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app), a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
an app defect that occurs when the phone is set to a right-to-left language, which causes app-pump pairing issues and graphical defects, which can potentially lead to incorrect therapy decisions and subsequent hypoglycemia or hyperglycemia.
What you should do
- 1 Stop using t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app) right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Tandem Diabetes Care, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Tandem Diabetes Care, Inc.
- Category
- Health
- Recall date
- October 1, 2025
- Units affected
- Not reported
- Sold at
- International distribution to the country of Israel.
- Recall number
- FDA-Z-2621-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Tandem Diabetes Care, Inc. has 3 recalls in our database, including 2 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.