Tandem Diabetes Care, Inc. 2025-09-03 Health critical FDA
Health · FDA · Recall #FDA-Z-2343-2025
Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; … Recall
Issued September 3, 2025 · Tandem Diabetes Care, Inc.
In September 2025, Tandem Diabetes Care, Inc. recalled the Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; …, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which prevents audible alerts and causes the pumps to become inoperable and stop infusing insulin which could result in a hyperglycemic event, which may lead to injury and/or hospitalization.
What you should do
- 1 Stop using Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; … 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
- September 3, 2025
- Units affected
- Not reported
- Sold at
- Worldwide distribution. US nationwide including Puerto Rico, Canada, Czech Republic, Slovakia, Spain, United Kingdom, Belgium, Luxembourg, A
- Recall number
- FDA-Z-2343-2025
- 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.