Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
t:slim X2 insulin pump Recalled by Tandem Diabetes Care Inc Due to Insulin pumps may have the following issues: 1)...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Tandem Diabetes Care Inc directly.
Affected Products
t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump with the Control-IQ Technology
Quantity: 8399
Why Was This Recalled?
Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate (Fluctuating) Battery Life Display, 3) Touchscreen Staying On, 4) Unexpected Open Loop, that can be mitigated with a software update. Issues could result in hypoglycemia, hyperglycemia or diabetic ketoacidosis.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Tandem Diabetes Care Inc
Tandem Diabetes Care Inc has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report