Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
t:connect mobile app used in conjunction with t:slim X2 insulin Recalled by Tandem Diabetes Care, Inc. Due to During normal use, the mobile app version 2.7...
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:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
Quantity: 85,863 applications
Why Was This Recalled?
During normal use, the mobile app version 2.7 may crash and be automatically relaunched by the iOS operating system. This cycle intermittently repeats, which leads to excessive Bluetooth communication that may result in pump battery drain and may lead to the pump shutting down sooner than typically expected. Pump shutdown will cause insulin delivery to suspend, which could lead to an under-delivery of insulin and may result in hyperglycemia, including severe hyperglycemia.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Tandem Diabetes Care, Inc.
Tandem Diabetes Care, Inc. has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report