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:slim X2 Insulin Pump with Interoperable Technology Recalled by Tandem Diabetes Care, Inc. Due to A software defect in Version 7.9 of the...
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 with Interoperable Technology
Quantity: 63 units
Why Was This Recalled?
A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends when the Estimated Glucose Value (EGV) is above 255 mg/dL at the start or end of a gap in data collection due to a lapse in connection from a paired continuous glucose monitor (CGM) sensor, which can lead to under-delivery or over-delivery of insulin based on inaccurate result leading to severe cases of hypoglycemia or hyperglycemia.
Where Was This Sold?
This product was distributed to 29 states: AZ, CA, CO, CT, FL, HI, ID, IL, IN, IA, ME, MD, MI, MS, MO, NE, NV, NJ, NM, NY, NC, ND, OH, PA, TX, UT, VA, WA, WI
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