FDA Medical devices recall ·
t:slim X2 Insulin Pump with Interoperable Technology recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-1519-2025
- Date
- (initiated February 27, 2025)
- Company / brand
- Tandem Diabetes Care, Inc.
12400 High Bluff Dr, San Diego, CA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 63 units
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
t:slim X2 Insulin Pump with Interoperable Technology
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Software versions 7.9/UDI: 00389152407012
Distribution
US: AZ, CA, CO, CT, FL, HI, IA, ID, IL, IN, MD, ME, MI, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, PA, TX, UT, VA, WA, WI OUS: N/A
States: Arizona California Colorado Connecticut Florida Hawaii Iowa Idaho Illinois Indiana Maryland Maine Michigan Missouri Mississippi North Carolina North Dakota Nebraska New Jersey New Mexico Nevada New York Ohio Pennsylvania Texas Utah Virginia Washington Wisconsin
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-1519-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.