Tandem Mobi Insulin Pump with Interoperable Technology — Class I medical device recall Z-1520-2025
Ongoing recall by Tandem Diabetes Care, Inc., reported 2025-04-23, distributed in AZ, CA, CO, CT, FL, HI, IA, ID…. A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used wi
| Recall number | Z-1520-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tandem Diabetes Care, Inc., San Diego, CA, United States |
| Recall initiated | 2025-02-27 |
| Classified | 2025-04-11 |
| Reported by FDA | 2025-04-23 |
| Distributed | 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 |
| Quantity | 85 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00389152480114 |
Product
Tandem Mobi Insulin Pump with Interoperable Technology
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1520-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.