t:slim X2 Insulin Pump with Interoperable Technology — Class II medical device recall Z-2621-2025
Ongoing recall by Tandem Diabetes Care, Inc., reported 2025-10-01. an app defect that occurs when the phone is set to a right-to-left language, which causes app-pump pairing iss
| Recall number | Z-2621-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tandem Diabetes Care, Inc., San Diego, CA, United States |
| Recall initiated | 2025-07-03 |
| Classified | 2025-09-24 |
| Reported by FDA | 2025-10-01 |
| Countries outside the US | IL |
| Quantity | 19 |
| UPC / GTIN / UDI-DI | 00389152470641 |
Product
t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
Reason for recall
an app defect that occurs when the phone is set to a right-to-left language, which causes app-pump pairing issues and graphical defects, which can potentially lead to incorrect therapy decisions and subsequent 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-2621-2025. 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.