Class II — Tandem Diabetes Care, Inc.
| Recalling firm | Tandem Diabetes Care, Inc. |
|---|---|
| Registered facility | View this company's 6 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app) |
| Quantity | 19 |
| Distribution | International distribution to the country of Israel. |
| Initiated | 2025-07-03 |
| Classified | 2025-09-24 |
| Recall number | Z-2621-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Tandem Diabetes Care, Inc. (Z-2621-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97264/
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