Food, drugs, devices › Tandem Diabetes Care, Inc.
Device recall: t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
FDA enforcement event 97264 is a device recall by Tandem Diabetes Care, Inc. of San Diego, CA, initiated 3 Jul 2025 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Tandem Diabetes Care, Inc. has 11 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Tandem Diabetes Care, Inc., San Diego, CA.
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."
Distribution
"International distribution to the country of Israel."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2621-2025 | t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app) | 19 | Class II | Ongoing | 1 Oct 2025 |
Context
Other enforcement events for Tandem Diabetes Care, Inc.
All 11 events for Tandem Diabetes Care, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "International distribution to the country of Israel."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.