t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
Reported: October 1, 2025 Initiated: July 3, 2025 #Z-2621-2025
Product Description
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.
Details
- Recalling Firm
- Tandem Diabetes Care, Inc.
- Units Affected
- 19
- Distribution
- International distribution to the country of Israel.
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app). Recalled by Tandem Diabetes Care, Inc.. Units affected: 19.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 1, 2025. Severity: Moderate. Recall number: Z-2621-2025.
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