Recall Z-2621-2025— Tandem Diabetes Care, Inc.
Class II · Ongoing
Class II FDA medical device recall by Tandem Diabetes Care, Inc., initiated 2025-07-03. It names one FDA 510(k) clearance: K232380. Product: t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app). 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..
- Recalling firm
- Tandem Diabetes Care, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-07-03
- Firm location
- San Diego, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.