Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2621-2025 — t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)

U.S. FDA — Device Enforcement · United States · 2025-07-03 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2621-2025
Date of alert
2025-07-03
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Tandem Diabetes Care, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00389152470641
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.