Official recall record
t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide when u
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2025-08-05
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00389152407012
- Brand on record
- Tandem Diabetes Care, Inc.
What the authority reported
A software defect in versions 7.9.0.1 and 7.10.1 of the pump software for Tandem t:slim X2 and version 7.9.0.1 of the Tandem Mobi pump with Control-IQ+ technology that are paired with a G7 sensor may result in an unexpected automatic insulin correction bolus (autobolus ) which could result in hypoglycemia.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Same barcode in other registries
The same EAN appears in 1 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.
- 2025-02-27 · US FDA — Medical Devices
t:slim X2 Insulin Pump with Interoperable Technology
Other recalls from this brand
- 2026-07-16 · US FDA — Medical Devices
Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number - 2026-01-30 · US FDA — Medical Devices
Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pump - 2025-07-21 · US FDA — Medical Devices
Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic,
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