Official recall record
Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF:
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2025-07-21
- Country of alert
- United States
- Alert level
- Class I
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00853052007318
- Brand on record
- Tandem Diabetes Care, Inc.
What the authority reported
Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which prevents audible alerts and causes the pumps to become inoperable and stop infusing insulin which could result in a hyperglycemic event, which may lead to injury and/or hospitalization.
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.
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 - 2025-08-05 · US FDA — Medical Devices
t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072,
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