Tandem Diabetes Care, Inc.

Devices and FDA recall records listed on MedWatcher for Tandem Diabetes Care, Inc..

What MedWatcher tracks

This page covers the devices and recall records listed below, not the complete product catalogue or recall history. A recall may apply only to specific models, lots, or serial numbers.

Tracked devices: 2
Recall records: 6
Source records last checked: Oct 28, 2026

Manufacturer names

Device and manufacturer names are linked using official product, UDI, or FDA records. The source links below show the supporting information.

Official records may use a legal name, brand, division, or shortened name. Similar names do not necessarily refer to the same manufacturer.

Tandem Diabetes Care, Inc.Source-name variantOfficial source (opens in a new tab)
Tandem Diabetes Care, Inc.Source-name variantOfficial source (opens in a new tab)

Sources used for this page

U.S. Food and Drug AdministrationFDA medical device recall recordsLast checked Aug 16, 2026 openFDAMedical device recall bulk dataLast checked Aug 16, 2026

Insulin pumps

View category

Tandem Mobi Insulin Pump

Tandem Diabetes Care, Inc. · Insulin pumps

Active recall record

Latest source check Oct 27, 2026

Tandem t:slim X2 Insulin Pump

Tandem Diabetes Care, Inc. · Insulin pumps

Active recall record

Latest source check Oct 27, 2026

Recent recall records

Class II recallOngoing

Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS soft recall — FDA event 99589

A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a software issue preventing successful pairing of the t:slim application with Abbott FreeStyle Libre 3 Plus (FSL3P) continuous glucose monitoring (CGM) sensors, resulting in…

FDA · FDA event 99589Posted Sep 29, 2026

Class II recallOngoing

Tandem pumps recall — FDA event 98478

The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infusion set is connected to the body, when it should instead direct users to confirm that the infusion…

FDA · FDA event 98478Posted Mar 25, 2026

Class I recallOngoing

Tandem Mobi Insulin Pump recall — FDA event 97662

Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions. Pump may exhibit false vibration motor failure due to a software issue causing Malfunction 12: "Pump cannot operate, the mobile app can no longer…

FDA · FDA event 97662Posted Nov 5, 2025Tandem Mobi Insulin Pump

Class II recallOngoing

Tandem Mobi Insulin Pump and Tandem t:slim X2 Insulin Pump recall — FDA event 97403

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…

FDA · FDA event 97403Posted Oct 23, 2025Tandem Mobi Insulin Pump,Tandem t:slim X2 Insulin Pump

Class I recallOngoing

Tandem t:slim X2 insulin pumps recall — FDA event 97003

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…

FDA · FDA event 97003Posted Aug 27, 2025Tandem t:slim X2 Insulin Pump

Class I recallOngoing

Tandem Mobi Insulin Pump and Tandem t:slim X2 Insulin Pump recall — FDA event 96417

A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps, when used with Control IQ+ technology, will cause the pump to incorrectly interpolate glucose trends when the Estimated Glucose Value (EGV) is above 255 mg/dL at…

FDA · FDA event 96417Posted Apr 11, 2025Tandem Mobi Insulin Pump,Tandem t:slim X2 Insulin Pump

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Recent recall records

Class II recallOngoing

Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS soft recall — FDA event 99589

FDA · FDA event 99589Posted Sep 29, 2026

Class II recallOngoing

Tandem Diabetes Care, Inc.

Follow Tandem Diabetes Care, Inc.

What MedWatcher tracks

Manufacturer names

Sources used for this page

Insulin pumps

Tandem Mobi Insulin Pump

Tandem t:slim X2 Insulin Pump

Recent recall records

Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS soft recall — FDA event 99589

Tandem pumps recall — FDA event 98478

Tandem Mobi Insulin Pump recall — FDA event 97662

Tandem Mobi Insulin Pump and Tandem t:slim X2 Insulin Pump recall — FDA event 97403

Tandem t:slim X2 insulin pumps recall — FDA event 97003

Tandem Mobi Insulin Pump and Tandem t:slim X2 Insulin Pump recall — FDA event 96417

Tandem Diabetes Care, Inc.

Follow Tandem Diabetes Care, Inc.

What MedWatcher tracks

Manufacturer names

Sources used for this page

Insulin pumps

Tandem Mobi Insulin Pump

Tandem t:slim X2 Insulin Pump

Recent recall records

Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS soft recall — FDA event 99589

Tandem pumps recall — FDA event 98478

Tandem Mobi Insulin Pump recall — FDA event 97662

Tandem Mobi Insulin Pump and Tandem t:slim X2 Insulin Pump recall — FDA event 97403

Tandem t:slim X2 insulin pumps recall — FDA event 97003

Tandem Mobi Insulin Pump and Tandem t:slim X2 Insulin Pump recall — FDA event 96417