Z-3330-2026

Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog...

Name: Z-3330-2026 Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog...
Creator: Tandem Diabetes Care, Inc.
Published: 2026-07-16
License: https://open.fda.gov/license/

Tandem Diabetes Care, Inc. / initiated 2026-07-16 / Open, Classified

FDA source

Recall record

Recall number: Z-3330-2026
Status: Open, Classified
Initiated: 2026-07-16
Posted: 2026-09-29
Recalling firm: Tandem Diabetes Care, Inc.
Product: Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS software version 2.13 Software Version: iOS software version 2.13 UDI-DI: 00389152470740 Component: No
Product code: QFG Alternate Controller Enabled Insulin Infusion Pump
Reason for recall: 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 the insulin pump being unable to establish a near-field communication (NFC) connection with the CGM and requiring FSL3P users to use their t:slim insulin pumps in manual mode. FSL3P users are unable to access their CGM's glucose values from within the t:slim app and cannot use their pumps in automated control (closed-loop) mode, which could lead to users experiencing hypoglycemia or hyperglycemia.
FDA root cause: Software Design Change
Action: On 07/16/2026, an "URGENT MEDICAL DEVICE CORRECTION" communication was sent via certified mail to customers informing them that an unexpected behavior was identified in the t:slim iOS mobile application version 2.13 made available through TestFlight. The issue involves users unable to pair a compatible FreeStyle Libre 3 Plus sensor after updating to version 2.13. If this occurs, the application will incorrectly display an "Incompatible Sensor" message and prevent sensor use. Customer are advised to: 1. Discontinue use of iOS t:slim mobile application version 2.13 2. Uninstall version 2.13 from their mobile device. 3. Return to the current production version of the t:slim mobile application (version 2.12.1) available on the Apple App Store. 4. Scan the compatible FreeStyle Libre 3 Plus sensor with version 2.12.1 when starting their next sensor session. For Questions - contact Tandum Customer Support at 1-877-801-6901 or email [email protected] (24/7/365).
Quantity in commerce: 177
Distribution: US Nationwide distribution.
Product codes and lots: Lot Code: UDI-DI: 00389152470641 Software Version: 2.13 (iOS only)

Product code QFG

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About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-10-02. View this recall on fda.gov (opens on fda.gov)