Class IIDeviceOngoing

Tandem Diabetes Care, Inc.

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

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.

Details

Recall number: Z-3330-2026
Event ID: 99589
Recall initiated: Jul 16, 2026
Classified: Sep 29, 2026
Reported: Oct 7, 2026
Quantity: 177
Distribution: US Nationwide distribution.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: San Diego, CA, United States
Lot / code info: Lot Code: UDI-DI: 00389152470641 Software Version: 2.13 (iOS only)