TemporaryFDAOngoing
Can cause harm that is usually temporary.
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
Check the device or its packaging for
Lot Code: UDI-DI: 00389152470641 Software Version: 2.13 (iOS only)
- Why
- 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.
- Distributed
- US Nationwide distribution.
- Company
- Tandem Diabetes Care, Inc.
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-3330-2026 · retrieved 29 September 2026
Read the official notice