Tandem Diabetes Care, Inc. recalls Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application

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.

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 Techsupport@tandumdiabetes.com (24/7/365).

• FDA enforcement recordOfficial FDA database entry for Z-3330-2026
• FDA 510(k) clearance · K201214The device's official FDA premarket clearance record
• FDA 510(k) clearance · K203234The device's official FDA premarket clearance record
• FDA 510(k) clearance · K232380The device's official FDA premarket clearance record
• FDA device classification · QFGOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.5730The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Tandem Diabetes Care, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.