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Brand Name: Tandem t:slim mobile application Product Name:… recallZ-3330-2026 · Tandem Diabetes Care, Inc. · initiated Jul 16, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Tandem Diabetes Care, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 category: Software Design Change

What the company is doing

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).

Recall details

Recall number
Z-3330-2026
Status
Open, Classified
Initiated by the company
Jul 16, 2026
Posted by the FDA
Sep 29, 2026
Recalling firm
Tandem Diabetes Care, Inc.
Quantity
177
Product code
QFG
FDA submissions
K201214, K203234, K232380
Distribution
US Nationwide distribution.

Product description

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

Code information (models, lots, serial numbers)

Lot Code: UDI-DI: 00389152470641 Software Version: 2.13 (iOS only)

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

1 device cleared under K201214, K203234, K232380 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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