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

Recalling company

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

Reason

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Jul 16, 2026

Reported

Oct 7, 2026

Distribution

US Nationwide distribution.

Status

Ongoing

Quantity

177

Lot / codes

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

Company location

San Diego, CA

Recall type

Voluntary: Firm initiated

Recall number

Z-3330-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-3330-2026 in the FDA Enforcement Report. Also see FDA recall press releases.