Recall Z-3330-2026— Tandem Diabetes Care, Inc.
Class II · Ongoing
Class II FDA medical device recall by Tandem Diabetes Care, Inc., initiated 2026-07-16. It names 3 FDA 510(k) clearances: K232380, K203234, K201214. 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..
- Recalling firm
- Tandem Diabetes Care, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-07-16
- Firm location
- San Diego, CA, United States
510(k) clearances named in this recall
3 on FDA's record- K232380 — t:slim X2 Insulin Pump with Interoperable Technology
- K203234 — t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)
- K201214 — t:slim X2 Insulin Pump with Interoperable Technology
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.