Reported Oct 7, 2026 · Ongoing · Updated Oct 13, 2026
Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS…
Tandem Diabetes Care, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tandem Diabetes Care, Inc. · 12400 High Bluff Dr · San Diego, CA · 92130-3077
Is this the product you have?
- Brand NameTandem t:slim
- mobile application Product Namet:slim Mobile Application
- iOS Model/Catalog NumberiOS software version 2.13
- Software VersioniOS software version 2.13
- UDI-DI00389152470740
- ComponentNo
- Lot codes and dates
- Lot CodeUDI-DI: 00389152470641
- Software Version2.13 (iOS only)
- Amount recalled
- 177
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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