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.
✎ GovInfoNow plain-language explainer
Tandem Diabetes Care is recalling a beta version of the t:slim mobile application for iOS (version 2.13) because it fails to pair correctly with Abbott FreeStyle Libre 3 Plus sensors. This software defect prevents the insulin pump from establishing a connection, forcing users into manual mode and blocking access to glucose values within the app. The recall affects approximately 177 units distributed nationwide. Read more at govinfonow.com/recall/1449555-tandem-diabetes-care-inc-recalls-brand-name-tandem-t-slim.
“Tandem t:slim App Recall: Pairing Issue With Abbott Sensors.” GovInfoNow, updated October 14, 2026. https://govinfonow.com/recall/1449555-tandem-diabetes-care-inc-recalls-brand-name-tandem-t-slim. Based on FDA recall #Z-3330-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3330-2026%22&limit=1).
The FDA announced on July 16, 2026, that Tandem Diabetes Care is recalling the t:slim Mobile Application for iOS, version 2.13. The software issue prevents pairing with Abbott FreeStyle Libre 3 Plus sensors, which could lead to hypoglycemia or hyperglycemia.
How to tell if you have it
Brand: Tandem Diabetes Care
Product: t:slim Mobile Application, iOS
Software Version: 2.13 (iOS only)
UDI-DI: 00389152470641
The hazard
The beta version of the application has a software issue preventing successful pairing with Abbott FreeStyle Libre 3 Plus sensors. This prevents users from accessing glucose values or using automated control mode, which could lead to hypoglycemia or hyperglycemia.
Context
GovInfoNow's records show Tandem Diabetes Care has had 10 other recalls since April 23, 2018. Recent brand recalls include pumps with Czech guide errors (Jan. 30, 2026) and Mobi insulin pump vibration motor failure risks (Oct. 6, 2025). Other recent recalls of similar products include FreeStyle Libre 14 Day Sensor Recall (Nov. 24, 2025), FreeStyle Libre 3 Plus Sensor Recall: Incorrect Low Glucose Results (Nov. 24, 2025), and Abbott Diabetes Care FreeStyle Libre 3 Plus Sensor Recall: Incorrect Low Glucose Results (Nov. 24, 2025).
How to tell if you have this one
Check if you are using the t:slim Mobile Application on iOS with software version 2.13 (specifically the TestFlight beta version). The product is identified by UDI-DI numbers 00389152470740 and 00389152470641.
Brand
Tandem Diabetes Care
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Stop Using Automated Mode
Cease using the automated control features of your t:slim pump immediately as you cannot rely on glucose data from the sensor.
Monitor Glucose Manually
Use alternative methods to check your blood glucose levels frequently to prevent hypoglycemia or hyperglycemia.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-3330-2026 (July 16, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3330-2026 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.