FDAFDA recall Z-3330-2026 · Oct 7, 2026
Tandem Diabetes Care, Inc.: Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application recall
Recall found
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 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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot Code: UDI-DI: 00389152470641 Software Version: 2.13 (iOS only)
- Quantity
- 177
- Distribution
- US Nationwide distribution.
- Recalling firm
- Tandem Diabetes Care, Inc., San Diego, CA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-16
Source: openFDA enforcement record Z-3330-2026 · search recall number Z-3330-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.