FDA Device recall Z-3330-2026
Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS software version 2.13 S…
- FDA Device
- Class II
- ongoing
- Published 2026-10-07
On 2026-10-07 the FDA classified a Class II recall of Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS software version 2.13 S… by Tandem Diabetes Care, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3330-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-16 |
| Published | 2026-10-07 |
| Last updated | 2026-10-13 05:30 UTC |
| Company | Tandem Diabetes Care |
| Distribution | US |
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.
Identifiers
| code_info | Lot Code: UDI-DI: 00389152470641 Software Version: 2.13 (iOS only) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-13 05:30 UTC. Current status: ongoing.
Other recalls by Tandem Diabetes Care
- Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin
FDA Device · Class II · 2026-04-01 · Tandem Diabetes Care - Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus del…
FDA Device · Class I · 2025-11-12 · Tandem Diabetes Care - t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071, 1014072, 1014073, and User Guide when…
FDA Device · Class II · 2025-10-29 · Tandem Diabetes Care - t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
FDA Device · Class II · 2025-10-01 · Tandem Diabetes Care - Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911
FDA Device · Class I · 2025-09-03 · Tandem Diabetes Care
All Tandem Diabetes Care recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3330-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.