Device recall
Z-3330-2026: Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile…
FDA device recall · Class II · Tandem Diabetes Care, Inc.
Key facts
| Recall number (Z-number) | Z-3330-2026 |
|---|---|
| Recall event | 99589 |
| 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 |
| Product code | QFG |
| Recalling firm | Tandem Diabetes Care, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K201214, K203234, K232380 |
| FEI number | 3007981285 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database