Device recall
Z-0427-2026: Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are…
FDA device recall · Class I · Tandem Diabetes Care, Inc.
Key facts
| Recall number (Z-number) | Z-0427-2026 |
|---|---|
| Recall event | 97662 |
| Product | Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s… |
| Product code | QFG |
| Recalling firm | Tandem Diabetes Care, Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K223213, K233044, K240309, K241078 |
| 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