Device recall
Z-1636-2026: Tandem pumps are battery-operated infusion pumps capable of both basal and bolus…
FDA device recall · Class II · Tandem Diabetes Care, Inc.
Key facts
| Recall number (Z-number) | Z-1636-2026 |
|---|---|
| Recall event | 98478 |
| Product | Tandem 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 subcutaneous tissue. As with current insulin infusion… |
| Product code | QFG |
| Recalling firm | Tandem Diabetes Care, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K232380, K232382, K243823, K250792, K250798 |
| 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