Device recall
Z-0132-2026: The failure occurs if a user on the Omnipod 5 iOS application selects and holds…
FDA device recall · Class II · Insulet Corporation
Key facts
| Recall number (Z-number) | Z-0132-2026 |
|---|---|
| Recall event | 97597 |
| Product | The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard. |
| Product code | QRX |
| Recalling firm | Insulet Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K231826 |
| FEI number | 3014585508 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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