Device recall
Z-2016-2025: Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number…
FDA device recall · Class II · Insulet Corporation
Key facts
| Recall number (Z-number) | Z-2016-2025 |
|---|---|
| Recall event | 96945 |
| Product | Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version: all Product Description: The Omnipod 5 iOS App software is available to download through the Apple app store. The Omnipod 5 App is the user interface that controls the Omnipod 5… |
| 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