Device recall
Z-0591-2024: Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3…
FDA device recall · Class I · Insulet Corporation
Key facts
| Recall number (Z-number) | Z-0591-2024 |
|---|---|
| Recall event | 93511 |
| Product | Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 App Software Package (provided through Google Play), EU: PT-001323- Omnipod 5 App Software Package (provided on locked-down Controllers (PT-001194 and PT-001193). Used to control an… |
| Product code | QFG |
| Recalling firm | Insulet Corporation |
| Recall class | Class I |
| 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
- 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