Device recall
Z-2604-2026: Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525…
FDA device recall · Class I · Insulet Corporation
Key facts
| Recall number (Z-number) | Z-2604-2026 |
|---|---|
| Recall event | 99034 |
| Product | Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack), POD-BLE-I1-520 (Single Pod). 2. POD-BLE-I1-529 (10-Pack), POD-BLE-I1-520 (Single Pod). 3. BLE-I1-529 (10-Pack), BLE-I1-520 (Single Pod). 4. BLE-C1-529 (10-Pack), BLE-C1-520 (Single Pod). |
| Product code | LZG |
| Recalling firm | Insulet Corporation |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K211575 |
| FEI number | 3014585508 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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