Device recall
Z-1809-2026: iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
FDA device recall · Class II · Beta Bionics, Inc.
Key facts
| Recall number (Z-number) | Z-1809-2026 |
|---|---|
| Recall event | 98528 |
| Product | iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software |
| Product code | QFG |
| Recalling firm | Beta Bionics, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K231485, K232224 |
| FEI number | 3019004087 |
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