Device recall
Z-3090-2026: Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF…
FDA device recall · Class I · Given Imaging Ltd.
Key facts
| Recall number (Z-number) | Z-3090-2026 |
|---|---|
| Recall event | 99626 |
| Product | Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule delivery device, 1-pack, Product Number FGS-0636. Used to attach a pH monitoring capsule to the esophagus. |
| Product code | FFT |
| Recalling firm | Given Imaging Ltd. |
| Recall class | Class I |
| Status | Open, Classified |
| FEI number | 3003348376 |
At a glance
- None 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