Device recall
Z-2047-2025: Bravo CF capsule delivery device, designed to place and attach a pH monitoring…
FDA device recall · Class I · Given Imaging Ltd.
Key facts
| Recall number (Z-number) | Z-2047-2025 |
|---|---|
| Recall event | 97029 |
| Product | Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack) |
| Product code | FFT |
| Recalling firm | Given Imaging Ltd. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K102543 |
| FEI number | 3003348376 |
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