Bravo CF capsule delivery device — Class I medical device recall Z-2047-2025
Ongoing recall by Given Imaging Ltd., reported 2025-07-16, distributed nationwide. It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its malfun
| Recall number | Z-2047-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Given Imaging Ltd., Yokne'Am Ilit, N/A, Israel |
| Recall initiated | 2025-06-03 |
| Classified | 2025-07-10 |
| Reported by FDA | 2025-07-16 |
| Distributed | Nationwide (US) |
| Quantity | 128,202 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 07290101369707, 07290101369714 |
| Lot numbers | 61164F, 61165F, 61166F, 61167F, 61168F, 61169F, 61170F, 61171F, 61172F, 61173F, 61352F, 61353F, 61354F, 61386F, 61387F, 61388F, 61389F, 61390F, 61391F, 61392F, 61393F, 61394F, 61395F, 61396F, 61397F, 61398F, 61399F, 61400F, 61401F, 61402F, 61403F, 61404F, 61405F, 61406F, 61407F, 61408F, 61409F, 61410F, 61411F, 61412F and 299 more |
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)
Reason for recall
It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its malfunction. Specifically, the misapplied adhesive may prevent the capsule from attaching to the patient's esophagus or detaching from the delivery device.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2047-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.