Bravo CF capsule delivery device — Class I medical device recall Z-3090-2026
Ongoing recall by Given Imaging Ltd., reported 2026-09-16, distributed nationwide. Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspirati
| Recall number | Z-3090-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Given Imaging Ltd., Yokne'Am Ilit, Israel |
| Recall initiated | 2026-08-06 |
| Classified | 2026-09-10 |
| Reported by FDA | 2026-09-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BG, BH, BR, CA, CH, CL, CN, CZ, DE, DO, ES, FR, GB, GR, HK, IE, IL, IN, IT, KE, KY, LU, NL, NO, NZ, PA, PL, PT, SE, SG, TH, TT, TW, ZA |
| Quantity | 127,416 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 07290101369707, 07290101369714 |
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.
Reason for recall
Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient aspiration/inhalation, perforation of esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus, a delay in diagnosis, and foreign bodies remaining in the patient.
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-3090-2026. 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.