FDA Device recall Z-3090-2026
Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule delivery device, 1-pack, Product Number FGS-0636
- FDA Device
- Class I
- ongoing
- Published 2026-09-16
On 2026-09-16 the FDA classified a Class I recall of Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule delivery device, 1-pack, Product Number FGS-0636 by Given Imaging, citing 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, h….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3090-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-08-06 |
| Published | 2026-09-16 |
| Last updated | 2026-09-23 05:30 UTC |
| Company | Given Imaging |
| Distribution | US |
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
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.
Identifiers
| code_info | Product Number FGS-0635 UDI-DI (GTIN) 07290101369707 Product Number FGS-0636 UDI-DI (GTIN) 07290101369714 Expiration…Product Number FGS-0635 UDI-DI (GTIN) 07290101369707 Product Number FGS-0636 UDI-DI (GTIN) 07290101369714 Expiration dates prior to and including October 20, 2027 (lot numbers from 64553F up to and including 68912F) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-23 05:30 UTC. Current status: ongoing.
Other recalls by Given Imaging
- Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guid…
FDA Device · Class I · 2025-07-16 · Given Imaging - Given Imaging SmartBar Cereal Bar
FDA Food · Class II · 2023-03-15 · Given Imaging
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3090-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.