Class I

Medical Device Recall: 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)

Given Imaging Ltd. · June 3, 2025

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.

Distribution

US Nationwide. Global Distribution.

States Affected

NATIONWIDE

Quantity Affected

128,202 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2047-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.