Given Imaging Ltd. recalls Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopi…

Recall date

June 3, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2047-2025

FDA classification

Class I

Brand / firm

Given Imaging Ltd.

Sold / distributed

US Nationwide. Global Distribution.

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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)