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FDA · Medical devices ·

Bravo CF capsule delivery device recall

Given Imaging Ltd. recalled Bravo CF capsule delivery device on September 16, 2026 because of capsule may fail to attach to the esophagus or detach from the delivery device. It was sold nationwide.

Why it was recalled

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.

What's recalled

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.

Quantity: 127,416

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Given Imaging Ltd., Yokne'Am Ilit
Date
Severity
Class I · most serious
the most serious: the product could cause serious health problems or death.
Where sold
Nationwide
Worldwide distribution. US nationwide including Puerto Rico; Argentina, Australia, Austria, Bahrain, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Czech Republic, Dominican Republic, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Kazakhstan, Kenya, Luxembourg, Netherla…
Status
Ongoing
Recall number
Z-3090-2026
Source
U.S. Food and Drug Administration

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