Class IDeviceOngoing

Given Imaging Ltd.

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.

Details

Recall number: Z-3090-2026
Event ID: 99626
Recall initiated: Aug 6, 2026
Classified: Sep 10, 2026
Reported: Sep 16, 2026
Quantity: 127,416
Distribution: 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, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, United Arab Emirates, and United Kingdom.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Yokne'Am Ilit, Israel