Bravo CF Capsule Delivery Device
Capsule may fail to attach to the esophagus or detach from the delivery device.
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
What happened
Given Imaging Ltd. of Yokne'Am Ilit, Israel, recalled the Bravo CF capsule delivery device, 5-pack (Product Number FGS-0635) and 1-pack (Product Number FGS-0636), used to attach a pH monitoring capsule to the esophagus.
The capsule may fail to attach to the esophagus or detach from the delivery device, posing risks including patient aspiration/inhalation, perforation of the esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus, a delay in diagnosis, and foreign bodies remaining in the patient.
The recall began August 6, 2026, with distribution worldwide, including the US nationwide and Puerto Rico.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI and lot code are listed under that 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.
- UDI-DI
- 07290101369707
- 07290101369714
- Lot
- 64553F
- 68912F
Details
- Company began the recall
- Sold in
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.
- Event ID
- 99626
- Recall No.
- Z-3090-2026
- Company
- Given Imaging Ltd.Yokne'Am Ilit, Israel
- Hazard
- Device defect
Company began the recall
Classified by FDA
Added to FDA's Enforcement Report
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
