Stop using nowMedical device recall · FDA · Published August 6, 2026
Given Imaging Bravo CF Capsule Device Recall: Risk of Esophageal Injury
Given Imaging recalls Bravo CF capsule delivery devices (5-pack FGS-0635 and 1-pack FGS-0636) due to risk of esophageal injury from capsule detachment. Devices sold before October 20, 2027, with specific lot numbers are affected.
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.
“Given Imaging Bravo CF Capsule Device Recall: Risk of Esophageal Injury.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/1009701-given-imaging-bravo-cf-capsule-device-recall-risk-of-esophageal. Based on FDA recall #Z-3090-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3090-2026%22&limit=1).
The FDA announced on August 6, 2026, that Given Imaging Ltd. is recalling Bravo CF capsule delivery devices due to a hazard where the capsule may fail to attach or detach from the device. Owners should contact the company for a remedy.
How to tell if you have it
Given Imaging Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635
Given Imaging Bravo CF capsule delivery device, 1-pack, Product Number FGS-0636
Product Number FGS-0635 UDI-DI (GTIN) 07290101369707
Product Number FGS-0636 UDI-DI (GTIN) 07290101369714
Expiration dates prior to and including October 20, 2027 (lot numbers from 64553F up to and including 68912F)
The hazard
The 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.
Context
GovInfoNow's records show Given Imaging Ltd. has 2 other recalls on record since 2023-02-02. Other recent recalls of similar products include Medline Airway Exam Kit Recall (2026-02-16), Medtronic Bio-Medicus Adult Cannula Kit Recall (2026-05-25), and Medline Recalls Olympus Biopsy Kits (2026-02-16).
How to tell if you have this one
Check for product numbers FGS-0635 (5-pack) or FGS-0636 (1-pack) with expiration dates before October 20, 2027. Lot numbers range from 64553F to 68912F.
Brand
Given Imaging
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Stop Using Now
Immediately stop using the device if it has the product numbers FGS-0635 or FGS-0636 with expiration dates before October 20, 2027.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 41 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-3090-2026 (August 6, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3090-2026 to see it in context.
Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.