Given Imaging recall: Bravo CF capsule delivery device
Given Imaging Ltd. is recalling Bravo CF capsule delivery device because of a laceration hazard – 127,416. The U.S. Food and Drug Administration published the recall on September 16, 2026; it began on August 6, 2026. Distributed nationwide.
Most serious Class I is the most serious level: a reasonable probability that using or eating the product will cause serious health problems or death.
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| Product | Bravo CF capsule delivery device |
| Brand | Given Imaging |
| Company | Given Imaging Ltd. |
| Type | Medical devices |
| Classification | Class I |
| Recall date | August 6, 2026 |
| Published by FDA | September 16, 2026 |
| Quantity | 127,416 |
| Recall ID | 99626 |
Recalled products
- 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.
- FDA recall number
- Z-3090-2026
- Codes, lots and dates
- 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)
- Quantity
- 127,416
- Classification
- Class I
Identifiers and details
- FDA event ID
- 99626
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Yokne'Am Ilit, Israel
Why it was recalled
The problem: a laceration hazard.
The reason the FDA lists: “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.”
Where it was sold
Nationwide. Distribution as the FDA records it: “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.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99626, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
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About this recall
Is Given Imaging Bravo CF capsule delivery device recalled?
Yes. Given Imaging Ltd. recalled it on August 6, 2026; FDA published it September 16, 2026 (Class I). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Because of a laceration hazard. The reason given: 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 pat…
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.