Given Imaging Ltd. medical device recall: Bravo CF capsule delivery device
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 99626
- Recall initiated
- Aug 6, 2026
- Classified by FDA
- Sep 10, 2026
- Posted in Enforcement Report
- Sep 16, 2026
- Recalling firm
- Given Imaging Ltd.
- Firm location
- Yokne'Am Ilit, Israel
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
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.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Aug 6, 2026. FDA classified it 35 days later, on Sep 10, 2026. Distribution reported by FDA: 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,… Given Imaging Ltd. has 3 recalls in our records.
Recalled products (1)
Z-3090-2026 Class I Ongoing
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.
Codes / lots: 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
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 99626
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.