Given Imaging Ltd. Recalls
2 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.
Medical Device Recalls (2)
- Class I
August 6, 2026
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.
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.
- Class I
June 3, 2025
Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack)
It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its malfunction. Specifically, the misapplied adhesive may prevent the capsule from attaching to the patient's esophagus or detaching from the delivery device.
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.