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Given Imaging Ltd.
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Given Imaging Ltd. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-07-16FDA-DeviceClass IBravo 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.
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