Given Imaging Ltd.: Device Recall
Recall #Z-2047-2025 · 06/03/2025
Class I: Dangerous
Recall Details
- Recall Number
- Z-2047-2025
- Classification
- Class I
- Product Type
- Device
- Recalling Firm
- Given Imaging Ltd.
- Status
- Ongoing
- Date Initiated
- 06/03/2025
- Location
- Yokne'Am Ilit, N/A, Israel
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 128,202 units
Reason for Recall
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.
Product Description
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)
Distribution Pattern
US Nationwide. Global Distribution.
Other Recalls by Given Imaging Ltd.
- Class II: Risk 02/02/2023
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.