Given Imaging recalls Bravo CF capsule delivery devices with misapplied adhesive that may prevent proper attachment to esophagus or cause detachment during use. Affected units include specific product numbers and lot numbers.
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.
Given Imaging is recalling Bravo CF capsule delivery devices that may have misapplied adhesive, preventing proper attachment to the esophagus or causing detachment from the device. This could lead to incorrect pH monitoring or device failure during medical procedures.
The misapplied adhesive may prevent the capsule from attaching to the patient's esophagus or detaching from the delivery device. This could cause the device to malfunction during pH monitoring procedures, potentially leading to incorrect results or device failure.
Patients undergoing pH monitoring procedures using the Bravo CF device are affected. Those with the specific product numbers and lot numbers listed in the recall are most at risk.
Check for product numbers FGS-0635 (5 pack) or FGS-0636 (1 pack) with specific lot numbers listed in the recall notice. The devices were sold with UDI-DI codes starting with 07290101369707 or 07290101369714.
Identify your product number and lot numbers by checking the device packaging or label.
Reach out to Given Imaging for specific guidance on whether your device is affected and next steps.
The misapplied adhesive on the device may prevent the capsule from attaching to the patient's esophagus or detaching from the delivery device.
Check for product numbers FGS-0635 (5 pack) or FGS-0636 (1 pack) with specific lot numbers listed in the recall notice.
Contact Given Imaging directly for specific guidance on whether your device is affected and next steps.
We’ve drafted a message you can send Given Imaging to request your refund or repair — edit it as you like.
Subject: Recall Z-2047-2025 — Given Imaging Given Imaging Hello, I own a Given Imaging that is covered by recall Z-2047-2025 from Given Imaging. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
