Given Imaging Bravo CF Capsule Device Recall: Misapplied Adhesive May Cause Malfunction
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.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/52160-given-imaging-bravo-cf-capsule-device-recall-misapplied-adhesive-may.
Source Summary by GovInfoNow · govinfonow.com/recall/52160-given-imaging-bravo-cf-capsule-device-recall-misapplied-adhesive-may · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2047-2025
Cite this page
“Given Imaging Bravo CF Capsule Device Recall: Misapplied Adhesive May Cause Malfunction.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52160-given-imaging-bravo-cf-capsule-device-recall-misapplied-adhesive-may. Based on FDA recall #Z-2047-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2047-2025%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Given Imaging- Category
Medical device
What to do — step by step
Check Device Details
Identify your product number and lot numbers by checking the device packaging or label.
Contact Manufacturer
Reach out to Given Imaging for specific guidance on whether your device is affected and next steps.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide. Global Distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 43 days after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-2047-2025 (June 3, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2047-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.