Given Imaging Ltd. medical device recall: Bravo CF capsule delivery device
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 97029
- Recall initiated
- Jun 3, 2025
- Classified by FDA
- Jul 10, 2025
- Posted in Enforcement Report
- Jul 16, 2025
- Recalling firm
- Given Imaging Ltd.
- Firm location
- Yokne'Am Ilit, Israel
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
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.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Jun 3, 2025. FDA classified it 37 days later, on Jul 10, 2025. Distribution reported by FDA: US Nationwide. Global Distribution. Given Imaging Ltd. has 3 recalls in our records.
Recalled products (1)
Z-2047-2025 Class I Ongoing
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)
Codes / lots: FGS-0635: UDI-DI: 07290101369707; Lot Numbers: 61164F 61407F 61933F 62142F 62418F 62884F 63152F 63668F 64065F 64096F 64291F 61165F 61408F 61934F 62143F 62419F 62885F 63154F 63669F 64066F 64261F 64550F 61166F 61409F 61935F 62144F 62420F 62886F 63155F 63670F 64067F 64262F 64551F 61167F 61410F 61936F 62145F 62421F 62887F 63156F 63671F 64068F 64263F 64552F 61168F 61411F 61937F 62146F 62422F 62888F 63157F 63672F 64069F 64264F 64553F 61169F 61412F 61938F 62147F 62656F 62889F 63158F 63673F 64070F 64265F 64554F 61170F 61413F 61939F 62148F 62657F 62890F 63159F 63674F 64071F 64266F 64555F 61171F 61414F 61940F 62149F 62658F 62891F 63391F 63675F 64072F 64267F 64557F 61172F 61415F 62031F 62150F 62659F 62892F 63392F 63676F 64073F 64268F 64558F 61173F 61416F 62032F 62151F 62660F 62893F 63393F 63677F 64074F 64269F 64559F 61352F 61708F 62033F 62152F 62661F 62894F 63394F 63679F 64075F 64270F 64560F…
Quantity: 128,202 units
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 97029
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.