Reported Jul 16, 2025 · Ongoing
Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using…
Given Imaging Ltd.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Given Imaging Ltd. · New Industrial Park, POB 258 · Yokne'Am Ilit, N/A · N/A
Is this the product you have?
- 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)
- Lot codes and dates
- FGS-0635UDI-DI: 07290101369707
- Lot Numbers
330 of 330 codes
61164F61407F61933F62142F62418F62884F63152F63668F64065F64096F64291F61165F61408F61934F62143F62419F62885F63154F63669F64066F64261F64550F61166F61409F61935F62144F62420F62886F63155F63670F64067F64262F64551F61167F61410F61936F62145F62421F62887F63156F63671F64068F64263F64552F61168F61411F61937F62146F62422F62888F63157F63672F64069F64264F64553F61169F61412F61938F62147F62656F
- FGS-0636UDI-DI: 07290101369714
- Lot Numbers
61353F61354F61399F61710F62032F62042F62140F62419F62669F62885F63153F63415F63678F65088F
- Amount recalled
- 128,202 units
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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