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FDAJune 3, 2025device

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)

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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 to do

FDA enforcement status: Ongoing

Brands named

given imaginggiven

UPCs

0729010136970707290101369714

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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) — Recall Details · AllClear