Drugs & medicalClass I

Given Imaging Ltd. recalls Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric…

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…

Read the official notice →
Date
2025-07-16
Country
United States
Brand
Given Imaging
Product
Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric…
Classification
Class I
Units
US Nationwide. Global Distribution.
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Given Imaging recalls

  1. 2026-09-16
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    Given Imaging Ltd. recalls Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule delivery device, 1-pack, Product Number FGS-0636. Used…

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  3. 2023-03-15
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