Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Given Imaging Bravo¿¿ pH capsule delivery device Recalled by Covidien LLC Due to Potential of an allergic reaction in a patient...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Covidien LLC directly.
Affected Products
Given Imaging Bravo¿¿ pH capsule delivery device, 1-pack. In- Vitor Diagnostic for pH monitoring of gastric reflux Item Number: FGS-0313 The Bravo pH Monitoring System is intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. The Bravo pH Capsule can be attached following either endoscopy or manometry. The RAPID pH software is intended to record, store, view, and analyze gastroesophageal pH data.
Quantity: 1,305 units
Why Was This Recalled?
Potential of an allergic reaction in a patient with nickel sensitivity.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Covidien LLC
Covidien LLC has 248 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report