Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
BRAVO PH CAPS DELIVERY DEV5-PK Recalled by Covidien Llc Due to The capsule may fail to attach to the...
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
BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age.
Quantity: 62551
Why Was This Recalled?
The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the capsule. In the event of capsule aspiration, immediate intervention to remove the capsule is required. Potential outcomes following capsule aspiration include low oxygen saturation, intervention to retrieve the capsule, potential need to intubate the patient, extended hospital stay and a delay of treatment. Thirteen reports of capsule aspiration have been received the last 2 years.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Covidien Llc
Covidien Llc has 59 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report