Use cautionMedical device recall · FDA · Published February 26, 2021
Covidien CF Delivery Dev Caps Bravo x5: Capsule may cause aspiration and serious injury
Covidien recalls CF Delivery Dev Caps Bravo x5 (FGS-0635/FGS-0636) for risk of capsule aspiration leading to low oxygen, intubation, and hospital stay. 13 reports of aspiration in 2 years.
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.
Take action
Contact the company
📍Recalling firmCovidien Llc15 Hampshire St · Mansfield, MA 02048-1113
✎ GovInfoNow plain-language explainer
Covidien is recalling CF Delivery Dev Caps Bravo x5 capsules that may fail to attach to the esophagus, causing the capsule to be aspirated into the lungs. This can lead to serious health issues requiring immediate medical intervention, including intubation and extended hospital stays. Read more at govinfonow.com/recall/63199-covidien-cf-delivery-dev-caps-bravo-x5-capsule-may-cause.
“Covidien CF Delivery Dev Caps Bravo x5: Capsule may cause aspiration and serious injury.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63199-covidien-cf-delivery-dev-caps-bravo-x5-capsule-may-cause. Based on FDA recall #Z-1334-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1334-2021%22&limit=1).
The FDA announced on Feb. 26, 2021, that Covidien LLC is recalling CF Delivery Dev Caps Bravo x5 devices because the capsule may fail to attach to the esophageal mucosa and be aspirated. Owners should contact the company for a replacement.
How to tell if you have it
Brand: Covidien
Product: CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636
GovInfoNow's records show the capsule may fail to attach to the esophageal mucosa, which can lead to aspiration. Thirteen reports of capsule aspiration have been received in the last two years. Potential outcomes include low oxygen saturation, need for intubation, extended hospital stay, and delay of treatment.
Context
GovInfoNow's records show Covidien LLC has 52 other recalls on record since 2017-08-07. Other recent recalls of similar products include Given Imaging Bravo CF Capsule Device Recall (2026-08-06), Erbe Medical CleverCap CO2 Tubing/Cap Set Recall (2026-03-31), and Erbe Medical CleverCap Recall (2026-03-31).
How to tell if you have this one
Check for the model numbers FGS-0635 or FGS-0636 on the packaging. These capsules are used for measuring stomach acid in adults and children 4 years and older.
Brand
Covidien
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide distribution.
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.; 49349Q 49350Q 49351Q 49352Q 49799Q 49800Q 49801Q 49802Q 49809Q 49849Q 49850Q 49851Q 50392Q 50393Q 50492Q 50493Q 50494Q 50495Q 50496Q 50497Q 50615Q 50616Q 50868Q 50869Q 50870Q 50871Q 50872Q 50873Q 50874Q 50875Q 50876Q 50877Q 50878Q 50879Q 50880Q 50881Q
62551
Based on the official FDA remedy
What to do — step by step
Check for Capsule Aspiration
If the capsule is inhaled into the lungs, seek immediate medical help.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 40 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1334-2021 (February 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1334-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.