Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported April 7, 2021
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.
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 rem…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Covidien Llc recalled BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended to be used fo… - a moderate-severity action.
BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended to be used fo… was recalled by Covidien Llc in April 7, 2021. Reason: The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the caps…. Check the official notice for the remedy. Verify recall #Z-1335-2021 with the FDA Devices before acting.
The recall
Covidien Llc issued this moderate-severity FDA Devices recall-The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the caps….
- Moderate
- severity level
- 63K units
- affected scope
- Class II
- classification
- April 7, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1335-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1335-2021) was formally reported on April 7, 2021, with the manufacturer initiating the action on February 26, 2021. It is classified under Moderate severity (Class II), with a current status of Ongoing. Covidien Llc is listed as the recalling firm, operating out of Mansfield, MA. Federal records list the affected scope as 62551.
The documented reason for this recall is: 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 o… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
62551
Related Recalls
6
3 from same agency
Product description
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.
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1335-2021 |
| Date reported | April 7, 2021 |
| Date initiated | February 26, 2021 |
| Recalling firm | Covidien Llc |
| Firm location | Mansfield, MA |
| Affected scope | 62551 |
| Distribution | Worldwide distribution - US Nationwide distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1335-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Covidien Llc. Units affected: 62551.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 7, 2021. Severity: Moderate. Recall number: Z-1335-2021.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1335-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 7, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.