Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported July 16, 2025
Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack)
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 …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Given Imaging Ltd. recalled Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to… - a critical-severity action.
Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to… was recalled by Given Imaging Ltd. in July 16, 2025. Reason: It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its malfu…. Check the official notice for the remedy. Verify recall #Z-2047-2025 with the FDA Devices before acting.
The recall
Given Imaging Ltd. issued this critical-severity FDA Devices recall-It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its malfu….
- Critical
- severity level
- 128K units
- affected scope
- Class I
- classification
- July 16, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2047-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2047-2025) was formally reported on July 16, 2025, with the manufacturer initiating the action on June 3, 2025. It is classified under Critical severity (Class I), with a current status of Ongoing. Given Imaging Ltd. is listed as the recalling firm, operating out of Yokne'Am Ilit, N/A. Federal records list the affected scope as 128,202 units, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: 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 esophagu… Distribution data in the federal record shows the product reached: US Nationwide. Global 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 high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
128,202 units
Related Recalls
6
3 from same agency
Product description
Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack)
Reason for recall
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 esophagus or detaching from the delivery device.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-2047-2025 |
| Date reported | July 16, 2025 |
| Date initiated | June 3, 2025 |
| Recalling firm | Given Imaging Ltd. |
| Firm location | Yokne'Am Ilit, N/A |
| Affected scope | 128,202 units |
| Distribution | US Nationwide. Global 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-2047-2025) 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.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. 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 CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack). Recalled by Given Imaging Ltd.. Units affected: 128,202 units.
Why was this product recalled? ▼
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 esophagus or detaching from the delivery device.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 16, 2025. Severity: Critical. Recall number: Z-2047-2025.
Where was the recalled product distributed? ▼
Distribution: US Nationwide. Global Distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2047-2025) 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 July 16, 2025. 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.