FDA Class 1 Recall: Bravo CF Capsule Delivery Device — Capsule May Fail to Attach to the Esophagus or Detach from the Delivery Device (Z-3090-2026)

FDA Classifies Bravo CF Capsule Delivery Device Recall as Class 1 in September 2026: Capsule May Fail to Attach to the Esophagus or Fail to Detach from the Delivery Device

On September 11, 2026, the U.S. Food and Drug Administration (FDA) published in its Medical Device Recall Database that the Bravo CF capsule delivery device manufactured by Given Imaging Ltd. has been classified as a Class 1 recall, recall number Z-3090-2026, Event ID 99626. Under FDA's classification system, a Class 1 recall is the most serious category, meaning that continued use of the device may cause serious injury or death.

Recall Summary at a Glance

• Product: Bravo CF capsule delivery device, used to attach a pH monitoring capsule to the esophagus
• Manufacturer: Given Imaging Ltd.; returns are directed to Medtronic
• Recall number / Event ID: Z-3090-2026 / 99626
• FDA publication date: September 11, 2026; manufacturer-initiated recall dated August 6, 2026; customer notification letter dated August 10, 2026
• Classification: Class 1 (most serious); database status remains “Open, Classified”
• Affected configurations: five-pack FGS-0635 (UDI-DI/GTIN 07290101369707); single-pack FGS-0636 (UDI-DI/GTIN 07290101369714)
• Affected lots: expiry on or before October 20, 2027; lot numbers 64553F through 68912F (inclusive)
• Quantity in commercial distribution: 127,416 units
• Distribution: global, including China, Taiwan, Hong Kong and Singapore

Product and Scope of Application

The affected product is used to attach a pH monitoring capsule to the esophagus and is intended for use in esophageal pH monitoring. Two packaging configurations are involved: the five-pack FGS-0635 (UDI-DI/GTIN 07290101369707) and the single-pack FGS-0636 (UDI-DI/GTIN 07290101369714).

According to the official record, the affected scope covers lots with an expiry date on or before October 20, 2027, with lot numbers ranging from 64553F to 68912F (inclusive of both ends). FDA records a quantity in commercial distribution of 127,416 units.

Failure Mode and Health Consequences

FDA states that the manufacturer's reason for the recall is that the capsule may fail to attach to the esophagus, or may fail to detach from the delivery device. Resulting risks include patient aspiration or inhalation, esophageal perforation, airway obstruction, bleeding and blood loss, esophageal tearing, delayed diagnosis, and retention of a foreign body in the patient. FDA identified the cause as “Nonconforming Material/Component.” It should be noted that this record currently remains “Open, Classified” in the database and may be updated.

Manufacturer Notification and Customer Actions

Per the official record, the manufacturer notified consignees on August 10, 2026 by means of an “Urgent: Medical Device Recall” letter; the recall was initiated by the manufacturer on August 6, 2026. The letter requires customers to:

• Immediately identify and quarantine all unused affected product;
• Return the product to Medtronic for replacement in accordance with the instructions in the letter;
• Complete and return the enclosed customer response form — even if there is no unused inventory;
• Notify personnel within the organization who need to know, as well as any parties to whom the product was transferred or distributed;
• Retain a copy of the recall letter for reference.

Difference from the 2025 Recall

The official record specifically notes that this recall is a separate matter from the one initiated in June 2025: the two recalls involve the same issue but different underlying causes. In other words, this is not a continuation notice covering the same products and the same root cause, but a new classified recall. When verifying, companies should handle the two recalls separately and should not skip the current lots on the grounds that “the previous one was already handled.”

Distribution Scope

FDA records the distribution scope as global. Within the United States, coverage is nationwide (including Puerto Rico); countries and regions listed outside the United States include China, Taiwan, Hong Kong, Singapore, Thailand, India, Brazil, Canada, Australia, the United Kingdom, Germany, France and Israel, among others. The record explicitly lists China, Taiwan, Hong Kong and Singapore, which is of direct reference value to parties involved in esophageal pH monitoring or related gastroenterology devices. The official pages do not break down quantities or lot distribution by market, and this article does not make judgments about the specific distribution situation within China.

Sources and Scope of Application

① Source: U.S. FDA Medical Device Recall Database, record “Class 1 Device Recall Bravo CF,” recall number Z-3090-2026, Event ID 99626, published September 11, 2026, at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=222013

FDA Recalls, Market Withdrawals, & Safety Alerts — Enforcement Reports entry point: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/enforcement-reports

② Verification scope and access date: the above official pages were verified and accessed on October 2, 2026. The recall number, manufacturer initiation date (August 6, 2026), FDA publication date (September 11, 2026), product numbers and GTINs, lot and expiry ranges, distribution quantity, distribution scope, failure mode and customer actions are all taken from the text of that record.

③ Applicability note: this article is an interpretation of publicly available regulatory information and does not constitute a conclusion or commitment regarding any specific product, company or registration application. Affected products, lot numbers and batches must be based on the official FDA record, and the information may change with subsequent official updates.

Sources

• U.S. Food and Drug Administration (FDA) – Medical Device Recall Database, September 11, 2026
• U.S. Food and Drug Administration (FDA) – Recalls, Market Withdrawals, & Safety Alerts, September 11, 2026

AIMEILI Regulatory Interpretation

1. The Class 1 designation sets the compliance tone for the entire field action

A Class 1 assignment means FDA's health hazard evaluation concluded that use of the device may cause serious adverse health consequences or death. In practice, this drives three consequences that matter to regulatory teams: the recall strategy must be proportionate to the highest risk category; recall communications must reach every consignee, including downstream distributors and end users; and effectiveness checks must be designed to verify that the affected lots have actually been removed from use, not merely that a letter was sent. Any entity in the supply chain that cannot demonstrate documented receipt, quarantine and disposition of affected lots is exposed during a subsequent inspection.

2. “Open, Classified” status and what typically follows

The record currently shows “Open, Classified.” This means FDA has reviewed the manufacturer's health hazard evaluation and assigned the Class 1 status, but the recall itself is not yet closed. The status normally progresses to “Terminated” only after FDA concludes that all reasonable efforts have been made to remove or correct the affected product. Until then, the record may be updated with revised distribution information, additional lot ranges or updated quantities. Regulatory and quality teams should therefore treat the current data as a snapshot and re-verify the official record before finalizing their own reports.

3. Root cause recorded as nonconforming material or component

FDA records the cause as “Nonconforming Material/Component.” This places the emphasis on supplier qualification, incoming inspection and component-level acceptance criteria, rather than on a software or labelling defect. For manufacturers of comparable delivery systems or capsule-based diagnostic devices, the practical takeaway is that attachment and detachment functions should be validated against worst-case tolerances and ageing conditions, with the acceptance criteria traceable to design inputs, and that component nonconformities must trigger a documented evaluation of field impact, not only a lot-level disposition.

4. Two recalls, two root causes — they must not be merged

The official record explicitly distinguishes this action from the June 2025 recall: the same issue was involved, but the underlying cause differs. For regulatory affairs teams, this means the corrective and preventive action file for the 2025 event cannot be treated as covering the 2026 event, and any internal or authority-facing documentation should reference both recalls separately, with their own root cause analysis, their own effectiveness verification and their own closure evidence.

5. Cross-market reporting considerations

The listed distribution scope includes China, Taiwan, Hong Kong and Singapore. Where an overseas recall affects product placed on their market, domestic responsible entities, agents and distributors are generally expected to report and coordinate under the applicable local medical device recall framework, in parallel with the manufacturer's global field action and within the timelines set by the relevant authority. The published record gives no market-level breakdown of quantities, so each responsible entity should determine its own exposure from its purchase, inventory and tracing records rather than from the global figures.

Business Impact

For distributors and importers

• Perform an immediate lot-level reconciliation using the UDI-DI/GTIN and lot range (64553F to 68912F) together with the expiry criterion (on or before October 20, 2027); matching on lot number alone is insufficient because the affected scope is defined by both lot range and expiry.
• Quarantine all unused affected stock on receipt of the notification and process returns to Medtronic for replacement as instructed; the customer response form must be returned even where no unused inventory is held, since this is the evidence that the notification was received and acted upon.
• Trace and notify downstream accounts and end users to whom product was transferred, and retain the notification letter and response records as part of the distribution record.

For hospitals and clinical users

• Gastroenterology and endoscopy departments performing esophageal pH monitoring should check current stock against the affected lot and expiry range and remove affected units from clinical use immediately.
• Clinical teams should be aware that the failure mode can present as a capsule that does not attach, or that remains attached to the delivery device, with risks including aspiration, perforation, airway obstruction, bleeding, esophageal tearing, delayed diagnosis and foreign body retention; any such event involving a potentially affected lot should be documented and reported through the applicable channels.
• Where affected stock is withdrawn, procedural scheduling may need to be reviewed, and the replacement timeline should be confirmed with the supplier.

For regulatory affairs and quality teams

• Confirm whether your organization is a consignee, a downstream distributor or an end user, and document the basis for that determination, since the obligations differ in each case.
• Assess whether the recall triggers reporting obligations in each market where affected units were placed, and file within the applicable local timelines; keep the local report, the manufacturer notification and the internal disposition record cross-referenced.
• Track the FDA record until its status changes from “Open, Classified,” and re-verify lot ranges, quantities and distribution scope before closing your own internal file.
• For manufacturers of comparable products, review attachment and detachment design validation, component acceptance criteria and supplier controls, and confirm that nonconforming material investigations include a documented field-impact assessment.

This article is an interpretation of public regulatory information. Affected products, lot numbers and batches must be verified against the official FDA record, and the content does not constitute a conclusion or commitment regarding any specific product, company or registration application.